The Women’s HIV SeroIncidence Study
What is HPTN 064?
HPTN 064, was a study designed to estimate the overall new HIV infection rate in women at risk for HIV in the US.
Who participated in the study?
A total of 2,099 women between the ages of 18 and 44 years were enrolled over 14 months (from May 2009 to July 2010). Eighty-eight percent of the participants in the study were black, 12% identified as Hispanic/Latina. Women were enrolled from 10 communities in six distinct geographical areas in the northeast and southeast regions of the US; Atlanta, GA, Raleigh-Durham, NC, Washington D.C., Baltimore, MD, Newark, NJ, New York City, NY.
What happened during the study?
The study used a novel approach to recruit participants, focusing on geographic areas of the US with the highest HIV prevalence rates in women, i.e. ‘hot spots’. Women without a prior positive HIV test living in areas with high HIV prevalence and poverty were eligible for enrollment and were interviewed about many key aspects of their lives including mental health, sexual behavior, history of sexually transmitted infections (STIs), domestic violence, social support, financial insecurity and health care utilization.
Why was this study important?
Women constitute roughly one-quarter of new HIV infections in the US with 66 percent of these infections occurring among black women, although black women constitute only 14 percent of the US female population. In the US, the age-adjusted death rate of black women with HIV is roughly 15 times higher than that observed for HIV-infected white women.
Study results indicated that the HIV incidence rate for U.S. women living in areas hardest hit by the epidemic was much higher than the overall estimated incidence rate in the U.S. for black adolescent and adult women. HPTN 064 found an HIV incidence of 0.24% in the study cohort of 2,099 women (88% black), a rate that was fivefold higher than that estimated for black women overall by the Centers for Disease Control and Prevention (CDC). The rate noted in HPTN 064 was comparable to estimated HIV incidence rates in the general population in several countries in sub-Saharan Africa including the Congo (0.28 %) and Kenya (0.53%), underscoring the substantial ongoing HIV transmission within specific US populations, including women at risk as defined in this study.
HPTN 064 Version 1.0
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.
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.
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).
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).
2 years total duration with follow-up of all participants to a common closing date. Participants will be followed for 6-12 months.
There is no study intervention.
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.
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