Improving HIV prevention for postpartum women in Malawi
UNCPM 22402 - Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
NA · University of North Carolina, Chapel Hill · NCT06506188
This study tests a new approach to help new mothers in Malawi prevent HIV by combining testing and treatment with their baby's vaccination visits and support from their partners and community.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 15 Years to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT06506188 on ClinicalTrials.gov |
What this trial studies
The LINK study aims to evaluate the effectiveness of a postpartum prevention package, known as the LINK model, among postpartum women in Malawi. This model integrates HIV testing and Pre-exposure Prophylaxis (PrEP) services with early infant vaccination visits, while also engaging male partners and providing community support. The study will compare outcomes from clinics implementing the LINK model to those providing standard care, using both qualitative and quantitative data collected from twelve randomized sites in Lilongwe. The goal is to assess the potential for broader implementation of the LINK model in HIV prevention efforts.
Who should consider this trial
Good fit: Ideal candidates for this study are breastfeeding women aged 15 and older who are enrolled in PrEP care and living without HIV.
Not a fit: Patients who are not breastfeeding or who are HIV-positive will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve PrEP persistence among postpartum women, thereby reducing the risk of HIV transmission.
How similar studies have performed: Other studies have shown success with integrated care models for HIV prevention, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lilongwe
- University of North Carolina Project Malawi (UNCPM) — Lilongwe, Malawi (RECRUITING)
Study contacts
- Principal investigator: Sarah E Rutstein, MD, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Rutstein E Sarah, MD, PhD
- Email: srutstein@unc.edu
- Phone: (919) 966-2537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breastfeeding, HIV Prevention, HIV