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

Temple University

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: Black Men's Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03579251

1K23MH111402-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Pilot test

Other group

Description:

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.

Treatment:

Behavioral: Black Men's Care