HIVNCT02786615
Increasing MSM in the Continuum of Care in Kazakhstan
A study testing Peer Unity in people with HIV and Substance-Related Disorders, run by Columbia University at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance-Related Disorders
- What is being tested?
- Peer Unity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 987 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Jun 2018to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- has a language or cognitive impairment that would prevent comprehension of study procedures, risks, and benefits (described in Russian during the informed consent process)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Columbia University School of Social Work
New York, New York, 10027
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Substance-Related Disorders
- Being tested
- Peer Unity
- Keywords
- men who have sex with men (MSM)
- Medical subject headings
- Substance-Related Disorders, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer UnityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer Unity |
| Pre-implementation | No intervention | Subjects assigned to this arm would not receive the group-delivered intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in the HIV care continuum: HIV testing
Has participant received an HIV test in the past 6 months
Measured: Past 6 months
Secondary outcomes (1)
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)
Measured: Since confirmed HIV infection diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start27 Jun 2018
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elwin Wu, Columbia University
- Investigators
- Elwin Wu, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786615
- Sponsor's protocol ID
- AAAQ7251
- Other IDs
- 1R01DA040513-01A1
- Status last verified
- May 2022
- First submitted
- 26 May 2016
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
Lee YG, Vinogradov V, Freedman EH, Reeder KG, Davis A, Paine EA, Laughney CI, Kali SV, Yelkeyev A, Alipova K, Mergenova G, Yang X, Primbetova S, Terlikbayeva A, Wu E. Remote training of behavioral intervention facilitators: model development and lessons learned. Front Digit Health. 2026 Jul 31;8:1768119. doi: 10.3389/fdgth.2026.1768119. eCollection 2026.
PubMed 42602291Reeder 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.
PubMed 39399678Wu 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.
PubMed 39132483
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Involvement of MSM in the Continuum of Care in Kazakhstan
- ClinicalTrials.gov ID
- NCT02786615
- Acronym / sponsor ID
- AAAQ7251
- Conditions
- HIV, Substance-Related Disorders
- Keywords
- men who have sex with men (MSM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 987 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Peer Unity | Experimental | Behavioral: Peer UnitySubjects 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. |
| Pre-implementation | No intervention | –Subjects assigned to this arm would not receive the group-delivered intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- has a language or cognitive impairment that would prevent comprehension of study procedures, risks, and benefits (described in Russian during the informed consent process)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer UnityA 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. | Behavioural | Peer Unity |
Primary outcome
Engagement in the HIV care continuum: HIV testing
Time frame: Past 6 months
Has participant received an HIV test in the past 6 months
1 secondary outcome
For PLWH, engagement in the HIV care continuum related to HIV medical treatment
Time frame: Since confirmed HIV infection diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 42602291Lee YG, Vinogradov V, Freedman EH, Reeder KG, Davis A, Paine EA, Laughney CI, Kali SV, Yelkeyev A, Alipova K, Mergenova G, Yang X, Primbetova S, Terlikbayeva A, Wu E. Remote training of behavioral intervention facilitators: model development and lessons learned. Front Digit Health. 2026 Jul 31;8:1768119. doi: 10.3389/fdgth.2026.1768119. eCollection 2026.
- Derived from this study: PubMed 39399678Reeder 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.
- Derived from this study: PubMed 39132483Wu 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.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elwin Wu, PhD principal investigator
Columbia University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Unity in people with HIV and Substance-Related Disorders, run by Columbia University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in the HIV care continuum: HIV testing (time frame: Past 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786615, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.