Texting to Improve Testing (TextIT): A Cluster Randomized Stepped Wedge Trial of Text Messaging to Improve Postpartum Retention in Care and Early Infant Diagnosis of HIV
试验速览
- 阶段
- 不适用
- 入组人数
- 2,508
- 试验地点
- 1
- 主要终点
- Postpartum retention in prevention of mother-to-child HIV transmission programs
研究概览
简要总结
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. The investigators recently concluded a successful randomized controlled trial in Kenya entitled, "Improving uptake of early infant diagnosis of HIV for prevention of mother-to-child HIV transmission (PMTCT): a randomized trial of a text messaging intervention" (ClinicalTrials.gov # NCT01433185). In this study, text messages developed using a behavioral theoretical framework significantly improved maternal attendance at post-partum clinic appointments and rates of testing to facilitate early infant diagnosis of HIV in a selected population and controlled setting. Understanding the effectiveness of this intervention (and its limitations) in a real-world, routine-care setting represents the next step in the translational pathway to public health impact. The investigators therefore now propose a cluster randomized, stepped wedge trial in 20 clinics operated by the Kenyan Ministry of Health in the Nyanza region of Kenya and use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework to understand the effectiveness of the text messaging to improve testing (TextIT) intervention. Our specific aims are:
- To determine the effect of TextIT on maternal attendance at postpartum clinic visits during the randomized stepped-wedge rollout of the intervention.
Hypothesis 1: A greater proportion of women at health facilities implementing TextIT will attend clinic within eight weeks postpartum compared to women at health facilities implementing standard care. 2. To determine the effect of TextIT on virological infant HIV testing within eight weeks after birth during the randomized stepped-wedge rollout of the intervention.
Hypothesis 2: Infants of women at health facilities implementing TextIT will be more likely to have virological HIV testing compared to infants of women at health facilities implementing standard care. 3. To determine the costs and cost-effectiveness of TextIT. The investigators will estimate the cost per patient and per health gain achieved (disability-adjusted life year, DALY) comparing TextIT to current standard care.
Hypothesis 3: The TextIT intervention will be more cost-effective than current standard care.
详细描述
The 2011 United Nations General Assembly Political Declaration on HIV/AIDS set a target to eliminate mother-to-child transmission of HIV by 2015. The continuum of care for women living with HIV and their babies includes retention in care and early infant diagnosis of HIV. Timely initiation of infant antiretroviral therapy (ART) requires HIV-positive women to be retained in care through the postpartum period and to bring their children for HIV testing. However, a high proportion of pregnant HIV-positive women in sub-Saharan Africa are lost to follow-up after delivery. The World Health Organization recommends infant HIV testing at six weeks using DNA polymerase chain reaction (PCR). However, the overall proportion of children who undergo early infant diagnosis by PCR remains low. In Kenya, the overall proportion of eligible children undergoing PCR testing in 2011 was 39%.
Low rates of infant HIV testing are an indirect indication of a large number of infants who may not benefit from early determination of HIV status, antiretroviral prophylaxis for HIV-negative breastfeeding infants, and infant feeding counseling and support. For HIV positive infants, failure to undergo testing is a critical barrier to receiving life-saving ART. There is an urgent need to investigate efficacious, cost-effective, and sustainable interventions to improve maternal retention in HIV care and increase the proportion of exposed infants tested for HIV.
With the exponential increase in the number of mobile phones in sub-Saharan Africa, the use of mobile technology to support HIV programs has shown promise. The United Nations Children's Fund is encouraging HIV programs to take advantage of high levels of mobile phone access among enrolled mothers by reminding them to return for critical appointments. Active follow-up of pregnant HIV positive women in resource-limited settings using mobile phones is feasible, and may be effective in improving postnatal retention and uptake of early infant diagnosis across different sub-Saharan African settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Are ≥18 years or emancipated minors;
- •Are at 28 weeks gestation or greater (or have delivered on the day of enrollment);
- •Provide informed consent
排除标准
- •Women who report sharing phones but have not disclosed their HIV status to the person with whom the phone is shared.
研究组 & 干预措施
Text messaging from beginning
Half of the health facilities will be randomly allocated to receive the TextIT intervention during the first time period (six months), while the other half to continue with current standard care (first step)
干预措施: Text messaging from beginning (Other)
Text messaging after 6 months of control
Half the facilities will receive standard of care for six months (first time period). After the first time period, the these facilities will then also receive the TextIT intervention (second step)
干预措施: Text messaging after 6 months of control (Other)
结局指标
主要结局
Postpartum retention in prevention of mother-to-child HIV transmission programs
时间窗: 1 year
Maternal attendance at postpartum clinic visits within eight weeks after delivery
Infant HIV testing by DNA PCR within 8 weeks after birth
时间窗: 1 year
Cost-effectiveness of TextIT
时间窗: 1 year
次要结局
- Reported infant feeding option(1 year)
- Overall public health impact(1 year)
- Place of delivery and skilled birth attendance(1 year)
- A combined outcome for stillbirth (after 28 weeks of pregnancy) or infant death within the first two months after a live birth(1 year)
- Birth weight(1 year)
- Incidence rate of HIV-1 among infants who undergo virological HIV testing(1 year)
- 18 month PMTCT outcomes(18 months)
研究者
Thomas Odeny
Research Scientist
Kenya Medical Research Institute