Clinical trial NCT04897737: Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP
Official title: Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Keywords: PrEP
PMTCT
adherence
pregnant
postpartum
counseling
HIV self-testing
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2021-05-21
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recent PrEP Adherence
timeFrame: 1 month after intervention
Secondary outcomes:
measure: Participant Partners Who Tested for HIV
timeFrame: 1 month after intervention
Other outcomes:
measure: Adverse Events
timeFrame: During study monitoring
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Midwife Obstetric Unit
Study officials:
References:
citation: Joseph Davey DL, Dovel K, Mvududu R, Nyemba D, Mashele N, Bekker LG, Gorbach PM, Coates TJ, Myer L. Pre-exposure Prophylaxis Recent Adherence With Real-Time Adherence Feedback and Partner Human Immunodeficiency Virus Self-Testing: A Pilot Trial Among Postpartum Women. Open Forum Infect Dis. 2021 Dec 23;9(2):ofab609. doi: 10.1093/ofid/ofab609. eCollection 2022 Feb.