Be Proud! Be Responsible!

Study 1

Summary

Jemmott et al. (1998) used a randomized controlled trial to examine 659 African American adolescents who attended three middle schools in Philadelphia. Participants were randomly assigned to an abstinence HIV intervention, a safer-sex HIV intervention, or a health promotion control group. Assessments at posttest and three, six, and 12 months later measured self-reported sexual behavior.

Jemmott et al. (1998) found that the HIV/STD intervention (safer sex) compared to the control condition resulted in significantly:

• higher reported levels of condom use at three-, six- and 12-month follow-ups,
• lower frequency of unprotected intercourse at three-month follow-up.

Evaluation Methodology

Design:
Recruitment:
African American adolescents from the 3 middle schools who had signed parent or guardian consent forms were eligible to participate (N=827). Recruitment relied on announcements in assemblies, classrooms, cafeterias, and letters to parents. The adolescents volunteered for the "Spruce Adolescent Health Promotion Project." The teens were offered $100 for participating: $40 at the end of the 2-session intervention and an additional $20 for each of the 3 follow-ups (3, 6, 12 months after intervention). Of those invited, 659 adolescents (80%) of eligible adolescents consented to participate in the study.

Study type/Randomization/Intervention:
These adolescents were stratified by gender and age, and based on computer-generated random number sequences, were assigned to 1 of 3 interventions (RCT): an abstinence HIV intervention, a safer-sex HIV intervention, or a health promotion intervention that served as the control group. They were also randomized into groups of 6 to 8 adolescents led by (1) 1 male or female adult facilitator or (2) 2 male, 2 female, or 1 male and 1 female peer co-facilitators. Each intervention consisted of 8 1-hour modules divided equally over 2 consecutive Saturdays. Designed to be educational, but entertaining and culture sensitive, each intervention involved group discussions, videos, games, brainstorming, experiential exercises, and skill-building activities. The abstinence intervention emphasized the reduction of intercourse frequency while the safer-sex intervention emphasized the importance of using condoms. The control group received a health promotion intervention that focused on behaviors associated with risk of cardiovascular disease, stroke, and certain cancers.

Assessment/Attrition:
Participants in all 3 groups completed confidential questionnaires before intervention, immediately after intervention, and at 3-, 6-, and 12-month follow-ups. Attrition was low: About 96.5% of the original participants attended the 3-month follow-up, 94.4% attended the 6-month follow-up, and 92.6% attended the 12-month follow-up.

Sample characteristics:
The participants were African American adolescents (mean age 11.8 years) recruited from sixth and seventh grade classes of 3 middle schools serving low-income African American communities in Philadelphia, PA. About 53.0% were female and 26.8% lived with both of their parents. On the pre-intervention questionnaire, 25.2% of respondents reported ever having sexual intercourse and 15.4% of respondents reported having sexual intercourse in the previous 3 months.

Measures:
Validity of measurement:
A number of steps were taken to increase the measurement validity. To reduce potential memory problems, the period of self reported behavior was short (3 months). The data were collected by proctors who were blind to the participant's intervention group. Proctors stressed the importance of responding honestly (tried to tap into "social responsibility motives"). Participants signed an agreement pledging to answer the questions honestly. Participants were ensured that data was treated confidentially.

Primary outcome measures:
The primary outcomes were self-reported sexual behaviors in the previous 3 months, including sexual intercourse, condom use, and unprotected sexual intercourse. Frequency of sexual intercourse was the number of days on which the participants had sexual intercourse. Frequency of condom use was rated on a scale from 1 (indicating never) to 5 (indicating always). Frequency of unprotected sexual intercourse was the number of days on which the participants had sexual intercourse without using a condom.

Secondary outcome measures (mediators):
Based on the theory of reasoned action, the theory of planned behavior, and social cognitive theory, a number of variables measured potential mediators of the effects of the interventions.

Safe-sex intervention:

• Condom-use prevention beliefs (5 items, Cronbach's alpha=.76)
• Condom-use hedonistic beliefs (7 items, alpha=.74)
• Condom availability beliefs (5 items, alpha=.75)
• Condom-use technical skills beliefs (3 items, alpha=.76)
• Condom-use impulse control beliefs (3 items, alpha=.73)
• Condom-use negotiation beliefs (3 items, alpha=.77)
• Condom-use self-efficacy (1 item)
• Intention to use condoms (3 items, alpha=.75)
• Knowledge specific to condom use (6 items, alpha=.53)

Abstinence intervention:

• Abstinence prevention beliefs (2 items, alpha=.57)
• Goal attainment beliefs (2 items, alpha=.80)
• Attitude towards having sexual intercourse (1 item)
• Intention to have sexual intercourse in next 3 months (1 item)

All participants:

• HIV risk reduction knowledge (34 items, alpha=.87)
• Participants' evaluation of the intervention (10 items, alpha=.84)
• Evaluation of facilitator (1 item)
• Evaluation of educational value of the intervention (3 items, alpha=.80)
• Extent to which participants would recommend the program (1 item)
• Marlowe-Crowne Social Desirability Scale

Analysis:
To compare the difference between self-reported sexual behavior between intervention and control groups, a two-tailed test (alpha=.05) was used. Analysis of covariance as well as logistic regression models were used for hypothesis testing, controlling for baseline scores. Baseline scores were not used as controls for hypotheses regarding condom use because of the small number of participants who reported sexual intercourse at both baseline and follow-up.

Linear regression models were used to predict frequency of unprotected sexual intercourse after the outcome variable was log-transformed (x+1) to account for the skewed distribution.

A series of analyses of variance and chi-square tests on baseline measures were conducted to determine whether the randomization procedures were successful. Chi-square tests and t tests were used to analyze attrition.

Intention-to-treat: The study used an intention-to-treat approach in which participants are analyzed in their original randomized group regardless of the number of intervention sessions they attended.

Outcomes

Implementation fidelity : Each intervention was pilot tested, highly structured, and was implemented by facilitators who used intervention manuals.

Facilitator training: The 25 adult facilitators (10 men and 15 women) were African Americans (mean age, 39.5 years). The facilitators had, on average, a master's degree and 8 years of experience working with African American adolescents. The adult facilitators were stratified by age and gender and randomly assigned to receive 2.5 days of training to implement one of the three interventions. The peer facilitators were 45 Philadelphia high school students (mean age, 15.6 years). The peer facilitators were selected based on letters of recommendation and interviews (about 56% were female). They participated in a 3-day intensive leadership training retreat on the basic skills of small-group facilitation. They were then stratified by age and gender and randomly assigned to receive 4 days of training to implement 1 of the 3 interventions.

Implementation: Several procedures were used to monitor the interventions. The facilitator trainers continually, and unobtrusively, monitored how each facilitator delivered the intervention. Facilitators reported their reactions and participants' reactions to the intervention and recorded any intervention activities they did not cover. In addition, participants' confidential evaluative ratings of the interventions were collected.

