Evidence map›Paper›PMID 30376872›Full record

ArticleTrials2018

The Enhanced Mentor Mother ProgrAm (EMMA) for the prevention of mother-to-child transmission of HIV in Kenya: study protocol for a cluster randomized controlled trial.

Bruce A Larson, Margaret Bii, Isaac Tsikhutsu, Nafisa Halim, Vanessa Wolfman, Peter Coakley, William Sugut, Fredrick Sawe

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02848235 (Implementing the PMTCT Standard of Care Under Routine Conditions With and Without the Enhanced Mentor Mother ProgrAm), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02848235 nacompletednot on this map

Implementing the PMTCT Standard of Care Under Routine Conditions With and Without the Enhanced Mentor Mother ProgrAm (EMMA): A Site-randomized Impact Evaluation Study Among Maternal and Child Health Clinics Supported by the South Rift Valley PEPFAR Program in Kenya

TypeinterventionalSponsorHenry M. Jackson Foundation for the Advancement of Military MedicineRan2017 to 2019Enrolled363ConditionsHIV, PregnancyArmsStandard of Care + EMMA
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Bruce A LarsonDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA. blarson@bu.edu.ORCID http://orcid.org/0000-0002-9322-2387
Margaret BiiKenya Medical Research Institute/Walter Reed Project, Kericho, Kenya.
Isaac TsikhutsuKenya Medical Research Institute/Walter Reed Project, Kericho, Kenya.
Nafisa HalimDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Vanessa WolfmanUS Military HIV Research Program (MHRP), Henry Jackson Foundation, Bethesda, MD, USA.
Peter CoakleyUS Military HIV Research Program (MHRP), Henry Jackson Foundation, Bethesda, MD, USA.
William SugutKenya Medical Research Institute/Walter Reed Project, Kericho, Kenya.
Fredrick SaweKenya Medical Research Institute/Walter Reed Project, Kericho, Kenya.

Funding

U.S. Department of Defense W81XWH-11-2-0174
6 · The paper itself

Abstract

backgroundAs of September 2014, Kenya implemented the WHO recommended Option B+ guidelines in which all newly diagnosed HIV-infected pregnant women are immediately eligible for triple antiretroviral therapy (ART) for life regardless of CD4 count. In addition, Kenya previously established the Kenya Mentor Mother Program (KMMP) in 2012 to improve peer education and psychosocial support services within the national prevention of mother-to-child transmission (PMTCT) program. The primary objectives of the study described in the current protocol are: (1) to evaluate implementation of these new guidelines (Option B+ with Mentor Mothers) as part of routine service delivery; and (2) to evaluate potential benefits of a package of services within the KMMP (called EMMA) to improve PMTCT service delivery.

methodsWe will conduct a cluster randomized controlled trial in western Kenya. We will allocate 12 clinics providing PMTCT services including ART to two study arms using pair matching: the standard of care (SOC) arm, which includes the KMMP as implemented by the clinics; and the intervention arm, which is the SOC (including KMMP) with the EMMA package of services (a targeted exit interview, visit reminders, and targeted follow-up). At the intervention clinics, the EMMA package of services is implemented as part of routine service delivery. A total of 360 (180 in each arm) pregnant women will be enrolled in the study at or near their first visit for antenatal care for prospective records review through 72 weeks post-partum. The primary and secondary outcomes are uninterrupted supplies of ART medications throughout the PMTCT cascade of care as well as infants completing HIV testing on schedule. DISCUSSION: The EMMA package of services provides specific structure to the use of Mentor Mothers within PMTCT programs. This strategy was developed in collaboration with local health facility and PMTCT program staff based on their experience providing PMTCT services within the integrated ART-MCH facilities. If successful, this approach has the potential to improve dramatically PMTCT service delivery with minor additional costs beyond the basic mother-mentor program and support global goals to eliminate mother-to-child transmission.

trial registrationClinicalTrials.gov, NCT02848235 . Registered on 19 July 2016.

Indexed as

MentorsData CollectionData Interpretation, StatisticalFemaleHIV InfectionsHumansInfectious Disease Transmission, VerticalKenyaMulticenter Studies as TopicOutcome Assessment, Health CarePatient Education as TopicPractice Guidelines as TopicPregnancyPsychosocial Support SystemsRandomized Controlled Trials as TopicResearch DesignAIDSAntiretroviral therapyEMMAKenyaMentor mothersPrevention of mother to child transmission

Identifiers

PMID30376872
PMCPMC6208066

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.