Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
PrEP
Increasing Family-based Support for PrEP Adherence Among Discordant Couples Through Storytelling
1 other identifier
interventional
128
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedResults Posted
Study results publicly available
July 25, 2024
CompletedJuly 25, 2024
February 1, 2024
2.5 years
August 23, 2019
June 20, 2023
February 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence to PrEP Medication
Maternal adherence to medication as measured via monthly medication pick up records
3 months
Study Arms (2)
Standard of Care
ACTIVE COMPARATORStandard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men)
Storytelling Intervention
EXPERIMENTALParticipants in this group will receive the same services as those in the SOC but will also be provided three storytelling sessions for themselves and their families as a way to educate and de-stigmatize PrEP services.
Interventions
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
Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- Friends in Global Healthcollaborator
Study Sites (1)
Minisitry of Health Health Facility
Quelimane, Zambezia Province, Mozambique
Related Publications (1)
Sack DE, De Schacht C, Paulo P, Graves E, Emilio AM, Matino A, Fonseca CL, Aboobacar AU, Van Rompaey S, Audet CM. Pre-exposure prophylaxis use among HIV serodiscordant couples: a qualitative study in Mozambique. Glob Health Action. 2021 Jan 1;14(1):1940764. doi: 10.1080/16549716.2021.1940764.
PMID: 34229580DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carolyn Audet
- Organization
- Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start
January 1, 2021
Primary Completion
June 20, 2023
Study Completion
June 20, 2023
Last Updated
July 25, 2024
Results First Posted
July 25, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share