Baseline Equivalence : The analyses of variance revealed a significant difference among groups in pre-intervention condom use knowledge (P=.05). Contrasts indicated that pre-intervention condom-use knowledge was greater in the safer-sex group than in the control group (P=.02). No other differences among groups on pre-intervention measures of conceptual variables, sexual behavior, or demographic variables were significant. The authors included the variable for pre-intervention condom-use knowledge as covariate in the regression models.

Differential attrition : The intervention groups did not differ significantly in the percentage of participants remaining in the follow-ups. Completers differed significantly on few preintervention variables. Completers scored higher in condom prevention beliefs, scored higher in abstinence prevention beliefs, and scored lower on condom use knowledge compared to attritors. However, no significant interaction of these variables with the intervention measure was observed in predicting self-reported sexual behaviors in the previous 3 months. Thus, attrition did not appear to bias the results.

Posttest : The post-test revealed that the intervention was successful for a number of conceptual variables (mediators).

Abstinence intervention: Out of 4 tests for abstinence-related conceptual variables, all were significant. The adolescents in the abstinence group believed more strongly (p<.05) that practicing abstinence would prevent pregnancy and AIDS, expressed less favorable (p<.05) attitudes toward sexual intercourse, and reported weaker (p<.05) intentions of having sexual intercourse in the next 3 months than did those in the control group or the safer-sex group. Adolescents in the abstinence group also believed more strongly (p<.05) that practicing abstinence would help them achieve their career goals than did those in the control group, but did not differ (p=.24) from those in the safer-sex group.

Safer-sex intervention: Out of 9 tests for condom use-related conceptual variables, 6 were significant. Immediately after the intervention, the adolescents in the safer-sex group scored significantly (p<.05) higher in condom use knowledge; believed more strongly (p<.05) that condoms can prevent pregnancy, STDs, and HIV; believed more strongly (p<.05) that using condoms would not interfere with sexual enjoyment; and expressed greater (p<.05) confidence that they could have condoms available when they needed them than did those in the control group or the abstinence group. Adolescents in the safer-sex group reported greater confidence (p<.05) that they could exercise sufficient impulse control to use condoms and greater (p<.05) self-efficacy for using condoms than did those in the control group, but not more than those in the abstinence group. Adolescents in the safer-sex group did not differ from those in the other 2 groups in technical skills belief, negotiation skills belief, or condom-use intentions.

Adolescents in both HIV-prevention groups scored significantly (p<.05) higher in HIV risk-reduction knowledge than did those in the control group. However, adolescents in the safer-sex group scored even higher (p<.05) than did those in the abstinence group.

Long-term effects : The main outcome of interest was a change in risky sexual behavior. Since behavior changes take time to manifest, the behavioral variables were not measured at post-test but rather were evaluated using three follow up questionnaires (3, 6, 12 months after the posttest).

Abstinence intervention: Adolescents in the abstinence group were significantly less likely to report having sexual intercourse in the 3 months after the intervention than were those in the control group (odds ratio [OR], 0.45). This effect was stronger for adolescents who were sexually inexperienced at pre-intervention (interaction: sexual experience x group). However, at the 6 and 12 month follow up, the reductive effect of the abstinence intervention was lost.

Safer-sex intervention: Adolescents in the safer-sex intervention were significantly more likely to report consistent condom use at the 3-month follow-up than were those in the control group (OR, 3.38). Self-reported frequency of condom use was also significantly higher in the safer-sex group than in the control group. Adolescents in the safer-sex group were less likely to report having unprotected sexual intercourse in the previous 3 months than were those in the control group (OR, 0.35). Adolescents in the safer-sex group also reported fewer days on which they had unprotected sexual intercourse than did those in the control group. The latter two effects were significantly stronger for adolescents who were sexually experienced at pre-intervention (interaction: sexual experience x group). At the 6-month follow-up the impact of the intervention was still strong and individuals in the safer-sex group reported significantly more frequent condom use compared to the control group. Among participants who reported pre-intervention sexual experience, the safer-sex intervention caused significantly less self-reported sexual intercourse than did the control or abstinence intervention and less self-reported unprotected sexual intercourse than did the control group. These three effects remained significant at the 12 month follow-up.

Study 2

This study differs from Jemmott et al. (1998) in that the subjects were recruited from an adolescent health clinic and not from a school. In this study, subjects were African American and Latino, while Jemmott et al. (1998) focused only on African Americans. Also, the study population was slightly older at 12-19 years of age (mean 16 years) compared to the 6^th and 7^th graders (mean 12 years) studied by Jemmott et al. (1998). Further, the focus was on comparing a skill-based vs. pure information-based intervention while Jemmott et al. (1998) investigated differences between an abstinence and a safer sex (condom use) intervention. While Jemmott et al. (1998) focused on differential effects between sexually experienced and sexually inexperienced adolescents, Jemmott et al. (2005) focused only on sexually experienced youth.

Summary

Jemmott et al. (2005) used a randomized controlled trial to examine 682 African American and Latino adolescent girls recruited from a health clinic in Philadelphia. Participants were randomly assigned to a skill-based HIV/STD intervention, an information-based intervention, or a health-promotion control group. Assessments at posttest and three, six, and 12 months later measured self-reported sexual behavior.

Jemmott et al. (2005) found that at 12-month follow-up, the HIV/STD intervention (skill-based, safer sex) compared to the control condition had significantly:

• lower frequency of unprotected intercourse,
• fewer sexual partners,
• lower STD rates.

Evaluation Methodology

Design:
Sample selection: African American and Latino adolescent girls were eligible to participate if they (1) were patients at the adolescent medicine clinic, (2) were sexually experienced, (3) were not pregnant, (4) were 12 to 19 years of age, (5) could read and speak English, and (6) did not plan to move from the area of the clinic. During the adolescents' biannual STD screening visit, clinicians referred eligible adolescents to the site coordinator who informed them about the study and scheduled interested adolescents to participate. Research subjects were reimbursed up to $120 for participating.

Attrition: Of the 1150 adolescents assessed for eligibility, only 682 (59%) adolescents participated in the study. However, for randomized study subjects, little attrition was reported. About 97.6% of the adolescents attended at least 1 follow-up; 94.3% attended the 3-month follow-up; 92.8% attended the 6-month follow-up, and 88.6% attended the 12-month follow-up.

Study type/Randomization/Intervention: The study was a randomized controlled trial (RCT) conducted at the hospital where the adolescents were recruited. Participants were stratified by age, and based on computer-generated random number sequences, they were assigned to 1 of the following 3 interventions: skill-based HIV/STD intervention, information-based intervention, or health-promotion control intervention. Each intervention involved 250 minutes of group discussions, videotapes, games, and experiential exercises implemented in a single session with 2 to 10 participants (mean = 5.3 participants).

Assessment: The adolescents completed confidential self-administered questionnaires pre-intervention, immediately after the intervention, and at the 3-, 6-, and 12-month follow-ups.

