Community Intervention for HIV Testing & Care Linkage Among Young MSM in Bulgaria

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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; HIV
• Intervention / Treatment: Behavioral: Social Network Leader Endorsement; Behavioral: HIV Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Health and Social Development Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Network Leader Endorsement; 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.	Behavioral: Social Network Leader Endorsement; 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.
Active Comparator: Routine Counseling; Members of social networks randomized to this arm will receive HIV counseling at baseline sessions.	Behavioral: HIV Counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months; 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months; 12 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jeffrey A. Kelly, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimated): December 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: PRO00024824; R01HD085833 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO