Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women

NCT03902418 | Completed Results DMC FDA Drug

• 1 other identifier: 1R01MH116771-01A1
• Study Type: observational
• Target: 1,195
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain subdistrict of the Metro Region (to be identified in conjunction with provincial and local health authorities) Midwife Obstetric Units in Cape Town (n=600 pregnant women per site). The enrolled women will be followed through 12-months post-delivery.

Conditions

HIV-I Infection

Keywords

Prevention in Pregnant and Breastfeeding Women; HIV Pre-Exposure Prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (5)

• Participants Initiating Pre-exposure Prophylaxis During Pregnancy

  Percentage of participants initiating pre-exposure prophylaxis during pregnancy

  Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant

• Adherence to TDF at 3-months on PrEP

  Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 3 months on PrEP

  Measured at 3 month follow up visit

• Women Initiating Pre-exposure Prophylaxis Post-partum

  Percentage of women initiating pre-exposure prophylaxis

  Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth

• Adherence to TDF at 6 Months Post-partum

  Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 6 month post-partum visit

  Measured at 6-month post-partum visit

• Number of Participants With Adherence to TFV-DP at 6-month Visit

  Quantifiable TFV (versus none) using dried blood spots (DBS) taken at 6-month study visit among subset of women who reported taking PrEP in the last 30-days at 6-months

  Measured at 6-month study visit

Secondary Outcomes (1)

• PrEP Initiation Among Those With STI POC Testing vs Syndromic Management

  Measured at enrollment and 1 month follow up

Interventions

emtricitabine/tenofovir DRUG

Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired

Also known as: Behavioral Counseling

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study counselors will enroll consecutive eligible, consenting pregnant adolescent girls (\>16 years) and women in ANC (n=600 women per site; N=1200 pregnant women) and follow them up for 12-months postpartum or until censorship for a mean of 18-months' follow-up. In a sub-study, STI and PrEP in Pregnancy Study (STIPPS), we will include n=268 women who recieve point of care STI results vs. those treated syndromically to evaluate PrEP initiation in pregnancy.

You may qualify if:

• \>16 years of age,
• 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

You may not qualify if:

• Concurrent enrollment in another HIV-1 vaccine or prevention trial;
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Cape Town: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, South Africa

Location

Related Publications (16)

• 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.

  PMID: 32576023 BACKGROUND

• 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.

  PMID: 37882113 RESULT

• 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.

  PMID: 37795521 RESULT

• 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.

  PMID: 37721699 RESULT

• 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.

  PMID: 36947792 RESULT

• 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.

  PMID: 36480171 RESULT

• 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.

  PMID: 36050648 RESULT

• 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.

  PMID: 35972853 RESULT

• 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.

  PMID: 35737280 RESULT

• 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.

  PMID: 35316471 RESULT

• 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.

  PMID: 35138678 RESULT

• 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.

  PMID: 35097151 RESULT

• 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.

  PMID: 35090604 RESULT

• 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.

  PMID: 34287756 RESULT

• 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.

  PMID: 34085132 RESULT

• 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.

  PMID: 38124133 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Behavior Therapy

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

We originally indicated reporting "Participants Missing Pre-natal Visit" as a Secondary Outcome, however are unable to report as the data is unavailable.

Results Point of Contact

• Title: Landon Myer
• Organization: University of CApe Town

landon.myer@uct.ac.za

0829430578

Study Officials

• Landon Myer, MD PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: April 4, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 23, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-10

Locations

ZA (1)