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. 2018 Jan 29;19(1):77.
doi: 10.1186/s13063-018-2464-3.

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

Thomas A Odeny  1   2 , Maricianah Onono  3 , Kevin Owuor  3 , Anna Helova  4 , Iris Wanga  3 , Elizabeth A Bukusi  3 , Janet M Turan  4 , Lisa L Abuogi  5
Affiliations

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

Thomas A Odeny et al. Trials. .

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.

Keywords: Community mentor mothers; HIV; Option B+; PMTCT; SMS; Text messages.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this study has been obtained from the institutional review boards of the University of Colorado Denver, the University of Alabama at Birmingham, and KEMRI. This trial will also be supported by an independent Safety Monitoring Committee. This trial is registered with ClinicalTrials.gov (NCT02491177). Written informed consent is obtained from all participants before study participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
2 × 2 factorial design. Using a 2 × 2 factorial design, this study will evaluate the effect of community-based mentor mothers (cMMs), text messaging, or both on service utilization and maternal and child health outcome indicators
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials Statement (SPIRIT) figure for the MOTIVATE! study. Schedule of enrollment, intervention and assessments
Fig. 3
Fig. 3
Flow Diagram for the MOTIVATE! study
See this image and copyright information in PMC

References

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