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Optimizing Antiretroviral Therapy (ART) for Maternal and Child Health (MCH): Rationale and Design of the MCH-ART Study.

ABSTRACT: BACKGROUND:Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally, particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women. METHODS:We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) study, an implementation science project examining strategies for providing HIV care and treatment to HIV-infected women who initiate ART during pregnancy and their HIV-exposed infants. RESULTS:MCH-ART is composed of 3 interrelated study designs across the antenatal and postnatal periods. Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women seeking antenatal care; phase 2 is an observational cohort of all women from phase 1 who are eligible for initiation of ART following local guidelines; and phase 3 is a randomized trial of strategies for delivering ART to breastfeeding women from phase 2 during the postpartum period. During each phase, a set of study measurement visits is carried out separately from antenatal care and ART services; a maximum of 9 visits takes place from the beginning of antenatal care through 12 months postpartum. In parallel, in-depth interviews are used to examine issues of ART adherence and retention qualitatively, and costs and cost-effectiveness of models of care are examined. Separate substudies examine health outcomes in HIV-uninfected women and their HIV-unexposed infants, and the role of the adherence club model for long-term adherence and retention. DISCUSSION:Combining observational and experimental components, the MCH-ART study presents a novel approach to understand and optimize ART delivery for MCH.

SUBMITTER: Myer L

PROVIDER: S-EPMC5113242 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Optimizing Antiretroviral Therapy (ART) for Maternal and Child Health (MCH): Rationale and Design of the MCH-ART Study.

Myer Landon L Phillips Tamsin K TK Zerbe Allison A Ronan Agnes A Hsiao Nei-Yuan NY Mellins Claude A CA Remien Robert H RH Le Roux Stanzi M SM Brittain Kirsty K Ciaranello Andrea A Petro Greg G McIntyre James A JA Abrams Elaine J EJ

Journal of acquired immune deficiency syndromes (1999) 20160801

<h4>Background</h4>Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally, particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women.<h4>Methods</h4>We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) study, an implementation science project examining strategies for providing HIV care and treatment to HIV-infected women who initiate ART duri ...[more]

PMID: 27355508

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Project description:Background: Poor engagement in postpartum maternal HIV care is a challenge worldwide and contributes to adverse maternal outcomes and vertical transmission. Our objective was to project the clinical and economic impact of integrated postpartum maternal antiretroviral therapy (ART) and pediatric care in South Africa.Methods: Using the CEPAC computer simulation models, parameterized with data from the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) randomized controlled trial, we evaluated the cost-effectiveness of integrated postpartum care for women initiating ART in pregnancy and their children. We compared two strategies: 1) standard of care (SOC) referral to local clinics after delivery for separate standard ART services for women and pediatric care for infants, and 2) the MCH-ART intervention (MCH-ART) of co-located maternal/pediatric care integrated in Maternal and Child Health (MCH) services throughout breastfeeding. Trial-derived inputs included: 12-month maternal retention in care and virologic suppression (SOC: 49%, MCH-ART: 67%), breastfeeding duration (SOC: 6 months, MCH-ART: 8 months), and postpartum healthcare costs for mother-infant pairs (SOC: $50, MCH-ART: $69). Outcomes included pediatric HIV infections, maternal and infant life expectancy (LE), lifetime HIV-related per-person costs, and incremental cost-effectiveness ratios (ICERs; ICER <US$903/YLS considered "cost-effective").Results: Compared to SOC, MCH-ART increased maternal LE (SOC: 25.26 years, MCH-ART: 26.20 years) and lifetime costs (SOC: $9,912, MCH-ART: $10,207; discounted). Projected pediatric outcomes for all HIV-exposed children were similar between arms, although undiscounted LE for HIV-infected children was shorter in SOC (SOC: 23.13 years, MCH-ART: 23.40 years). Combining discounted maternal and pediatric outcomes, the ICER was $599/YLS.Conclusion: Co-located maternal HIV and pediatric care, integrated in MCH services throughout breastfeeding, is a cost-effective strategy to improve maternal and pediatric outcomes and should be implemented in South Africa.

Project description:OBJECTIVES:In April 2017, the United Nations Relief and Works Agency for Palestine Refugees in the Near East (UNRWA) released the electronic Maternal and Child Health Handbook, the e-MCH Handbook application. One of the first mobile health (m-Health) interventions in a refugee setting, the application gives pregnant women and mothers access to educational information and health records on smartphones. This study investigated factors associated with the dissemination and implementation of m-Health in the refugee setting. SETTING AND PARTICIPANTS:A cross-sectional study was conducted in 9 of 25 UNRWA health centres for Palestine refugees in Jordan. Self-administered questionnaires were distributed for 1?week to pregnant women and mothers with children aged 0-5 years. OUTCOME MEASURES:The outcomes were whether participants knew about, downloaded or used the application. Multiple regression analyses were conducted to determine factors associated with application download and usage. RESULTS:1042 participants were included in the analysis. 979 (95.5%) had a mobile phone and 862 (86.9%) had a smartphone. 499 (51.3%) knew about, 235 (23.8%) downloaded and 172 (17.4%) used the application. Having other mobile applications (OR 6.17, p<0.01), staff knowledge of the application (OR 11.82, p<0.01), using the internet as a source of medical information (OR 1.63, p=0.01) and having internet access at home (OR 1.46, p=0.05) were associated with application download. The age of the husband was associated with application usage (OR 1.04, p=0.11). CONCLUSIONS:Though m-Health may be a promising means of promoting health in refugees, multiple barriers may exist to its dissemination and implementation. Those who regularly use mobile applications and get medical information from the internet are potential targets of m-Health dissemination. For successful implementation of a m-Health intervention, health staff should have thorough knowledge of the application and users should have access to the internet. Husband-related factors may also play a role.

Project description:OBJECTIVE:To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. METHODS:Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. RESULTS:CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. CONCLUSIONS:CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. TRIAL REGISTRATION:ClinicalTrials.gov NCT00052078.

Dataset Information

Optimizing Antiretroviral Therapy (ART) for Maternal and Child Health (MCH): Rationale and Design of the MCH-ART Study.

Publications

Optimizing Antiretroviral Therapy (ART) for Maternal and Child Health (MCH): Rationale and Design of the MCH-ART Study.

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