Enabling Women to Participate in HIV Vaccine Efficacy Trials: Lessons Learned from a U.S. Vaccine Preparedness Study

Issue: The women most suitable to enroll in HIV vaccine efficacy trials are those at highest risk for HIV. A vaccine preparedness study (VPS) that followed at-risk women for 2 years can offer some ways to enable these women, who are often disenfranchised, to adhere to the rigorous schedules required in trials.

Project: The VPS consisted of 865 women enrolled at five sites across the United States. Women were at risk for HIV through recent injection drug use and/or sexual contact with men. Participation consisted of risk assessment interviews, vaccine trial information, counseling, and HIV-1 antibody testing every 6 months for 2 years. The participants were aged 18 to 60, largely unemployed (86%), many had limited education (42%), and many presented with issues that threatened to interfere with their ability to keep subsequent appointments. These included substance abuse, domestic violence, survival sex, inadequate housing, and a history of incarceration. Transportation and childcare needs posed additional challenges.

Results: Staff found that they had to be creative in their efforts to retain these participants. This meant taking on the additional task of dealing with the social service issues presented in order to effectively address HIV-risk related behaviors, and offering referrals. At one site, case management was also provided. Direct retention strategies included reimbursement for participation, distributing free prevention supplies, assisting with transportation and childcare when possible, and engaging in intense outreach efforts to locate the hard to reach. Visits, meant to occur at study sites, also took place in homes, prisons, restaurants, and residential drug treatment centers. After 18 months, 82% of these women have been retained.

Lessons learned: At-risk women can be successfully recruited and retained over time. Counseling women about more than just HIV and having a strong referral network is recommended to support women’s involvement in HIV vaccine trials. Flexibility regarding where visits can take place may also need to be considered to assist this cohort in adhering to the required study protocols of such trials.

Pamela Brown-Peterside
New York Blood Center
1309 Fulton Avenue, Room 312
Bronx, NY 10456