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Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use

Increasing Family-based Support for PrEP Adherence Among Discordant Couples Through Storytelling

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04071470
Acronym
PrEP
Enrollment
128
Registered
2019-08-28
Start date
2021-01-01
Completion date
2023-06-20
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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 70 HIV-uninfected pregnant women and 70 of their HIV-infected partners (total 140) 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.

Interventions

BEHAVIORALStorytelling

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

DRUGPrEP

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

Sponsors

Friends in Global Health
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

We will be comparing standard of care PrEP services with a storytelling intervention arm

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to PrEP Medication3 monthsMaternal adherence to medication as measured via monthly medication pick up records

Countries

Mozambique

Participant flow

Participants by arm

ArmCount
Standard of Care
Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men) PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
62
Storytelling Intervention
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. 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 PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
66
Total128

Baseline characteristics

CharacteristicStorytelling InterventionTotalStandard of Care
Age, Continuous25.8 years
STANDARD_DEVIATION 6.64
25.1 years
STANDARD_DEVIATION 6.17
24.5 years
STANDARD_DEVIATION 5.59
Occupation
Domestic
26 Participants49 Participants23 Participants
Occupation
Farmer
21 Participants43 Participants22 Participants
Occupation
Fisherman
1 Participants1 Participants0 Participants
Occupation
Merchant
6 Participants16 Participants10 Participants
Occupation
Other
12 Participants19 Participants7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
66 Participants128 Participants62 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
33 Participants64 Participants31 Participants
Sex: Female, Male
Male
33 Participants64 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 660 / 62
other
Total, other adverse events
0 / 660 / 62
serious
Total, serious adverse events
0 / 660 / 62

Outcome results

Primary

Adherence to PrEP Medication

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

Time frame: 3 months

Population: We only looked at PrEP use among the women in the study

ArmMeasureValue (MEDIAN)
Standard of CareAdherence to PrEP Medication96.6 percentage of pills taken daily
Storytelling InterventionAdherence to PrEP Medication95.5 percentage of pills taken daily

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026