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

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ClinicalTrials.gov Identifier: NCT02639754
Recruitment Status : Enrolling by invitation
First Posted : December 24, 2015
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Medical College of Wisconsin

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Change in Frequency of HIV Testing [ Time Frame: 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 :
  1. Change in Medical Appointment Keeping [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639754


Locations
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Bulgaria
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
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Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin
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Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02639754    
Other Study ID Numbers: PRO00024824
R01HD085833 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases