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HPTN 064

The Women’s HIV SeroIncidence Study (ISIS)

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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 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: Nirupama Sista 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: Waheeda Shabazz-El get info

Protocol Statistician: Jim 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
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Info

Ponce de Leon Ctr. CRS

5802

Atlanta, United States

200 women

 

Designated

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Johns Hopkins AIDS CRS

201

Baltimore, United States

200 women

 

Designated

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Bronx-Lebanon Hospital Center Clinical Research Site

30261

Bronx, United States

200 women

 

Designated

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UNC AIDS CRS

3201

Chapel Hill, United States

200 women

 

Registered

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Hope Clinic of the Emory Vaccine Center CRS

31440

Decatur, United States

200 women

 

Designated

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Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

31471

New York, United States

200 women

 

Designated

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New Jersey Medical School- Adult Clinical Research Ctr. CRS

31477

Newark, United States

400 women (2 communities)

 

Designated

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Wake County Health and Human Services CRS

30076

Raleigh, United States

200 women

 

Registered

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George Washington University CRS

31608

Washington, United States

200

 

Initial Registration in Progress

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This page was last updated: April 03, 2008