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NCT Number: NCT07546344

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

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.

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Key information

Conditions

HIV Prevention Adherence, Medication Behavior Contraception Behavior Contraceptive Usage Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Reproductive Behavior Treatment Adherence and Compliance

Age range

15 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shangani Rural Hospital, Shangani, Insiza, Zimbabwe

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility: YMM who completed the training

    Time frame: 1 month

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

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

    Time frame: 15 months

    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)

  3. Feasibility of extracting effectiveness outcome data

    Time frame: Study duration (15 months) + 6 months pre-randomization

    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

Secondary outcomes

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

    Time frame: Study duration (15 months) + 6 months pre-randomization

    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).

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

    Time frame: Study duration (15 months) + 6 months pre-randomization

    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).

Other outcomes

  1. 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)

    Time frame: Study duration (15 months) + 6 months pre-randomization

    The registry contains the question "Does the client agree to initiate PrEP?"

  2. 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.

    Time frame: Study duration (15 months) + 6 months pre-randomization

    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).

  3. 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.

    Time frame: Study duration (15 months) + 6 months pre-randomization

    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.

  4. 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.

    Time frame: Study duration (15 months) + 6 months pre-randomization

    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.

  5. 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.

    Time frame: Study duration (15 months) + 6 months pre-randomization

    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.

  6. 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.

    Time frame: Study duration (15 months) + 6 months pre-randomization

    Modern contraception prescriptions are recorded in the Mother Baby Pair Register.

  7. 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

    Time frame: Study duration (15 months) + 6 months pre-randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Kudzai Chidhanguro, MSc

CONTACT

[email protected]

+263774217614

Valentina Cambiano, PhD

CONTACT

[email protected]

+447949741305

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Ontanga

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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