HPTN 064

The Women’s HIV SeroIncidence Study (ISIS)

What is HPTN 064?

 


 

Protocol Status: Participants Off Study & Primary Analysis Complete

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: 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

The Ponce de Leon Ctr. CRS

5802

Atlanta, United States

200 women

210

Closed to Follow Up

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Johns Hopkins Adult AIDS CRS

201

Baltimore, United States

200 women

210

Closed to Follow Up

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Bronx Prevention Center CRS

30261

Bronx, United States

200 women, focus groups with men

210

Closed to Follow Up

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Chapel Hill CRS

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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New Jersey Medical School Clinical Research Center CRS

31786

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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George Washington Univ. CRS

31608

Washington, United States

200 women, focus groups with men

210

Closed to Follow Up

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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

Haley DF, Justman JE. The HIV epidemic among women in the United States: a persistent puzzle. J Womens Health. 2013, 22: 715-7 PMCID: 3768238

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: 4033695

Adimora AA, Hughes JP, Wang J, Haley DF, Golin CE, Magnus M, Rompalo A, Justman J, Del Rio C, El-Sadr W, Mannheimer S, Soto-Torres L, Hodder SL; for the HPTN 064 Protocol Team. Characteristics of Multiple and Concurrent Partnerships among Women at High Risk for HIV Infection. J Acquir Immune Defic Syndr. 2014, 65: 99-106 PMCID: In Process

Haley DF, Golin C, El-Sadr W, Hughes JP, Wang J, Roman Isler M, Mannheimer S, Kuo I, Lucas J, DiNenno E, Justman J, Frew PM, Emel L, Rompalo A, Polk S, Adimora AA, Rodriquez L, Soto-Torres L, Hodder S. Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study. J Womens Health (Larchmt). 2014, 23: 541-51 PMCID: 4046355

Haley DF, Lucas J, Golin CE, Wang J, Hughes JP, Emel LM, El-Sadr W, Frew PM, Justman J, Adimora AA, Watson CC, Mannheimer S, Rompalo A, Soto-Torres L, Tims-Cook Z, Carter Y, Hodder SL. Retention Strategies and Factors Associated with Missed Visits Among Low Income Women at Increased Risk of HIV Acquisition in the US (HPTN 064. AIDS Patient CARE STDS. 2014, 28: 206-17 PMCID: 3985524

Jennings L, Rompalo AM, Wang J, Hughes J, Adimora AA, Hodder S, Soto-Torres LE, Frew PM, Haley DF; HIV Prevention Trials Network (HPTN 064) Women’s HIV SeroIncidence Study (ISIS). Prevalence and Correlates of Knowledge of Male Partner HIV Testing and Serostatus Among African-American Women Living in High Poverty, High HIV Prevalence Communities (HPTN 064). AIDS Behav. 2014, Epub: PMCID in process

Kuo I, Golin CE, Wang J, Haley DF, Hughes J, Mannheimer S, Justman J, Rompalo A, Frew PM, Adimora AA, Soto-Torres L, Hodder S; HPTN 064 Study Team. Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend. 2014, Jun 1: 93-9 PMCID: 4104540