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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Feasibility: YMM who completed the training [Срок оценки: 1 month]
• Feasibility: Proportion of YMM with contacts with at least 20 PL-AGYW [Срок оценки: 15 months]
• Feasibility of extracting effectiveness outcome data [Срок оценки: Study duration (15 months) + 6 months pre-randomization]

Вторичные конечные точки (2)

• Primary Effectiveness Pre-Exposure Prophylaxis: PrEP use during the intervention compared to before [Срок оценки: Study duration (15 months) + 6 months pre-randomization]
• Primary Effectiveness Contraception: Modern contraception use during the intervention compared to before [Срок оценки: Study duration (15 months) + 6 months pre-randomization]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Zimbabwe · 3 центра

• Shangani Rural Hospital — Shangani
• Empandeni clinic — Empandeni Mission
• Mawabeni Clinic — Mawabeni

Идентификаторы

NCT: NCT07546344 · 8033051 · MR/Y034015/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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