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Not yet recruiting NCT07546344

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

No phase Interventional HIV Prevention Contraceptive Usage Adherence, Medication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peers who are stars.
Who it may be relevant to
Registry conditions: HIV Prevention, Contraceptive Usage, Adherence, Medication. Basic parameters: 15 years — 24 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Zimbabwe
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

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 r

Primary outcome measures

  • Feasibility: YMM who completed the training [Time frame: 1 month]
  • Feasibility: Proportion of YMM with contacts with at least 20 PL-AGYW [Time frame: 15 months]
  • Feasibility of extracting effectiveness outcome data [Time frame: Study duration (15 months) + 6 months pre-randomization]
Secondary outcome measures (2)
  • Primary Effectiveness Pre-Exposure Prophylaxis: PrEP use during the intervention compared to before [Time frame: Study duration (15 months) + 6 months pre-randomization]
  • Primary Effectiveness Contraception: Modern contraception use during the intervention compared to before [Time frame: Study duration (15 months) + 6 months pre-randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Zimbabwe · 3 centers
  • Shangani Rural Hospital — Shangani
  • Empandeni clinic — Empandeni Mission
  • Mawabeni Clinic — Mawabeni

Identifiers

NCT: NCT07546344 · 8033051 · MR/Y034015/1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