Adapting the HITSystem to Support Prevention of Mother-to-child HIV Transmission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 6
- 主要终点
- Complete PMTCT retention
研究概览
简要总结
The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women before, during and after delivery and evaluate the HITSystem impact on prevention of mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0 intervention will support a range of PMTCT outcomes including retention in care, ART adherence, and integration of maternal and pediatric HIV services in low-resource settings.
详细描述
The study will be conducted in three phases:
Phases 1: The researchers will conduct formative research (focus groups and interviews) with HIV+ pregnant women and PMTCT providers to customize communication strategies for text messaging and inform patient flow and optimal implementation across the various PMTCT-related services at the intervention site.
Phase 2: The researchers will design and refine the HITSystem 2.0 technical components to support PMTCT outcomes guided by clinical content experts, technology analysts, and findings from Phase 1.
Phase 3: The researchers will implement HITSystem 2.0 at one hospital over an 18 month period, and compare targeted PMTCT outcomes to those at a matched control hospital.
The study will be conducted at two government hospitals in Kenya. HIV+ pregnant women will be enrolled in the HITSystem 2.0 at Kapsabet Hospital. HIV+ pregnant women receiving the current standard of PMTCT care at Nandi Hills Hospital will be the comparison group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV+ pregnant women
- •Present for first PMTCT appointment at one of the study Hospitals
- •Own or have reliable access to mobile phone
排除标准
- 未提供
结局指标
主要结局
Complete PMTCT retention
时间窗: first PMTCT visit during pregnancy to the return of the infant's first HIV DNA PCR test result by 12 weeks postnatal
The primary outcome is retention (complete or incomplete), measured from first PMTCT appointment until HIV status determination of the HIV-exposed infant at 12 weeks postnatal. This aggregate outcome includes completion of several intermediate outcomes throughout the PMTCT cascade of care, including: ART initiation (if not already on ART at time of pregnancy) (Yes/No), attendance at PMTCT appointments (Yes/No), a hospital delivery (Yes/No), infant enrollment in EID prior to hospital discharge (Yes/No), infant blood sample collected and HIV DNA PCR test result obtained (Yes/No). Complete retention requires completion of all of these steps.
次要结局
- Duration of PMTCT Retention(Date of first PMTCT appointment through date of last PMTCT service. Final eligible service is date of infant HIV PCR test.)
- Infant HIV status(Results obtained by 12 weeks postnatal)
- Number of antenatal PMTCT appointments attended(First antenatal PMTCT appointment through delivery date)
研究者
Sarah Kessler, PhD, MPH
Associate Professor
University of Kansas Medical Center