N/A
N=106
Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP
HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT04897737 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Recent PrEP Adherence — 33; 18 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIVST and enhanced adherence biofeedback (Behavioral); Orasure/UrSure test (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recent PrEP Adherence |
33; 18 | <0.001 sig |
| SECONDARY Participant Partners Who Tested for HIV |
35; 9 | <0.001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04897737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.