Sample characteristics: The participants were sexually experienced African American (n=463) and Latino (n=219) adolescent girls, 12 to 19 years of age (mean age, 15.5 years) who were family planning patients at the adolescent medicine clinic in a children's hospital serving a low-income, inner-city community in Philadelphia, PA. Thus, study subjects showed some concern for the consequences of sexual behavior prior to the intervention. Of the Latinos, 92.7% were Puerto Rican. The participants had volunteered for the "Women's Health Project" designed to reduce the chances that African American and Latino adolescent girls would develop devastating health problems, including cardiovascular diseases, cancer, and AIDS.

Measures:
Validity: The proctors emphasized to participants the importance of responding honestly and assured them that their responses were confidential. Participants signed an agreement pledging to answer the questions honestly, a procedure that has been shown to yield more valid self-reports on sensitive issues. To reduce the likelihood of demand from giving their responses to the intervention facilitators, proctors blind to the participants' intervention assignment collected the questionnaire data.

Primary outcome measures:
The primary outcome measure was the number of days on which the adolescent reported having unprotected sexual intercourse in the previous 3 months.

Secondary outcome measures (mediators):
Other sexual risk behaviors: Participants reported the number of sexual partners, the number of days on which they had sexual intercourse while high on drugs or alcohol in the previous 3 months, and the number of days on which they had unprotected sexual intercourse while high on drugs or alcohol in the previous 3 months.

STD prevalence: As patients in the clinic, all the participants underwent biannual STD screening by clinicians who were blind to their intervention assignment. This allowed for obtaining sexually transmitted disease data from medical records which were used as the measure of STD presence.

Mediator measures: Several variables from the theory of reasoned action, the theory of planned behavior, and social cognitive theory that might mediate the efficacy of the interventions were measured with 5-point Likert scales:

• Intention to use condoms (3 items, alpha=.86)
• Condom use hedonistic beliefs (7 items; alpha=.84)
• Beliefs regarding partner's approval of using condoms (1 item)
• Condom use technical skills beliefs (3 items, alpha=.65)
• Condom use impulse control beliefs (2 items; alpha=.61)
• Condom use negotiation beliefs (3 items; alpha=.82)
• HIV/STD risk-reduction knowledge (48 true-false items)
• Knowledge specific to condom use (6 true-false items)

Intervention evaluation:

• Evaluation of the intervention overall (5 items; alpha=.87)
• Evaluation of learning success (3 items; alpha=.83)
• Extent to which participants would recommend the intervention to others (1 item)
• Marlowe-Crowne Social Desirability Scale

Analysis: Hypotheses regarding primary and secondary outcomes were tested in analyses that used planned contrasts of pre-specified hypotheses and 2-tailed tests, controlling for baseline scores. Analyses of counts of sexual behaviors were performed using Poisson regression. Analyses of conceptual mediator variables used analyses of covariance. Hypotheses regarding STDs and sexual behaviors measured with dichotomous variables were tested using logistic regression analyses.

Validity tests: Chi-square tests, analyses of variance, and Poisson regression analyses were performed to identify significant differences among conditions on pre-intervention measures. Chi-square and t-tests were performed to analyze attrition.

Intention-to-treat: The study gathered and used data on all subjects who were randomized.

Outcomes

Implementation fidelity: The facilitators were 14 African American women (mean age = 38.2 years) who had at least a baccalaureate degree and experience working with inner-city adolescents. They received an 8-hour facilitator training. Implementation fidelity was emphasized during the training sessions and before each intervention session when the facilitators met with the project coordinator.

Baseline Equivalence: The authors conducted a statistical comparison of all demographic characteristics, sexual behavior measurements, conceptual mediator variables, and STD test results at baseline. No statistically significant differences were observed.

Differential attrition: The intervention conditions did not differ significantly in the percentage of adolescent participants who attended at least 1 follow-up, 2 follow-ups, or all 3 follow-ups. Across all measured characteristics, 4 significant differences between returnees and nonreturnees were observed. Nonreturnees reported more frequent intercourse while intoxicated (mean = 3.44 vs. 0.40, P<.001) and more unprotected sexual intercourse while intoxicated than did returnees (mean = 0.94 vs. 0.24, P<.001). Latinos compared with African Americans were less likely to return (95.9% vs. 98.5%, P=.04). Adolescents who did not live with their mother were less likely to return than were those who lived with their mother (93.9% vs. 98.7%, P=.001). No measures were taken to account for differential attrition.

Posttest (mediators): Both HIV/STD risk-reduction interventions had significant effects on the conceptual mediator variables, measured directly after the intervention.

Skill-based intervention: Female adolescents who received the skill based intervention scored higher in post-intervention HIV/STD knowledge (d=0.62; P<.001), condom use knowledge (d=0.59; P<.001), intentions (d=0.21; P=.008), hedonistic beliefs (d=0.28; P<.001), sexual partner approval (d=0.20; P=.009), technical skills beliefs (d=0.20; P=.01), and impulse control beliefs (d=0.19; P=.02) than did those who received the health-promotion control intervention. Out of 8 tests, 7 were significant.

Skill vs. information: In addition, the skill-based intervention caused significantly greater increases in condom use knowledge than did the information-based intervention (d=0.30; P<.001). No other differences on conceptual mediator variables between the skill- and information-based interventions were statistically significant. Thus, out of 8 tests, only 1 was significant.

Information-based intervention: Information-based intervention participants scored higher in HIV/STD knowledge (d=0.72; P<.001), condom use knowledge (d = 0.30; P<.001), intentions (d=0.29; P<.001), hedonistic beliefs (d=0.31; P<.001), technical skills beliefs (d=0.15; P=.049), and impulse control (d=0.19; P=.02) than did health-promotion control intervention participants. Out of 8 tests, 6 were significant.

Long-term effects: Overall, the skill-based intervention had significant effects on risky sexual behaviors while the information-based intervention did not significantly reduce risky behaviors compared to the control group. However, it is important to note that the significant difference between skill intervention and control emerged for most outcome variables only at the 12-month follow-up. The numbers indicated that although the general health treatment (control) decreased sexual behavior, the effect was lost over time while the positive effect of the skill intervention remained. To illustrate, the number of days of sex without condom use in the past 3-months increased for the control group across time (3mo=2.71; 6mo=3.47; 12mo=5.73) while it stayed constant for the skill based intervention (3mo=2.58; 6mo=2.99; 12mo=2.80). A significant positive effect at the 12-months follow-up, comparing the skill based intervention to the control intervention, was observed for the following outcome measures:

• No. of days of sex without condom use in the past 3 months (2.80 vs. 5.73; d=.28; p=.002)
• No. of partners in the past 3 months (0.93 vs. 1.06; d=.17; p=.04)
• Percentage reporting multiple partners in the past 3 months (7.4 vs. 17.5; d=.25; p=.002)
• No. of days of having unprotected sex while high on drugs or alcohol in the past 3 months (0.10 vs. 0.50; d=.20; p=.02)
• Percentage testing positive for an STD (10.8 vs. 17.4; d=.18; p=.05)
• No differences were observed at the 12-month follow-up for self-reported frequency of sexual intercourse while intoxicated. However, for this outcome (as the only outcome) a significant positive short term effect was observed after 3 months (0.11 vs. 0.29; d=0.18; P=.03) and after 6 months (0.10 vs. 0.36; d=0.23; P=.005).

