Community Intervention for HIV Testing & Care Linkage Among Young MSM in Bulgaria
Primary Purpose
Acquired Immunodeficiency Syndrome, HIV
Status
Active
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Social Network Leader Endorsement
HIV Counseling
Sponsored by
About this trial
This is an interventional health services research trial for Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria:
- Individuals must identify as male at birth;
- Individuals must report having sex with other males;
- Individuals will be between the ages of 16 and 20;
- Individuals must live in the greater Sofia metropolitan area;
- Individuals must be able to provide written informed consent.
Exclusion Criteria:
- Individuals who do not report they were male at birth;
- Individuals who do not report having sex with other males;
- Individuals younger than 16 or older than 20;
- Individuals who reside outside of the greater Sofia metropolitan area;
- Individuals who are unable to provide written informed consent.
Sites / Locations
- Health and Social Development Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Social Network Leader Endorsement
Routine Counseling
Arm Description
Leaders of social networks randomized to this arm will be trained to endorse frequent HIV testing, compliance with medical guidelines, and effective ways to communicate these concepts to social network members.
Members of social networks randomized to this arm will receive HIV counseling at baseline sessions.
Outcomes
Primary Outcome Measures
Change in Frequency of HIV Testing
Change in the number of HIV tests completed within the 6 months prior to baseline will be compared with the number of HIV tests completed 0-6 months post-intervention and 7-12 months post-intervention
Secondary Outcome Measures
Change in Medical Appointment Keeping
Changes in the number of medical appointments scheduled and kept relative to baseline will be compared at 6 and 12 months post-intervention
Full Information
NCT ID
NCT02639754
First Posted
December 21, 2015
Last Updated
April 4, 2023
Sponsor
Medical College of Wisconsin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02639754
Brief Title
Community Intervention for HIV Testing & Care Linkage Among Young MSM in Bulgaria
Official Title
Community Intervention for HIV Testing & Care Linkage Among Young MSM in Bulgaria
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Young men who have sex with men (MSM) in low- and middle-income countries often do not seek out HIV testing, are unaware of their HIV-positive status, and do not receive early medical care, compromising their health and contributing to downstream disease incidence. This situation is of great concern in post-socialist countries of Eastern Europe, where stigma about HIV/AIDS and same-sex behavior are great, HIV epidemics are still increasing, and the health needs of young MSM are rarely acknowledged or addressed. The planned research will be conducted in Sofia, Bulgaria, where MSM account for nearly half of HIV infections. The study will be conducted in two phases.
Detailed Description
In an initial qualitative phase, the investigators will conduct in-depth interviews with MSM ages 16 to 20 and other key informants to gain an understanding of factors related to HIV testing. The project's second phase is a trial of a network intervention to increase regular HIV testing and care linkage among young MSM. The investigators' prior studies in Bulgaria have shown that young MSM are clustered with other young MSM in social networks. The intervention trial will recruit 54 small social networks of MSM, each consisting of a young MSM "seed" between age 16 and 20 and also all close MSM friends surrounding the seed. All participants will complete baseline measures assessing recent HIV testing practices and testing history; attitudes, intentions, perceived norms, barriers, and understanding about HIV testing and medical care; sexual risk practices; and substance use. All participants will receive HIV risk reduction counseling. Networks will then be randomized to comparison and intervention conditions. Influence leaders of each experimental condition network will be identified, and network leaders will together attend a 5-session intervention, which will train, guide, and engage leaders to deliver theory-based, personally-tailored advice and counseling to their network members to correct misconceptions about HIV testing and care; strengthen friends' norms, attitudes, intentions, and perceived benefits of regular testing; and address barriers to testing. All members of intervention and comparison condition networks will be re-assessed at 6- and 12-month followup to determine the intervention's effects on HIV testing, regular testing, and testing- and care-related scale measures. Participants diagnosed with HIV infection at any point will be linked to medical care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Network Leader Endorsement
Arm Type
Experimental
Arm Description
Leaders of social networks randomized to this arm will be trained to endorse frequent HIV testing, compliance with medical guidelines, and effective ways to communicate these concepts to social network members.
Arm Title
Routine Counseling
Arm Type
Active Comparator
Arm Description
Members of social networks randomized to this arm will receive HIV counseling at baseline sessions.
Intervention Type
Behavioral
Intervention Name(s)
Social Network Leader Endorsement
Intervention Description
Leaders of social networks will attend a multi-session intervention during which they will be trained to deliver messages endorsing frequent HIV testing, compliance with medical guidelines, and adherence to medical treatment regimens to friends. Additionally, these leaders will be trained on how to deliver effective messages.
Intervention Type
Behavioral
Intervention Name(s)
HIV Counseling
Intervention Description
At the baseline session, participants in this condition will receive counseling about the benefits and availability of HIV care and the importance of frequent HIV testing.
Primary Outcome Measure Information:
Title
Change in Frequency of HIV Testing
Description
Change in the number of HIV tests completed within the 6 months prior to baseline will be compared with the number of HIV tests completed 0-6 months post-intervention and 7-12 months post-intervention
Time Frame
6 months; 12 months
Secondary Outcome Measure Information:
Title
Change in Medical Appointment Keeping
Description
Changes in the number of medical appointments scheduled and kept relative to baseline will be compared at 6 and 12 months post-intervention
Time Frame
6 months; 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals must identify as male at birth;
Individuals must report having sex with other males;
Individuals will be between the ages of 16 and 20;
Individuals must live in the greater Sofia metropolitan area;
Individuals must be able to provide written informed consent.
Exclusion Criteria:
Individuals who do not report they were male at birth;
Individuals who do not report having sex with other males;
Individuals younger than 16 or older than 20;
Individuals who reside outside of the greater Sofia metropolitan area;
Individuals who are unable to provide written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Kelly, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Social Development Foundation
City
Sofia
Country
Bulgaria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Community Intervention for HIV Testing & Care Linkage Among Young MSM in Bulgaria
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