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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
social capital intervention
group-based health promotion intervention
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring MSM: Men who have sex with Men, Social Capital

Eligibility Criteria

18 Years - 29 Years (Adult)MaleDoes not accept healthy volunteers

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

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

Sites / Locations

  • Emory University 1518 Clifton Rd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

social capital intervention

group-based health promotion intervention

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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 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
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
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
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
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
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.
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
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.

Full Information

First Posted
September 7, 2018
Last Updated
August 23, 2021
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03664817
Brief Title
Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
Official Title
Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
MSM: Men who have sex with Men, Social Capital

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized, Controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
social capital intervention
Arm Type
Experimental
Arm Description
This group will receive intervention developed from Phase 1 study and based on photovoice project
Arm Title
group-based health promotion intervention
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
social capital intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
group-based health promotion intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention
Description
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.
Time Frame
Baseline, 4 months after beginning intervention, 10 months after beginning intervention
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, 4 months and 10 months
Title
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
Description
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
Time Frame
Up to 10 months
Title
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
Description
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
Time Frame
Up to 10 months
Title
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
Description
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.
Time Frame
Baseline and 10 months
Title
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
Description
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.
Time Frame
Up to 10 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male sex at birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Hussen, M.D., M.P.H.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University 1518 Clifton Rd
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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