Strategies to optimize antiretroviral therapy services for maternal & child health: the MCH-ART study

Columbia University0 个研究点目标入组 1,600 人开始时间: 2014年9月11日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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
•Has not initiated triple-drug antiretroviral therapy or AZT for PMTCT during the current pregnancy
•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 current local guidelines
•Started or scheduled to start ART at Gugulethu MOU in the current pregnancy (women started on AZT for PMTCT during the current pregnancy are eligible)
•Women who were previously receiving lifelong ART must have not used ART for at least 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 #3)

•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:
•oRefusal to take ART/ARVs
•oDenial of HIV status

发起方