Evaluation of Mhealth Strategies to Optimize Adherence and Efficacy of PMTCT/ART
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 825
- 试验地点
- 6
- 主要终点
- Infant HIV-free Survival
研究概览
简要总结
The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.
详细描述
The investigators will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant HIV or HIV-free survival.
The investigators will determine correlates of maternal loss to follow-up and virologic failure and correlates of infant HIV in the overall study and stratified by trial arm. In the bidirectional SMS arm, the investigators will determine the rate of SMS interactivity, impact of critical time-points on messaging, and characteristics of high and low 'interactors'.
The investigators will determine cost-effectiveness of unidirectional and bidirectional SMS interventions. These data will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 'virtual elimination' of infant HIV.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years
排除标准
- •enrolled in another research study
结局指标
主要结局
Infant HIV-free Survival
时间窗: 2 years postpartum
Incidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression.
Retention in Care
时间窗: Assessed at 24 months postpartum
Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link.
Loss to Follow-up
时间窗: Assessed at 24 months postpartum
The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.
Maternal Virologic Failure
时间窗: 2 years postpartum
Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link.
次要结局
- Maternal ART Resistance(2 years postpartum)
- Maternal ART Adherence(2 years postpartum)
- Maternal Perceptions of Intervention and Care Received(2 years postpartum)
研究者
Grace John-Stewart
Professor
University of Washington