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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Thomas A. Odeny, Maricianah Onono, Kevin Owuor, Anna Helova, Iris Wanga, Elizabeth A. Bukusi, Janet M. Turan, Lisa L. Abuogi
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2464-3) contains supplementary material, which is available to authorized users.

Abstract

Background

Successful completion and retention throughout the multi-step cascade of prevention of mother-to-child HIV transmission (PMTCT) remains difficult to achieve. The Mother and Infant Visit Adherence and Treatment Engagement study aims to evaluate the effect of mobile text messaging, community-based mentor mothers (cMMs), or both on increasing antiretroviral therapy (ART) adherence, retention in HIV care, maternal viral load suppression, and mother-to-child HIV transmission for mother-infant pairs receiving lifelong ART.

Methods/design

This study is a cluster randomized, 2 × 2 factorial, controlled trial. The trial will be undertaken in the western Kenyan counties of Migori, Kisumu, and Homa Bay. Study sites will be randomized into one of four groups: six sites will implement both text messaging and cMM, six sites will implement cMM only, six sites will implement text messaging only, and six sites will implement the existing standard of care. The primary analysis will be based on the intention-to-treat principle and will compare maternal ART adherence and maternal retention in care.

Discussion

This study will determine the impact of long-term (up to 12 months postpartum) text messaging and cMMs on retention in and adherence to ART among pregnant and breastfeeding women living with HIV in Kenya. It will address key gaps in our understanding of what interventions may successfully promote long-term retention in the PMTCT cascade of care.

Trial registration

ClinicalTrials.gov, NCT02491177. Registered on 11 March 2015.
Zusatzmaterial
Additional file 1: Standard Protocol Item: Recommendation for Interventional Trials (SPIRIT) checklist for the MOTIVATE! study. (DOC 123 kb)
13063_2018_2464_MOESM1_ESM.doc
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