Strategies to Optimize Antiretroviral Therapy Services for Maternal & Child Health: the MCH-ART Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,554
- 试验地点
- 1
- 主要终点
- Combined endpoint of (i) maternal HIV viral suppression, and (ii) maternal retention in ART services, at 12 months postpartum
研究概览
简要总结
The purpose of this study is to understand how to improve health care services for HIV-positive women during their pregnancy and after delivery. The study's aim is to compare two different ways of providing antiretroviral therapy for pregnant women with HIV. The study is to be conducted at the Gugulethu Midwife Obstetric Unit (MOU) in Cape Town. There are three phases of the study: Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women attending their first antenatal clinic visit (n=1600); Phase 2 is an observational cohort that will follow women from Phase 1 who are eligible for ART (n=600) from the second antenatal clinic visit until the first postpartum visit; Phase 3 is a randomized trial of women from Phase 2 who are breastfeeding and will compare two different service models for delivering ART to women after they delivery their babies (n=480). For Phase 3, women who are taking ART will randomly be assigned to either (1) referral to receive ART at the nearest adult clinic at 4-8 weeks after delivery (this is currently how all women receive care in this setting) or (2) to continue to come to the antenatal clinic for ART services until the end of breastfeeding. All women will received the standard local ART services (with identical medications and medical treatment); they are different because some women will stay longer in care at the antenatal clinic. All women participating in Phase 3 will be followed through at least 2 months after they deliver.
详细描述
This study includes a three-phase design in which HIV-positive pregnant women are followed during the antenatal and postnatal periods. Throughout, participants will attend study measurement visits conducted separately from routine ART service appointments.
Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women attending their first antenatal clinic visit seeking care at the study clinic. This phase of the study will allow characterization of the health status of the population of HIV-positive pregnant women seeking care at the Gugulethu (Midwife Obstetric Unit)MOU and the services they receive. At their first antenatal clinic visit, women will be approached to complete Informed Consent #1, including consent for abstraction of routine clinic data on obstetric and HIV-related care. As part of this cross-sectional study, participating women will complete a short questionnaire and undergo phlebotomy.
Phase 2 of the study is an observational cohort of all women who are eligible for initiation of lifelong antiretroviral therapy (following SA guidelines), from their second antenatal clinic visit until their first postpartum clinic visit (conducted within 7 days postpartum). This phase of the study will provide detailed description of ART initiation and antenatal follow-up in the population of women who will be involved in the postnatal component of the study, and be used to measure potential predictors of the primary outcome. At the second antenatal clinic visit, women from Phase 1 who are ART-eligible or who initiated ART during the pregnancy will be approached to complete Informed Consent #2, be interviewed with questionnaire on behavioral and psychosocial measures, and undergo phlebotomy. Women will complete another study measurement visit during the third trimester and again within 1 week postpartum (with study measurement visits timed to coincide with routine care appointments). At these visits, additional questionnaires and phlebotomy will be used to collect study measures.
Phase 3 of the study is a randomised trial of strategies for delivering ART to women during the postpartum period (the primary objective) with measurement of secondary outcomes during the postnatal period. Women enrolled in Phase 2 who are breastfeeding their infants will be approached to participate in the trial at the routine postpartum clinic visit (this takes place within 7 days of birth and is the only standard postpartum care for women). After completing Informed Consent #3, women will be interviewed with behavioral and psychosocial questionnaires and undergo phlebotomy for study measurements before randomization.
Randomization will be to one of two approaches to providing ART during the postpartum period to HIV-infected mothers who are breastfeeding:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Age 18 years or older
- •Documented HIV-infection according to two finger-prick rapid tests using different test types (per routine protocol in this setting) or documentation of HIV status for those women self reporting HIV diagnosis.
- •Confirmed pregnancy according to urine pregnancy test, ultrasound or clinical assessment
- •Able to provide informed consent for research (Informed Consent #1)
- •Phase 2: Subset of Phase 1 participants who are ART-eligible
- •Consented and participated in Phase 1
- •Documented ART eligibility based on CD4 count and/or WHO staging according to public sector testing or assessment
- •Not currently using triple-drug antiretroviral therapy (women started on AZT for PMTCT during the current pregnancy are eligible) or have not used ART within the previous 6 months.
- •Able to provide informed consent for research (Informed Consent #2)
- •Phase 3: Subset of Phase 2 participants eligible for randomization
- •Consented and participated in Phase 2
- •Initiated ART during the antenatal period
- •Currently breastfeeding within <7 days postpartum (with an allowable window of up to 28 days postpartum)
- •Willingness to be randomized and return for postnatal study visits
- •Able to provide informed consent for research (Informed Consent #
排除标准
- •Individuals meeting any of the following exclusion criteria at the point in the study will be excluded:
- •Not currently pregnant (Phases 1 and 2) or loss of pregnancy/neonate (Phase 3) at the time of eligibility determination
- •Intention to relocate out of Cape Town permanently during the study period (Phase 2 and 3 only)
- •Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study (all phases), including:
- •Refusal to take ART/ARVs
- •Denial of HIV status
结局指标
主要结局
Combined endpoint of (i) maternal HIV viral suppression, and (ii) maternal retention in ART services, at 12 months postpartum
时间窗: Up to one year post partum follow-up for all phase 3 participants
次要结局
- Maternal retention in care up to 12 months postpartum(Up to one year post-partum)
- Maternal viral suppression throughout the breastfeeding period as well as before and after cessation of breastfeeding(Up to one year post partum)
- Rates of HIV transmission from mother-to-child at 6 weeks and up to 12 months postpartum(Up to one year post partum)
- Breastfeeding practices, including duration of exclusive feeding and weaning patterns(Up to one year post partum)
- Acceptability of different strategies for delivering HIV care and treatment during the postpartum period(Up to one year post partum)
研究者
Professor Landon Myer
Professor
University of Cape Town