Telehealth Delivery (Tele-B6)

Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (Tele-B6)

The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.

Study Overview

• Status: Completed
• Conditions: HIV Seropositivity; Bisexuality
• Intervention / Treatment: Behavioral: Tele-B6; Behavioral: Delayed intervention (waitlist control)

Detailed Description

Subjects will participate in synchronous, online discussion sessions via videoconference for two hours per week over five weeks. Sessions will include engaging educational components and interactive activities, including discussions of case scenarios and sharing of personal experiences where desired. At the end of each videoconference session, participants will be asked to complete a brief session evaluation form rating the content, facilitation, and overall experience for the week. The long-term goal is to improve engagement across the HIV continuum of care (HIV-CoC) by enhancing individual- and community-level resilience processes among young Black gay, bisexual, and other men who have sex with men (YB-GBMSM) living with HIV. To this end, the research team has used community-based participatory research methods to develop Brothers Building Brothers by Breaking Barriers (B6), a novel group-level intervention designed to affirm intersectional identities and augment social capital among YB-GBMSM. The goal of this current study is to adapt and pilot B6 for telehealth delivery (creating tele-B6) within the context of an established community-based organization (CBO), as a strategy to enhance feasibility and scalability before a larger efficacy trial.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Grady Infectious Diseases Program Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Black race, inclusive of multiracial identities male gender, inclusive of transgender men
• self-identification as gay, bisexual, or another non-heterosexual orientation, and/or any history of consensual anal or oral sex with men
• HIV-positive serostatus
• age 18-29 years inclusive
• residence in the Atlanta Metropolitan Statistical Area
• available and interested in meeting for two hours weekly over five weeks.

Exclusion Criteria:

