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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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ClinicalTrials.gov Identifier: NCT03664817
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Sophia Hussen, 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: social capital intervention Behavioral: group-based health promotion intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Controlled
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: social capital intervention
This group will receive intervention developed from Phase 1 study and based on photovoice project
Behavioral: social capital intervention
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.

Active Comparator: 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)
Behavioral: group-based health promotion intervention
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 Measures :
  1. Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention [ Time Frame: Baseline and 3 months (after completing 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 :
  1. 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 [ Time Frame: Baseline, 3 months and 9 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.

  2. 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 [ Time Frame: Up to 9 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

  3. 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 [ Time Frame: Up to 9 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

  4. 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 [ Time Frame: Baseline and 9 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.

  5. 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 [ Time Frame: Up to 9 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male sex at birth
Accepts Healthy Volunteers:   No
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

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): NCT03664817


Contacts
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Contact: Sophia Hussen, M.D., M.P.H. 404-727-2446 sophia.ahmed.hussen@emory.edu

Locations
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United States, Georgia
Emory University 1518 Clifton Rd Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sophia Hussen, M.D., M.P.H.    404-727-2446    sophia.ahmed.hussen@emory.edu   
Principal Investigator: Sophia Hussen, M.D., M.P.H.         
Sponsors and Collaborators
Emory University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Sophia Hussen, M.D., M.P.H. Emory University

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Responsible Party: Sophia Hussen, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03664817     History of Changes
Other Study ID Numbers: IRB00088255
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sophia Hussen, Emory University:
MSM: Men who have sex with Men
Social Capital

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases