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Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP

NCT04897737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-12-08

Study results available
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Summary

The postpartum PrEP study (PPS) seeks to evaluate how best to improve adherence to PrEP in postpartum women and to evaluate how acceptable it is to offer HIV self tests for the participant and partner, and provide enhanced adherence biofeedback following a urine test of recent PrEP use (measuring tenofovir). The primary outcome is recent PrEP adherence following the intervention. The secondary outcome is HIV testing uptake in participants' partners.

Conditions

Interventions

BEHAVIORAL

HIVST and enhanced adherence biofeedback

The intervention includes the provision of an OraQuick HIV self-test (HIVST) for the woman and one test for each of her reported sex partners, along with instructions on how to use and interpret the results. Women were asked to report back within one month if their partner was able to test via a SMS, WhatsApp or by bringing in the test to confirm that he had tested. Women then received adherence based feedback following the urine lateral flow assay (that measures recent tenofovir use in past 48 hours). Study counsellors requested that women provide a urine sample that was tested using the UrSure/Orasure test that provides feedback on the result in 2-3 minutes. Counselors provided counseling based on the results including how to improve daily adherence (for women without tenofovir present in their urine) and importance of condom use.

DIAGNOSTIC_TEST

Orasure/UrSure test

See above

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2021-04-30
Completion
2021-05-18

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897737 on ClinicalTrials.gov