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

HIV/AIDS Clinical Trial

— BMC  

Official title:

An Intervention to Increase Retention in Care Among HIV-Positive Black Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579251
• Other study ID #: 1K23MH111402-01A1
• Secondary ID: 1K23MH111402-01A
• Status: Completed
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Black Men's Care
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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	At 12 weeks (at three months)
Secondary	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.	At six months (i.e., at three-month follow-up after the three-month intervention)
Secondary	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.	At six months (i.e., at three-month follow-up after the three-month intervention)
Secondary	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."	At six months (i.e., at three-month follow-up after the three-month intervention)
Secondary	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.	At six months (i.e., at three-month follow-up after the three-month intervention)