Increasing MSM in the Continuum of Care in Kazakhstan

HIV Clinical Trial

Official title:

Increasing Involvement of MSM in the Continuum of Care in Kazakhstan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786615
• Other study ID #: AAAQ7251
• Secondary ID: 1R01DA040513-01A
• Status: Completed
• Phase: N/A
• Start date: June 27, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 987
• Est. completion date: April 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Kazakhstan	Global Health Research Center of Central Asia	Almaty
United States	Columbia University School of Social Work	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in the HIV care continuum: HIV testing	Has participant received an HIV test in the past 6 months	Past 6 months
Secondary	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