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

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: group-based health promotion intervention; Behavioral: social capital intervention

• Registration Number: NCT03664817
• Lead Sponsor: Emory University

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.

Detailed Description

Young black men who have sex with men (YBMSM) have high rates of HIV infection, and are also at risk for falling out of clinical care. Social capital, which refers to the resources in a person's social network, has been shown to be beneficial for people living with HIV in other places. The study wants to understand and build upon social capital in the YBMSM population in Atlanta, with the goal of ultimately improving HIV-related outcomes for these youth.

To achieve this study is conducted in 3 phases. In Phase I, study will conduct interviews with YBMSM and community leaders to get advice about developing a social capital intervention that will improve social capital. Phase II is a randomized controlled trial of groups of YBMSM implementing the social capital intervention versus groups of YBMSM receiving a general health promotion intervention (Health for Life; H4L). This is followed by Phase III which is mainly to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 month timepoints.

The study plan to enroll 180 total participants (120 in the randomized controlled trial and 60 in preliminary interviews) over the four year study period.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-07-26
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Primary Completion: 2021-04-09
• Study Completion: 2021-04-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 77

Inclusion Criteria

• 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

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Exclusion Criteria

• Age < 18 years or >= 30 years
• Unwilling or unable to provide written informed consent
• Enrollment in one phase of the study is an exclusion criteria for enrollment in other phases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group-based health promotion intervention	group-based health promotion intervention	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)
social capital intervention	social capital intervention	This group will receive intervention developed from Phase 1 study and based on photovoice project

Primary Outcome Measures

Name	Time	Method
Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention	Baseline, 4 months after beginning intervention, 10 months after beginning 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.

Secondary Outcome Measures

Name	Time	Method
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	Retention in Care will be measured by determining participation in continuous care, that is, at least two or more routine HIV visits at least three months apart. This information will be gathered from subject's electronic medical record
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	Retention in Care will be measured by determining receiving two or more viral load tests. This information will be gathered from subject's electronic medical record.
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	Retention in Care will be measured by determining receiving two or more cluster of differentiation 4 (CD4) tests. This information will be gathered from subject's electronic medical record
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	Viral load values will be extracted from the participants' electronic medical records (EMR). Viral load refers to the number of viral particles found in each millilitre of blood. Viral load tests measure the amount of HIV's genetic material in a blood sample. The results of a viral load test are described as the number of copies of HIV RNA in a millilitre of blood. The viral load test should consistently detect and measure virus levels down to 50 copies/mL, have a high specificity and provide reproducible results. The technologies used are advanced and very sensitive for measuring the amount of HIV genetic material present in the blood.
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	Adherence to antiretroviral medications will be measured using a composite of single item self-report question and pharmacy refill records that will be conducted and evaluated at baseline and at 9 months.

Trial Locations

Locations (1)

Emory University 1518 Clifton Rd; 🇺🇸 Atlanta, Georgia, United States