Mother Infant Retention for Health: Evaluation of a Multicomponent Strategy to Link and Retain Newly Identified HIV-infected Pregnant Women and Their Infants Throughout the Antenatal and Post-partum Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 10
- 主要终点
- Proportion of mothers and infants non-retained in care at 6 months
研究概览
简要总结
Linking HIV-infected pregnant women into prevention of mother to child transmission (PMTCT) services and keeping them in care is important in ensuring that both mother and infant benefit from interventions that improve maternal health and decrease HIV transmission to infants. We propose an evaluation of strategies to link newly diagnosed HIV-infected women to care and keep them in care during pregnancy and after delivery in our study called MIR4HEALTH. The study will be conducted in Nyanza Province, Kenya. All participants will provide informed consent and will be randomized to receive the intervention, including individualized patient education, adherence support and phone call/Short Message Service (SMS) reminders for clinic appointments, or the standard of care (no additional intervention services).
详细描述
Mother Infant Retention for Health (MIR4HEALTH) is an innovative implementation science study focused on testing an effective multicomponent strategy to improve linkage and retention of newly identified HIV-infected pregnant women accessing maternal child health (MCH) services in Nyanza Province, Kenya. MIR4HEALTH is distinguished by several innovations including the recognition that newly identified HIV-infected pregnant woman are especially vulnerable to poor retention within PMTCT services and that both mother and child must be retained in care to ensure optimal health outcomes.
The study is a randomized trial to compare the effectiveness of a novel strategy using Active Patient Follow-Up (APFU) to the current standard of care (SOC) routinely provided for the retention of women and their exposed infants postpartum. The proposed APFU includes a package of evidence-based interventions including health education, provision of phone and short message service (SMS) appointment reminders, active tracking of patients for linkage and retention, and individualized retention and adherence support. Patients enrolled in the APFU intervention arm will complete three antenatal study visits after enrollment as well as two postnatal study visits with their infants at 6 weeks and 6 months postpartum. Laboratory blood specimens will be collected from mothers and infants at two separate visits to assess viral load and and drug levels. Additionally, all staff will be offered a chance to participate in an interview assessing the feasibility and acceptability of APFU.
Study participants will be recruited from various clinics in the Nyanza Province in Kenya. This study will enroll pregnant women who test positive for HIV during their first antenatal visit and have no prior HIV diagnosis. Upon live birth, the infants of participating women will also be included in the study. The study will enroll 214 newly-infected pregnant women, with 107 participants in the APFU arm (intervention) and 107 participants in the SOC arm. Infants born to women enrolled in the study will also be included so there will be a total of 214 mother-infant pairs, totaling 428 participants.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-infection according to two finger-prick rapid tests (both previously diagnosed and newly detected)
- •Confirmed pregnancy by urine pregnancy test or clinical assessment
- •Age 16 years or older
- •Able to provide informed consent for research
- •Fluent in Luo or English
- •Own a cell phone or have access to one in their households
- •Live born infants of women enrolled in the study
排除标准
- •Patients who fail to meet any of the inclusion criteria will be excluded
- •Significant obstetric condition documented at the first antenatal visit requiring urgent referral to another facility for specialized obstetric care (e.g., significant hypertension or active bleeding per vagina).
- •Denial of HIV status or refusal to initiate ART/ARV prophylaxis.
- •Stated intention to move from study site area during the pregnancy or within six months postpartum.
结局指标
主要结局
Proportion of mothers and infants non-retained in care at 6 months
时间窗: 6 months
Mother/infant attrition at 6 months postpartum
次要结局
- Proportion of women & staff reporting APFU highly acceptable(12 months)
- Proportion of infants receiving PCR testing at 6 weeks of age and 6 months(6 months)
- Proportion of infants exclusively breastfeeding at 6 months and number of months infant spent breastfeeding(6 months)
- Proportion of infants adherent to postnatal ARV regimen during first six weeks of life(1.5 months)
- Proportion of women completing the 2nd ANC visit and all ANC and PN visits(6 months)
- Proportion of women who had a hospital delivery(6 months)
- Change in CD4+ cell count from study enrollment to 6 month postpartum for women(12 months)
- Proportion of women with undetectable HIV RNA at delivery and 6 months postpartum(12 months)
- Proportion of women adherent to ARV regimen during pregnancy and postpartum period(12 months)
- Proportion of male partners receiving HIV testing(12 months)
研究者
Elaine J. Abrams, MD
Director Research Unit, ICAP
Columbia University