Clinical trial NCT02786615: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Substance-Related Disorders
Keywords: men who have sex with men (MSM)
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-06-01
Enrollment: 987
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Engagement in the HIV care continuum: HIV testing
timeFrame: Past 6 months
Secondary outcomes:
measure: For PLWH, engagement in the HIV care continuum related to HIV medical treatment
timeFrame: Since confirmed HIV infection diagnosis
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Social Work
state: New York
city: Almaty
country: Kazakhstan
facility: Global Health Research Center of Central Asia
Study officials:
affiliation: Columbia University
name: Elwin Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: