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HIV SeropositivityNCT05829759

Telehealth Delivery (Tele-B6)

A study testing Tele-B6 in people with HIV Seropositivity and Bisexuality, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 29 years, men only
Conditions the study is for
HIV Seropositivity, Bisexuality
What is being tested?
Tele-B6
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
18 Apr 2023to 5 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Grady Infectious Diseases Program Clinic

    Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Tele-B6, Delayed intervention (waitlist control)
Keywords
black, Multiracial identity
Medical subject headings
HIV Seropositivity, Bisexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-B6Behavioural

    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).

  • Delayed intervention (waitlist control)Behavioural

    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).

Study groups in NCT05829759
Study groupRoleWhat they receive
Tele-B6ExperimentalThe 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).
Receives: Behavioral: Tele-B6
Wait-list control -delayed interventionOtherA 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.
Receives: Behavioral: Delayed intervention (waitlist control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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?)

    Measured: Study Exit (up to 6 months)

  2. 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.

    Measured: During intervention sessions up to 5 weeks (5 weeks total)

  3. Number of Participants Reporting Adverse Events (Safety)

    Review of Adverse Event Tracking Forms during study participation up to six months.

    Measured: During study participation up to 6 months

Secondary outcomes (6)

  1. 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.

    Measured: 0, 2, 4, 6 months

  2. 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.

    Measured: 0, 2, 4 months

  3. 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.

    Measured: 0, 2, 4, 6 months

  4. 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.

    Measured: 0, 2, 4, 6 months

  5. 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

    Measured: 0, 2, 4, 6 months

  6. 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).

    Measured: 0, 2, 4, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start18 Apr 2023
  3. Primary completion5 Nov 2024
  4. Study completion5 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829759
Sponsor's protocol ID
STUDY00003404
Other IDs
R34MH129187-01, 2025P013132
Status last verified
Mar 2026
First submitted
13 Apr 2023
Last updated
20 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The research team will share the results of surveys and clinical abstracted data in a de-identified dataset.

Publications

  • Hussen SA, Newman A Jr, Bullock M Jr, Reed MO, Murden RJ, Gutlay N, Opara SCO, Tewodros T, Dutta S, Doraivelu K, Camacho Gonzalez A, Gamarel K, Harper GW. Social Capital as Intervention: A Pilot Telehealth Trial (Tele-B6) Among Young Black Sexual Minority Men Living with HIV. AIDS Patient Care STDS. 2026 Jul;40(6-7):259-267. doi: 10.1177/10872914261453197. Epub 2026 May 19.

    PubMed 42157631

  • 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.

    PubMed 41325601

Questions about this trial

What is this clinical trial studying?

A study testing Tele-B6 in people with HIV Seropositivity and Bisexuality, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability Scale (time frame: Study Exit (up to 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829759, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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