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Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use (PrEP)

Primary Purpose

HIV Infections

Status
Active
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
Storytelling
PrEP
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Pregnant women/male partner

  1. Discordant couple, one pregnant woman (HIV-) and her HIV+ male partner
  2. Both persons must agree to take PrEP (pregnant woman)/ART (male partner)
  3. The woman's due date is >4 weeks from study enrollment
  4. Both persons must be 18 years or older
  5. Both persons (parents) must be willing to consent to an infant record search
  6. Neither member of the couple can be under the influence of alcohol at the time of consent.

Family members of expectant couple

  1. Must be a relative living in the participants household or living in the study community
  2. Must agree to participate in at least one of the storytelling sessions;
  3. Must be 18 years of age or older
  4. Must not be under the influence of alcohol
  5. Must be willing to participate in the interview.

Exclusion Criteria:

Pregnant woman/Male Partner

1. One member of the couple is unwilling to enroll in treatment

Family members

  1. Unable to attend storytelling session
  2. Expectant couple expresses unwillingness for the family member to participate

Sites / Locations

  • Minisitry of Health Health Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Storytelling Intervention

Arm Description

Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men)

Participants 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.

Outcomes

Primary Outcome Measures

Adherence to PrEP medication
Maternal adherence to medication as measured via monthly medication pick up records

Secondary Outcome Measures

Partner/Family support
family support for PrEP use as measured via the Berlin Social Support Scale (a quantitative scale)

Full Information

First Posted
August 23, 2019
Last Updated
June 2, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
Friends in Global Health
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1. Study Identification

Unique Protocol Identification Number
NCT04071470
Brief Title
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Acronym
PrEP
Official Title
Increasing Family-based Support for PrEP Adherence Among Discordant Couples Through Storytelling
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Friends in Global Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Project Summary: Pregnancy and the postpartum period are associated with an increased risk of HIV acquisition. HIV acquisition is of particular concern during pregnancy and while the mother is breastfeeding given the associated increased risk of mother-to-child transmission (MTCT). Approximately 10% of pregnant women attending antenatal care (ANC) in Mozambique are in serodiscordant relationships (HIV-negative woman/ HIV-positive man). High rates of MTCT (14%; 12,000 infants/ year) may be affected by the high rate at which pregnant women seroconvert after their first ANC visit. Beginning in 2018, pre-exposure prophylaxis (PrEP) was available to serodiscordant couples, yet only 44% of pregnant women were retained in care at 3 months. Our current R01-funded project, Partners-based HIV Treatment for Seroconcordant Couples (R01MH113478), is testing a couple-based intervention for HIV-positive expectant parents living in extremely rural communities. Our Men for Health intervention ("Homens para Saúde+"- HoPS+) consists of (1) couple-based HIV care and treatment; (2) couple-centered education; and (3) expert-patient support. Preliminary data the HoPS+ study suggest that couple-based counseling and education is more successful at reducing maternal depression than individual care. However, couple-based sessions have not led to significantly greater improvements in HIV knowledge or social support. Given the importance of these factors on treatment adherence, this grant would allow us to revise the peer engagement strategy to increase knowledge transfer and engender partner support. The investigators propose testing the impact of a peer-delivered oral storytelling intervention to increase retention in, and adherence to, PrEP/ART among expectant serodiscordant couples. People are 7 times more likely to remember a story compared to facts alone. Couples are also highly influenced by their immediate and extended families; >95% of patients disclose their HIV status to members of their family. The investigators hypothesize that the use of oral storytelling will facilitate learning and encourage family support and advocacy. The investigator will compare this model to couple-based education and counseling. This innovative intervention tests a culturally relevant approach to improve ART/PrEP delivery. The investigators propose a rigorous individually randomized controlled trial at one of our current HoPS+ sites where 11% of expectant couples were serodiscordant in 2018. The investigators will randomize 35 HIV-uninfected pregnant women and their HIV-infected partners to either the intervention or control condition. The Specific Aims of this study are: (1) Compare the effect of a storytelling intervention (vs. couples-based counseling) on participant knowledge, motivation, and behavioral skills associated with PrEP retention and adherence; and (2) Evaluate the impact of a storytelling intervention on adherence to PrEP/ART medications. Our team of Mozambican and U.S. investigators has a proven record of international HIV research success, specific recent experience with partner-based HIV and PrEP delivery, and experience with the use of theater/storytelling to change HIV-related behaviors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will be comparing standard of care PrEP services with a storytelling intervention arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men)
Arm Title
Storytelling Intervention
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
Storytelling
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PrEP
Intervention Description
Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
Primary Outcome Measure Information:
Title
Adherence to PrEP medication
Description
Maternal adherence to medication as measured via monthly medication pick up records
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Partner/Family support
Description
family support for PrEP use as measured via the Berlin Social Support Scale (a quantitative scale)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 1. 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
Facility Information:
Facility Name
Minisitry of Health Health Facility
City
Quelimane
State/Province
Zambezia
Country
Mozambique

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34229580
Citation
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.
Results Reference
derived

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Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use

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