Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
NCT ID: NCT03902418
Last Updated: 2024-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
1195 participants
OBSERVATIONAL
2019-07-01
2024-09-30
Brief Summary
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Detailed Description
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1\. Determine the distribution of women across the PrEP cascade:
1. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP out of all women offered PrEP
2. Evaluate the proportion of pregnant and breastfeeding women who are retained in the PrEP cohort
3. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP who adhere to PrEP using objective dried blood spot measures and subjective measures of self-reported pill count and adherence
4. Evaluate the proportion of pregnant and breastfeeding women on PrEP (and not on PrEP) who acquire HIV, who transmit HIV to their infant, and who report adverse events 2. Evaluate patient and provider-level factors associated with the PrEP cascade using quantitative and qualitative approaches (including in-depth interviews) 3. Apply an established mathematical model to simulate the impact of improvement in the PrEP cascade on HIV infections averted (maternal and perinatal)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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emtricitabine/tenofovir
Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* confirmed HIV-negative (using 2 rapid tests,
* confirmed with a 4th generation antigen HIV test;
* lives within 20 km. of the clinic;
* confirmed to be pregnant;
* without psychiatric or medical contraindications to PrEP
Exclusion Criteria
* medical hospitalization in the past year for any reason;
* receipt of TB treatment in the past 30 days; history of renal disease;
* exhibiting psychotic symptoms (including hallucinations, suicidal or homicidal ideation, or violent behavior),
* currently or history of taking anti-psychotic medications;
* positive Hepatitis B surface antigen test on screening;
* history of bone fracture not related to trauma;
* any other medical, psychiatric, or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study.
16 Years
FEMALE
No
Sponsors
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University of Cape Town
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Dvora Joseph Davey, PhD, MPH
Principal Investigator
Principal Investigators
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Landon Myer, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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University of Cape Town
Cape Town, Western Cape, South Africa
Countries
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References
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Joseph Davey DL, Daniels J, Beard C, Mashele N, Bekker LG, Dovel K, Ncayiyana J, Coates TJ, Myer L. Healthcare provider knowledge and attitudes about pre-exposure prophylaxis (PrEP) in pregnancy in Cape Town, South Africa. AIDS Care. 2020 Oct;32(10):1290-1294. doi: 10.1080/09540121.2020.1782328. Epub 2020 Jun 23.
Joseph Davey DL, Wilkinson L, Grimsrud A, Nelson A, Gray A, Raphael Y, Wattrus C, Pillay Y, Bekker LG. Urgent appeal to allow all professional nurses and midwives to prescribe pre-exposure prophylaxis (PrEP) in South Africa. S Afr Med J. 2023 Aug 3;113(8):12-16. doi: 10.7196/SAMJ.2023.v113i8.1191. No abstract available.
Khadka N, Gorbach PM, Nyemba DC, Mvududu R, Mashele N, Javanbakht M, Nianogo RA, Aldrovandi GM, Bekker LG, Coates TJ, Myer L, Joseph Davey DL. Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa. Front Reprod Health. 2023 Sep 19;5:1224474. doi: 10.3389/frph.2023.1224474. eCollection 2023.
Li KT, Li F, Jaspan H, Nyemba D, Myer L, Aldrovandi G, Joseph-Davey D. Changes in the Vaginal Microbiome During Pregnancy and the Postpartum Period in South African Women: a Longitudinal Study. Reprod Sci. 2024 Jan;31(1):275-287. doi: 10.1007/s43032-023-01351-4. Epub 2023 Sep 18.
Haribhai S, Khadka N, Mvududu R, Mashele N, Bekker LG, Gorbach P, Coates TJ, Myer L, Joseph Davey DL. Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study. Int J STD AIDS. 2023 Jul;34(8):548-556. doi: 10.1177/09564624231152776. Epub 2023 Mar 22.
Joseph Davey D, Nyemba DC, Castillo-Mancilla J, Wiesner L, Norman J, Mvududu R, Mashele N, Johnson LF, Bekker LG, Gorbach P, Coates TJ, Myer L. Adherence challenges with daily oral pre-exposure prophylaxis during pregnancy and the postpartum period in South African women: a cohort study. J Int AIDS Soc. 2022 Dec;25(12):e26044. doi: 10.1002/jia2.26044.
