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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

B. Larson, M. Bii, I. Tsikhutsu, Nafisa Halim, Vanessa Wolfman, Peter Coakley, W. Sugut, Fredrick Sawe
Published 2018 · Medicine

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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.DiscussionThe 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.
This paper references
10.1111/biom.12214
Estimation of treatment effects in matched-pair cluster randomized trials by calibrating covariate imbalance between clusters.
Z. Wu (2014)
10.1191/1740774504cn004rr
Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials
M. Sydes (2004)
an example using the Alere PimaTM analyzer in South Africa
B Larson (2018)
10.1002/SIM.4780141309
Breaking the matches in a paired t-test for community interventions when the number of pairs is small.
P. Diehr (1995)
Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: A rapid advice. Nairobi: Ministry of Health
(2014)
Bootstrap-Based Improvements for Inference with Clustered Errors
AC Cameron (2008)
10.1371/journal.pone.0052045
Costs and Cost-Effectiveness of a Mobile Phone Text-Message Reminder Programmes to Improve Health Workers' Adherence to Malaria Guidelines in Kenya
D. Zurovac (2012)
10.1136/bmj.e1590
Mentor mothers to prevent mother-to-child transmission of HIV
K. Mccoll (2012)
10.1097/QAI.0b013e31820bb448
Implementation Science for the US President's Emergency Plan for AIDS Relief (PEPFAR)
N. Padian (2011)
10.1097/QAI.0b013e318253258a
Patient Attrition Between Diagnosis With HIV in Pregnancy-Related Services and Long-Term HIV Care and Treatment Services in Kenya: A Retrospective Study
Laura C. Ferguson (2012)
10.7448/IAS.19.1.21484
Reimagining HIV service delivery: the role of differentiated care from prevention to suppression
A. Grimsrud (2016)
10.1136/bmjqs-2014-003620
How to study improvement interventions: a brief overview of possible study types
Margareth Crisóstomo Portela (2015)
10.2105/AJPH.94.3.416
Pitfalls of and controversies in cluster randomization trials.
A. Donner (2004)
10.1371/journal.pone.0035444
How to Estimate the Cost of Point-of-Care CD4 Testing in Program Settings: An Example Using the Alere Pima™ Analyzer in South Africa
B. Larson (2012)
10.1097/QAD.0000000000000143
Retention in care under universal antiretroviral therapy for HIV-infected pregnant and breastfeeding women (‘Option B+’) in Malawi
L. Tenthani (2014)
10.1097/QAD.0b013e32833298be
Antiretroviral therapy in antenatal care to increase treatment initiation in HIV-infected pregnant women: a stepped-wedge evaluation
W. Killam (2010)
10.7448/IAS.16.1.17994
Frequency and factors associated with adherence to and completion of combination antiretroviral therapy for prevention of mother to child transmission in western Kenya
P. Ayuo (2013)
10.1186/1758-2652-14-59
How to calculate the annual costs of NGO-implemented programmes to support orphans and vulnerable children: a six-step approach
B. Larson (2011)
10.2139/ssrn.964224
T-Statistic Based Correlation and Heterogeneity Robust Inference
R. Ibragimov (2007)
10.1097/QAI.0000000000000331
The Impact of Mentor Mother Programs on PMTCT Service Uptake and Retention-in-Care at Primary Health Care Facilities in Nigeria: A Prospective Cohort Study (MoMent Nigeria)
N. Sam-Agudu (2014)
10.1093/cid/ciw500
Adherence to Antiretroviral Therapy During and After Pregnancy: Cohort Study on Women Receiving Care in Malawi's Option B+ Program
A. Haas (2016)
10.1371/journal.pone.0064717
Mother to Mother (M2M) Peer Support for Women in Prevention of Mother to Child Transmission (PMTCT) Programmes: A Qualitative Study
A. Shroufi (2013)
National Guidelines for PMTCT Peer Education and Psychosocial Support in Kenya: The Kenya Mentor Mother Program. Ministry of Public Health and Sanitation. Nairobi: Government of Kenya
(2012)
10.1214/08-STS274
The essential role of pair matching in cluster-randomized experiments, with application to the Mexican Universal Health Insurance Evaluation
K. Imai (2009)
10.1080/09540121.2010.507750
Effectiveness of a PMTCT programme in rural Western Kenya
A. Azcoaga-Lorenzo (2011)
Using the Linear Probability Model to Estimate Impacts on Binary Outcomes in Randomized Controlled Trials
J. Deke (2014)
Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya. Nairobi: Ministry of Health
(2016)



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