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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: HIV-1-infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04897737

K01TW011187

K01TW011187-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Currently enrolled in PrEP-PP study and on PrEP
2. 18+ years old
3. confirmed HIV-negative (confirmed with a 4th generation antigen HIV test)
4. confirmed to be postpartum (1-6 months postpartum)
5. confirmed to currently have a male partner
6. confirmed to have a cell phone that can read and respond to SMS/Whatsapp messages

Exclusion criteria

Failure to meet all of inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: HIVST and enhanced adherence biofeedback

Diagnostic Test: Orasure/UrSure test

Control

No Intervention group

Description:

Standard of care intervention including facility based HIV testing, referral for partner to attend facility for testing, and PrEP adherence counseling without biofeedback