HIV/AIDSBMCNCT03579251
Black Men's Care, and Intervention to Re-Engage HIV+ Black Men in Care
A study testing Black Men's Care in people with HIV/AIDS, run by Temple University at 1 site in United States.
Trial summary
The proposed study aims to develop an intervention that is strategic in that it will 1) be a focused on an approach that combines an in-person session with post-session, two-way text messaging to continue the intervention and reinforce the gains from the in-person session and 2) ultimately find HIV+ Black men who have… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Black Men's Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 25 Jun 2024
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Staff (interviews): administrators and frontline workers who have worked in their respective positions for at least 6 months and have a caseload that includes +BMSM or a position at an organization that serves +BMSM. These staff members will be recruited from the San Francisco Bay Area.
- HIV-positive Black male patients (interviews): 1) HIV+, 2) self-identified as men who have sex with men, 3) 18 years or older, 4) have left HIV care, as indicated by less than 2 appointment in the past year and no scheduled appointments in the next 6 months or are engaged in care, as indicated by at least 2 appointment at least 90 days apart in the last year, and 5) live in or near the San Francisco Bay Area
- HIV-positive Black male patients (pilot study): 1) HIV+, 2) self-identified as men who have sex with men, 3) 18 years or older, 4) have left HIV care, as indicated by less than 2 appointment in the past year and no scheduled appointments in the next 6 months, 5) live in or near the San Francisco Bay Area, and 6) must also be available for the Pre-Intervention Survey; the BMC in-person session, 12 weeks of SMS, and Post-Intervention Survey upon completion of the intervention; and 3-Month Follow-Up after the intervention
Who cannot join
- Non-native English speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Intervention to Increase Retention in Care Among HIV-Positive Black Men
The proposed study aims to develop an intervention that is strategic in that it will 1) be a focused on an approach that combines an in-person session with post-session, two-way text messaging to continue the intervention and reinforce the gains from the in-person session and 2) ultimately find HIV+ Black men who have sex with men who have left HIV care where they are likely to present (e.g., city and county health clinics, community-based organizations, emergency rooms).
Read the detailed description
The overarching goal of this application is to develop and conduct a preliminary test of a "portable" intervention, "Black Men's Care" (BMC), to re-engage in HIV care HIV+ Black men who have sex with men who have left HIV care (+BMSM-LC) that is flexible with respect to where it can be conducted. The aims of the study are: Aim 1-to conduct formative research to develop BMC content and optimize its delivery; Aim 2-to develop BMC, a theory-based, combination in-person and text messaging (mHealth) intervention for +BMSM-LC; and Aim 3-to evaluate the acceptability, feasibility, and preliminary outcomes of BMC in preparation for submitting an R01 proposal to finalize and conduct an efficacy trial of BMC. Aims 1 and 2 will comprise the formative phase of the proposed study. Aim 1 will consist of semi-structured interviews with 2 staff members at each of 3 city and county health clinics, 3 community-based organizations, and 3 emergency rooms to identify effective settings for intervention. Aim 2 will consist of semi-structured interviews with 10 +BMSM-LC and 10 HIV+ Black men who have sex with men who remain in care to develop intervention content. Findings from these semi-structured interviews and Aim 1 will be used to develop a preliminary intervention protocol that will be refined across 2 sets of 3 sequential, single-subject iterations of the intervention sampled by age (n=3 for ages 18 to 29 years, n =3 for ages 30 and up). For Aim 3, a pilot study of 18 +BMSM-LC purposively sampled by age will assess acceptability, feasibility, and preliminary outcomes of BMC for re-engaging +BMSM-LC in care. The research and career development activities of this K23 proposal will allow the PI to achieve the goal of becoming an independent, R01-funded investigator. The PI will gain a broad range of critical skills (e.g., intervention development; qualitative research methods; trial design, safety monitoring, and process and outcome evaluation) and experiences to address the health needs of vulnerable populations at greatest risk of morbidity and mortality.
