HPTN 064
The Women’s HIV SeroIncidence Study (ISIS)
What is HPTN 064?
Protocol Status: Enrolling
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 get info
Protocol Team Member: Ada Adimora get info
Protocol Team Member: Ann O'Leary get info
Protocol Team Member: Bernard Lo get info
Protocol Team Member: Carol Golin get info
Protocol Team Member: Cathie Fogel get info
Protocol Team Member: Elizabeth DiNenno get info
Protocol Team Member: Gina Wingood get info
Protocol Team Member: Jonathan Lucas get info
Protocol Team Member: Nirupama Sista get info
Protocol Team Member: Noranik Zadeyan get info
Protocol Team Member: Paul Richardson get info
Protocol Team Member: Sten Vermund get info
Protocol Team Member: Susan Eshleman get info
Protocol Team Member: Wafaa El-Sadr get info
Protocol Team Member: Waheedah Shabaz-El get info
Protocol Statistician: James Hughes get info
Protocol Co-Chair: Jessica Justman get info
Protocol Chair: Sally Hodder get info
DAIDS Medical Officer: Lydia Soto-Torres get info
CORE Protocol Specialist: Danielle Haley get info
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
|
5802 Atlanta, United States |
200 women |
13 |
Enrolling |
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|
201 Baltimore, United States |
200 women |
88 women as of 2/2/2010 |
Enrolling |
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|
Bronx-Lebanon Hospital Center Clinical Research Site 30261 Bronx, United States |
200 women, focus groups with men |
200 women, 30 women INT, 60 women FG, 30 men FG |
Enrollment Closed |
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|
3201 Chapel Hill, United States |
200 women |
200 women |
Enrolling |
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|
Hope Clinic of the Emory Vaccine Center CRS 31440 Decatur, United States |
200 women, focus groups with men |
29 women, 4 women INT |
Enrolling |
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|
Harlem Prevention Center Clinical Research Site 30276 New York, United States |
200 women |
29 |
Enrolling |
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|
New Jersey Medical School- Adult Clinical Research Ctr. CRS 31477 Newark, United States |
400 women (2 communities) |
|
Enrolling |
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|
Wake County Health and Human Services CRS 30076 Raleigh, United States |
200 women, focus groups with men |
152 women, 9 women INT |
Enrolling |
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George Washington University CRS 31608 Washington, United States |
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