Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
HIV Infections
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: We will be comparing standard of care PrEP services with a storytelling intervention armMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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%...

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.

Tracking Information

NCT #
NCT04071470
Collaborators
Friends in Global Health
Investigators
Not Provided