Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV

NCT03664817 | Completed

• 1 other identifier: IRB00088255
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized controlled trial to evaluate the social capital intervention versus a general health promotion intervention (Health for Life; H4L) among groups of Young black men who have sex with men (YBMSM) and to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 months.

Conditions

HIV Infections

Keywords

MSM: Men who have sex with Men; Social Capital

Outcome Measures

Primary Outcomes (1)

• Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention

  Modified Social Capital Scale (MSCS) is an In-Depth Interview Guide that asks questions about social capital and engagement in care. The scale is recently modified, pilot tested, and validated Chen's Social Capital Scale. The instrument contained 10 composite items based on 42 items for assessing personally owned social capital, including bonding and bridging capitals. The questionnaire is a open ended questionnaire with probe questions. The scale contains subscales for bonding and bridging capital, and it also contains items that specify sources (including family, friends, and lesbian, gay, bisexual, and transgender (LGBT) organizations) and types of support (e.g. emotional support, instrumental support and informational support). The data will be transcribed verbatim by a professional business transcription service. Thematic analysis using a combination of inductive and deductive coding will be conducted to analyze the score.

  Baseline, 4 months after beginning intervention, 10 months after beginning intervention

Secondary Outcomes (5)

• Change in viral load suppression measured as copies/ml at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention

  Baseline, 4 months and 10 months

• Change in number of receiving two or more cluster of differentiation 4 (CD4) tests at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention

  Up to 10 months

• Number of HIV visits at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention

  Up to 10 months

• Change in subjects self report to question at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention

  Baseline and 10 months

• Number of viral load tests at post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention

  Up to 10 months

Study Arms (2)

social capital intervention

EXPERIMENTAL

This group will receive intervention developed from Phase 1 study and based on photovoice project

Behavioral: social capital intervention

group-based health promotion intervention

ACTIVE COMPARATOR

The intervention will be a modified version of "Health for Life" or H4L, which was used as a control arm intervention in a recently completed protocol of the Adolescent Trials Network which was co-chaired by Dr. Harper (University of Michigan)

Behavioral: group-based health promotion intervention

Interventions

social capital intervention BEHAVIORAL

The social capital intervention will focus on developing skills and group-work that culminate in participant-derived photovoice projects. Each group of YBMSM will be encouraged to complete a 30 day photovoice challenge. The 30 day challenge is based on a prior community action project done as a part of our Centers for AIDS Research (CFAR)-funded research, which was a Photovoice project conducted by Dr. Hussen. Photovoice is a participatory action research methodology in which groups of individuals from a population of interest are given cameras to document events, people and places of significance in their lives.

social capital intervention

group-based health promotion intervention BEHAVIORAL

The control arm will participate in a health education intervention that will be delivered in a group, but without a specific goal of creating group cohesion or social capital. The intervention will be a modified version of "Health for Life" or H4L, which was used as a control arm intervention in a recently completed protocol of the Adolescent Trials Network which was co-chaired by Dr. Harper (University of Michigan).

group-based health promotion intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Male sex at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \<= 29 years and \>= 18 years
• Self-identify as Black/African-American (inclusive of multiracial identities)
• Male sex at birth
• Endorse history of sex with men ever (inclusive of gay and bisexual men)
• HIV-positive (self-reported by participant and confirmed by medical record)
• Able and willing to provide written consent and participate in surveys, interviews, and/or group intervention

You may not qualify if:

• Age \< 18 years or \>= 30 years
• Unwilling or unable to provide written informed consent

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Emory University 1518 Clifton Rd

Atlanta, Georgia, 30322, 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 Officials

• Sophia Hussen, M.D., M.P.H.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, Randomized, Controlled

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: July 26, 2018
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)