Increasing MSM in the Continuum of Care in Kazakhstan

Increasing Involvement of MSM in the Continuum of Care in Kazakhstan

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; HIV
• Intervention / Treatment: Behavioral: Peer Unity

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.

• Study Type: Interventional
• Enrollment (Actual): 987
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan
    • Global Health Research Center of Central Asia
• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer Unity; 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.	Behavioral: Peer Unity; 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.
No Intervention: Pre-implementation; Subjects assigned to this arm would not receive the group-delivered intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in the HIV care continuum: HIV testing	Has participant received an HIV test in the past 6 months	Past 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Since confirmed HIV infection diagnosis

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Elwin Wu, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: men who have sex with men (MSM)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: AAAQ7251; 1R01DA040513-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No