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

NCT02639754 | Completed

• 2 other identifiers: PRO00024824R01HD085833
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Immunodeficiency Syndrome; HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Medical Appointment Keeping

  6 months; 12 months

Study Arms (2)

Social Network Leader Endorsement

EXPERIMENTAL

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

Routine Counseling

ACTIVE COMPARATOR

Members of social networks randomized to this arm will receive HIV counseling at baseline sessions.

Behavioral: HIV Counseling

Interventions

Social Network Leader Endorsement BEHAVIORAL

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.

Social Network Leader Endorsement

HIV Counseling BEHAVIORAL

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.

Routine Counseling

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Health and Social Development Foundation

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jeffrey A. Kelly, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 24, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2020
• Study Completion: July 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)