Prevention for Persons Living with HIV (PLH) is a critical national priority (CDC, 2001). This is addressed by conducting the first multi-site randomized controlled prevention trial aimed at reducing HIV-related transmission acts among PLH in 4 cities (NYC, LA, SF, & MW). Secondary goals are to assist PLH to maintain positive coping styles & mental health & to enhance health care behaviors. The intervention design & the assessments were informed by qualitative studies with 152 PLH, focus groups with providers, & observations in recruitment sites. Based on these results & Social Action Theory (Ewart, 1991), a 3 module intervention was designed to be delivered over 15 sessions: 1) Stress, Coping, & Adjustment to enhance PLH's quality of life; 2) Risk Behaviors to reduce transmission acts; & 3) Health Behaviors that may increase individuals' prospects for long-term survival & decrease viral loads. After assessing 3819 PLH, 943 adult PLH who had engaged in recent transmission acts & met eligibility criteria were randomized to an Immediate Intervention (n=469) or Lagged Condition (n = 474) & have been followed longitudinally at 5 month intervals (baseline, 5, 10, 15, 20, & 25 months), with 70%-87% follow-up rates across assessments. The sample is ethnically diverse (45% African American, 15% Latino), composed of PLH from multiple subgroups (57%, MSM; 21%, women; 11%, IDU), & with high-risk backgrounds (49% jail, 14% recently homeless; 63% hard drug use). Attendance at each intervention module ranges from 56% - 90%. We are requesting extended funding for 2 years in order to: 1) complete data collection (662 assessments & interventions with 342 PLH in the Lagged Condition from 8/03- 5/04); & 2) complete data analysis (including analysis of all viral loads from each PLH at 4 time points). Extended recruitment was required because screening was not feasible (low reliability, sensitivity, & specificity; Wight et al., 2000) & full assessments were required to determine eligibility, the rate of PLH with transmission acts was lower than anticipated (28% vs. 66%), & more recruitment sites were needed. The results of this trial will inform treatment guidelines for both HRSA & the CDC, as well as potentially provide a model for delivery of prevention services in treatment & community-based settings. Not only will we be able to evaluate the program's efficacy on primary & secondary outcomes, cost, & cost-effectiveness, we will also be able to examine predictors of change & to identify barriers to implementation.
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