Black Men's Care, and Intervention to Re-Engage HIV+ Black Men in Care

NCT03579251 | Completed

• 1 other identifier: 1K23MH111402-01A1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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

  At 12 weeks (at three months)

• Number of Missed Appointments

  At six months (i.e., at three-month follow-up after the three-month intervention)

• CD4 Count

  At six months (i.e., at three-month follow-up after the three-month intervention)

• Viral Load

  At six months (i.e., at three-month follow-up after the three-month intervention)

• Percent of Appointments Missed

  At six months (i.e., at three-month follow-up after the three-month intervention)

Study Arms (1)

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.

Behavioral: Black Men's Care

Interventions

Black Men's Care BEHAVIORAL

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

Pilot test

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: A man living with HIV from a population that is disparately affect by HIV, particularly men who have sex with men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-native English speaker

Sponsors & Collaborators

• Temple University: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Wilson Vincent, Ph.D., MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1\) Semi-structured, qualitative interviews; 2) protocol development; 3) single-arm pilot study

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: July 6, 2018
• Study Start: August 1, 2017
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)