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

Not Applicable

Recruiting

• Conditions: HIV/AIDS

• Registration Number: PACTR201411000884278
• Lead Sponsor: Columbia University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1600

Inclusion Criteria

Phase 1
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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified