Skip to main content
OpenTrials
Completed

NCT Number: NCT04897737

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gugulethu Midwife Obstetric Unit

Cape Town, South Africa

About this study

Pregnant and breastfeeding women in South Africa are at very high risk of HIV acquisition and vertical HIV transmission during pregnancy, labour and breastfeeding. One-third to half of perinatal HIV transmission occurs in women who are seroconvert during the pregnancy and post-partum period. Effective use of pre-exposure prophylaxis (PrEP) could contribute to eliminating maternal HIV acquisition, and hence mother to child transmission (MTCT) of HIV. However, PrEP efficacy requires high levels of adherence, and adherence requires high levels of acceptability, yet there are few data on how best to promote adherence to PrEP in postpartum women.

We will conduct a study of the feasibility and acceptability of an adherence promotion package in n=100 postpartum women enrolled in an ongoing PrEP study (PrEP-PP; ongoing, R01MH116771) to evaluate the feasibility, acceptability and efficacy of a package of interventions to improve PrEP adherence in pregnancy and postpartum women. Specifically the package of interventions will include:

  • Offer of HIV self-test in women and their partners with counseling on use
  • Integrating urine based lateral flow assays in enhanced counseling using biofeedback on adherence levels to postpartum women on PrEP

The primary outcome is recent PrEP adherence at 1-month following the intervention. The secondary outcome is HIV testing uptake in participants' partners.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently enrolled in PrEP-PP study and on PrEP
  • 18+ years old
  • confirmed HIV-negative (confirmed with a 4th generation antigen HIV test)
  • confirmed to be postpartum (1-6 months postpartum)
  • confirmed to currently have a male partner
  • confirmed to have a cell phone that can read and respond to SMS/Whatsapp messages

Exclusion criteria

Failure to meet all of inclusion criteria

Treatment and study plan

HIVST and enhanced adherence biofeedback

Behavioral

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.

Other names: urine tenofovir test, HIV self test

Orasure/UrSure test

Diagnostic Test

See above

Other names: urine tenofovir test

Primary outcomes

  1. Recent PrEP Adherence

    Time frame: 1 month after intervention

    The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.

Secondary outcomes

  1. Participant Partners Who Tested for HIV

    Time frame: 1 month after intervention

    The secondary outcome was number of partners who tested for HIV (as reported by the female partner and confirmed with photo or used HIVST in intervention arm) by study arm.

Other outcomes

  1. Adverse Events

    Time frame: During study monitoring

    Any adverse event occurring in the study including intimate partner violence, relationship issues, or conflict

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • University of Cape Town

Registry information

Official study title

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

Acronym: PPS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2021
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.