Increasing MSM in the Continuum of Care in Kazakhstan
Primary Purpose
HIV, Substance-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Peer Unity
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring men who have sex with men (MSM)
Eligibility Criteria
Inclusion Criteria:
- be at least 18 years old;
- identify as male; and
- report oral or anal intercourse with another man in the past 12 months; and
- report binge alcohol consumption and/or illicit use of substances in the past 12 months
Exclusion Criteria:
- has a language or cognitive impairment that would prevent comprehension of study procedures, risks, and benefits (described in Russian during the informed consent process)
Sites / Locations
- Columbia University School of Social Work
- Global Health Research Center of Central Asia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Peer Unity
Pre-implementation
Arm Description
Subjects assigned to this arm would receive a 4-session, group-delivered intervention focusing on peer/social network-based recruitment and referral program to receive HIV prevention and treatment services in the community.
Subjects assigned to this arm would not receive the group-delivered intervention.
Outcomes
Primary Outcome Measures
Engagement in the HIV care continuum: HIV testing
Has participant received an HIV test in the past 6 months
Secondary Outcome Measures
For PLWH, engagement in the HIV care continuum related to HIV medical treatment
For PLWH, visiting AIDS center, receiving ART, and/or achieving viral suppression (descriptive/exploratory due to limited statistical power given only a smaller fraction of sample will have known HIV infection)
Full Information
NCT ID
NCT02786615
First Posted
May 26, 2016
Last Updated
May 23, 2022
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02786615
Brief Title
Increasing MSM in the Continuum of Care in Kazakhstan
Official Title
Increasing Involvement of MSM in the Continuum of Care in Kazakhstan
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study addresses the disproportionate representation of men who have sex with men (MSM) in the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic in Kazakhstan, a country that has seen some of the largest growth in new HIV infections since the turn of the century. Using a stepped wedge trial across 3 cities in Kazakhstan, the proposed study will test a strategic and innovative social network-based intervention for MSM who use drugs in Kazakhstan as a strategy to increase their numbers in the HIV continuum of care.
Detailed Description
The intervention is designed to utilize MSM as experts and leverage social network processes to increase the number of MSM in Kazakhstan to be engaged in the HIV continuum of care. The unit of randomization will be a city, with the timing of roll-out of the social network-based intervention in each of the study's cities-Almaty, Nur-Sultan (formerly Astana), and Shymkent-under experimental control. Receipt/delivery of an intervention to enrolled participants will depend on whether the city is in the intervention delivery phase or not. If a participant is in a city during a time period where the intervention is not being delivered then for that time period, the participant is in the control condition. If the participant is in a city during a time period where the intervention is being delivered then the participant (in fact, all participants in that city) will be considered assigned to the intervention group at that time. In theory, all participants will have the opportunity to experience and receive the intervention. Some participants will be enrolled after the intervention has been rolled out in the city in which they reside; thus, they will only experience the intervention condition and not the control condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Substance-Related Disorders
Keywords
men who have sex with men (MSM)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped-wedge design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
987 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer Unity
Arm Type
Experimental
Arm Description
Subjects assigned to this arm would receive a 4-session, group-delivered intervention focusing on peer/social network-based recruitment and referral program to receive HIV prevention and treatment services in the community.
Arm Title
Pre-implementation
Arm Type
No Intervention
Arm Description
Subjects assigned to this arm would not receive the group-delivered intervention.
Intervention Type
Behavioral
Intervention Name(s)
Peer Unity
Intervention Description
A 4-session, group-delivered intervention focusing on peer/social network-based recruitment and referral program to receive HIV prevention and treatment services in the community.
Primary Outcome Measure Information:
Title
Engagement in the HIV care continuum: HIV testing
Description
Has participant received an HIV test in the past 6 months
Time Frame
Past 6 months
Secondary Outcome Measure Information:
Title
For PLWH, engagement in the HIV care continuum related to HIV medical treatment
Description
For PLWH, visiting AIDS center, receiving ART, and/or achieving viral suppression (descriptive/exploratory due to limited statistical power given only a smaller fraction of sample will have known HIV infection)
Time Frame
Since confirmed HIV infection diagnosis
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
be at least 18 years old;
identify as male; and
report oral or anal intercourse with another man in the past 12 months; and
report binge alcohol consumption and/or illicit use of substances in the past 12 months
Exclusion Criteria:
has a language or cognitive impairment that would prevent comprehension of study procedures, risks, and benefits (described in Russian during the informed consent process)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elwin Wu, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Global Health Research Center of Central Asia
City
Almaty
Country
Kazakhstan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication will be shared: (1) in accordance with journal requirements, and/or (2) via publicly accessible data repository (e.g., Academic Commons)
IPD Sharing Time Frame
With or after publication, in perpetuity
Learn more about this trial
Increasing MSM in the Continuum of Care in Kazakhstan
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