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Telehealth Delivery (Tele-B6)

Primary Purpose

HIV Seropositivity, Bisexuality

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-B6
Delayed intervention (waitlist control)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Seropositivity focused on measuring black, Multiracial identity

Eligibility Criteria

18 Years - 29 Years (Adult)MaleDoes not accept healthy volunteers

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 to meet for two hours weekly over a six-week period. 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

Sites / Locations

  • Grady Infectious Diseases Program ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tele-B6

Wait-list control -delayed intervention

Arm Description

The tele-B6 intervention includes six group sessions delivered over the course of six 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).

Await-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.

Outcomes

Primary Outcome Measures

Acceptability
Qualitative interviews: Open-ended questions adapted from the original B6 exit interview guide. *8-month timepoint only applies to waitlist control participants
Change in the Acceptability Surveys
Post-session evaluation forms (adapted from original B6) after each group session. *8-month timepoint only applies to waitlist control participants
Change in Recruitment Rates
Rates of participation from screened and eligible participants. *8-month timepoint only applies to waitlist control participants
Change in retention
Attendance logs during each visit. *8-month timepoint only applies to waitlist control participants
Change in the intervention fidelity
Review of the Structured intervention logs (adapted from original B6) *8-month timepoint only applies to waitlist control participants
Safety (adverse events)
Review of Adverse event tracking forms *8-month timepoint only applies to waitlist control participants

Secondary Outcome Measures

Change in Perception of Structural Racism and Discrimination.
Participants will complete surveys measuring socioeconomic status, material resources scale. The material resources survey has 18 questions asking how often the participants' family needs are adequately met. 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). The highest score means that needs are adequately met. *8-month timepoint only applies to waitlist control participants
Change in Perception of discrimination
Participants will complete the Everyday Discrimination Scale at baseline and after each session. Each response is given a value according to the Likert scale ('never'=1 to 'almost everyday'=6). Responses are summed across items to produce a score ranging from 10 to 60. A higher score may indicate higher perception of discrimination. *8-month timepoint only applies to waitlist control participants
Change in Perception of HIV stigma
Participants will complete the HIV stigma scale at baseline and after each session. This scale includes which includes 10 item stigma rated on a 5-point scale from "Strongly Disagree" to "Strongly Agree". *8-month timepoint only applies to waitlist control participants
Change in Perception of 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. *8-month timepoint only applies to waitlist control participants
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. *8-month timepoint only applies to waitlist control participants
Change in 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. *8-month timepoint only applies to waitlist control participants
Change in logistical barriers
Participants will be asked to complete surveys and matched to Zipcode to derive neighborhood measures. *8-month timepoint only applies to waitlist control participants
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. *8-month timepoint only applies to waitlist control participants
Changes in perception of individual resilience process: Identity Affirmation
Participants will complete the multidimensional model of black identity lesbian, gay, and bisexual identity scale, *8-month timepoint only applies to waitlist control participants
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. *8-month timepoint only applies to waitlist control participants
Changes in the community resilience process: social capital
Participants will complete the personal social capital scale. 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 such that a higher score indicates a greater perceived collective efficacy. *8-month timepoint only applies to waitlist control participants
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. *8-month timepoint only applies to waitlist control participants
Changes in the perception of minority stress: depression
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 the presence of more symptomatology. *8-month timepoint only applies to waitlist control participants
Changes in the perception of minority stress: general well-being
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). *8-month timepoint only applies to waitlist control participants
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. *8-month timepoint only applies to waitlist control participants

