HIV InfectionsNCT03664817
Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
A study testing social capital intervention and group-based health promotion intervention in people with HIV Infections, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- social capital intervention and group-based health promotion intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 9 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University 1518 Clifton Rd
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- social capital intervention, group-based health promotion intervention
- Keywords
- MSM: Men who have sex with Men, Social Capital
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social capital interventionBehavioural
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.
group-based health promotion interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| social capital intervention | Experimental | This group will receive intervention developed from Phase 1 study and based on photovoice project Receives: Behavioral: social capital intervention |
| group-based health promotion intervention | Active comparator | 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) Receives: Behavioral: group-based health promotion intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 months after beginning intervention, 10 months after beginning intervention
Secondary outcomes (5)
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.
Measured: Baseline, 4 months and 10 months
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
Measured: Up to 10 months
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
Measured: Up to 10 months
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.
Measured: Baseline and 10 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.
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start26 Jul 2018
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Controlled
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Sophia Hussen, Emory University
- Investigators
- Sophia Hussen, M.D., M.P.H., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664817
- Sponsor's protocol ID
- IRB00088255
- Status last verified
- Aug 2021
- First submitted
- 7 Sep 2018
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
- ClinicalTrials.gov ID
- NCT03664817
- Acronym / sponsor ID
- IRB00088255
- Conditions
- HIV Infections
- Keywords
- MSM: Men who have sex with Men, Social Capital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Controlled
| Arm | Type | Receives |
|---|---|---|
| social capital intervention | Experimental | Behavioral: social capital interventionThis group will receive intervention developed from Phase 1 study and based on photovoice project |
| group-based health promotion intervention | Active comparator | Behavioral: group-based health promotion interventionThe 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) |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| social capital interventionThe 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. | Behavioural | social capital intervention |
| group-based health promotion interventionThe 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). | Behavioural | group-based health promotion intervention |
Primary outcome
Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention
Time frame: 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.
5 secondary outcomes
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, 4 months and 10 months
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 10 months
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 10 months
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 10 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
Time frame: Up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Hussen, M.D., M.P.H. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social capital intervention and group-based health promotion intervention in people with HIV Infections, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention (time frame: Baseline, 4 months after beginning intervention, 10 months after beginning intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.