Other outcomes:
Participant evaluation: Participants liked the information-based intervention better than the health-promotion control intervention or the skill-based intervention.
African Americans vs. Latinos: Analyses testing whether the efficacy of the interventions was different with African Americans and Latinos revealed no significant differences on sexual risk behavior or the STD rates as the main outcomes of interest. However, few significant differences were reported for mediator variables.
Social desirability: Social desirability scores did not interact with intervention condition to influence sexual behavior at any of the follow-ups.

Study 3

This replication study implemented the program at urban and suburban high schools as part of the school activities. Thus, compared to the original study (Jemmott et al., 1998), this study shifts the focus away from inner-city minority youth. The original intervention was executed in a nonschool environment (Saturday program) and in small groups (6-8 individuals), while Borawski et al. (2009) tested the program in a school setting, taught by teachers and other school personnel. The school setting differs in that it provides a less controllable environment in which program fidelity is not guaranteed and where participants include young people who may be unlikely to volunteer for a weekend program. The intervention in this study was delivered in six small (50-minute) modules while the original intervention was delivered in two consecutive Saturday programs.

The intervention curriculum in this study was slightly changed and adjusted compared to the original curriculum (Jemmott, Jemmott, & McCaffree 1996) in that a condom use skill activity was dropped, the term "inner-city" was changed to "community," and a message-specific booster session was implemented between the 4- and 12-month follow-ups. Finally, the adolescents in the study were significantly older than those in the original studies.

Summary

Borawski et al. (2009, 2015) used a cluster randomized controlled trial to examine 1,576 students attending 10 midwestern high schools. The schools were randomly assigned to an intervention condition that adapted the program for a health class or to a control condition based on the usual health curriculum. Follow-ups at posttest, four months later, and 12 months later measured self-reported sexual behavior.

Borawski et al. (2009, 2015) reported no significant effects of the intervention on sexual risk behaviors.

Evaluation Methodology

Design:
Sample selection: Five pairs of high schools were recruited; pairs were selected on the basis of the schools' location (inner city, suburb) and similarity regarding community socioeconomic status and racial composition of the student body. Two pairs were from an urban school district in an area of low socioeconomic status; one pair had predominantly black student bodies, and the other had mixed student bodies. Two pairs of schools were from inner-ring suburbs; one pair was in an area of low socioeconomic status and had predominantly white students, and the other was in an area of moderate socioeconomic status and had racially mixed populations. The last pair of schools was from outer-ring suburbs; both schools were in areas of high socioeconomic status and had predominantly white populations. Of each pair, one school implemented the Be Proud! Be Responsible! intervention while the other school implemented the general health control intervention. Thus, the study population comprised ninth- (46%) and tenth-grade (54%) students enrolled between the years 2000 and 2002 in mandatory health education classes in 10 high schools in a midsize, metropolitan area in the Midwest.

Attrition: Due to a number of reasons (expelled, transferred, or no longer attended school), the sample was reduced from 1,576 eligible individuals to 1,357 adolescents (86%). Of these, 99% completed the immediate posttest, 97% completed the 4-month follow-up and 92% completed the 12-month follow-up.

Study type/Randomization/Intervention/Follow-up: Schools agreed to be randomly assigned to intervention or control curriculum and to recruit all teachers responsible for teaching health to be trained in their respective curriculum. A two-stage, double blinded randomization procedure was used to randomize each pair.

The intervention was delivered by trained teacher and nurse facilitators (majority was female and white), using six 50-minute modules that include a variety of developmentally appropriate teaching methods, such as group discussions, role model stories depicted in videos, interactive exercises and role playing. The three core themes of the intervention curriculum were the role of sexual responsibility and accountability, the importance of having a sense of community, and the role of pride in making safer sexual choices. The intervention was focused on abstinence as the best way to avoid HIV/STD contraction and unwanted pregnancies, and recommended safer-sex practices in case the adolescents decided to be sexually active.

Three adjustments to the original curriculum were made:

• Because of objections from several urban as well as suburban schools, one 10-minute activity (How to make condoms fun and pleasurable) in the condom-use skills session was dropped.
• The ethnocentric and urban focus of the curriculum was retained across all schools, except that the term "inner-city" was replaced with "community."
• Both intervention and control groups received a message-specific booster session between 4 and 12 months after the initial programs. Students in the intervention arm attended an assembly featuring a young HIV-positive woman, while students in the control arm attended an assembly in which a speaker discussed healthy eating and exercise.

Data were collected from students via confidential, self-administered questionnaires at four time points: prior to the intervention (baseline), immediately following the intervention (post-test), and 4 and 12 months later.

Sample characteristics:
The research subjects were 52% female, 61% lived with two parents, and in 60% of the cases, at least one parent had some postsecondary education. Students lived in neighborhoods with an average poverty rate of 15%. Of the study population, 50% were white, 36% black, 12% Hispanic, and 3% identified with another racial/ethnic group. 38% of all participants had had sexual intercourse by baseline. 67% of sexually experienced students had had sex in the three months preceding the study, and 60% of this group had always used a condom in this period.

Measures:
Primary outcome measures:
The primary outcome measures were a number of questions regarding sexual behavior patterns. The questions asked:

• Whether students had ever had sexual intercourse
• Whether they had talked to a nurse or doctor about a sex-related issue
• Whether they carried condoms or had quick access to them
• Whether students had had intercourse within the past three months
• Whether students had avoided sex in the last three months because they did not have a condom
• How often they had drunk alcohol or used drugs before having sex
• How often they had used condoms when they had had sex in the past three months

Secondary outcome measures (mediators):
The intervention was positioned to influence sex-related behaviors both directly and indirectly through cognitive processes that are assumed to mediate behavioral change. Five categories of sex-related cognitive mediators were included in the study: knowledge, efficacy, participant's beliefs, perceived peer beliefs, and behavioral intention.

