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

Peer-led Service Delivery Model to Increase HIV Prevention and Contraception in Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe: a Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Prevention; Adherence, Medication; Contraceptive Usage
• Intervention / Treatment: Behavioral: Peers who are stars

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kudzai Chidhanguro, MSc; Phone Number: +263774217614; Email: kudzai.chidhanguro@ceshhar.org
• Study Contact Backup: Name: Valentina Cambiano, PhD; Phone Number: +447949741305; Email: v.cambiano@ucl.ac.uk

Study Locations

• Zimbabwe
  • Insiza
    • Shangani, Insiza, Zimbabwe
      • Shangani Rural Hospital
      • Contact: Kudzai Chidhanguro; Phone Number: +263774217614; Email: kudzai.chidhanguro@ceshhar.org
  • Matabeleland South Province
    • Empandeni Mission, Matabeleland South Province, Zimbabwe
      • Empandeni clinic
      • Contact: Kudzai Chidhanguro; Phone Number: +263774217614; Email: phlongwane@ophid.co.zw
    • Mawabeni, Matabeleland South Province, Zimbabwe
      • Mawabeni Clinic
      • Contact: Kudzai Chidhanguro; Phone Number: +263774217614; Email: kudzai.chidhanguro@ceshhar.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Young Mentor Mothers support; 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; 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.
No Intervention: Control (Standard of Care); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Pre-Exposure Prophylaxis: PrEP use during the intervention compared to before	Ratio between the average number of PrEP prescriptions (per week; "took PrEP", either initiated or refill) in the last phase of intervention implementation (last 6 months) and before the intervention (6 months preceding the randomization).	Study duration (15 months) + 6 months pre-randomization
Primary Effectiveness Contraception: Modern contraception use during the intervention compared to before	Ratio between the average number of modern contraception prescriptions (per week) in the last phase of intervention implementation (last 6 months) and before the intervention (6 months preceding the randomization).	Study duration (15 months) + 6 months pre-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The registry contains the question "Does the client agree to initiate 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 RCT) in the proportion of HIV-negative PL-AGYW at risk who received PrEP.	The denominator of the proportion includes only those for which an HIV Testing Services Register line is filled in and in which it is indicated that they are at risk. This is the tool in which it is recorded if they are at risk (de facto eligible for 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.	The denominator of the proportion includes HIV-negative PL-AGYW for which at least one of the following register was filled in: PrEP Register, HTS Register, ANC register, Mother Baby Pair register, Family Planning register.	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 HIV-negative PL-AGYW at risk, not already on PrEP, who initiate PrEP.	The denominator of the proportion includes PL-AGYW for which an HIV Testing Services Register line is filled in and in which it is indicated that they are at risk and for which it is indicated that they were not on 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, not already on PrEP, who initiate PrEP.	The denominator of the proportion includes HIV-negative PL-AGYW for which at least one of the following register was filled in (PrEP Register, HTS Register, ANC register, Mother Baby Pair register, Family Planning register) and for which it is indicated that they were not on PrEP.	Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness Contraception: difference pre (6 months preceding the randomization) to post (last 6 months of RCT) in the proportion of post-natal AGYW, in which modern contraception is prescribed.	Modern contraception prescriptions are recorded in the Mother Baby Pair Register.	Study duration (15 months) + 6 months pre-randomization
Secondary Effectiveness Contraception: difference pre (6 months preceding the randomization) to post (last 6 months of RCT) in the proportion of post-natal AGYW, which collected male and/or female condoms		Study duration (15 months) + 6 months pre-randomization

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Liverpool School of Tropical Medicine; Ministry of Health and Child Welfare, Zimbabwe; Organization for Public Health Interventions and Development; UK Research and Innovation; Centre for Sexual Health and HIV/AIDS Research Zimbabwe
• Investigators: Principal Investigator: Valentina Cambiano, PhD, University College, London

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Reproductive Behavior; Medication Adherence; Contraception Behavior
• Other Study ID Numbers: 8033051; MR/Y034015/1 (Other Grant/Funding Number: UKRI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

An anonymized copy of the data collected through this study (transcription of the audio diaries and in-depth interviews, data from the paper registries and the YMM collection tool and costing dataset) will be created to ensure they are suitable for sharing.

We plan to make these data accessible to others outside our team 2 years after study completion to allow time to clean the data and produce manuscripts.

• IPD Sharing Time Frame: 2 years after study completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No