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

NCT07546344 | Not Yet Recruiting

• 2 other identifiers: 8033051MR/Y034015/1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (3)

• Feasibility: YMM who completed the training

  Proportion of young mentor mother (YMMs) who agreed to take part in the study that completed the training

  1 month

• Feasibility: Proportion of YMM with contacts with at least 20 PL-AGYW

  Proportion of YMM who had contact with at least 20 PL-AGYW with which they had three more conversations (whether face to face, via phone or via message, including Whatsapp)

  15 months

• Feasibility of extracting effectiveness outcome data

  The effectiveness outcome data will be extracted from the paper-registries routinely used in the clinics: PrEP Register, ANC register, Mother Baby Pair register, Family Planning register and HIV Testing Register

  Study duration (15 months) + 6 months pre-randomization

Secondary Outcomes (2)

• Primary Effectiveness Pre-Exposure Prophylaxis: PrEP use during the intervention compared to before

  Study duration (15 months) + 6 months pre-randomization

• Primary Effectiveness Contraception: Modern contraception use during the intervention compared to before

  Study duration (15 months) + 6 months pre-randomization

Other Outcomes (7)

• Secondary Effectiveness PrEP: ratio pre (6 months preceding the randomization) to post (last 6 months of RCT) in the average number of PrEP initiations (per week)

  Study duration (15 months) + 6 months pre-randomization

• Secondary Effectiveness PrEP: Difference pre (6 months preceding the randomization) to post (last 6 months of RCT) in the proportion of HIV-negative PL-AGYW at risk who received PrEP.

  Study duration (15 months) + 6 months pre-randomization

• Secondary Effectiveness PrEP: difference pre (6 months preceding the randomization) to post (last 6 months of cRCT) in the proportion of all HIV-negative PL-AGYW who received PrEP.

  Study duration (15 months) + 6 months pre-randomization

Study Arms (2)

Young Mentor Mothers support

EXPERIMENTAL

Pregnant and lactating adolescent girls and young women in addition to the normal service that they have already been receiving from health facilities in their communities, are supported by young mentor mothers.

Behavioral: Peers who are stars

Control (Standard of Care)

NO INTERVENTION

Pregnant and lactating adolescent girls and young women in the standard of care arm will receive the normal service they have already been receiving from health facilities in their communities. These include antenatal care, delivery and postnatal care covering immunization and child health, family planning and contraception services that are offered at facility level. In addition, the services include facility-delivered offer of HIV prevention and sexual and reproductive health (including HIV testing, offer of Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis and access to antiretroviral treatment for HIV) services. Health facility staff (or designated community health workers) may from time to conduct community visits for education purposes, commodity distribution, follow up of people wh

Interventions

Peers who are stars BEHAVIORAL

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.

Young Mentor Mothers support

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• either pregnant or have at least one child who is less than 18 months of age at the time of initial engagement
• Aged 15 - 24 years old

Sponsors & Collaborators

• University College, London: lead
• Centre for Sexual Health and HIV/AIDS Research Zimbabwe: collaborator
• Liverpool School of Tropical Medicine: collaborator
• UK Research and Innovation: collaborator
• Organization for Public Health Interventions and Development: collaborator
• Ministry of Health and Child Welfare, Zimbabwe: collaborator

Study Sites (3)

Shangani Rural Hospital

Shangani, Insiza, Zimbabwe

Location

Empandeni clinic

Empandeni Mission, Matabeleland South Province, Zimbabwe

Location

Mawabeni Clinic

Mawabeni, Matabeleland South Province, Zimbabwe

Location

MeSH Terms

Conditions

Contraception Behavior; Medication Adherence

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Valentina Cambiano, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kudzai Chidhanguro, MSc

CONTACT

+263774217614; kudzai.chidhanguro@ceshhar.org

Valentina Cambiano, PhD

CONTACT

+447949741305; v.cambiano@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 years after study completion.
• Access Criteria: External users will be asked to provide questions that they would like to address using the data. The PI and co-I will make decisions on whether to supply this data. Decisions will be made within four weeks of the request. Requests will only be denied with good reason. Upon being granted permission they will be required to sign documents which specify that use of the data will be restricted to address those questions that have ethical approval.

Locations

ZI (3)