HIV/AIDS
Conditions
Sponsors
Columbia University
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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: o Refusal to take ART/ARVs o Denial of HIV status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare an MCH-focused ART service to general adult ART services as strategies for providing ART during the postpartum period on (i) maternal HIV viral suppression, and (ii) maternal retention in ART services, at 12 months postpartum. | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the health status of the population of HIV+ pregnant women seeking antenatal care at the Gugulethu Midwife Obstetric Unit (MOU) including maternal and infant outcomes ;To describe uptake and timing of services received throughout the PMTCT cascade, including antenatal ART initiation and follow-up, at the Gugulethu MOU;To describe changes in women¿s clinical and/or psychosocial characteristics between the antenatal and postnatal periods, and investigate how these are independently associated with the primary outcome;To compare MCH-focused ART services to general adult ART services on: | — |
Countries
South Africa
Contacts
Public ContactTammy Phillips
Project Coordinator
Outcome results
None listed