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

October 10, 2024 updated by: Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles

Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women

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.

Study Overview

Status

Completed

Conditions

HIV-I Infection

Intervention / Treatment

Drug: emtricitabine/tenofovir

Detailed Description

The objectives of the study are to:

1. Determine the distribution of women across the PrEP cascade:

Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP out of all women offered PrEP
Evaluate the proportion of pregnant and breastfeeding women who are retained in the PrEP cohort
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
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 Type

Observational

Enrollment (Actual)

1195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

South Africa
- Western Cape
  - Cape Town, Western Cape, South Africa
    - University of Cape Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Initiating Pre-exposure Prophylaxis During Pregnancy Time Frame: 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	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 Time Frame: 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	Measured at 3 month follow up visit
Women Initiating Pre-exposure Prophylaxis Post-partum Time Frame: 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	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 Time Frame: 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	Measured at 6-month post-partum visit
Number of Participants With Adherence to TFV-DP at 6-month Visit Time Frame: 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	Measured at 6-month study visit

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

University of Cape Town

Investigators

Principal Investigator: Landon Myer, MD PhD, University of Cape Town

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

1R01MH116771-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

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