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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02639754
• Other study ID #: PRO00024824
• Secondary ID: R01HD085833
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: July 2024
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bulgaria	Health and Social Development Foundation	Sofia

Sponsors (2)

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

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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