Clinical trial NCT03664817: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: MSM: Men who have sex with Men
Social Capital
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-09-11
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Controlled
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention
timeFrame: Baseline, 4 months after beginning intervention, 10 months after beginning intervention
Secondary outcomes:
measure: 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
timeFrame: Baseline, 4 months and 10 months
measure: 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
timeFrame: Up to 10 months
measure: 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
timeFrame: Up to 10 months
measure: 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
timeFrame: Baseline and 10 months
measure: 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
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University 1518 Clifton Rd
state: Georgia
Study officials:
affiliation: Emory University
name: Sophia Hussen, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: