Preventive misconception as a motivation for participation and adherence in microbicide trials: evidence from female participants and male partners in Malawi and Zimbabwe.

This paper presents empirical data on motivation to join an HIV prevention trial of vaginal microbicide gels in Malawi and Zimbabwe, and participant assumption of a preventive misconception. Interviews were conducted with women participating in the trial and their male partners. Most of the female participants were able to adequately describe basic aspects of the trial design. HIV counseling and testing were primary reasons motivating women's participation, and male partners' support of the trial. 29% of women and 20% of men also provided indications of a preventive misconception, attributing gel use and trial participation to avoiding HIV infection.

Sexual pleasure, gender power and microbicide acceptability in Zimbabwe and Malawi.

Topical vaginal microbicides are being developed to reduce HIV infection in women for whom correct and consistent condom use is impossible or undesirable. Although microbicides have been heralded as a "women-initiated" method that requires no action of the male partner, gender norms for sexual relationships and sexual practices could impede acceptability and use. To facilitate development of microbicides and look ahead to their eventual introduction, it is necessary to understand couples' sexual dynamics, including power and pleasure. This article presents data from a study of microbicide acceptability ancillary to a microbicide clinical trial in Malawi and Zimbabwe. Female trial participants, male partners, health care professionals and community stakeholders were interviewed about norms for sexual decision-making, sexual pleasure, and associated intravaginal practices that ensure this pleasure. Even though acceptability of microbicides was found to be high, sexual intercourse is accompanied by issues of power and gender norms that place women, particularly those in stable union, at a disadvantage for enactment of risk reduction strategies. Although woman-initiated use is an important goal in development of microbicides, the need for men's cooperation or agreement must be addressed in strategies for future product introduction.

Partnering for Care in HIV Prevention Trials.

QUALITATIVE CASE STUDIES WERE conducted at seven international sites conducting HIV prevention research in Africa, Asia, and the Americas to identify strategies for ensuring that health needs of research participants identified in the course of research are adequately addressed. Key factors were identified that contribute to the balance between direct care and healthcare referrals at a research site, as well as the overall quality of the healthcare made available to research participants. The case studies exemplify the concept of "moral negotiation" in research (Weijer & LeBlanc, 2006), that is, a process where researchers and sponsors negotiate with increasingly empowered local communities and host countries to achieve meaningful and substantive benefits from biomedical research for all stakeholders.

Pregnancy prevention practices among women with multiple partners in an HIV prevention trial.

BACKGROUND: Women enrolled in microbicide and pre-exposure prophylaxis (PrEP) HIV prevention trials are not allowed to continue use of study products when pregnant because of fetal safety concerns. High pregnancy rates among women in trials can undermine statistical measures of safety and effectiveness. METHODS: Women enrolled in a PrEP trial in Ghana, Nigeria, and Cameroon had an overall pregnancy rate of 52 per 100 person-years of observation. In-depth interviews were conducted with 67 women who were asked to describe any changes made in their pregnancy prevention practices after enrolling in the trial. RESULTS: Most women (n = 44, 65%) reported changing pregnancy prevention practices after enrolling in the trial. Twice as many reported using condoms for pregnancy prevention after enrollment (n = 56, 84%) than before (n = 27, 40%). Cluster analysis identified site-specific patterns. Nigerian women tended to report using condoms for dual protection before and after trial enrollment. Cameroonian women tended to rely on natural methods before and after trial enrollment. Ghanaian women tended to switch from hormonal methods to condoms. CONCLUSIONS: The role of condoms in HIV prevention trials must not be diminished. Their use-effectiveness for contraception is likely too low for microbicide and PrEP trial needs, however. HIV prevention trials with women should be appropriately staffed to provide effective contraceptive counseling and, if needed, direct provision of contraceptives. This must be done without undermining women's reproductive rights.