Knowledge (additive scale of yes/no items):

• Knowledge of condoms (5 items)
• Knowledge of HIV/STDs (7 items)
• Health promotion knowledge (9 items)

Efficacy:

• Impulse control (2 items, alphas .81-.87 across time points)
• Condom negotiation skills (3 items, alphas .60-.64)
• Condom technical skills (3 items, alphas .67-.72)

Beliefs:

• Condom use belief (3 items, alphas .86-.89)
• Condom use hedonistic beliefs (3 items, alphas .55-.61)
• Condom use prevention belief (2 items, alphas .42-.64)
• Abstinence belief (4 items, alphas .78-.80

Perceived peer beliefs:

• Acceptability of sexual activity (3 items, .64-.72)
• Condom use (3 items, .85-.87)

Intentions:

• Intention to have sexual intercourse (3 items, .90-.94)
• Intention to use condom should they have sex (1 item)

Demographics:

• Age, gender, ethnicity, living arrangement, parents' education were assessed at baseline.
• A SES measure for the neighborhood of residency was generated by using proportion of households in the neighborhood that lived below the federal poverty line based on the 2000 census.
• In addition the proportion of curriculum sessions attended was measured.

Facilitator performance and student assessment:
Students rated:

• How well their facilitator presented the material and how comfortable the facilitator was in doing so
• How much the curriculum challenged how students thought about their health
• How comfortable students were with the activities
• How the classroom was organized
• How seriously their peers regarded the curriculum

Analysis:
To test the impact of the curriculum on the change in sexual behavior, the authors used general linear models with group membership as the main predictor, controlling for baseline characteristics. In order to account for intragroup (school) correlation, they used STATA's cluster option, which adjusts the standard errors of estimates but does not affect the estimates themselves. Using stratified analyses, the authors explored the intervention effects by gender, location, and race.

Intention-to-treat: The study gathered and used data on all subjects who were randomized and completed the surveys.

Outcomes

Implementation fidelity : Each intervention facilitator received a 2-day training session on how to implement the intervention curriculum. Facilitators were instructed on how to complete a detailed checklist for each session, including rating their command of the materials, their rapport with the students, and the extent to which the material was covered. In addition, each facilitator was observed at least once during the six curriculum sessions to assess his/her fidelity to the curriculum. However, curriculum fidelity was limited since on average only 70% of the original intervention activities were implemented.

Baseline Equivalence : The two groups had similar scores for the cognitive mediators. However, a few small but significant differences between the intervention and control groups at baseline were observed. Differences were observed in gender, ethnicity, neighborhood SES, and session attendance. To control for possible confounding, these variables were included as covariates in all models.

Differential attrition : The rates of follow-up did not differ between the intervention and control groups. However, compared with students who completed every questionnaire, students lost to follow-up were older, more likely to be male, non-white, less likely to live with two parents, attended fewer sessions, and lived in lower SES neighborhoods.

Posttest :
Mediators: For the mediator variables, significant effects were found for 7 out of 11 predictors. The intervention group scored higher on condom and STD knowledge, reported better impulse control, condom negotiation skills, condom technical skills, and believed more strongly that condom use effectively prevents pregnancies and HIV/STD contraction. Further, the intervention group reported higher intentions to use a condom.

Long-term effects :
Main outcome: None of the sexual risk behavior variables differed significantly between the intervention and control group. The intervention had a significant effect on only one out of twenty behavioral outcomes. At the four-month follow-up, among students who had been sexually inexperienced at baseline, a higher proportion of intervention students reported having talked to a health professional about sex-related matter.

Mediators: For the mediator variables only condoms and STDs knowledge was significantly higher for the intervention vs. control group after 12 months. Condom negotiations skills and condom technical skills were higher for the intervention compared to the control group after 4 months but lost significance at the 12 month follow up.

The stratified analysis revealed some gender, ethnicity, and location effects on mediators:
Gender effects: The largest gender differences were found in the area of self-efficacy, for which males in the intervention group scored higher than the control group. Regarding behavioral intentions, female intervention students reported significantly lower intentions to have sex than their control peers.

Effects by geographic location: The effects for both condoms and STD knowledge as well as for condom technical skills and condom negotiation skills were stronger and lasted longer for suburban than for urban schools when comparing the intervention group to the control group.

Ethnicity effects: The intervention had a stronger and sustained impact on condom knowledge among white students, while a stronger and longer lasting impact was observed for STD knowledge among black students. Also, only significant for whites, the intervention group showed higher scores on condom negotiation and condom technical skills at four months compared with the control.

Other outcomes: Many differences emerged in student's evaluation of the intervention. On average, students receiving the BPBR curriculum gave higher ratings to their facilitators than did their control peers; they also gave a higher score to the extent to which the curriculum made them think about their health. Finally, when compared with the control group, BPBR students reported that their fellow classmates took the material more seriously and that the classroom was more orderly.

Moderation. Borawski et al. (2015) examined intervention effects separately for classes taught by school nurses and classes taught by classroom health education teachers. The outcomes included five cognitive mediators (knowledge, efficacy, participants' beliefs, perceived peer beliefs, and behavioral intentions) but no sexual behaviors. At the 12-month follow-up, three of 13 outcomes showed significant condition differences in classrooms taught by school nurses, while one of 13 outcomes showed significant condition differences in classrooms taught by health education teachers. However, the authors did not present tests of significance for differences in effects across the two groups of intervention instructors.

Study 4

This study is a close replication of Jemmott et al., (1998). For example, both studies recruited African American adolescents of similar age range and both genders. However, a few differences deserve mentioning: this study was fielded in a different geographical setting (New Jersey vs. Philadelphia), and the intervention was delivered in a single session (5 hours) as compared to a two-Saturdays program. While Jemmott et al., (1998) compared abstinence and risky sex reduction interventions, this study tested the matching hypothesis, that is, whether effects of the intervention were enhanced when the characteristics of the participants and facilitators (gender, race) were matched.

Summary

Jemmott et al. (1999) used a randomized controlled trial to examine 496 African American adolescents who attended middle schools in Trenton, NJ. Participants were randomly assigned to the HIV intervention condition or a health education control condition. Assessments at posttest, three months later, and six months later measured self-reported sexual behavior.

Jemmott et al. (1999) found that the HIV/STD intervention, compared to the control condition, had significantly:

• reduced unprotected intercourse at six-month follow-up,
• lower frequency of anal intercourse at three-month follow-up,
• fewer anal sex partners at three-month follow-up.

Methodology

Design:
Recruitment: The study was conducted in New Jersey, which ranks high among states in reported AIDS cases and new infections. The participants were 496 African American adolescents from Trenton, an urban, low SES, high STD risk area of New Jersey. The adolescents volunteered in response to public school announcements by project staff during 7th- and 8th-grade assemblies or lunch periods.

Attrition: Of the original 496 participants, 480 (96.8%) attended the 3-month follow-up assessment and 460 (92.7%) attended the 6-month follow-up assessment.

Study type/randomization: The authors used a randomized control trial with a four-way factorial design, crossing intervention (HIV, health education control) with facilitator gender (male, female), facilitator race (African American, White), and gender composition of the small group (single gender, mixed gender). The main focus, however, was on comparing the HIV intervention and health education control group.

