Retaining Hard-to-Reach Women in HIV Prevention and Vaccine Trials: Project ACHIEVE

Finding a preventive vaccine for HIV will mean asking people at high risk for HIV infection to participate in vaccine efficacy trials. Although vaccine preparedness studies indicate that high-risk cohorts are willing to participate in trials, many women at risk for HIV infection in the United States are poor and disenfranchised and are confronted with life issues that can interfere with their ability to adhere to scheduled study visits. To ensure broad participation in clinical trials and other cohort studies by those at high risk for HIV infection, successful retention strategies are needed.

From April to September 1998, Project ACHIEVE's South Bronx site enrolled 164 HIV-negative women, ages 18 to 60, in a vaccine preparedness study as part of a larger multisite study. To qualify as being at high risk of HIV infection, each participant had to meet 1 or more of the following criteria: have a current male sex partner who is HIV-infected or an injection drug user; or in the past year have smoked crack, exchanged sex for money or drugs, had 5 or more male sex partners, or had an STD. Recruitment strategies included street outreach, newspaper ads, flyers, posters and tabling in clinics and at health fairs. At enrollment, most of the women were poor; half of them reported 5 or more partners or exchanging sex for money or drugs, and two-thirds had smoked crack in the preceding year.

At the initial visit, informed consent and locator information were obtained, eligibility was confirmed, vaccine trial information was provided, willingness to participate in vaccine trials was assessed and sexual and drug history interviews were conducted. Women were counseled and tested for HIV. Participants returned two weeks later. Those who tested positive were referred to primary care. Those who tested negative were enrolled in the study and returned to the clinic for further counseling and testing every 6 months for 1 year. Referrals for social services were provided when needed. Three months after enrollment, researchers were able to contact 98 percent of the participants. Six months into the study, 96 percent of enrollees completed study visits. At the 9-month contact point, researchers reached 96 percent of the participants. At the 12-month visit, 92 percent of enrollees completed their study visits; 88 percent completed both the 6- and 12-month visits.

At each visit, women were reimbursed for their time ($20), given a $3 Metrocard to cover roundtrip public transportation, and offered male and female condoms and small gifts. The counseling that women received was part of the researchers' approach. It offered the participants support to cope with difficulties in their lives and may have helped them keep their appointments. Retention support for this population requires at least 1 full-time staff member who focuses on retention; financial support for home visits, and a computerized tracking system.

The efforts reported are purely descriptive; in the absence of a comparison group, the researchers have no way of knowing which specific strategies contributed to retention. Furthermore, the research is based on a vaccine preparedness study, not on participation in an actual vaccine trial. The researchers' findings suggest that high-risk women who are living in poverty can be successfully retained in HIV vaccine trials. Preconceived ideas about retention should not lead to the exclusion of hard-to-reach populations from HIV vaccine or other prevention trials, according to the study.

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