HPTN 063

Study Purpose: To conduct preparatory research needed to design a behavioral intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in care and to determine whether a similar intervention structure can be used across various sexual risk groups and cultural settings.

Study Design: Multi-site, observational, cohort study (quantitative component). In-depth interviews and focus groups (qualitative component).

Study Population: HIV-infected men and women in Africa, Asia, and South America, who have reported recent (within 3 months) HIV sexual transmission risk behavior.

Study Size: 920 participants – HIV infected participants: 300 heterosexual men (100 per site), 300 heterosexual women (100 per site), 200 MSM (100 per site in Asia and South American only); approximately 120 qualitative participants (40 from each site)

Study Duration: Approximately two years total: One year for participant accrual – participants will be followed for one year with interviews and assessments quarterly. Qualitative assessment will occur during this 2 year time frame.

Treatment Regimen: This is an observational study.

Primary Objectives: 1) To establish baseline rates of sexual HIV transmission risk behavior in high risk, HIV-infected individuals, and to observe the rates and patterns of behavioral change over time. 2) To gather formative data on the potential structure and content of a behavioral intervention for individuals with HIV in care in international settings and to determine the best, culturally appropriate model for the intervention that will link prevention to care for HIV-infected individuals. 3) To examine potential psychosocial and sociodemographic correlates of sexual risk taking in these individuals in order to help shape the content of an individualized behavioral intervention.

Secondary Objectives: Evaluate STI prevalence and incidence and investigate whether these biomarkers may be used to corroborate self-reported sexual behavior associated with potential transmission risks

Protocol Team Member: Alex London get info

Protocol Team Member: Charlotte A. Gaydos get info

Protocol Team Member: David DuPuy Celentano get info

Protocol Team Member: Estelle Piwowar-Manning get info

Protocol Team Member: Jonathan Lucas get info

Protocol Team Member: Matthew Mimiaga get info

Protocol Team Member: Rhonda White get info

Protocol Statistician: James Dai get info

Protocol Statistician: Jim Hughes get info

Protocol Co-Chair: Kenneth H. Mayer get info

Protocol Chair: Steven Alex Safren get info

DAIDS Medical Officer: Vanessa Elharrar get info