On one of three Saturdays, the adolescents participated in the intervention (duration of 5 hours) to which they were assigned. Each intervention involved group discussions, videos, games, experimental exercises, and skill-building activities. On the morning of the intervention session, the adolescents completed pre-intervention questionnaires and were stratified by gender and age and, based on computer-generated random number sequences, were randomly assigned to a small group (6-8 people) that was either homogeneous or heterogeneous in gender and that was led by a male or female facilitator who was African American or White.

Assessment: Immediately after the intervention, the participants completed a post-intervention questionnaire. They also completed follow-up questionnaires 3 and 6 months after the intervention.

Sample characteristics: Participants were African-American adolescents (mean age =13.2 years). About 53.8% were female and 46.2% were male. All were currently enrolled in school, and their average grade was 7.51 (SD = 0.53). Pre-intervention measures indicated that 55.3% of respondents reported having experienced coitus at least once, and 30.2% of respondents reported having coitus in the previous 3 months.

Measures:
Validity of measurements:
All questions had been carefully pilot-tested to ensure that the questions were clear and that the phrasing was appropriate for the specific population in this study. To reduce potential memory problems, adolescents were asked to report their behaviors over a relatively brief period (i.e., 3 months). To reduce the likelihood of demand from giving their responses to the same individuals from whom they received an intervention, the data were collected by specially trained proctors who were blind to the participants' intervention condition. Proctors emphasized the importance of the data collection, and assured confidentiality. In addition, participants signed an "agreement" pledging to answer the questions honestly.

Primary outcomes:
The participants answered questions about their sexual behaviors, including coitus, unprotected coitus, sex with multiple partners, and anal intercourse. They were asked whether they had ever engaged in the behaviors and the frequency of the behaviors in the previous 3 months. An additive risk behavior index was created based on the standardized logged frequency of unprotected sexual intercourse, sexual partners, anal intercourse, anal intercourse partners (alpha=.72-.77).

Secondary outcomes (mediators):
Several potential mediators of the effects of the intervention on HIV risk-associated sexual behavior were measured at pre- and post-intervention.

• HIV risk-reduction knowledge (56 items, alpha=.83-.90)
• Prevention beliefs (3 items, alpha=.78-.85)
• Hedonistic beliefs (5 items, alpha=.61-.63)
• Perceived self-efficacy (2 items, alpha=.65-.69)
• Condom-use intention (1 item)
• Norms regarding condoms (3 items, alpha=.91-.94)

Participants' assessment of intervention:

• How much they liked the intervention (13 items, alpha=.93)
• How much they thought they have learned from intervention (5 items, alpha=.74)
• How much they talked and actively participated (3 items, alpha=.74)

Facilitator's perception:

• How much participants liked the intervention (3 items, alpha=.79)
• How much participants talked and actively participated (3 items, alpha=.81)
• How much participants learned from the intervention (3 items, alpha=.81)

Social desirability measure:

• Marlowe-Crowne Social Desirability Scale

Analysis: Analysis of covariance was performed to test for the effectiveness of the HIV intervention on important mediator variables, controlling for baseline outcomes. No effect sizes were reported. A set of interactions was used to test the matching hypothesis, whether effects of the intervention were enhanced when the characteristics of the participants and facilitators (gender, race) were matched. Chi-square tests were used to investigate attrition.

Intention-to-treat: The study gathered and used data on all subjects who were randomized and completed the surveys.

Outcomes

Implementation fidelity : The 41 adult facilitators were generally well educated and were experienced in working with adolescents. One week before the first intervention day, the facilitators received 8 hours of training. The training stressed strict adherence to the intervention procedure.

Baseline Equivalence : No statistical evaluation of the baseline equivalence between intervention and controls was reported.

Differential attrition : The HIV risk-reduction intervention group and the health intervention group did not differ significantly in the percentage of adolescents who completed the 3-month follow-up (97.8 and 95.6%, respectively) or the 6-month follow-up (94.0 and 91.2%, respectively).

Attrition at the 3-month follow-up was not related to any of the 17 behavior and belief variables. Attrition at the 6-month follow-up was related to 3 of the 17 measurements: Completers had more positive pre-intervention hedonistic beliefs about condoms, were less likely to having had coitus in the previous 3 months, and were younger compared to attritors.

The authors tested the impact of attrition on the intervention condition (interaction terms) and found that one interaction was significant (treatment x pre-intervention self-reported coitus in predicting HIV knowledge). However, no additional steps were taken to adjust for differential attrition.

Posttest : The HIV risk-reduction intervention had significant effects in the predicted direction on most (5 out of 6) of the conceptual variables. At post-intervention, the adolescents who had received the HIV risk-reduction intervention scored higher in HIV risk-reduction knowledge (p =.0001); believed more strongly that condoms can prevent pregnancy and STD, including HIV (p =.003); believed more strongly that condoms would not interfere with sexual enjoyment, (p =.014), had greater self-efficacy to use condoms (p =.044) and expressed firmer condom use intentions than did those who had received the general health promotion intervention (p =.02). These effects were sustained through the 3- and 6-month follow-ups, with the exception of the prevention belief which lost its significance after 6-months.

Long-term effects : Behavior reported at the 3-month follow-up revealed no significant difference between the HIV risk-reduction condition and the general health promotion condition on the risky sexual behavior index or any of the contributing variables separately. In contrast, at the 6-month follow-up, responses revealed that adolescents in the HIV risk-reduction condition reported significantly (p =.007) less HIV risk-associated sexual behavior, as measured by the risky sexual behavior index, than did those in the general health promotion condition.

The following factors contributed to this result: After 6 months, adolescents in the HIV risk-reduction condition were less likely to report unprotected coitus (p =.031). The HIV intervention also reduced the percentage of adolescents who reported engaging in anal intercourse in the previous 3 months (p =.0007) and the frequency of this sexual practice (p=.001) as well as the number of anal sex partners (p=.004).

Other outcomes: Analyses performed on conceptual mediator variables as well as on the self-reported sexual behavior revealed little support for the matching hypothesis. Out of 144 tests on the conceptual mediator variables (various forms of matching [gender and ethnicity of subjects and participants] for each of the 6 variables and each of the 3 time points), only 3 were significant. Out of the 112 tests on the sexual behavior variables, only 1 one was significant and in the expected direction. For example, a significant Condition x Gender composition interaction indicated that the effects of the HIV risk-reduction intervention on self-reported coitus were enhanced in single-gender as compared with mixed-gender groups (p =.04).

Study 5

This study was chronologically the first implementation of Be Proud! Be Responsible! Compared to Jemmott et al., (1998), the study population comprised only male African-American inner-city adolescents and the adolescents were considerably older (mean age=15 years vs. 12 years). Instead of a general health intervention, this study used a career opportunities intervention as control.

Summary

Jemmott, Jemmott, and Fong (1992) used a randomized controlled trial to examine 157 African American male adolescents recruited from a medical clinic, a YMCA, and a high school in Philadelphia, PA. Participants were randomly assigned to the HIV intervention or a career-opportunity control condition. A posttest and three-month follow-up measured self-reported sexual behavior.

