Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)

NCT03826199 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: K01TW011187
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.

Conditions

Hiv

Keywords

pre-exposure prophylaxis; PrEP; pregnancy; prevention of mother to child transmission; PMTCT

Outcome Measures

Primary Outcomes (2)

• PrEP Retention

  number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP

  18 months

• PrEP Adherence

  number of women taking PrEP who have \>80 percent levels at \>40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)

  3 months

Secondary Outcomes (3)

• PrEP Initiation

  18 months

• PrEP Adherence (Peri-sexual)

  3 months

• PrEP Adherence (Subjective, Self-reported)

  3 months

Interventions

TDF-FTC DRUG

We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.

Also known as: PrEP, Truvada

Counselling on PrEP in antenatal and postnatal care BEHAVIORAL

Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Only pregnant women will be included
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen HIV test at study enrollment
• No previous exposure triple-drug antiretroviral therapy
• Age 18 years or older
• Lives within 20 kilometers of a clinic
• Without psychiatric or medical contraindications to PrEP use
• Able to provide informed consent for research

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Cape Town: collaborator
• Desmond Tutu HIV Foundation: collaborator

Study Sites (1)

Gugulethu Midwife Obstetric Unit

Cape Town, South Africa

Location

Related Publications (6)

• Joseph Davey D, Myer L, Coates T. PrEP implementation in pregnant and post-partum women. Lancet HIV. 2020 Jan;7(1):e5-e6. doi: 10.1016/S2352-3018(19)30371-6. Epub 2019 Dec 5. No abstract available.

  PMID: 31813838 BACKGROUND

• 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

• 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

• 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

• 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

• 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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Prenatal Care; Postnatal Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

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; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Perinatal Care

Results Point of Contact

• Title: Dvora Joseph Davey
• Organization: UCLA

dvoradavey@ucla.edu

3107011526

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label cohort study

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 1, 2019
• Study Start: August 23, 2019
• Primary Completion: December 1, 2021
• Study Completion: September 30, 2023
• Last Updated: December 1, 2023
• Results First Posted: March 16, 2023

Record last verified: 2023-11

Locations

ZA (1)