Evaluation of the Impact of Point-of-Care Early Infant Diagnostic (EID) Testing on Timely Receipt of EID Results and Treatment Initiation in HIV-Exposed Children in Kenya and Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,539
- 试验地点
- 2
- 主要终点
- Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks
研究概览
简要总结
This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.
详细描述
This study seeks to evaluate the impact of point of care (POC) early infant HIV diagnosis (EID) on turn-around time from sample collection until notification of parents/caregivers of test result, linkage to care, and time to initiation of treatment, and early retention in HIV care (3-6 months) for those infected.
The study will take place in two countries, Zimbabwe and Kenya, with high HIV prevalence, and where EGPAF-supported POC EID platforms are being implemented as part of a Unitaid-funded POC EID project. As part of POC program implementation activities, in each country up to 50 EGPAF-supported sites will implement POC EID platforms. These sites may be prevention of mother-to-child transmission (PMTCT) of HIV clinics, HIV clinics or multidisciplinary health facilities. Project sites have been selected as part of the program implementation. In each country, 18 sites will be randomly selected as study sites for the impact evaluation.
Using a stepped wedge design, the intervention (the POC EID platforms) will be rolled out sequentially to the study facilities over three randomly-assigned time periods. Quantitative data will be derived from routine medical and laboratory charts and longitudinal tracking and follow-up of HIV-infected infants.
Qualitative data on feasibility and acceptability of POC will be derived from in-depth interviews with mothers/caregivers of HIV-exposed infants at the beginning and end of the study and community focus group discussions at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any infant who receives an EID test, either conventional or POC, for the 4-6 week EID indication at one of the study sites (which were randomly selected from project sites in country)
- •HEI under 12 weeks of age or their parents/caregivers
- •Some methods will only include HEI who test positive (medical chart extraction and longitudinal follow up)
- •Purposively selected caregivers of HEI for in-depth interviews
- •Focus groups with community members will not require participants to have sought testing for EID
排除标准
- •Participants not at selected study sites
- •For some methods (medical chart extraction and longitudinal follow-up), HEI who test negative
- •For qualitative component, excluded if unable to consent due to age, competence, or inability to speak any of the study languages
结局指标
主要结局
Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks
时间窗: 12 weeks
The number of children for whom a sample was drawn for the 4-6-week indication receiving EID result by 12 weeks, divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing
次要结局
- Testing coverage for the 4-6 week indication(18 months)
- Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification(18 months)
- Age of patient at test result notification for 4-6 week EID test indication(18 months)
- Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants(18 months)
- Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART(18 months)
- Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months(24 months)