CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
HIVST and enhanced adherence biofeedback +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04897737
NCT04897737N/ACompleted

Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP)

University of California, Los Angeles·interventional·Posted May 21, 2021·Updated Dec 8, 2023

In Brief

A clinical study evaluating HIVST and enhanced adherence biofeedback and Orasure/UrSure test for HIV-1-infection. Completed, enrolled 106 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesSouth Africa

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 21, 2021
Enrollment StartNov 5, 2020
Primary CompletionApr 30, 2021
Study CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.1 years ago

Interventions

HIVST and enhanced adherence biofeedbackbehavioral

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.

Orasure/UrSure testother

See above