N/A
Completed N=128
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Source: ClinicalTrials.gov NCT04071470 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Adherence to PrEP Medication — 96.6; 95.5 percentage of pills taken daily
Summary
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women. The purpose of this proposal is to evaluate the clinical impact and mechanisms of a family-based storytelling intervention (vs. couples counseling) to improve PrEP adherence and retention among at-risk pregnant/lactating women and their HIV-infected male partners in rural Mozambique. This potentially high impact intervention provides the opportunity to test a culturally relevant approach to PrEP engagement; if proven feasible and effective, family-based storytelling for PrEP engagement could be adopted to reduce HIV incidence among pregnant/lactating women and eliminate mother-to-child transmission (MTCT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to PrEP Medication |
96.6; 95.5 | — |
Eligibility Criteria
Inclusion Criteria
Pregnant women/male partner
- Discordant couple, one pregnant woman (HIV-) and her HIV+ male partner
- Both persons must agree to take PrEP (pregnant woman)/ART (male partner)
- The woman's due date is >4 weeks from study enrollment
- Both persons must be 18 years or older
- Both persons (parents) must be willing to consent to an infant record search
- Neither member of the couple can be under the influence of alcohol at the time of consent.
Family members of expectant couple
- Must be a relative living in the participants household or living in the study community
- Must agree to participate in at least one of the storytelling sessions;
- Must be 18 years of age or older
- Must not be under the influence of alcohol
- Must be willing to participate in the interview.
Exclusion Criteria
Pregnant woman/Male Partner
- One member of the couple is unwilling to enroll in treatment
Family members
- Unable to attend storytelling session
- Expectant couple expresses unwillingness for the family member to participate
Data sourced from ClinicalTrials.gov (NCT04071470). 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. Informational only — not medical advice.