Bisexuality, HIV Seropositivity
Conditions
Keywords
black, Multiracial identity
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 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.
Interventions
BEHAVIORALTele-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).
BEHAVIORALDelayed 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).
Sponsors
Emory University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Scale | Study Exit (up to 6 months) | 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?) |
| Number of Attended Sessions | During intervention sessions up to 5 weeks (5 weeks total) | 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. |
| Number of Participants Reporting Adverse Events (Safety) | During study participation up to 6 months | Review of Adverse Event Tracking Forms during study participation up to six months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Material Resources Survey | 0, 2, 4, 6 months | 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. |
| Everyday Discrimination Scale | 0, 2, 4 months | 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. |
| Perception of HIV Stigma Scale | 0, 2, 4, 6 months | 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. |
| Personal Social Capital Scale | 0, 2, 4, 6 months | 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. |
| Number of Participants With Studies Depression Scale Greater Than 16 | 0, 2, 4, 6 months | 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 |
| General Well-being (GWB) Survey | 0, 2, 4, 6 months | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSophia A. Hussen, MD, MPH
Emory University
Participant flow
Recruitment details
Summary results include only Phase 2, the randomized clinical trial, and participants who consented and participated in the online intervention. No consent or outcome data were collected in Phases 1 or 3, which were conducted solely to develop and adapt the program for online delivery and implementation. Participants were recruited from community and clinical partners in Atlanta. Enrollment began April 18, 2023; follow-up ended November 5, 2024.
Pre-assignment details
Survey assessments for the Tele-B6 arm were conducted at enrollment (baseline), 2 months (post-intervention), 4 months (interim, post-intervention), and 6 months (endline). Wait-list control (delayed intervention) participants began the full intervention at month 2, after their matched Tele-B6 completed the program and one follow-up survey. The wait-list control arm completed surveys at baseline, 2 months (pre-intervention), 4 months (immediate post-intervention), and 6 months (endline).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 25.4 years STANDARD_DEVIATION 3.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
None listed