• Age < 18 years or > 30 years
• Unwilling or unable to provide written informed consent
• Enrollment in one phase of the study is an exclusion criterion for enrollment in other phases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-B6; The tele-B6 intervention includes five group sessions delivered over the course of five weeks. Survey assessments for the intervention group will be conducted at enrollment (baseline), 2 months (immediate post-intervention survey), 4 months (interim-survey, post-intervention), and 6 months (endline).	Behavioral: Tele-B6; Participants will be part of the Tele-B6 intervention that includes five group sessions delivered over the course of five weeks. Survey assessments for the intervention group (first phase) will be conducted at enrollment (baseline), 2 months (immediate post-intervention survey), 4 months (interim-survey, post-intervention), and 6 months (endline).
Other: Wait-list control -delayed intervention; A wait-list control design to safeguard ethical treatment of participants by ensuring that a potentially impactful intervention will be available to all after a brief waiting period.	Behavioral: Delayed intervention (waitlist control); Wait-list control participants will be assigned to initiate the full intervention at month 2 after their enrollment (i.e., after they and their corresponding intervention group have completed their intervention and one follow-up survey). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (immediate post-intervention), and 6 months (endline).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Scale	Post-session evaluation forms were administered after each intervention session and were evaluated collectively at the end of the study. This evaluation form included 7 statements (examples: "I felt comfortable in this virtual space", "I am confident I can apply the tools we learned today to my life") to be answered on a 5-point Likert scale (e.g., 5=strongly agree, 4=agree, 3=neutral, 2=disagree, 1=strongly disagree) as well as open ended questions (e.g., what did you like most?)	Study Exit (up to 6 months)
Number of Attended Sessions	Attendance was assessed using session logs recorded at each intervention visit, capturing the number of sessions attended during the five-week intervention period. For the immediate intervention arm (Tele-B6), attendance was recorded from baseline through completion of the five-week intervention (up to 2 months post-enrollment). For the delayed intervention (wait-list control) arm, attendance was recorded during the five-week intervention delivered between months 2 and 4 of study participation.	During intervention sessions up to 5 weeks (5 weeks total)
Number of Participants Reporting Adverse Events (Safety)	Review of Adverse Event Tracking Forms during study participation up to six months.	During study participation up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Material Resources Survey	Participants will complete the material resources survey to measure socioeconomic status. The material resources survey has 18 questions that ask how often the participants' family needs are adequately met. Items addressed resources such as having food for two meals a day, a house or apartment, money to pay monthly bills, time to get enough sleep/rest, and money to save. There are six options (never=0; rarely=1; less than half of the time=w, about half of the time=3; more than half of the time=4; and always=5). A sum score was computed with a potential range from 0 (never enough resources for all items) to 5 (always enough resources for all items), with a higher score indicative of more resources. The highest score means that needs are adequately met.	0, 2, 4, 6 months
Everyday Discrimination Scale	Participants will complete the Everyday Discrimination Scale at baseline and after each session. Each response is assigned a value on the Likert scale ('never'=1 to 'almost every day'=6). Responses are averaged across items to produce a score ranging from 1 to 6. A higher score may indicate a higher perception of discrimination.	0, 2, 4 months
Perception of HIV Stigma Scale	Participants will complete the HIV stigma scale at baseline and after each session. This scale includes 10 items, stigma rated on a 5-point scale from "Strongly Disagree"= 1 to "Strongly Agree"=5. For scoring, items are averaged, with higher total scores indicating greater perceived HIV stigma.	0, 2, 4, 6 months
Personal Social Capital Scale	Participants will complete the personal social capital scale. The Personal Social Capital Scale (PSCS) measures an individual's personal social capital, assessing both bonding capital (strong ties like family/close friends) and bridging capital (weaker ties to diverse groups) through cognitive (trust, reciprocity) and structural (network size, frequency) elements, to understand resources for health, support, and behavior. A five-point Likert scale is used to assess these questions, with 1 = none and 5 = all. A composite score will be derived by summarizing the item scores. The overall score range is typically 8 to 40 points. Higher scores indicate greater personal social capital, meaning the individual has a larger, more trustworthy social network with more resources and support available. Lower scores suggest fewer social connections and resources, which may be associated with increased stress or poorer health outcomes.	0, 2, 4, 6 months
Number of Participants With Studies Depression Scale Greater Than 16	Participants will complete the Studies Depression Scale (CES-D) survey. In scoring the CES-D, a value of 0, 1, 2, or 3 is assigned to a response depending upon whether the item is worded positively or negatively. The possible range of scores is 0 to 60, with the higher scores indicating greater symptomatology. The standard cut-off score on the 20-item Center for Epidemiologic Studies Depression Scale (CES-D) to indicate a risk for clinical depression is 16 or higher. Scores are interpreted as follows: 0-14: Mild or no depressive symptoms 15-23: Moderate or significant depressive symptoms 24 or higher: Severe depressive symptoms	0, 2, 4, 6 months
General Well-being (GWB) Survey	Participants will complete the general well-being (GWB) survey. The General Well-Being Schedule (GWB) is designed to assess an individual's mental health or quality of life. The GWB consists of 18 items indicating subjective feelings of psychological well-being and distress. All of the items utilize the past month as the time frame of interest. The first 14 questions use a six-point rating scale that represents either intensity or frequency. The remaining items use a 0-10 rating scale that is anchored by adjectives. Because some items are reverse scored (items 1, 3, 6, 7, 9, 11, 15, and 16), 14 is subtracted from the total score, yielding a total possible range of scores from 0 to 110. Low scores represent greater distress. Proposed cutoffs representing three levels of distress are 0-60 (severe distress), 61-72 (moderate distress), and 73-110 (positive well-being).	0, 2, 4, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Description of Intersectional Stigma	Participants will be asked to complete surveys with open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.	Exit of study (up to 6 months)
Qualitative Description of Logistical Barriers	Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.	Exit of study (up to 6 months)
Perception of Individual Resilience Process: Identity Affirmation	Participants will complete the multidimensional model of black identity lesbian, gay, and bisexual identity scale,	0, 2, 4, 6 months
Qualitative Description of the Minority Stress	Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.	Exit of study (up to 6 months)
Qualitative Description Individual Resilience Process: Identity Affirmation	Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.	Exit of study (up to 6 months)
Intersectional Stigma	Participants will be asked to complete surveys with open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.	Exit of study (up to 6 months)
Qualitative Description of the Community Resilience Process: Social Capital	Participants will be asked to complete open-ended questions adapted from the original B6 exit interview guide. There is no summary score of the open-ended questions asked during the interview.	Exit of study (up to 6 months)
Logistical Barriers	Participants will be asked to complete surveys and matched to a Zipcode to derive neighborhood measures.	0, 2, 4, 6 months
Perception of the Internalized Homonegativity Inventory	Participants will complete the Internalized Homonegativity Inventory at baseline and after each session. This 26-item scale has four subscales: (a) Public Identification as Gay, (b) Perception of Stigma Associated with Being Gay, (c) Social Comfort with Gay Men, (d) Moral and Religious Acceptability of Being Gay.	0, 2, 4, 6 months
HIV Viral Load	The research team will review the electronic medical record (EMR) to abstract HIV viral load information	0 and 6 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sophia A. Hussen, MD, MPH, Emory University

Publications and helpful links

General Publications

• Reed MO, Bullock M, Newman A Jr, Dutta S, Opara SCO, Tewodros T, Doraivelu K, Camacho-Gonzalez A, Murden R, Gamarel K, Harper GW, Hussen SA. Brothers Building Brothers by Breaking Barriers: Protocol for a Pilot Trial of a Telehealth Social Capital Intervention for Young Black Sexual Minority Men Living With HIV. JMIR Res Protoc. 2025 Dec 1;14:e69961. doi: 10.2196/69961.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Actual): November 5, 2024
• Study Completion (Actual): November 5, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: black; Multiracial identity
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Behavior; Sexual Behavior; Sexuality; HIV Seropositivity; Bisexuality
• Other Study ID Numbers: STUDY00003404; R34MH129187-01 (U.S. NIH Grant/Contract); 2025P013132 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research team will share the results of surveys and clinical abstracted data in a de-identified dataset.
• IPD Sharing Time Frame: The de-identified dataset will be available after the study and data analysis are complete.
• IPD Sharing Access Criteria: All requests should be sent by email to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No