NCT02786615

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
987

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

3.8 years

First QC Date

May 26, 2016

Last Update Submit

May 23, 2022

Conditions

HIVSubstance-Related Disorders

Keywords

men who have sex with men (MSM)

Outcome Measures

Primary Outcomes (1)

  • Engagement in the HIV care continuum: HIV testing

    Has participant received an HIV test in the past 6 months

    Past 6 months

Secondary Outcomes (1)

  • For PLWH, engagement in the HIV care continuum related to HIV medical treatment

    Since confirmed HIV infection diagnosis

Study Arms (2)

Peer Unity

EXPERIMENTAL

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

Pre-implementation

NO INTERVENTION

Subjects assigned to this arm would not receive the group-delivered intervention.

Interventions

Peer UnityBEHAVIORAL

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.

Peer Unity

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • has a language or cognitive impairment that would prevent comprehension of study procedures, risks, and benefits (described in Russian during the informed consent process)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University School of Social Work

New York, New York, 10027, United States

Location

Global Health Research Center of Central Asia

Almaty, Kazakhstan

Location

Related Publications (2)

  • Reeder KG, Lee YG, Sung J, Vinogradov V, Zhakupova G, Mergenova G, Davis A, Paine EA, Primbetova S, Terlikbayeva A, Kali S, Hunt T, Wu E. Trans Health is Public Health: The Prevalence of HIV Among Trans and Gender Expansive People in Kazakhstan. Res Sq [Preprint]. 2024 Sep 24:rs.3.rs-5124958. doi: 10.21203/rs.3.rs-5124958/v1.

    PMID: 39399678DERIVED

  • Wu E, Lee YG, Vinogradov V, Zhakupova G, Mergenova G, Davis A, Paine EA, Hunt T, Reeder K, Primbetova S, Terlikbayeva A, Laughney C, Chang M, Baiserkin B, Abishev A, Tukeyev M, Abdraimov S, Denebayeva A, Kasymbekova S, Tazhibayeva G, Kozhakhmet M. Increasing HIV Testing Among Sexual and Gender Expansive Men in Kazakhstan: A Stepped-Wedge Randomized Trial of a Community-Level Intervention. medRxiv [Preprint]. 2024 Aug 2:2024.08.01.24311235. doi: 10.1101/2024.08.01.24311235.

    PMID: 39132483DERIVED

MeSH Terms

Conditions

Substance-Related DisordersHomosexuality

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSexualitySexual BehaviorBehavior

Study Officials

  • Elwin Wu, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped-wedge design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Social Work

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 1, 2016

Study Start

June 27, 2018

Primary Completion

March 31, 2022

Study Completion

April 30, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
With or after publication, in perpetuity

Locations

US(1)KA(1)