UNCPM 22402 - Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package (LINK model) among post-partum women and its implementation into existing clinical care models in Lilongwe, Malawi. The main question the study seeks to answer is: Do women at clinics implementing the LINK model have improved Pre-exposure Prophylaxis (PrEP) persistence compared to women at clinics receiving the standard of care? Researchers will compare the LINK model to standard of care by randomizing twelve sites to either the LINK model or the standard of care. Then researchers will review existing medical record and health surveillance data, and qualitative and quantitative data collected from intervention and control sites.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 99
Healthy Volunteers: t
View:

• Female enrolled in PrEP care at a study site

• Breastfeeding documented while on PrEP

• Living without HIV

• Female who has presented for PrEP visit at a participating clinical site at least \

⁃ 6 months after initiating PrEP

• Aged 15 years (assent with parental/guardian consent for women aged 15-17)

• Living without HIV

⁃ \- Female presenting with infant under 3 for under-five visit to participating clinical site

• Female presenting for child vaccination to participating clinical site

• Aged15 years and older (assent with parental/guardian consent for women aged 15-17)

• Aged 18 years and older

• Involved in relevant activities pertinent to integration or provision of PrEP services such as PrEP providers, peer mothers, HIV diagnostic assistants, or clinic managers, OR policy and implementing partner stakeholders such as officials from the Malawi Ministry of Health, donors in HIV prevention (e.g. PEPFAR, the Global Fund), members of community advocacy groups, the Lilongwe DHO, and other persons involved in infant vaccine and HIV prevention program and policy development and implementation in HIV prevention in Lilongwe

Locations
Other Locations
Malawi
University of North Carolina Project Malawi (UNCPM)
RECRUITING
Lilongwe
Contact Information
Primary
Rutstein E Sarah, MD, PhD
srutstein@unc.edu
(919) 966-2537
Time Frame
Start Date: 2024-09-15
Estimated Completion Date: 2028-03
Participants
Target number of participants: 5000
Treatments
Experimental: LINK model
Women at these sites receive the LINK model, which includes integrated EPI/HIV testing, screening for HIV risk, support for male partner engagement, and community-facility linkage (CFL) peer moms for breastfeeding women using PrEP for ongoing support and follow-up for breastfeeding women who disengage from PrEP care. This model is integrated into the SOC and does not replace SOC activities.
No_intervention: Standard of Care
Women at these sites continue to receive the current standard of care (SOC) for postpartum HIV testing, PrEP screening, and PrEP care in Malawi.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov