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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Feasibility: YMM who completed the training
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Peers who are stars (Behavioral)
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
结局指标
主要结局
Feasibility: YMM who completed the training
时间窗: 1 month
Proportion of young mentor mother (YMMs) who agreed to take part in the study that completed the training
Feasibility: Proportion of YMM with contacts with at least 20 PL-AGYW
时间窗: 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)
Feasibility of extracting effectiveness outcome data
时间窗: 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
次要结局
- 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)