HPTN 063

Preparing for international prevention trials involving HIV-infected individuals in care settings

 

What is HPTN 063?

 


 

Protocol Status: Closed to Follow Up

Study Summary

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 (Zambia), Asia (Thailand), and South America (Brazil), who have reported recent (within 3 months) HIV sexual transmission risk behavior.

Study Size: 800 quantitative (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 sites only); approximately 120 qualitative participants (community members/stakeholders; 40 from each site, a subset of the HIV-infected participants will also participate in qualitative individual interviews).

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 Celentano get info

Protocol Team Member: Erica Hamilton get info

Protocol Team Member: Estelle Piwowar-Manning get info

Protocol Team Member: Jonathan Lucas get info

Protocol Team Member: Lynda Marie Emel get info

Protocol Team Member: Matthew Mimiaga get info

Protocol Team Member: Rhonda White get info

Protocol Team Member: Stewart Reid get info

Protocol Team Member: Vanessa Cummings get info

Protocol Statistician: James Dai get info

Protocol Statistician: James Hughes get info

Protocol Co-Chair: Kenneth H. Mayer get info

Protocol Chair: Steve Safren get info

DAIDS Medical Officer: Vanessa Elharrar get info

CORE Protocol Specialist: Ayana Moore get info

Site Target
Enrollment
Cumulative
Enrollment
Implementation
Status
More
Info

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

12101

Manguinhos, Brazil

100 hetereosexual men 100 heterosexual women 100 MSM

64 heterosexual men 100 heterosexual women 100 MSM

De-Registered

get more

Chiang Mai Univ. AIDS Prevention CRS

31458

Chiang Mai, Thailand

100 heterosexual men 100 heterosexual women 100 MSM

100 heterosexual men 100 heterosexual women 100 MSM

Closed to Follow Up

get more

Matero Reference Clinic CRS

30290

Lusaka, Zambia

100 heterosexual men 100 heterosexual women

87 heterosexual men 100 heterosexual women

Closed to Follow Up

get more