Effectiveness of an HIV/STD Risk-Reduction Intervention for Adolescents When Implemented by Community-Based Organizations: A Cluster-Randomized Controlled Trial

摘要

Objectives. We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). Methods. In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Results. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (β = 0.06; 95% CI = 0.00, 0.12) than did the control group. Conclusions. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established. The HIV/AIDS pandemic has had a particularly devastating effect on young people throughout the world. 1 Those aged 15 to 24 years account for half of all new HIV infections. 2 Young people are also at high risk for other STDs. In the United States, although youths aged 15 to 24 years constitute only 25% of the sexually active population, they account for about half of new STD cases. 3 Controlled studies have identified developmentally appropriate interventions that reduce self-reported sexual-risk behavior 4 – 10 and rates of biologically confirmed STDs 11 , 12 among adolescents. Less well-documented is whether efficacious HIV/STD interventions retain their ability to reduce sexual risks when implemented under more realistic real-world circumstances. 13 This has led to calls for evidence from different types of studies—not studies of the efficacy of HIV/STD risk-reduction interventions under highly controlled circumstances, but studies of their effectiveness in real-world settings. 13 – 15 We conducted a cluster-randomized controlled trial testing the effectiveness of the “Be Proud! Be Responsible!” HIV/STD risk-reduction intervention 16 when implemented by community-based organizations (CBOs). Several randomized controlled trials have demonstrated this intervention's efficacy. One reported that African American adolescents who received the intervention reported less sexual-risk behavior at 3-month follow-up than did the control group and that the facilitators' gender did not moderate the intervention's efficacy. 17 Another found that African American adolescents who received the intervention reported less sexual-risk behavior at 6-month follow-up than did the control group and that the intervention's efficacy did not vary by the facilitators' race or gender, the participants' gender, or the gender composition of the intervention groups. 18 A randomized controlled trial found that a culturally adapted version of the intervention reduced sexual risk in Latino adolescents, including monolingual Spanish speakers, at 12-month follow-up. 19 Moreover, the intervention was included in the Centers for Disease Control and Prevention dissemination initiative “Programs that Work” and distributed to US schools and CBOs. An economic analysis suggests that the intervention is cost-effective. 20 We employed a cluster design with CBOs as the unit of randomization to allow us to draw conclusions about effectiveness of implementation by CBOs. CBOs have played a central role in the fight against HIV since the beginning of the epidemic 21 – 24 and are seen as an essential component of any multisectoral national strategy to curtail the spread of HIV. 2 Although previous research has examined factors that increase the likelihood that CBOs will adopt evidence-based HIV risk-reduction strategies, 24 – 26 no large, randomized, controlled trials have tested the effectiveness of evidence-based interventions when implemented by CBOs. We hypothesized that adolescents in CBOs randomly assigned to implement “Be Proud! Be Responsible!” would be more likely to report consistent condom use than those in CBOs implementing a health-promotion control intervention. A secondary hypothesis was that the intervention's effectiveness would increase with increases in the amount of training the CBOs received, which varied as follows: only the intervention packet; the packet and 2 days of training; or the packet, the training, a practice intervent