{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T17:04:08Z","timestamp":1792688648227,"version":"4.5.0"},"reference-count":62,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T00:00:00Z","timestamp":1684713600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Reprod. Health"],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>The pipeline for multi-purpose prevention technologies includes products that simultaneously prevent HIV, pregnancy and\/or other sexually transmitted infections. Among these, the Dual Prevention Pill (DPP) is a daily pill co-formulating oral pre-exposure prophylaxis (PrEP), and combined oral contraception (COC). Clinical cross-over acceptability studies for the DPP require training providers to counsel on a combined product. From February 2021\u2013April 2022, 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Assessment of policy\/guidelines options and implications<\/jats:title><jats:p>The working group conducted a mapping of counseling messages from COC and oral PrEP guidance and provider training materials. Six topics were prioritized: uptake, missed pills, side effects, discontinuation and switching, drug interactions and monitoring. Additional evidence and experts were consulted to answer outstanding questions and counseling recommendations for the DPP were developed. <jats:italic>Missed pills<\/jats:italic> was the topic with the most complexity, raising questions about whether women could \u201cdouble up\u201d on missed pills or skip the last week of the pack to recover protection faster. <jats:italic>Uptake<\/jats:italic> required aligning the time to reach protective levels for both DPP components and explaining the need to take DPP pills during week 4 of the pack. The potential intensity of DPP <jats:italic>side effects<\/jats:italic>, given the combination of oral PrEP with COC, was an important consideration. <jats:italic>Discontinuation and switching<\/jats:italic> looked at managing risk of HIV and unintended pregnancy when stopping or switching from the DPP. Guidance on <jats:italic>drug interactions<\/jats:italic> contended with differing contraindications for COC and PrEP. <jats:italic>Monitoring<\/jats:italic> required balancing clinical requirements with potential user burden.<\/jats:p><\/jats:sec><jats:sec><jats:title>Actionable recommendations<\/jats:title><jats:p>The working group developed counseling recommendations for the DPP to be tested in clinical acceptability studies. <jats:italic>Uptake<\/jats:italic>: Take one pill every day for the DPP until the pack is empty. Days 1\u201321 contain COC and oral PrEP. Days 22\u201328 do not contain COC to allow for monthly bleeding, but do contain oral PrEP and pills should be taken to maintain HIV protection. Take the DPP for 7 consecutive days to reach protective levels against pregnancy and HIV. <jats:italic>Missed pills<\/jats:italic>: If you miss 1 pill multiple times in a month or 2+ consecutive pills, take the DPP as soon as you remember. Do not take more than 2 pills in a day. If 2+ consecutive pills are missed, only take the last missed pill and discard the other missed pills. <jats:italic>Side effects<\/jats:italic>: You may experience side effects when you start using the DPP, including changes to monthly bleeding. Side effects are typically mild and go away without treatment. <jats:italic>Discontinuation\/switching<\/jats:italic>: If you decide to discontinue use of the DPP, but want to be protected from HIV and\/or unintended pregnancy, in most cases, you can begin using PrEP or another contraceptive method right away. <jats:italic>Drug interactions<\/jats:italic>: There are no drug-drug interactions from combining oral PrEP and COC in the DPP. Certain medications are not recommended due to their contraindication with oral PrEP or COC. <jats:italic>Monitoring<\/jats:italic>: You will need to get an HIV test prior to initiating or restarting the DPP, and every 3 months during DPP use. Your provider may recommend other screening or testing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Developing recommendations for the DPP as a novel MPT posed unique challenges, with implications for efficacy, cost, and user and provider comprehension and burden. Incorporating counseling recommendations into clinical cross-over acceptability studies allows for real-time feedback from providers and users. Supporting women with information to use the DPP correctly and confidently is critically important for eventual scale and commercialization.<\/jats:p><\/jats:sec>","DOI":"10.3389\/frph.2023.1155948","type":"journal-article","created":{"date-parts":[[2023,5,22]],"date-time":"2023-05-22T04:44:53Z","timestamp":1684730693000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":7,"title":["Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond"],"prefix":"10.3389","volume":"5","author":[{"given":"Kate","family":"Segal","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle M.","family":"Harris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andy","family":"Carmone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa B.","family":"Haddad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay","family":"Hadigal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"Hatzold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Lathrop","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Mason","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meridith","family":"Mikulich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,5,22]]},"reference":[{"key":"B1","year":""},{"key":"B2","volume-title":"State of the world population 2022","year":"2022"},{"key":"B3","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1016\/S0140-6736(22)00936-9","article-title":"Measuring contraceptive method mix, prevalence, and demand satisfied by age and marital status in 204 countries and territories, 1970\u20132019: a systematic analysis for the Global Burden of Disease Study 2019","volume":"400","author":"Haakenstad","year":"2022","journal-title":"Lancet"},{"key":"B4","doi-asserted-by":"publisher","first-page":"502","DOI":"10.1016\/j.chom.2020.03.020","article-title":"PrEP for HIV prevention: evidence, global scale-up, and emerging options","volume":"27","author":"Celum","year":"2020","journal-title":"Cell Host Microbe"},{"key":"B5","doi-asserted-by":"publisher","first-page":"313","DOI":"10.1097\/QAI.0000000000001093","article-title":"Intimate\u00a0partner violence and adherence to HIV pre-exposure prophylaxis (PrEP) in African women in HIV serodiscordant relationships: a prospective cohort study","volume":"73","author":"Roberts","year":"2016","journal-title":"J Acquir Immune Defic Syndr"},{"key":"B6","doi-asserted-by":"publisher","first-page":"e0248307","DOI":"10.1371\/journal.pone.0248307","article-title":"Experiences of oral pre-exposure prophylaxis (PrEP) use disclosure among South African adolescent girls and young women and its perceived impact on adherence","volume":"16","author":"Giovenco","year":"2021","journal-title":"PLoS One"},{"key":"B7","year":""},{"key":"B8","doi-asserted-by":"publisher","first-page":"145","DOI":"10.12688\/gatesopenres.13330.2","article-title":"Integration of HIV and sexual and reproductive health in the era of anti-retroviral-based prevention: findings from assessments in Kenya, Malawi and Zimbabwe [version 2; 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