Evaluating Healthy Families PrEP: an intervention to promote PrEP use during periconception, pregnancy, and postpartum periods for women in rural Uganda - ABSTRACT Periconception, pregnant, and postpartum women in HIV-endemic settings are at high risk for acquiring HIV. In Uganda, both fertility rates (4.7 children/woman) and HIV prevalence (8%) are high, and many women conceive with partners with HIV who are not virally suppressed. Oral tenofovir-based PrEP is a highly effective strategy for reducing HIV-acquisition and approved for use during pregnancy and breastfeeding. We designed and pilot tested the 3-session Healthy Families-PrEP intervention in a Ugandan HIV care clinic. Women planning pregnancy were counseled on how to conceive while avoiding HIV acquisition; offered PrEP; and, for those choosing PrEP, provided with quarterly adherence support. Of 131 women enrolled, 90% initiated PrEP and 85% of those initiating PrEP took at least 80% of doses (electronic pill cap) over 9 months; 54% had whole blood tenofovir metabolites consistent with protective dosing at 6 months, and thus 43% of all enrolled used effective PrEP at 6 months. For women with pregnancy, adherence persisted over 9 months. Given compelling pilot data and the importance of HIV prevention for perinatal women, we propose to adapt and test this promising intervention to reduce HIV incidence among periconception, pregnant, and postpartum women accessing community care in Uganda. In Aim 1, qualitative focus group discussions with women, interviews with key stakeholders, and clinic observations guided by the Consolidated Framework for Implementation Research and our client-level conceptual framework will inform adaptation of the intervention to community clinics and postpartum women. We then propose a cluster-randomized control trial with N=10 health centers to evaluate effectiveness (Aim 2) by enrolling N=600 women planning for pregnancy from intervention and control clinics (1:1). Women will be followed for at least 6 months; those who become pregnant will remain enrolled through 18 months to allow for postpartum follow-up. The primary effectiveness outcome will be proportion of women with whole blood PrEP metabolites (TFV-DP) consistent with taking at least 4 weekly doses at 6 months. Tenofovir concentrations in whole blood and plasma (quarterly), questionnaires, and in-depth interviews will provide data to understand factors associated with PrEP use among peripartum women in the community setting. In Aim 3, we will determine the incremental cost-per-person participating in Healthy Families- PrEP and estimate the cost-effectiveness per incident HIV infection averted and per life-year saved among enrolled women and their infants. Adapting this intervention to community clinics and testing effectiveness addresses NIH Office of AIDS Research priorities to reduce HIV incidence and implement research discoveries for public health impact. Moreover, the work aligns with global and Ugandan Ministry of Health goals to reduce HIV incidence among women of reproductive age and eliminate perinatal transmission.
