Status:
RECRUITING
Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Breastfeeding
HIV Prevention
Eligibility:
All Genders
15-99 years
Phase:
NA
Brief 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 p...
Detailed Description
Study Design Overview: The LINK study is an effectiveness-implementation type I hybrid cluster randomized trial. Prospective data collection and existing medical record and health surveillance data w...
Eligibility Criteria
Inclusion
- PrEP user cohort:
- PrEP user cohort includes all adolescent and adult women \>=15 years old who are on PrEP and breastfeeding, enrolled in PrEP at each of the participating 12 sites during the study follow-up period. PrEP provision and clinical management will be at the discretion of the non-study PrEP providers according to Malawi PrEP guidelines and eligibility. Data for these women are abstracted from PrEP records. We are seeking a waiver of informed consent for all health record abstraction for the LINK study.
- Inclusion criteria:
- Female enrolled in PrEP care at a study site
- Breastfeeding documented while on PrEP
- Living without HIV
- Exclusion criteria:
- \- None
- PrEP user survey and dried blood spot sub-group Breastfeeding women 15 years and older who are presenting \~6 months after initiating PrEP are eligible participation in study surveys and dried blood spot using fingerstick specimen collection. Women aged 15-17 will be asked to provide assent with parental/guardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.
- Inclusion criteria:
- 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
- Exclusion criteria:
- \- Decline informed consent
- Postpartum women - health passport review We review use existing health records (Health passports) of postpartum women presenting to infant immunization appointments with their child. No identifying information will be collected from this group.
- Inclusion criteria:
- \- Female presenting with infant under 3 for under-five visit to participating clinical site
- Exclusion criteria:
- \- None
- Postpartum women - surveys Postpartum women 15 years and older who are presenting to under-five visits with their child under 3 will be eligible for participation in study surveys. Women aged 15-17 will be asked to provide assent with parental/guardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.
- Inclusion criteria:
- Female presenting for child vaccination to participating clinical site
- Aged15 years and older (assent with parental/guardian consent for women aged 15-17)
- Exclusion criteria:
- \- Decline informed consent
- Non-patient key stakeholder Non-patient stakeholders relevant to intervention implementation at the clinic and national level, including clinical and policy stakeholders. Examples of clinical stakeholders may include key clinic staff working in PrEP, HIV testing, EPI, and CFL peer support mothers. Policy and implementing partner stakeholders may include 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.
- Inclusion criteria:
- 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
- Exclusion criteria:
- \- Decline informed consent
Exclusion
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06506188
Start Date
September 15 2024
End Date
March 1 2028
Last Update
August 24 2025
Active Locations (1)
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1
University of North Carolina Project Malawi (UNCPM)
Lilongwe, Malawi