Clinical trial NCT02301533: Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men
Official title: Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: HIV infection
antiretroviral therapy
adherence
men who have sex with men
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2014-11-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: assessed at month 6 in each arm
Secondary outcomes:
measure: MEMS adherence
timeFrame: assessed at months 3 and 6 in each arm
measure: plasma viral load
timeFrame: assessed at months 3 and 6 in each arm
Other outcomes:
Locations:
city: Mtwapa
country: Kenya
facility: Kenya Medical Research Institute Mtwapa Research Clinic
Study officials:
affiliation: University of Washington
name: Susan M Graham, MD MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.