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

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: Black Men's Care

• Registration Number: NCT03579251
• Lead Sponsor: University of California, San Francisco

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).

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 Timeline

• Study First Submitted: 2018-05-03
• Study Start: 2018-05-25
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-06
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

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Exclusion Criteria

• Non-native English speaker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot test	Black Men's Care	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Level of Engagement in Care--Future Appointments	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)
Change from Baseline Level of Engagement in Care--Appointments in the Past Six Months	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)

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire--8-item version	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.
CD4 Count	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.
Viral Load	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 viral load number or, if applicable, if the viral load is "undetectable."
Number of Missed Appointments	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.
Percent of Appointments Missed	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.

Trial Locations

Locations (1)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States