Full Information

First Posted
April 13, 2023
Last Updated
July 6, 2023
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05829759
Brief Title
Telehealth Delivery (Tele-B6)
Official Title
Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (Tele-B6)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
Detailed Description
Subjects will participate in synchronous, online discussion sessions via videoconference for two hours per week over a six-week period. 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 in which they will rate 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 for enhancing feasibility and scalability prior to a larger efficacy trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Seropositivity, Bisexuality
Keywords
black, Multiracial identity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-B6
Arm Type
Experimental
Arm Description
The tele-B6 intervention includes six group sessions delivered over the course of six 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).
Arm Title
Wait-list control -delayed intervention
Arm Type
Other
Arm Description
Await-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.
Intervention Type
Behavioral
Intervention Name(s)
Tele-B6
Intervention Description
Participants will be part of the Tele-B6 intervention that includes six group sessions delivered over the course of six 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).
Intervention Type
Behavioral
Intervention Name(s)
Delayed intervention (waitlist control)
Intervention Description
Wait-list control participants will be assigned to a group for initiation of the full intervention beginning at month 4 after their enrollment (i.e., beginning after they, and their corresponding intervention group, have completed their intervention and two follow-up surveys). Wait-list control participants will complete surveys at enrollment (baseline), 2 months (pre-intervention), 4 months (preintervention), 6 months (immediate post-intervention), and 8 months (post-intervention).
Primary Outcome Measure Information:
Title
Acceptability
Description
Qualitative interviews: Open-ended questions adapted from the original B6 exit interview guide. *8-month timepoint only applies to waitlist control participants
Time Frame
Study Exit (up to 8* months)
Title
Change in the Acceptability Surveys
Description
Post-session evaluation forms (adapted from original B6) after each group session. *8-month timepoint only applies to waitlist control participants
Time Frame
2, 4, 6, up to 8* months
Title
Change in Recruitment Rates
Description
Rates of participation from screened and eligible participants. *8-month timepoint only applies to waitlist control participants
Time Frame
2, 4, 6, up to 8* months
Title
Change in retention
Description
Attendance logs during each visit. *8-month timepoint only applies to waitlist control participants
Time Frame
2, 4, 6, up to 8* months
Title
Change in the intervention fidelity
Description
Review of the Structured intervention logs (adapted from original B6) *8-month timepoint only applies to waitlist control participants
Time Frame
2, 4, 6, up to 8* months
Title
Safety (adverse events)
Description
Review of Adverse event tracking forms *8-month timepoint only applies to waitlist control participants
Time Frame
During study participation up to 8* months
Secondary Outcome Measure Information:
Title
Change in Perception of Structural Racism and Discrimination.
Description
Participants will complete surveys measuring socioeconomic status, material resources scale. The material resources survey has 18 questions asking how often the participants' family needs are adequately met. 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). The highest score means that needs are adequately met. *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, 8* months
Title
Change in Perception of discrimination
Description
Participants will complete the Everyday Discrimination Scale at baseline and after each session. Each response is given a value according to the Likert scale ('never'=1 to 'almost everyday'=6). Responses are summed across items to produce a score ranging from 10 to 60. A higher score may indicate higher perception of discrimination. *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Change in Perception of HIV stigma
Description
Participants will complete the HIV stigma scale at baseline and after each session. This scale includes which includes 10 item stigma rated on a 5-point scale from "Strongly Disagree" to "Strongly Agree". *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Change in Perception of internalized homonegativity inventory
Description
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. *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Qualitative description of intersectional stigma
Description
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. *8-month timepoint only applies to waitlist control participants
Time Frame
Exit of study (up to 8 months)
Title
Change in intersectional stigma
Description
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. *8-month timepoint only applies to waitlist control participants
Time Frame
Exit of study (up to 8 months)
Title
Change in logistical barriers
Description
Participants will be asked to complete surveys and matched to Zipcode to derive neighborhood measures. *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Qualitative description of logistical barriers
Description
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. *8-month timepoint only applies to waitlist control participants
Time Frame
Exit of study (up to 8 months)
Title
Changes in perception of individual resilience process: Identity Affirmation
Description
Participants will complete the multidimensional model of black identity lesbian, gay, and bisexual identity scale, *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Qualitative description individual resilience process: Identity Affirmation
Description
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. *8-month timepoint only applies to waitlist control participants
Time Frame
Exit of study (up to 8 months)
Title
Changes in the community resilience process: social capital
Description
Participants will complete the personal social capital scale. 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 such that a higher score indicates a greater perceived collective efficacy. *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Qualitative description of the community resilience process: social capital
Description
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. *8-month timepoint only applies to waitlist control participants
Time Frame
Exit of study (up to 8 months)
Title
Changes in the perception of minority stress: depression
Description
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 the presence of more symptomatology. *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Changes in the perception of minority stress: general well-being
Description
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). *8-month timepoint only applies to waitlist control participants
Time Frame
0, 2, 4, 6, up to 8* months
Title
Qualitative description of the minority stress
Description
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. *8-month timepoint only applies to waitlist control participants
Time Frame
Exit of study (up to 8 months)
Other Pre-specified Outcome Measures:
Title
Changes in HIV viral load
Description
The research team will review the electronic medical record (EMR) to abstract HIV viral load information
Time Frame
0 and 6 months
Title
Rate of retention care
Description
The research team will review the electronic medical record (EMR) to abstract data on missed appointments
Time Frame
0 and 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male gender, inclusive of transgender men
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 to meet for two hours weekly over a six-week period. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia A. Hussen, MD, MPH
Phone
(404) 616-2440
Email
shussen@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia A. Hussen, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Infectious Diseases Program Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophia A Hussen, MD, MPH
Phone
404-616-2440
Email
shussen@emory.edu
First Name & Middle Initial & Last Name & Degree
Andres Camacho-Gonzalez, MD, MsC

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Telehealth Delivery (Tele-B6)

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