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Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use

NCT04071470 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-07-25

Study results available
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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).

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Storytelling

Couples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP

DRUG

PrEP

Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC

Sponsors & Collaborators

  • Friends in Global Health

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-06-20
Completion
2023-06-20

Countries

  • Mozambique

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071470 on ClinicalTrials.gov