Peer-led Service Delivery Model for Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe

NCT07546344 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-04-22

No results posted yet for this study

Summary

This is a pilot cluster-randomized control trial co-led by Dr. Valentina Cambiano, Associate Professor of Epidemiology at University College London, UK and Professor Euphemia Sibanda, Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe). The goal of the proposed study is to evaluate the appropriateness, feasibility, acceptability, uptake, costs and cost-effectiveness of a community-based, HIV-status neutral peer-led service delivery model in which young mentor mothers (YMM) work with pregnant and lactating adolescent girls and young women (PL-AGYW, aged 15-24), up to two-years post-birth, in Zimbabwe to promote uptake of contraception and HIV prevention.

YMM living with HIV have been found to be effective in supporting their peers for prevention of mother-to-child transmission of HIV and adherence to treatment through the "Zvandiri" programme. The investigators propose adapting the "Zvandiri" YMM to include those without HIV to promote behaviour to prevent HIV and unintended pregnancies. This proposed intervention is building on the formative work that had the overall aim of co-developing with AGYW (aged 15-24) a Pre-Exposure Prophylaxis (PrEP) implementation intervention for AGYW who need it, that attracts them to PrEP, and supports pregnant and lactating adolescent girls and young women while taking it.

Conditions

  • HIV Prevention
  • Contraceptive Usage
  • Adherence, Medication

Interventions

BEHAVIORAL

Peers who are stars

A community-based HIV status-neutral intervention will be delivered by peers known as young mentor mothers (YMM) who will mobilise uptake of HIV prevention and contraception among pregnant and lactating adolescent girls and young women (PL-AGYW; aged 15-24 years old). Specific YMM roles will include: i) conducting educational home-visits; ii) accompanying the most vulnerable PL-AGYW to clinics; if needed iii) encouragement for HIV testing; iv) distribution of educational materials; v) making referrals/linkages between YMM and existing services for HIV self-testing, Pre-Exposure Prophylaxis, Post-Exposure Prophylaxis, contraception pills and for counselling/support with family/relationship challenges.

Sponsors & Collaborators

  • Centre for Sexual Health and HIV/AIDS Research Zimbabwe

    collaborator OTHER
  • Liverpool School of Tropical Medicine

    collaborator OTHER
  • UK Research and Innovation

    collaborator OTHER
  • Organization for Public Health Interventions and Development

    collaborator OTHER
  • Ministry of Health and Child Welfare, Zimbabwe

    collaborator OTHER
  • University College, London

    lead OTHER

Principal Investigators

  • Valentina Cambiano, PhD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Zimbabwe

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546344 on ClinicalTrials.gov