Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men

Summary

Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection, and prevent HIV transmission by making people less infectious. Men who have sex with men (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can make ART adherence difficult. Our goal is to find out if an intervention involving provider counselling and support from an MSM peer will improve ART adherence and engagement in care among Kenyan MSM. This study will be carried out in the KEMRI clinic in Mtwapa with 70 MSM patient participants who reside in this area, identified through our outreach and testing programs in Mtwapa. Six providers and five peers who are trained for the intervention will also be consented in order to collect data on their feedback and help monitor the study. Our intervention consists of support from a trained peer with experience taking ART and enhanced counselling from providers that is aimed to motivate patients to improve and maintain their health. In an initial pilot test, we will implement our intervention with 10 MSM starting ART for the first time. After any needed revisions to research procedures and training, we will next conduct a small randomized controlled trial with 60 MSM patient participants to determine feasibility, acceptability, tolerability, and safety, and estimate an initial effect size for the adherence intervention. The 60 patient participants will be randomized to our intervention or to standard counselling care, and will be followed for 6 months to evaluate their ART adherence and retention in care. Providers and peers will give feedback at regular project meetings and in in-depth interviews after the pilot test and after the RCT. The work proposed for this project will be carried out over 2 years, from June 1, 2014 through May 31, 2016.

Conditions

• Medication Adherence

Interventions

BEHAVIORAL

Shikamana Intervention

See arm description

BEHAVIORAL

Standard Care

See arm description

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Susan M Graham, MD MPH PhD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2016-10-31

Completion

2016-10-31

Countries

• Kenya

Study Locations