Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond
IntroductionThe 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...
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-05-01
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| Series: | Frontiers in Reproductive Health |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/frph.2023.1155948/full |
| _version_ | 1797822561155809280 |
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| author | Kate Segal Danielle M. Harris Andy Carmone Lisa B. Haddad Sanjay Hadigal Karin Hatzold Chris Jones Eva Lathrop Jennifer Mason Meridith Mikulich |
| author_facet | Kate Segal Danielle M. Harris Andy Carmone Lisa B. Haddad Sanjay Hadigal Karin Hatzold Chris Jones Eva Lathrop Jennifer Mason Meridith Mikulich |
| author_sort | Kate Segal |
| collection | DOAJ |
| description | IntroductionThe 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–April 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.Assessment of policy/guidelines options and implicationsThe 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. Missed pills was the topic with the most complexity, raising questions about whether women could “double up” on missed pills or skip the last week of the pack to recover protection faster. Uptake 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 side effects, given the combination of oral PrEP with COC, was an important consideration. Discontinuation and switching looked at managing risk of HIV and unintended pregnancy when stopping or switching from the DPP. Guidance on drug interactions contended with differing contraindications for COC and PrEP. Monitoring required balancing clinical requirements with potential user burden.Actionable recommendationsThe working group developed counseling recommendations for the DPP to be tested in clinical acceptability studies. Uptake: Take one pill every day for the DPP until the pack is empty. Days 1–21 contain COC and oral PrEP. Days 22–28 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. Missed pills: 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. Side effects: 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. Discontinuation/switching: 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. Drug interactions: 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. Monitoring: 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.DiscussionDeveloping 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. |
| first_indexed | 2024-03-13T10:09:54Z |
| format | Article |
| id | doaj.art-cb9c83165f784ff6a7b0467310481ba7 |
| institution | Directory Open Access Journal |
| issn | 2673-3153 |
| language | English |
| last_indexed | 2024-03-13T10:09:54Z |
| publishDate | 2023-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Reproductive Health |
| spelling | doaj.art-cb9c83165f784ff6a7b0467310481ba72023-05-22T04:44:38ZengFrontiers Media S.A.Frontiers in Reproductive Health2673-31532023-05-01510.3389/frph.2023.11559481155948Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyondKate Segal0Danielle M. Harris1Andy Carmone2Lisa B. Haddad3Sanjay Hadigal4Karin Hatzold5Chris Jones6Eva Lathrop7Jennifer Mason8Meridith Mikulich9AVAC, Product Introduction and Access, New York, NY, United StatesCatalyst Global, Carlsbad, CA, United StatesClinton Health Access Initiative (CHAI), Boston, MA, United StatesPopulation Council, Center for Biomedical Research, New York, NY, United StatesViatris, Department of Global Medical Affairs, Pittsburgh, PA, United StatesPopulation Services International (PSI), Washington, DC, United StatesMann Global Health, Columbus, NC, United StatesPopulation Services International (PSI), Washington, DC, United StatesUnited States Agency for International Development (USAID), Office of Population and Reproductive Health, Bureau of Global Health, Washington, DC, United StatesUnited States Agency for International Development (USAID), Office of Population and Reproductive Health, Bureau of Global Health, Washington, DC, United StatesIntroductionThe 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–April 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.Assessment of policy/guidelines options and implicationsThe 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. Missed pills was the topic with the most complexity, raising questions about whether women could “double up” on missed pills or skip the last week of the pack to recover protection faster. Uptake 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 side effects, given the combination of oral PrEP with COC, was an important consideration. Discontinuation and switching looked at managing risk of HIV and unintended pregnancy when stopping or switching from the DPP. Guidance on drug interactions contended with differing contraindications for COC and PrEP. Monitoring required balancing clinical requirements with potential user burden.Actionable recommendationsThe working group developed counseling recommendations for the DPP to be tested in clinical acceptability studies. Uptake: Take one pill every day for the DPP until the pack is empty. Days 1–21 contain COC and oral PrEP. Days 22–28 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. Missed pills: 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. Side effects: 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. Discontinuation/switching: 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. Drug interactions: 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. Monitoring: 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.DiscussionDeveloping 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.https://www.frontiersin.org/articles/10.3389/frph.2023.1155948/fullpre-exposure prophlyaxisoral contraceptionHIV preventionfamily planningsexual and reproductive healthmulti-purpose prevention technologies |
| spellingShingle | Kate Segal Danielle M. Harris Andy Carmone Lisa B. Haddad Sanjay Hadigal Karin Hatzold Chris Jones Eva Lathrop Jennifer Mason Meridith Mikulich Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond Frontiers in Reproductive Health pre-exposure prophlyaxis oral contraception HIV prevention family planning sexual and reproductive health multi-purpose prevention technologies |
| title | Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond |
| title_full | Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond |
| title_fullStr | Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond |
| title_full_unstemmed | Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond |
| title_short | Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond |
| title_sort | equipping providers to offer novel mpts developing counseling messages for the dual prevention pill in clinical studies and beyond |
| topic | pre-exposure prophlyaxis oral contraception HIV prevention family planning sexual and reproductive health multi-purpose prevention technologies |
| url | https://www.frontiersin.org/articles/10.3389/frph.2023.1155948/full |
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