HPTN 064
The Women’s HIV SeroIncidence Study (ISIS)
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What
is HPTN 064?
Protocol Status:
Pending
Study
Summary
Study Purpose: To estimate the overall HIV-1 incidence rate in women at risk for HIV acquisition in the US and to evaluate the feasibility of enrolling and following a cohort of these women.
Study Design: Multi-site, prospective observational cohort with a retrospective component.
Qualitative components are also incorporated including semi-structured interviews of participants and focus group discussions with women enrolled in the cohort and focus groups with men recruited from high risk area (HRA) venues.
Study Population: Women in the US residing in a high risk area (HRA) and possessing specific characteristics that place them at risk for HIV acquisition.
Men in the US who reside in HRAs (for qualitative component only).
Study Size: 2,000 women from 10 geographically distinct HRA communities will constitute the study cohort.
A subset of women already enrolled in the study cohort from 4 of the 10 communities will also participate in either a semi-structured interview or focus group. A total of 120 women (30 per community, 4 communities) will participate in individual interviews and 120 women will participate in focus groups (2-6 focus groups in each of 4 communities).
A total of 120 men from 4 of the 10 communities will participate in focus groups (2-6 focus groups in each of 4 communities).
Study Duration: 2 years total duration with follow-up of all participants to a common closing date. Participants will be followed for 6-12 months.
Treatment Regimen: There is no study intervention.
Primary Objectives: The primary objective of this study is to estimate the overall HIV-1 incidence rate among 2,000 women in the US from defined geographic areas with high HIV prevalence and poverty.
Secondary Objectives: The secondary objectives of this study are:
• To evaluate laboratory assays for HIV-1 incidence determination
• To estimate recruitment and retention rates
• To describe sexual behaviors, alcohol and drug use, prevalence of domestic violence, and mental health indicators of women at risk of HIV acquisition
• To assess women’s preferred recruitment and retention strategies for future studies
• To describe social, structural and contextual factors in a subgroup of female participants to inform future intervention studies
• To estimate HIV-1 prevalence rate among women who have not reported previously testing HIV positive
• To explore facilitators and barriers to HIV testing among men residing in high risk areas to inform future intervention studies
SDMC Protocol Specialist:
Lynda Marie Emel
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Protocol Team Member:
Ada Adimora
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Protocol Team Member:
Ann O'Leary
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Protocol Team Member:
Bernard Lo
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Protocol Team Member:
Carol Golin
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Protocol Team Member:
Cathie Fogel
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Protocol Team Member:
Elizabeth DiNenno
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Protocol Team Member:
Gina Wingood
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Protocol Team Member:
Nirupama Sista
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Protocol Team Member:
Paul Richardson
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Protocol Team Member:
Sten Vermund
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Protocol Team Member:
Susan Eshleman
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Protocol Team Member:
Wafaa El-Sadr
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Protocol Team Member:
Waheeda Shabazz-El
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Protocol Statistician:
Jim Hughes
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Protocol Co-Chair:
Jessica Justman
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Protocol Chair:
Sally Hodder
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DAIDS Medical Officer:
Lydia Soto-Torres
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CORE Protocol Specialist:
Danielle Haley
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