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

Hiv Clinical Trial

— PrEP-PP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826199
• Other study ID #: K01TW011187
• Status: Completed
• Phase: Phase 4
• Start date: August 23, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. No previous exposure triple-drug antiretroviral therapy

3. Age 18 years or older

4. Lives within 20 kilometers of a clinic

5. Without psychiatric or medical contraindications to PrEP use

6. Able to provide informed consent for research Exclusion Criteria: Failure to meet any of the inclusion criteria

Related Conditions & MeSH terms

• Hiv

Intervention

Drug:
• TDF-FTC
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.

Behavioral:
• Counselling on PrEP in antenatal and postnatal care
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.

Locations

Country	Name	City	State
South Africa	Gugulethu Midwife Obstetric Unit	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Desmond Tutu HIV Foundation, University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & Publications (6)

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 — View Citation

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. — View Citation

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 T — View Citation

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 — View Citation

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 wom — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PrEP Initiation	number of women who initiate PrEP over time/ total number of women in active cohort	18 months
Secondary	PrEP Adherence (Peri-sexual)	number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)	3 months
Secondary	PrEP Adherence (Subjective, Self-reported)	number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)	3 months