Jemmott, Jemmott, and Fong (1992) found that at three-month follow-up, adolescents in the HIV intervention group compared to the control group reported significantly:

• less risky sexual behavior.

Evaluation Methodology

Design:
Recruitment:
Study subjects were recruited from among outpatients at a medical clinic in West Philadelphia (44%); students attending the 10^th, 11^th, and 12^th grade assemblies at a local high school (32%); and adolescents at a local YMCA (24%).

Sample size/Attrition:
Of the 157 participants, 150 (96%) completed the 3-month follow-up questionnaire. The return rate did not differ between experimental conditions.

Study type/Randomization/Intervention/Assessment:
With parental consent, adolescents were stratified by age and randomly assigned to a HIV intervention or a career opportunity control intervention, and to one of 27 small groups. The intervention sessions (5-hours) were led by trained male or female facilitators and were held at a local school on Saturday, October 15, 1988. Participants completed questionnaires pre-intervention, post-intervention, and 3-months after the intervention had taken place.

Sample characteristics: Only African-American males were eligible for participation in the study. About 97% of the participants were currently enrolled in school. The mean number of years of education of their mothers was 13.82. Few participants (4.5%) reported ever sharing needles or ever having same sex relationships (1.6%). About 33.9% reported having more than one coital partner in the previous 3 months. About 20.9% who had sexual intercourse in the previous 3 months reported that they never used condoms during those experiences and only 30.2% reported always using condoms.

Measures:
Validity of measurements:
Four measures were taken to ensure the reliability of responses:

• Code numbers rather than names were used on the questionnaires
• Facilitators were not involved in any way in the administration of questionnaires (research assistants administered the questionnaires)
• The importance of responding honestly was emphasized (participants signed an agreement)
• Participants were assured that their responses would be kept confidential

Primary outcomes:
On the pre-intervention and follow-up questionnaires, the participants answered a series of questions about their sexual practices in the previous 3 months, including coitus, multiple sexual partners, condom use, and heterosexual and anal intercourse. The resulting variables were z-standardized and an additive risky sexual behavior scale was created (alpha=.67-.72).

Secondary outcomes (mediators):
The participants' attitudes and intentions regarding engaging in risky sexual behavior were measured at pre-intervention, immediately post-intervention, and at the 3-month follow-up.

• Intention to engage in risky sexual behavior (5 items, alpha=.68-.72)
• Attitude towards risky sexual behavior (5 items, alpha=.63-.68)
• HIV/STD knowledge (57 items, alpha=.73-.89)
• Participants rating of intervention activity (multiple items - number not specified)
• Marlow-Crowne Social Desirability Scale

Analysis: Although not formally described, ANCOVA was used to compare mean differences (adjusted for the baseline outcome) between the intervention and control group. No effect sizes were reported.

Intention-to-treat: The study gathered and used data on all subjects who were randomized and willing to complete the assessments.

Outcomes

Implementation fidelity: All 27 facilitators were of the same race (African-American) as the study subjects. One week before the intervention, the facilitators received 6 hours of training. The training sessions emphasized that all facilitators of the same intervention must implement it in the same way so as to reduce facilitator effects.

Baseline Equivalence & Differential Attrition: No statistical analysis for baseline equivalence or differential attrition was performed.

Posttest: Immediately after the intervention, participants in the HIV intervention group had greater knowledge about HIV/STDs (p<.0001), expressed less favorable attitudes toward risky sexual behaviors (p<.004), and reported weaker intentions to engage in such behavior (p<.0001) than did their counterparts in the control group. Thus, 3 out of 3 tests were significant.

Long-term effects :
Main outcome: Participants in the HIV condition reported engaging in less (p<.01) risky sexual behavior in the 3 months following the intervention compared to the control group. The effects of the intervention were fairly consistent across different sexual behaviors. Although adolescents in the HIV condition were not significantly (p=.10) more likely than those in the career-opportunities condition to practice complete abstinence in the 3 months after intervention, they did report having coitus on fewer days, with fewer women, and with fewer women who were involved in sexual relationships with other men. Subjects in the HIV condition also reported fewer occasions of coitus without a condom and were less likely to report having anal intercourse.

Mediators: Three-months after the intervention, participants in the HIV intervention still scored higher on HIV/STD knowledge (p<.003), and reported weaker intentions to engage in risky sexual behavior in the next 3 months (p<.007), than did those in the career opportunity control group. However, no significant difference was observed in the intention to engage in risky sexual behavior, comparing HIV intervention to the control group (p=.10). Thus, 2 out of 3 tests were significant.

Study 6

This study differed in its general set-up from Jemmott et al., (1998) in that the interventions were shorter (105 min), and the study population was smaller (19 participants). In addition, this study was conducted with a female-only sample (mean age 18), recruited from an inner-city family planning clinic, while Jemmott et al., (1998) recruited younger (mean age 12) study subjects of both genders from three schools. Since the study did not assess the long-term effects on behavioral changes, which constitutes the main program effect of interest, the study results do little to support the program.

Summary

Jemmott, Jemmott, Spears et al. (1992) used a quasi-experimental design to examine 19 African American adolescent females in New Jersey. Two randomly assigned interventions, one skills-based and one information-based, were compared to a non-randomly assigned general health control condition. A posttest measured self-reported sexual behavior.

Jemmott, Jemmott, Spears et al. (1992) found that at post-test, the social cognitive (skills-based) intervention group, relative to the combined information-based intervention group and control group, reported significantly:

• stronger intentions to use condoms,
• greater confidence regarding their ability to implement condom use.

Evaluation Methodology

Design:
Recruitment: Participants were black female adolescents recruited from a family planning clinic serving a low-income inner-city area of New Jersey. Participants were recruited in the waiting room of the family planning clinic by an assistant who described the project and informed them of the possibility that they might be assigned to one of the AIDS risk-reduction conditions or to the control condition on general health promotion.

Sample size/Attrition: Participants were 19 sexually active black female adolescents. No attrition was reported.

Study type/Randomization/Intervention: The study defined three conditions, a skill-based intervention, an information-based intervention, and a general health intervention. Those who came to the program for the first two days were randomly assigned to the skill-based or information-based intervention. Those showed up on the third and fourth day were all assigned to the general health control intervention. There was no apparent random assignment for the third group, which may differ in unknown ways from the first two groups. The intervention sessions were held during evening hours over a 3-week period at the family planning clinic during the summer of 1990. A total of six women participated in the skill-based condition, six participated in the information-based condition, and seven participated in the general health condition. Four female facilitators implemented the interventions. All interventions lasted 105 minutes.

Assessment: The impact of the intervention on cognitive mediator variables, which are associated with risky sexual behavior, was evaluated through pre- and post-test questionnaires.

Sample characteristics: Participants were African-American female adolescents (mean age 18). Study subjects came from a low SES background which is reflected in the average formal schooling of their mothers of around 11 years. Study subjects mean age of first coitus was 15.78 years, and all experienced coitus in the past 6 months. About half reported having been pregnant at least once. Only 22% of the sample reported using a condom the last time they had coitus.

