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

HIV-1-infection Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04897737
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase N/A
Start date November 5, 2020
Completion date May 18, 2021
View Details
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