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

Phase 4

Completed

• Conditions: Hiv

• Registration Number: NCT03826199
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-08-23
• Primary Completion: 2021-12-01
• Results First Submitted: 2023-01-05
• Results First Submitted QC: 2023-03-13
• Results First Posted: 2023-03-16
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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Exclusion Criteria

Failure to meet any of the inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PrEP Retention	18 months	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
PrEP Adherence	3 months	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)

Secondary Outcome Measures

Name	Time	Method
PrEP Initiation	18 months	number of women who initiate PrEP over time/ total number of women in active cohort
PrEP Adherence (Peri-sexual)	3 months	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)
PrEP Adherence (Subjective, Self-reported)	3 months	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)

Trial Locations

Locations (1)

Gugulethu Midwife Obstetric Unit; 🇿🇦 Cape Town, South Africa