Measures:
 Validity of measurements: Participants were assured that their answers would be confidential, and their name would not be put on their questionnaire.

Primary outcomes: A number of questions were used to assess attitudes, beliefs, knowledge, and intentions regarding sexual risky behavior.

• Intention to use condoms (1 item)
• Perceived self-efficacy to use condoms (6 items, alpha=.42-.65)
• Hedonistic expectancies regarding condom use (5 items, alpha=.82-.79)
• Prevention expectancies regarding condom use (3 items, alpha=.56-.94)
• Knowledge about AIDS/STDs (56 items, alpha=.78-.82)
• Participants answered factual true-false questions on general health
• Participants rated their attitudes and intentions toward specific health behaviors in the next 3 months
• Participants evaluated the intervention
• Participants answered questions about their sexual practices in the past 6 months, including intercourse, multiple sexual partners, condom use, and anal intercourse

Analysis: The study used analysis of covariance and planned contrasts to compare the social cognitive (skill-based) intervention with the combined information-alone and general health-promotion intervention, controlling for pre-intervention scores on the outcome of interest.

Intention-to-treat: The study gathered and used data on all subjects who were randomized.

Outcomes

Baseline Equivalence and Differential attrition : No test for baseline equivalence was performed. Attrition did not occur.

Posttest : Adolescents in the social cognitive condition reported significantly (p<.04) stronger intentions to use condoms than did those in the other conditions considered together. The information-alone and general health-promotion conditions did not differ in intentions (p=.18). Women who received the social cognitive intervention expressed significantly (p<.05) greater confidence regarding their ability to implement condom use (p<.05) and scored higher on hedonistic expectancies (p<.02) than did women in the other two conditions. Adolescents in the information-alone and social cognitive conditions scored substantially (p<.002) higher on AIDS knowledge than did those in the general health-promotion condition.

Study 7

This study evaluated a version of the program that was implemented by community-based organizations. Similar to the general program, this version included six 50-minute modules of activities that were delivered in two sessions of three modules each.

Summary

Jemmott et al. (2010) used a cluster randomized controlled trial to examine 1,707 adolescents living in Philadelphia and New Jersey. The study randomly assigned 86 community-based organizations to intervention or control groups, which then recruited the adolescent participants. Self-reports of participant condom use were obtained at posttest and three, six, and 12 months later.

Jemmott et al. (2010) found that, among teens who were sexually active at baseline and relative to the control group, the intervention group reported significantly greater:

• condom use.

Evaluation Methodology

Design:

Recruitment: The study first recruited community-based organizations in New Jersey and Philadelphia, Pennsylvania. Eligible organizations were nonprofit, delivered services to the community, served at least 50 adolescents aged 13 to 18 years, served an adolescent population that was at least 50% African American, and had at least one full-time service provider. Government agencies, religious organizations, schools, hospitals, and organizations that exclusively served special populations (e.g., mentally ill or homeless adolescents) were not eligible. Recruitment and follow-up took place from February 1998 to February 2002.

A total of 122 organizations were eligible to participate, and 86 enrolled. The organizations then recruited 3,445 English-fluent and parent-consented adolescents aged 13 to 18 years.

Assignment: The cluster randomized controlled trial randomly assigned the 86 community-based organizations to either the intervention group (n = 43 organizations, 1,729 students) or a health-promotion control group (n = 43 organizations, 1,716 students). In addition, the design randomized the organizations in each condition to one of three levels of facilitator training (manual only, standard training, and enhanced training). The random assignment was stratified by organization size, experience with HIV/STD prevention programs, and facilitators' gender and age, and it was done separately for New Jersey and Philadelphia organizations.

Because the study could maintain sufficient power with a smaller sample of adolescents, it randomly selected a subset of 1,707 participants (50%) for follow-up. For the intervention group, 863 of the 1,729 adolescents (50%) remained in the follow-up sample; for the control group, 844 of the 1,716 adolescents (49%) remained in the follow-up sample.

Adolescents enrolled in the study before assignment but also signed assent forms after learning of their assigned intervention. The study did not present information on assent rates overall or by condition.

Assessments/Attrition: Follow-up surveys occurred at posttest and three, six, and 12 months after the intervention end. All organizations were retained through the 12-month follow-up. Among the adolescents, 93%, 81%, 78%, and 79% of those selected for follow-up completed the posttest and three-, six-, and 12-month surveys, respectively. The authors appeared to use attending the follow-up sessions to mean completing follow-up surveys.

Sample:

About 26% of the organizations were located in Philadelphia, and the other 74% were located in New Jersey. The mean age of the follow-up sample (n = 1,707) was 14.8 years. The follow-up sample included more females (56%) than males (44%) and was nearly all African American (90%).

Measures:

Data collectors were blind to the participants' intervention. The authors reported from previous research that the reliability and validity of the measures had been established and that the strategies used to obtain honest responses had been shown to avoid social desirability response bias.

The primary outcome, self-reported consistent condom use in the previous three months, was supplemented by four other measures related to condom use and sexual intercourse. These outcomes were assessed at the three follow-ups, but not at posttest.

Analysis:

The analysis used linear, logistic, or Poisson generalized estimating equation regression models that estimated program effects averaged over time. The models accounted for clustering with an unstructured working correlation matrix and used robust sandwich estimators of the standard errors. A time variable represented the three-, six-, and 12-month follow-ups. Time-independent covariates included the baseline outcome measure, gender, age, and race.

Intent-to-Treat: The analysis limited the sample to participants who were sexually experienced at baseline. For this subsample, the authors otherwise stated that they used an intent-to-treat analysis by keeping all participants in their originally assigned condition, "regardless of the number of intervention or data-collection sessions attended" (p. 722). They otherwise provided no details on the sample size for the analysis.

Outcomes

Implementation Fidelity:

About 95.4% of participants attended both sessions of their assigned intervention, and 91.3% of participants attended at least one follow-up session.

Baseline Equivalence:

Tables 1 and 2 present baseline means for demographic and outcome measures among the randomly selected follow-up sample. The condition means appear similar, but the tables lack significance tests.

Differential Attrition:

Attrition rates did not differ by condition. However, a greater percentage of Black adolescents, younger adolescents, and adolescents reporting lower baseline condom use returned for the follow-up than those who did not return.

Posttest and Long-term:

The analysis presented results averaged over the three follow-up assessments for sexually experienced youth only. For the primary outcome of consistent condom use in the prior three months, the intervention group reported significantly greater usage than the control group (OR = 1.39). Three of the other four measures, each a different measure of condom use, showed significant intervention benefits. All effects were stable across the follow-up periods.

Moderation tests found that the intervention increased consistent condom use significantly more in older adolescents than younger adolescents. Effects did not differ by participants' gender or race, or by the intensity of facilitator training.