An interventional study of Black Men's Care in HIV/AIDS, sponsored by Temple University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Temple University · Not applicable, Interventional, and Supportive care
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).
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 28 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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)
Time frame: 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)
Time frame: At baseline, at the end of the intervention (at three months), and three months after the intervention (at six months)
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.
Time frame: At 12 weeks (at three months)
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.
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
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.
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
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."
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
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.
Time frame: At six months (i.e., at three-month follow-up after the three-month intervention)
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Temple University