- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03579251
Black Men's Care, and Intervention to Re-Engage HIV+ Black Men in Care (BMC)
January 22, 2024 updated by: University of California, San Francisco
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wilson Vincent, Ph.D., MPH
- Phone Number: 4042004193
- Email: wilson.vincent@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-native English speaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pilot test
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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
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)
|
At baseline, at the end of the intervention (at three months), and three months after the intervention (at six months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Client Satisfaction Questionnaire--8-item version
Time Frame: At 12 weeks (at three months)
|
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.
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At 12 weeks (at three months)
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Number of Missed Appointments
Time Frame: At six months (i.e., at three-month follow-up after the three-month intervention)
|
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.
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At six months (i.e., at three-month follow-up after the three-month intervention)
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CD4 Count
Time Frame: At six months (i.e., at three-month follow-up after the three-month intervention)
|
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.
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At six months (i.e., at three-month follow-up after the three-month intervention)
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Viral Load
Time Frame: At six months (i.e., at three-month follow-up after the three-month intervention)
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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."
|
At six months (i.e., at three-month follow-up after the three-month intervention)
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Percent of Appointments Missed
Time Frame: At six months (i.e., at three-month follow-up after the three-month intervention)
|
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.
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At six months (i.e., at three-month follow-up after the three-month intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wilson Vincent, Ph.D., MPH, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2018
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
June 25, 2018
First Posted (Actual)
July 6, 2018
Study Record Updates
Last Update Posted (Estimated)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 1K23MH111402-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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