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

Completed

• Conditions: HIV-I Infection

• Registration Number: NCT03902418
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

The objectives of the study are to:

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)

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-04
• Study Start: 2019-07-01
• Results First Submitted: 2023-12-22
• Results First Submitted QC: 2024-02-20
• Results First Posted: 2024-03-19
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1195

Inclusion Criteria

• >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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Women Initiating Pre-exposure Prophylaxis Post-partum	Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth	Percentage of women initiating pre-exposure prophylaxis
Adherence to TDF at 6 Months Post-partum	Measured at 6-month post-partum visit	Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 6 month post-partum visit
Number of Participants With Adherence to TFV-DP at 6-month Visit	Measured at 6-month study 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
Participants Initiating Pre-exposure Prophylaxis During Pregnancy	Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant	Percentage of participants initiating pre-exposure prophylaxis during pregnancy
Adherence to TDF at 3-months on PrEP	Measured at 3 month follow up visit	Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 3 months on PrEP

Secondary Outcome Measures

Name	Time	Method
PrEP Initiation Among Those With STI POC Testing vs Syndromic Management	Measured at enrollment and 1 month follow up	Proportion of those with POC (point of care) STI vs syndromic management who initiate oral PrEP

Trial Locations

Locations (1)

University of Cape Town; 🇿🇦 Cape Town, Western Cape, South Africa