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

Not Applicable

Completed

Interventions: Behavioral: HIVST and enhanced adherence biofeedback
Diagnostic Test: Orasure/UrSure test

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intervention	HIVST and enhanced adherence biofeedback	HIV self-testing kits and counseling on use for participant and partner use + enhanced adherence counseling including urine tenofovir test to provide biofeedback in women using PrEP
Intervention	Orasure/UrSure test	HIV self-testing kits and counseling on use for participant and partner use + enhanced adherence counseling including urine tenofovir test to provide biofeedback in women using PrEP

Primary Outcome Measures

Name	Time	Method
Recent PrEP Adherence	1 month after intervention	The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm.

Secondary Outcome Measures

Name	Time	Method
Participant Partners Who Tested for HIV	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.