A strategic action framework for multipurpose prevention technologies combining contraceptive hormones and antiretroviral drugs to prevent pregnancy and HIV.

OBJECTIVE: Multipurpose prevention technologies (MPTs) are an innovative class of products that deliver varied combinations of human immunodeficiency virus (HIV) prevention, other sexually transmitted infection (STI) prevention, and contraception. Combining separate strategies for different indications into singular prevention products can reduce the stigma around HIV and STI prevention, improve acceptability of and adherence to more convenient products, and be more cost-effective by addressing overlapping risks. METHODS: This article outlines a strategic action framework developed as an outcome of a series of expert meetings held between 2014 and 2016. The meetings focused on identifying opportunities and challenges for MPTs that combine hormonal contraception (HC) with antiretroviral drugs into single products. The framework aims to present an actionable strategy, by addressing key research gaps and outlining the key areas for progress, to guide current and future HC MPT development. RESULTS: We identified eight primary action areas for the development of impactful HC MPTs, and includes aspects from epidemiology, pharmacology, clinical trial design, regulatory requirements, manufacturing and commercialisation, behavioural science, and investment needs for research and development. CONCLUSION: Overall, the challenges involved with reconciling the critical social-behavioural context that will drive MPT product use and uptake with the complexities of research and development and regulatory approval are of paramount importance. To realise the potential of MPTs given their complexity and finite resources, researchers in the MPT field must be strategic about the way forward; increased support among policy-makers, advocates, funders and the pharmaceutical industry is critical.

Lime juice as a candidate microbicide? An open-label safety trial of 10% and 20% lime juice used vaginally.

OBJECTIVE: Lime has a long history as a contraceptive and vaginal hygiene douche, and ongoing use in Africa is documented. We report on the first safety study on diluted lime juice to assess its potential as a candidate microbicide. METHODS: Twenty-five sexually abstinent women were randomly assigned to apply a 10% or 20% concentration of lime juice or 0% (water-only) through a soaked tampon once daily for 14 consecutive days. Tests for genital infections, measurement of inflammatory biomarkers, and a colposcopy were performed before and after treatment. RESULTS: No participant showed severe vaginal irritation. Two women developed a yeast infection after using lime juice. More than 70% of women in all groups reported side effects, most being singular, mild, and transient events. The users of 20% diluted lime juice experienced a significantly higher frequency of burning and dryness. Vaginal inflammatory biomarkers showed no significant change between preexposure and postexposure levels. The naturally low vaginal pH showed little change, and lactobacilli colonization did not decrease. CONCLUSIONS: Lime juice up to 20% concentration has an acceptable safety profile for vaginal use. However, as new in vitro research shows that the effectiveness of lime juice to prevent HIV transmission in concentrations lower than >or=50% is unlikely and concentrations of 50% have been shown to be toxic, women should be discouraged from commencing or continuing the vaginal use of lime juice.