HPTN 064
The Women’s HIV SeroIncidence Study (ISIS)
What is HPTN 064?
Protocol Status: Closed to Follow Up
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: 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: Paul Richardson get info
Protocol Team Member: Sten H. 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
DAIDS Medical Officer: Wairimu Chege get info
CORE Protocol Specialist: Danielle Haley get info
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
|
5802 Atlanta, United States |
200 women |
210 |
Closed to Follow Up |
get more |
|
201 Baltimore, United States |
200 women |
210 |
Closed to Follow Up |
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|
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS) 30261 Bronx, United States |
200 women, focus groups with men |
210 |
Closed to Follow Up |
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|
3201 Chapel Hill, United States |
200 women |
210 |
Closed to Follow Up |
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|
Hope Clinic of the Emory Vaccine Center CRS 31440 Decatur, United States |
200 women, focus groups with men |
210 |
Closed to Follow Up |
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|
Harlem Prevention Ctr. CRS (El-Sadr CTU) 30276 New York, United States |
200 women |
210 |
Closed to Follow Up |
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|
31604 Newark, United States |
400 women (2 communities) |
420 |
Closed to Follow Up |
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|
Wake County Health and Human Services CRS 30076 Raleigh, United States |
200 women, focus groups with men |
210 |
Closed to Follow Up |
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|
31608 Washington, United States |
200 women, focus groups with men |
210 |
Closed to Follow Up |
get more |
HPTN 064 Publications
Hodder SL, Justman J, Haley DF, Adimora AA, Fogel CI, Golin CE, O'Leary A, Soto-Torres L, Wingood, G, El-Sadr WM Behalf of the HIV Prevention Trials Network, Domestic Prevention Working Group (HPTN DPWG) Women at Risk Group. Challenges of a Hidden Epidemic: HIV Prevention Among Women in the United States. JAIDS. 2010, 55: S69-S73 PMCID: 3551266
Eshleman SH, Hughes JP, Laeyendecker O, Wang J, Brookmeyer R, Johnson-Lewis L, Mullis CE, Hackett J Jr, Vallari AS, Justman J, Hodder S. Use of a multi-faceted approach to analyze HIV incidence in a cohort study of women in the United States: HIV Prevention Trials Network 064 Study. J Infect Dis. 2013, 207: 223-31 PMCID: 3532822
Hodder SL, Justman J, Hughes JP, Wang J, Haley DF, Adimora AA, Del Rio C, Golin CE, Kuo I, Rompalo A, Soto-Torres L, Mannheimer SB, Johnson-Lewis L, Eshleman SH, El-Sadr WM for HPTN 064, the Women's SeroIncidence Study Team. HIV Acquisition Among Women From Selected Areas of the United States: A Cohort Study. Ann Intern Med. 2013, 158: 10-18 PMCID: In Process
