Trial Outcomes & Findings for Telehealth Delivery (Tele-B6) (NCT NCT05829759)

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.

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).

Telehealth Delivery (Tele-B6)

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?)

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.

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

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.

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.

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.

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

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).

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.

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.

Participants will complete the multidimensional model of black identity lesbian, gay, and bisexual identity scale,

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.

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.

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.

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.

Participants will be asked to complete surveys and matched to a Zipcode to derive neighborhood measures.

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.

The research team will review the electronic medical record (EMR) to abstract HIV viral load information