Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men
Shikamana
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 26, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJuly 13, 2017
July 1, 2017
1.3 years
November 13, 2014
July 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Any adverse events, such as confidentiality breaches, as a result of study participation
assessed at month 6 in each arm
Secondary Outcomes (2)
MEMS adherence
assessed at months 3 and 6 in each arm
plasma viral load
assessed at months 3 and 6 in each arm
Study Arms (2)
Shikamana Intervention
EXPERIMENTALThe Shikamana Intervention consists of provider support (modified Next Step Counseling) and peer support (trained peer navigator) to promote adherence to antiretroviral therapy
Standard Care
OTHERThe standard care arm will receive adherence counseling per standard Kenyan Ministry of Health guidelines, along with the recommendation to disclose to a family member or friend in order to obtain support
Interventions
Eligibility Criteria
You may qualify if:
- Male
- years or older
- Live or work in or around Mtwapa
- Kenyan nationality
- Engaged in any sex (manual, oral, anal) with a man during the past 12 months
- Documented HIV-1-infection
- Eligible for ART by current Kenyan guidelines
- Able to communicate in Swahili or English
- Willing to undergo randomization and participate in study procedures as outlined in the consent
- Not planning to move from area during the next 12 months To enhance study feasibility, we will recruit up to 30 men with prior ART experience. We will collect data on the duration of ART at the time of study enrolment.
You may not qualify if:
- Inability to understand the research, as assessed during informed consent
- Refusal to consider ART initiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Kenya Medical Research Institutecollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Kenya Medical Research Institute Mtwapa Research Clinic
Mtwapa, Kenya
Related Publications (1)
Graham SM, Micheni M, Kombo B, Van Der Elst EM, Mugo PM, Kivaya E, Aunon F, Kutner B, Sanders EJ, Simoni JM. Development and pilot testing of an intervention to promote care engagement and adherence among HIV-positive Kenyan MSM. AIDS. 2015 Dec;29 Suppl 3(0 3):S241-9. doi: 10.1097/QAD.0000000000000897.
PMID: 26562813BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M Graham, MD MPH PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 13, 2014
First Posted
November 26, 2014
Study Start
June 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
July 13, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Available from July 2017 for 2 years
- Access Criteria
- Researchers requesting access to data/resources will be asked to submit a request in writing describing their qualifications including their certification by their local IRB, analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data.
Study data will be available after publication of the main study manuscripts. Researchers requesting access to data/resources will be asked to submit a request in writing describing their qualifications including their certification by their local IRB, analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data. Given the sensitive nature of the data we are collecting, including HIV diagnosis and mental health status, we will not create a public access file.