Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT03579251
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:
NCT03579251
Study Brief:
Protocol Section:
NCT03579251