Mobilizing Social Network Resources for HIV Care Support

NCT05123274 | Active Not Recruiting

• 1 other identifier: R34MH125715
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The intervention study will recruit 100 out-of-care HIV+ men who have sex with men in online and in community settings located throughout St. Petersburg, Russia. After completing baseline assessments, participants will be randomized to either an individual care counseling (ICC) comparison condition or ICC plus a social support mobilization (SSM) intervention. In each intervention, participants will attend five main and two booster sessions that underscore the benefits of medical care engagement, counter the effects of internalized intersectional stigma and promote resilience, and help participants develop and mobilize social resources supportive of HIV care. Support mobilization will begin by assisting participants develop care-supportive bonds with other group members, friends who are also living with HIV, and connections made with LGBT and other non-governmental organizations. They will also be guided in developing and expanding supportive links with affirmative friends, family members, and other resources. In this way, the intervention will bolster care-related social support resources, resilience, and feelings of self-worth. Assessments administered at baseline will be repeated 6 and 12 months post-intervention, and in-depth followup interviews will be conducted with a subset of 20 participants to elicit feedback about the intervention experience. The study will investigate whether the SSM intervention will produce greater preliminary evidence of benefit on the primary outcome of medical care attendance in the past 6 months and on secondary outcomes of having undetectable viral load, ART adherence, and psychosocial well-being.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• HIV Medical Appointments Kept

  The number of HIV medical care appointments a participant has attended

  6 months

• HIV Medical Appointments Missed

  The number of HIV medical care appointments a participant has missed

  6 months

Study Arms (2)

Individual Care Counseling

ACTIVE COMPARATOR

After completing the baseline survey, each participant will receive a 20-minute individual counseling session focused on HIV medical care. The session will convey that effective HIV treatment is now available at no cost, protects health, and that most individuals who are in treatment can lead long and healthy lives. Referral will be made and assistance provided in accessing LGBT-friendly HIV medical care, mental health, substance abuse, and other services.

Behavioral: Individual Care Counseling

Social Support Mobilization

EXPERIMENTAL

In addition to the post-baseline 20-minute individual counseling session, each participant in this arm will attend five main intervention sessions and two booster sessions that have three inter-related objectives: (1) ensuring that participants understand that viral suppression through ART maintains health and protects others; (2) increasing resilience and feelings of self-worth; and (3) guiding participants in identifying, accessing, and mobilizing social resources for both general psychosocial support and also specific supports for HIV care. For individuals who have potential supports in their social environment, the intervention will seek to mobilize or increase the frequency and quality of interactions with them. For participants who are presently socially isolated or whose social resources are not supportive of HIV care, the intervention will help to build new social ties with potentially supportive life figures.

Behavioral: Social Support Mobilization

Interventions

Social Support Mobilization BEHAVIORAL

Five main sessions and two booster sessions focused on providing accurate information about HIV medical care, increasing participants' feelings of resilience and self-worth, and mobilizing or creating social supports.

Also known as: SSM

Social Support Mobilization

Individual Care Counseling BEHAVIORAL

Twenty-minute individual counseling session focused on HIV medical care

Individual Care Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• male at birth
• reports being HIV-positive with no HIV medical care visit in the prior 6 months or adhering to \<95% of ART medication in the past month
• reports a history of sex with males in the prior 12 months
• not a participant in the earlier pilot test of the intervention

You may not qualify if:

• age 17 or younger
• not male at birth
• reports being HIV-negative or unknown HIV status
• reports being HIV-positive with at least one HIV medical care visit in the prior 6 months or reports adherence to \>95% of prescribed ART in the past month
• reports no history of sex with males in the prior 12 months
• participation in the earlier pilot test of the intervention

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 17, 2021
• Study Start: January 15, 2021
• Primary Completion: October 31, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (1)