HIV Infections Clinical Trial
Official title:
Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
NCT number | NCT03664817 |
Other study ID # | IRB00088255 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 26, 2018 |
Est. completion date | April 9, 2021 |
Verified date | August 2021 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | April 9, 2021 |
Est. primary completion date | April 9, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 29 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University 1518 Clifton Rd | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline, 4 months and 10 months | |
Secondary | 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 | Up to 10 months | |
Secondary | 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 | Up to 10 months | |
Secondary | 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. | Baseline and 10 months | |
Secondary | 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. | Up to 10 months |
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