Joseph Davey D, Hsiao NY, Wendy Spearman C, Sonderup M, Hu NC, Mashele N, Mvududu R, Myer L. Low prevalence of hepatitis B virus infection in HIV-uninfected pregnant women in Cape Town, South Africa: implications for oral pre-exposure prophylaxis roll out. BMC Infect Dis. 2022 Sep 1;22(1):719. doi: 10.1186/s12879-022-07697-5.
Beesham I, Mansoor LE, Joseph Davey DL, Palanee-Phillips T, Smit J, Ahmed K, Selepe P, Louw C, Singata-Madliki M, Kotze P, Heffron R, Parikh UM, Wiesner L, Rees H, Baeten JM, Beksinska M. Brief Report: Quantifiable Plasma Tenofovir Among South African Women Using Daily Oral Pre-exposure Prophylaxis During the ECHO Trial. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):26-30. doi: 10.1097/QAI.0000000000003023. Epub 2022 Jun 9.
Miller AP, Shoptaw S, Mvududu R, Mashele N, Coates TJ, Bekker LG, Essack Z, Groenewald C, Petersen Z, Gorbach PM, Myer L, Joseph Davey DL. Sexual Risk among Pregnant Women at Risk of HIV Infection in Cape Town, South Africa: What Does Alcohol Have to Do with It? AIDS Behav. 2023 Jan;27(1):37-50. doi: 10.1007/s10461-022-03742-1. Epub 2022 Jun 23.
Beesham I, Dovel K, Mashele N, Bekker LG, Gorbach P, Coates TJ, Myer L, Joseph Davey DL. Barriers to Oral HIV Pre-exposure Prophylaxis (PrEP) Adherence Among Pregnant and Post-partum Women from Cape Town, South Africa. AIDS Behav. 2022 Sep;26(9):3079-3087. doi: 10.1007/s10461-022-03652-2. Epub 2022 Mar 22.
Joseph Davey DL, Mvududu R, Mashele N, Lesosky M, Khadka N, Bekker LG, Gorbach P, Coates TJ, Myer L. Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa. J Int AIDS Soc. 2022 Feb;25(2):e25866. doi: 10.1002/jia2.25866.
Joseph Davey DL, Dovel K, Mvududu R, Nyemba D, Mashele N, Bekker LG, Gorbach PM, Coates TJ, Myer L. Pre-exposure Prophylaxis Recent Adherence With Real-Time Adherence Feedback and Partner Human Immunodeficiency Virus Self-Testing: A Pilot Trial Among Postpartum Women. Open Forum Infect Dis. 2021 Dec 23;9(2):ofab609. doi: 10.1093/ofid/ofab609. eCollection 2022 Feb.
Joseph Davey DL, Bekker LG, Bukusi EA, Chi BH, Delany-Moretlwe S, Goga A, Lyerly AD, Mgodi NM, Mugo N, Myer L, Noguchi LM, Stranix-Chibanda L, Slack C, Pintye J. Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap. Lancet HIV. 2022 Mar;9(3):e214-e222. doi: 10.1016/S2352-3018(21)00280-0. Epub 2022 Jan 25.
Moran A, Mashele N, Mvududu R, Gorbach P, Bekker LG, Coates TJ, Myer L, Joseph Davey D. Maternal PrEP Use in HIV-Uninfected Pregnant Women in South Africa: Role of Stigma in PrEP Initiation, Retention and Adherence. AIDS Behav. 2022 Jan;26(1):205-217. doi: 10.1007/s10461-021-03374-x. Epub 2021 Jul 21.
Joseph Davey DL, Knight L, Markt-Maloney J, Tsawe N, Gomba Y, Mashele N, Dovel K, Gorbach P, Bekker LG, Coates TJ, Myer L. "I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa. AIDS Behav. 2021 Dec;25(12):3978-3986. doi: 10.1007/s10461-021-03320-x. Epub 2021 Jun 3.
de Voux A, Nyemba DC, Silliman M, Mashele N, Mvududu R, Myer L, Joseph Davey D. Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021-2022: randomised controlled trial. Sex Transm Infect. 2024 Feb 19;100(2):77-83. doi: 10.1136/sextrans-2023-055975.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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