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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02639754

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

320

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acquired Immunodeficiency Syndrome HIV	Behavioral: Social Network Leader Endorsement Behavioral: HIV Counseling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Frequency of HIV Testing [6 months; 12 months]
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 [6 months; 12 months]
Changes in the number of medical appointments scheduled and kept relative to baseline will be compared at 6 and 12 months post-intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 20 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health and Social Development Foundation	Sofia		Bulgaria

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jeffrey A. Kelly, PhD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey Kelly, Professor, Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT02639754

Other Study ID Numbers:

PRO00024824
R01HD085833

First Posted:

Dec 24, 2015

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Apr 11, 2022