Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial

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dc.contributor.authorJoseph Davey, Dvora L.
dc.contributor.authorDovel, Kathryn
dc.contributor.authorCleary, Susan
dc.contributor.authorKhadka, Nehaa
dc.contributor.authorMashele, Nyiko
dc.contributor.authorSilliman, Miriam
dc.contributor.authorMvududu, Rufaro
dc.contributor.authorNyemba, Dorothy C.
dc.contributor.authorCoates, Thomas J.
dc.contributor.authorMyer, Landon
dc.date.accessioned2022-09-15T11:53:57Z
dc.date.available2022-09-15T11:53:57Z
dc.date.issued2022-07-07
dc.date.updated2022-07-10T03:19:11Z
dc.description.abstractBackground HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women’s engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use. Methods Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation. Discussion This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting. Trial registration NCT05322629 : Date of registration: April 12, 2022.en_US
dc.identifier.citationBMC Public Health. 2022 Jul 07;22(1):1306
dc.identifier.citationBMC Public Health. 2022 Jul 07;22(1):1306
dc.identifier.urihttps://doi.org/10.1186/s12889-022-13652-5
dc.identifier.urihttp://hdl.handle.net/11427/36813
dc.language.isoenen_US
dc.language.rfc3066en
dc.publisher.departmentDepartment of Public Health and Family Medicineen_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceBMC Public Healthen_US
dc.source.journalissue1en_US
dc.source.journalvolume22en_US
dc.source.pagination1306en_US
dc.subjectPre-exposure prophylaxisen_US
dc.subjectPrEPen_US
dc.subjectPMTCTen_US
dc.subjectPregnanten_US
dc.subjectBreastfeedingen_US
dc.subjectSouth Africaen_US
dc.subjectPersistenceen_US
dc.subjectPersistenceen_US
dc.subjectProtocolen_US
dc.subjectRandomized control trialen_US
dc.subjectEconomic evaluationen_US
dc.titleStepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trialen_US
dc.typeJournal Articleen_US
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