Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278,833
- 试验地点
- 10
- 主要终点
- Proportion of eligible HEI who present 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, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.
详细描述
This Unitaid-funded study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings. Outcomes measures will include age at uptake of testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of ART initiation for HIV-positive infants. This study will compare outcomes between HIV-exposed at high vs low risk of maternal HIV transmission. The study will also assess the impact of POC birth testing on retention in care and impact on subsequent testing at 6 weeks.
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 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-exposed infants (HEI)
- •All HEI who access maternity/post-natal services within 48 hours of life
- •Tested for HIV at birth using the POC NAT platform
- •Caregiver provides informed consent for participation
- •Mother/caregiver of an HEI who was offered POC EID at birth
- •Able to provide informed consent to participate in the study
- •Health workers
- •All health workers working in maternity services in the study sites
- •Provides informed consent to be interviewed
- •Key informants (laboratory managers and program leads/focal persons)
- •Health managers working in the field of pediatric HIV services or PMTCT
- •Provides informed consent to be interviewed
排除标准
- •HIV-exposed infants (HEI)
- •HEI tested for HIV using conventional EID at project 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)
- •Caregivers of HEI who cannot legally provide consent to participate in the study
- •Health workers
- •Healthcare workers who do not make use of EID or results of EID
- •Key informants
- •Key informants who cannot legally provide consent to participate in the study
结局指标
主要结局
Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth
时间窗: 18 months
Number of eligible HEI who received POC EID divided by the total number of eligible HEI
次要结局
- Average number of days between sample collection of HEI and results received by caregiver(18 months)
- Proportion of HEI tested at birth who are HIV positive(18 months)
- Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks(18 months)
- The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life(18 months)
- Proportion of tested HEI whose caregivers receive results of the POC EID birth testing(18 months)
- Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test(18 months)
- Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive(18 months)
- Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth(18 months)
- Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission(18 months)
- Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth(18 months)
- Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth(18 months)