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

July 10, 2017 updated by: Susan Graham, University of Washington
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Although men who have sex with men (MSM) are at very high risk for HIV globally, this group has only recently become an important focus of national HIV/AIDS programs in sub-Saharan Africa. While it is clear that antiretroviral therapy (ART) can reduce AIDS-related morbidity and mortality and prevent sexual transmission from HIV-infected MSM, this group faces significant stigma that can impede engagement in care. Based on qualitative research conducted in 2013-2014 in coastal Kenya, we have developed an intervention called "Shikamana" (a Kiswahili word meaning "to form a bond or stick together") to improve HIV treatment engagement, ART adherence, and clinical outcomes in this group. We now propose a 2-year study to pilot test and conduct an initial evaluation of this intervention. Our specific aims are to: 1) pilot test our evidence-based intervention for MSM and ensure that the intervention is feasible and acceptable to patient, peer, and provider participants; and 2) implement a small randomized controlled trial (RCT) of the resulting multi-component intervention versus standard care with 60 MSM patient participants. Ten patient participants will be followed in the pilot test for 3 months each, with monthly measurement of ART adherence, baseline and month 3 measurement of adherence correlates, and feedback from participants and staff on the intervention procedures. After fine-tuning of the intervention based on the pilot test, we will follow 60 MSM patient participants for 6 months each, with monthly measurement of ART adherence, baseline and quarterly measurement of adherence correlates, viral load testing at month 3 and month 6 as a biomarker of treatment success, and feedback from participants and staff on the intervention procedures. Findings from this formative 2-year study will provide qualitative data on the feasibility, acceptability, tolerability, safety, and quantitative data on preliminary effect sizes to test this intervention and its components in a fully powered RCT including a larger, more diverse sample of MSM from multiple sites in sub-Saharan Africa.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Mtwapa, Kenya
        • Kenya Medical Research Institute Mtwapa Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • 18 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.

Exclusion Criteria:

  • Inability to understand the research, as assessed during informed consent
  • Refusal to consider ART initiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Shikamana Intervention
The Shikamana Intervention consists of provider support (modified Next Step Counseling) and peer support (trained peer navigator) to promote adherence to antiretroviral therapy
Behavioral: Shikamana Intervention
See arm description
Other: Standard Care
The 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
Behavioral: Standard Care
See arm description

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: assessed at month 6 in each arm
Any adverse events, such as confidentiality breaches, as a result of study participation
assessed at month 6 in each arm

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MEMS adherence
Time Frame: assessed at months 3 and 6 in each arm
Adherence to antiretroviral therapy, measured by MEMS Caps
assessed at months 3 and 6 in each arm
plasma viral load
Time Frame: assessed at months 3 and 6 in each arm
plasma HIV-1 RNA level
assessed at months 3 and 6 in each arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SUSAN M GRAHAM, MD MPH PHD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 44022
  • 1R34MH099946 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Available from July 2017 for 2 years

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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