Strategies to Optimize Antiretroviral Therapy Services for Maternal & Child Health: the MCH-ART Study

NCT01933477 | Completed

• 1 other identifier: Acct#5-30539
• Study Type: interventional
• Target: 1,554
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

Maternal Health; Child Health; HIV infection; Antenatal care; Postpartum care; Prevention of mother to child transmission (PMTCT); Breast feeding; Antiretrovirals

Outcome Measures

Primary Outcomes (1)

• Combined endpoint of (i) maternal HIV viral suppression, and (ii) maternal retention in ART services, at 12 months postpartum

  Up to one year post partum follow-up for all phase 3 participants

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Subgroup analyses of the primary outcome according to participant demographic characteristics, medical history, clinical characteristics and psychosocial characteristics

  up to 12 months postpartum

Study Arms (2)

Local Standard of Care

NO INTERVENTION

Arm A: Referral of post-partum women from the antenatal clinic to general adult ART services at approximately 4-8 weeks postpartum (the local current standard of care in this setting)

MCH-focused ART services

ACTIVE COMPARATOR

Arm B: Continued receipt of MCH-focused ART services based at the antenatal clinic throughout the period of breastfeeding. Post-partum women will only be referred to general adult ART services after the end of breastfeeding and once infants' final HIV status is determined.

Other: MCH-focused ART services

Interventions

MCH-focused ART services OTHER

Post-partum women who are breast feeding will be retained in the antenatal clinic to receive continued MCH-focused ART services until after the end of breastfeeding and once infants' final HIV status is determined.

MCH-focused ART services

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead
• Columbia University: collaborator

Study Sites (1)

Gugulethu Midwife Obstetric Unit

Cape Town, Western Cape, South Africa

Location

Related Publications (7)

• Weber AZ, Pellowski JA, Brittain K, Harrison A, Phillips TK, Zerbe A, Abrams EJ, Myer L. "This is My Life We are Talking About": Adaptive Strategies for HIV Care Retention and Treatment Adherence Among Postpartum Women Living with HIV in Cape Town, South Africa. Matern Child Health J. 2020 Dec;24(12):1454-1463. doi: 10.1007/s10995-020-02995-3.

  PMID: 32816255 DERIVED

• le Roux SM, Abrams EJ, Donald KA, Brittain K, Phillips TK, Zerbe A, le Roux DM, Kroon M, Myer L. Infectious morbidity of breastfed, HIV-exposed uninfected infants under conditions of universal antiretroviral therapy in South Africa: a prospective cohort study. Lancet Child Adolesc Health. 2020 Mar;4(3):220-231. doi: 10.1016/S2352-4642(19)30375-X. Epub 2020 Jan 10.

  PMID: 31932246 DERIVED

• Pellowski JA, Weber AZ, Phillips TK, Brittain K, Zerbe A, Abrams EJ, Myer L. "You must leave but I didn't want to leave": qualitative evaluation of the integration of ART into postnatal maternal and child health services in Cape Town, South Africa. AIDS Care. 2020 Apr;32(4):480-485. doi: 10.1080/09540121.2019.1659913. Epub 2019 Aug 27.

  PMID: 31455090 DERIVED

• le Roux SM, Abrams EJ, Donald KA, Brittain K, Phillips TK, Nguyen KK, Zerbe A, Kroon M, Myer L. Growth trajectories of breastfed HIV-exposed uninfected and HIV-unexposed children under conditions of universal maternal antiretroviral therapy: a prospective study. Lancet Child Adolesc Health. 2019 Apr;3(4):234-244. doi: 10.1016/S2352-4642(19)30007-0. Epub 2019 Feb 15.

  PMID: 30773459 DERIVED

• Myer L, Phillips TK, Zerbe A, Brittain K, Lesosky M, Hsiao NY, Remien RH, Mellins CA, McIntyre JA, Abrams EJ. Integration of postpartum healthcare services for HIV-infected women and their infants in South Africa: A randomised controlled trial. PLoS Med. 2018 Mar 30;15(3):e1002547. doi: 10.1371/journal.pmed.1002547. eCollection 2018 Mar.

  PMID: 29601570 DERIVED

• Sania A, Brittain K, Phillips TK, Zerbe A, Ronan A, Myer L, Abrams EJ. Effect of alcohol consumption and psychosocial stressors on preterm and small-for-gestational-age births in HIV-infected women in South Africa: a cohort study. BMJ Open. 2017 Mar 20;7(3):e014293. doi: 10.1136/bmjopen-2016-014293.

  PMID: 28320796 DERIVED

• Bernstein M, Phillips T, Zerbe A, McIntyre JA, Brittain K, Petro G, Abrams EJ, Myer L. Intimate partner violence experienced by HIV-infected pregnant women in South Africa: a cross-sectional study. BMJ Open. 2016 Aug 16;6(8):e011999. doi: 10.1136/bmjopen-2016-011999.

  PMID: 27531735 DERIVED

MeSH Terms

Conditions

HIV Infections; Breast Feeding

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Landon Myer, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Elaine J Abrams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 2, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

ZA (1)