Experiences with Decision-Making for Microbicide Clinical Trial Enrollment among Women in Lusaka, Zambia

Background: In sub-Saharan Africa, women comprise more than 60% of HIV infections. Vaginal microbicides represent a female-controlled HIV prevention option. The success of microbicide trials depends on participant recruitment from high HIV prevalence areas.

Objective: To explore why women participating in a microbicide trial enrolled

Methods: In August 2008, 31 semi-structured interviews were conducted with women who participated in the HPTN-035 microbicide clinical trial in Lusaka, Zambia. Interviews were conducted in English, Nyanja or Bemba; lasted 30 to 60 minutes; and explored factors influencing the decision to enroll. Interviews were audio recorded, transcribed, entered in ATLAS.ti for coding and analyzed using a Grounded Theory approach to content analysis.

Results: Women's mean age was 24.3 years; most (93.3%) had current sexual partners. Women primarily learned about the trial through friends or study recruiters. Participants described 3 main approaches to deciding to enroll. Some deliberated internally, making the decision on their own. Others sought opinions from family, friends and/or partners. Others were influenced by friends also considering enrolling. Almost all women cited free health services (e.g., medications, STD testing, transportation to health visits) as a major reason for enrolling. Few women were concerned about the intentions of the researchers. No woman cited disapproval from family or sexual partners as an impediment.

Conclusions: Recruitment using women's informal social networks may increase study acceptability. Women's decisional autonomy regarding vaginal microbicide use does not appear to be compromised by family or partner disapproval. Access to health services is an important motivator for participation.