- Conditions
- HIV/AIDS
- Being tested
- Black Men's Care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Men's CareBehavioural
12 weeks of behavioral intervention, including an in-person session and two-way SMS, to re-engage in HIV care HIV-positive Black men who have fallen out of care
| Study group | Role | What they receive |
|---|---|---|
| Pilot test | Other | 12 weeks of behavioral intervention (Black Men's Care), including an in-person session and two-way SMS, with a three-month follow-up period post-intervention. Receives: Behavioral: Black Men's Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Level of Engagement in Care--Appointments in the Past Six Months
This is a simple, explicit behavioral outcome measure. The measures is to ask participants whether they have attended HIV care appointment in the past 6 months (response options: yes or no)
Measured: At baseline, at the end of the intervention (at three months), and three months after the intervention (at six months)
Change from Baseline Level of Engagement in Care--Future Appointments
This is a simple, explicit behavioral outcome measure. The measures is to ask participants whether they have a future HIV care appointment schedule (response options: yes or no)
Measured: At baseline, at the end of the intervention (at three months), and three months after the intervention (at six months)
Secondary outcomes (5)
Client Satisfaction Questionnaire--8-item version
The measure assesses participants' satisfaction with the intervention. Response options range from 1 (a lower degree of satisfaction) to 4 (a higher degree of satisfaction), and the mean of the eight items will be calculated to yield an overall score. Higher values indicated greater satisfaction.
Measured: At 12 weeks (at three months)
Number of Missed Appointments
This measure is contingent upon whether patient and provider consent to give access to the medical record. This is a measure of the number of schedule appointments missed during a six-month period.
Measured: At six months (i.e., at three-month follow-up after the three-month intervention)
CD4 Count
This measure is contingent upon whether patient and provider consent to give access to the medical record. This is the last measure of the patient's CD4 count.
Measured: At six months (i.e., at three-month follow-up after the three-month intervention)
Viral Load
This measure is contingent upon whether patient and provider consent to give access to the medical record. This is the viral load number or, if applicable, if the viral load is "undetectable."
Measured: At six months (i.e., at three-month follow-up after the three-month intervention)
Percent of Appointments Missed
This measure is contingent upon whether patient and provider consent to give access to the medical record. This is the ratio of the number of schedule appointments missed to the number of scheduled appointments during a six-month period.
Measured: At six months (i.e., at three-month follow-up after the three-month intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Aug 2017
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 1\) Semi-structured, qualitative interviews; 2) protocol development; 3) single-arm pilot study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilson Vincent, Ph.D., MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579251
- Sponsor's protocol ID
- 1K23MH111402-01A1
- Other IDs
- 1K23MH111402-01A1
- Acronym
- BMC
- Status last verified
- Sep 2024
- First submitted
- 3 May 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Increase Retention in Care Among HIV-Positive Black Men
- ClinicalTrials.gov ID
- NCT03579251
- Acronym / sponsor ID
- BMC / 1K23MH111402-01A1
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Francisco
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 6 Jul 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 proposed study aims to develop an intervention that is strategic in that it will 1) be a focused on an approach that combines an in-person session with post-session, two-way text messaging to continue the intervention and reinforce the gains from the in-person session and 2) ultimately find HIV+ Black men who have sex with men who have left HIV care where they are likely to present (e.g., city and county health clinics, community-based organizations, emergency rooms).
