Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond

The DPP is designed to prevent HIV and pregnancy simultaneously, addressing the persistent shortcomings in women's access to comprehensive sexual and reproductive health (SRH) services. The DPP is a multi-purpose prevention technology (MPT) that could transform the prevention field by providing a convenient and effective solution for women to prevent both HIV and pregnancy. The development of the DPP is a response to the dedicated efforts to reduce unmet need for family planning (FP) and HIV incidence globally. Despite these efforts, cisgender women encounter barriers to accessing contraception and HIV prevention in many settings, hindering progress toward global targets. In sub-Saharan Africa, women of reproductive age account for 65% of new HIV infections among adults ages 15-49, and have varying levels of unmet need for FP, ranging from 8% in Botswana to 27% in Angola. The DPP is a daily pill that co-formulates tenofovir disoproxil and emtricitabine (TDF/FTC), the only approved formulation of oral PrEP for cisgender women, and levonorgestrel and ethinyl estradiol (LNG/EE), a combined oral contraceptive (COC). The DPP is likely to complete FDA regulatory requirements for approval and could reach the market in 2024, pending regulatory approval. Clinical cross-over acceptability studies for the DPP in South Africa and Zimbabwe are currently evaluating adherence, acceptability, and preference for a single, over-encapsulated DPP. The development of counseling recommendations for the DPP is crucial for its successful implementation. A working group of eight HIV and FP experts with clinical and implementation expertise developed counseling recommendations for the DPP based on existing PrEP/COC guidance. The working group conducted a mapping of counseling messages from COC and oral PrEP guidance and provider training materials, prioritizing six topics: uptake, missed pills, side effects, discontinuation and switching, drug interactions, and monitoring. The counseling recommendations for the DPP include taking one pill every day for the DPP until the pack is empty, with days 1-21 containing COC and oral PrEP, and days 22-28 containing oral PrEP only. If a woman misses one pill multiple times in a month or 2+ consecutive pills, she should take the DPP as soon as she remembers, but not take more than 2 pills in a day. If 2+ consecutive pills are missed, only the last missed pill should be taken, and the other missed pills discarded. The recommendations also address side effects, discontinuation and switching, drug interactions, and monitoring. The development of the DPP and its counseling recommendations is a significant step forward in addressing the persistent shortcomings in women's access to comprehensive SRH services. The DPP has the potential to transform the prevention field by providing a convenient and effective solution for women to prevent both HIV and pregnancy.