HPTN 064

The Women’s HIV SeroIncidence Study (ISIS): A Study of the HIV Prevention Trials Network

The purpose of this study was to estimate the overall HIV type 1 (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.  Secondary objectives included assessing recruitment and retention strategies for future studies, as well as describing sexual behaviors, substance abuse, prevalence of domestic violence, and mental health indicators of women at risk for HIV to inform future intervention studies. This was a multi-site, prospective observational cohort with a retrospective component.  Study duration was 2 years total, with a follow-up of all participants for 6-12 months.

This study focused on women living in the US, residing in High Risk Areas (HRAs), defined as areas where high prevalence of poverty overlaps with high incidence of HIV.  2,000 women from 10 geographically distinct HRA communities (200 women per HRA) constituted the study cohort. We were responsible for enrollment of 200 women at each of two (2) clinical research sites – Emory Hope Clinic, and Grady IDP/GCRC (400 women total).

Qualitative components were also incorporated, including semi-structured interviews of participants and focus group discussions with women enrolled in the cohort, as well as focus groups with men recruited from high risk area (HRA) venues. Goal of the qualitative component was to describe social, structural, and contextual factors of at-risk female participants, as well as to explore facilitators and barriers to HIV Testing among men residing in HRAs, to inform future intervention studies.