Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,316
- 试验地点
- 1
- 主要终点
- Percent of eligible HEI born at or presenting to pilot facilities who receive POC EID testing at birth
研究概览
简要总结
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
详细描述
This UNITAID-funded study aims to assess feasibility and utility of birth testing, [early infant diagnosis for HIV, (EID)], using point-of-care (POC) HIV nucleic acid testing (NAT) at high volume maternity settings. Birth testing is defined as tests within 3 days of life. Outcome measures will include age at testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of anti-retroviral therapy (ART) initiation for HIV-positive infants. The study will document retention in care for those who tested positive at birth, and the percent of those who tested negative at birth who returned for six week testing. The study will also assess the feasibility and acceptability of POC birth testing using interviews with policymakers, health care workers and caregivers of HIV-exposed infants (HEI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV Exposed Infants
- •Must have been newly born at the study sites or presenting in study sites within 3 days after birth
- •Tested for HIV using POC EID platform (mother or caregiver agreed to have infant tested)
- •Health Care Workers (HCWs)
- •HCWs who have used POC EID for at least three months, at project sites
- •HCWs that work directly with POC EID services at maternity providing clinical services or operating the platform
- •HCWs who consent to be interviewed
- •HCWs able to speak one of the study languages
- •Laboratory Managers and program leads/focal persons:
- •National or regional level manager or head of department whose responsibilities include EID
- •Member of a national technical working group or advisory board member working on EID
- •National level representative from the MOH
- •Laboratory managers in the 3 study sites
- •Participants 18 years and above who consent to be interviewed
- •Mothers/caregivers:
- •Mother/caregiver of an HEI who was offered POC EID at birth
- •Provides consent to participate in the study
- •Is 18 years or older, or is less than 18 years old but is legally married (and thus legally emancipated)
- •Speaks one of the study languages
排除标准
- •HEI tested for HIV using conventional EID at projects sites
- •HEI whose caregivers refuse birth testing
- •HEI where the clinician deems there is a contra-indication for sample collection for birth testing (e.g. severe hemophilia)
- •HCWs who work within project sites that do not make use of EID (i.e. HCWs who are not involved directly with EID)
- •HCWs working in non-project sites
- •HCWs who are unable to consent or do not speak a study language
- •Laboratory Managers and program leads/focal persons:
- •Inability to give consent
- •Inability to speak study language
- •Mothers/Caregivers:
- •Not eligible for POC birth testing services
- •Not able to consent
- •Does not speak English or SiSwati
结局指标
主要结局
Percent of eligible HEI born at or presenting to pilot facilities who receive POC EID testing at birth
时间窗: 24 months
Number of eligible HEI born at or presenting to pilot facilities receiving POC EID testing as a proportion of the number of HEI born or presenting to pilot facilities
次要结局
- Percent of HII testing HIV positive at birth or at 6-8 weeks in care for the first 3 and/or 6 months of life(24 months)
- Number of HIV-infected infants (HII) tested at birth who are started on ART within 2 weeks of the birth test(24 months)
- Percent of HEI testing HIV negative at birth who return for testing at 6-8 weeks(24 months)
- Percent of tested HEI whose caregivers receive results of the POC EID birth testing(24 months)
- Percent of HEI who test HIV negative at birth and who test positive at 6-8 weeks(24 months)
- HIV positivity rate among HEI tested at birth(24 months)