Acceptability of a non-woven device for vaginal drug delivery of microbicides or other active agents.

Vaginal microbicides could reduce incidence of HIV. However, the current method of delivering gel formulations (standard applicator) can result in acceptability concerns/issues. This study evaluated the concept of using a non-woven textile material (modified tampon) for vaginal drug delivery. The study was nested within a Phase I randomized safety trial of lime juice concentrations used intra-vaginally. Of 47 women completing the safety trial, 16 were interviewed about their experiences. Overall, women found the concept of non-woven materials for vaginal drug delivery acceptable for use in delivering yeast medications (13 of 16) and STI/HIV preventives (10 of 16).

Acceptability of a nipple shield delivery system administering antiviral agents to prevent mother-to-child transmission of HIV through breastfeeding.

BACKGROUND: Breastfeeding is a route of mother-to-child transmission (MTCT) of the human immunodeficiency virus (HIV). The World Health Organization recommends antiretroviral (ARV) prophylaxis as the best method to prevent mother-to-child transmission of HIV (PMTCT) during breastfeeding. The nipple shield delivery system (NSDS) is being developed as an accessible method to deliver ARVs to infants and PMTCT during breastfeeding. The NSDS can potentially circumvent hygiene and storage issues in delivering drugs to infants in low-resource settings. OBJECTIVES: The primary objective was to determine acceptability of the NSDS for PMTCT in Kenya. Secondary objectives included assessing mothers' understanding of MTCT and identifying cultural and implementation issues that might affect NSDS acceptability. METHODS: Eleven focus group discussions were conducted, each group consisting of 7 to 12 participants. Seven focus group discussions consisted of HIV-positive mothers, 2 included grandmothers/mothers-in-law, and 2 included fathers/husbands. Ten in-depth interviews were also conducted with individual maternal/child health care providers. Topics included infant feeding and HIV stigma, as well as safety, effectiveness, and feasibility of the NSDS. Device prototypes were used in discussions. RESULTS: Participants felt that the NSDS could be trusted if validated scientifically and promoted by health care professionals. HIV-related stigma, access, efficacy, and hygiene were identified as important considerations for acceptance. CONCLUSION: The NSDS is a potentially acceptable method of PMTCT during breastfeeding. Further studies are needed to confirm acceptability, safety, and efficacy. For NSDS adoption to PMTCT, strategies will need to be developed to minimize HIV-related stigma and to ensure that continuous hygiene of the device is maintained.

Perspectives related to the potential use of vaginal microbicides among drug-involved women: focus groups in three cities in the United States and Puerto Rico.

HIV transmission through heterosexual contact remains the greatest risk factor for women globally. Topical microbicides applied intravaginally may offer a female-initiated HIV prevention option for many who are unable or unwilling to use male condoms or who would want additional protection. This article presents results of focus groups in Bridgeport, Connecticut, Providence, Rhode Island, and San Juan, Puerto Rico, with women who use crack or heroin or have male partners who inject illegal drugs. Participants revealed motivation for and openness to using microbicides effective against HIV should they become available. Additional lubrication during intercourse was one of several expected positive features of microbicides; women saw lubrication as a means of enhancing pleasure and reducing condom irritation and breakage while also protecting them from infection. Conversely, some women feared that their male partners would interpret excessive lubrication as an indication of infection, improper hygiene, or evidence of sex with another man. Focus groups also provided insight into how aspects of different women's sexual lives, including partner type, might influence the issues that would concern them if and when they tried out new microbicidal products in the future.