Detailed description
The overarching goal of this application is to develop and conduct a preliminary test of a "portable" intervention, "Black Men's Care" (BMC), to re-engage in HIV care HIV+ Black men who have sex with men who have left HIV care (+BMSM-LC) that is flexible with respect to where it can be conducted. The aims of the study are: Aim 1-to conduct formative research to develop BMC content and optimize its delivery; Aim 2-to develop BMC, a theory-based, combination in-person and text messaging (mHealth) intervention for +BMSM-LC; and Aim 3-to evaluate the acceptability, feasibility, and preliminary outcomes of BMC in preparation for submitting an R01 proposal to finalize and conduct an efficacy trial of BMC. Aims 1 and 2 will comprise the formative phase of the proposed study. Aim 1 will consist of semi-structured interviews with 2 staff members at each of 3 city and county health clinics, 3 community-based organizations, and 3 emergency rooms to identify effective settings for intervention. Aim 2 will consist of semi-structured interviews with 10 +BMSM-LC and 10 HIV+ Black men who have sex with men who remain in care to develop intervention content. Findings from these semi-structured interviews and Aim 1 will be used to develop a preliminary intervention protocol that will be refined across 2 sets of 3 sequential, single-subject iterations of the intervention sampled by age (n=3 for ages 18 to 29 years, n =3 for ages 30 and up). For Aim 3, a pilot study of 18 +BMSM-LC purposively sampled by age will assess acceptability, feasibility, and preliminary outcomes of BMC for re-engaging +BMSM-LC in care. The research and career development activities of this K23 proposal will allow the PI to achieve the goal of becoming an independent, R01-funded investigator. The PI will gain a broad range of critical skills (e.g., intervention development; qualitative research methods; trial design, safety monitoring, and process and outcome evaluation) and experiences to address the health needs of vulnerable populations at greatest risk of morbidity and mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1) Semi-structured, qualitative interviews; 2) protocol development; 3) single-arm pilot study
| Arm | Type | Receives |
|---|---|---|
| Pilot test | Other | Behavioral: Black Men's Care12 weeks of behavioral intervention (Black Men's Care), including an in-person session and two-way SMS, with a three-month follow-up period post-intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Staff (interviews): administrators and frontline workers who have worked in their respective positions for at least 6 months and have a caseload that includes +BMSM or a position at an organization that serves +BMSM. These staff members will be recruited from the San Francisco Bay Area.
- HIV-positive Black male patients (interviews): 1) HIV+, 2) self-identified as men who have sex with men, 3) 18 years or older, 4) have left HIV care, as indicated by less than 2 appointment in the past year and no scheduled appointments in the next 6 months or are engaged in care, as indicated by at least 2 appointment at least 90 days apart in the last year, and 5) live in or near the San Francisco Bay Area
- HIV-positive Black male patients (pilot study): 1) HIV+, 2) self-identified as men who have sex with men, 3) 18 years or older, 4) have left HIV care, as indicated by less than 2 appointment in the past year and no scheduled appointments in the next 6 months, 5) live in or near the San Francisco Bay Area, and 6) must also be available for the Pre-Intervention Survey; the BMC in-person session, 12 weeks of SMS, and Post-Intervention Survey upon completion of the intervention; and 3-Month Follow-Up after the intervention
Key exclusion criteria (1 listed)
- Non-native English speaker
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 |
|---|---|---|
| Black Men's Care12 weeks of behavioral intervention, including an in-person session and two-way SMS, to re-engage in HIV care HIV-positive Black men who have fallen out of care | Behavioural | Pilot test |
Primary outcome
Change from Baseline Level of Engagement in Care--Appointments in the Past Six Months
Time frame: At baseline, at the end of the intervention (at three months), and three months after the intervention (at six months)
This is a simple, explicit behavioral outcome measure. The measures is to ask participants whether they have attended HIV care appointment in the past 6 months (response options: yes or no)
Change from Baseline Level of Engagement in Care--Future Appointments
Time frame: At baseline, at the end of the intervention (at three months), and three months after the intervention (at six months)
This is a simple, explicit behavioral outcome measure. The measures is to ask participants whether they have a future HIV care appointment schedule (response options: yes or no)
5 secondary outcomes
Client Satisfaction Questionnaire--8-item version
Time frame: At 12 weeks (at three months)
Number of Missed Appointments
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
CD4 Count
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
Viral Load
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
Percent of Appointments Missed
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
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 19 Sep 2024.
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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.
Wilson Vincent, Ph.D., MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Men's Care in people with HIV/AIDS, run by Temple 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 3 inclusion and 1 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 19 Sep 2024. 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 from Baseline Level of Engagement in Care--Appointments in the Past Six Months (time frame: At baseline, at the end of the intervention (at three months), and three months after the intervention (at six months)). The study lists 2 primary outcomes in all. 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 19 Sep 2024.