Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (Tele-B6)
Phase: NA
Conditions: HIV Seropositivity, Bisexuality
Sponsor: Emory University

 
 
 
 
 
 
 
 
Brothers Building Brothers by Breaking Barriers for Telehealth 
Delivery (Tele-B6)   
STUDY00003404 
 
 
Date: November 03, 2025 
NCT05829759 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
B6) 
 
 
 
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PROTOCOL TITLE:   Brothers Building Brothers by Breaking Barriers for Telehealth 
Delivery (tele-B6) 
EXTERNAL (NON-EMORY) COLLABORATORS                                                                   
 
 
 
Professor of Public Health (University of Michigan) 
 
 
Assistant Professor of Health Behavior and Health Education (University of Michigan) 
 
PRINCIPAL INVESTIGATOR: 
 
Associate Professor of Public Health and Medicine 
 
  
 
EMORY Co-INVESTIGATOR: 
 
Associate Professor of Pediatrics 
 
VERSION: 1 
FUNDING SOURCE: NIH 
 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
B6) 
 
 
 
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REVISION HISTORY 
Revision # Version 
Date 
Summary of Changes 
1 
11/8/21 
Addressed comments 
2 
12/7/2021 
Clarified role of THRIVE SS 
3 
11/3/2025 
Adjusted follow up survey timepoints 
 
 
 
 
 
 
 
 
 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
B6) 
 
 
 
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Table of Contents 
 
1. 
Study Summary ...................................................................................................................4 
2. 
Objectives ...........................................................................................................................5 
3. 
Background .........................................................................................................................6 
4. 
Study Endpoints ..................................................................................................................8 
5. 
Study Intervention/Design ...................................................................................................9 
6. 
Procedures Involved ............................................................................................................9 
7. 
Data Specimen Banking .................................................................................................... 19 
8. 
Sharing of Results with Participants .................................................................................. 19 
9. 
Study Timelines ................................................................................................................ 19 
10. 
Inclusion and Exclusion Criteria .................................................................................... 20 
11. 
Population ..................................................................................................................... 21 
12. 
Vulnerable Populations .................................................................................................. 21 
13. 
Local Number of Participants ........................................................................................ 21 
14. 
Recruitment Methods .................................................................................................... 21 
15. 
Withdrawal of Participants ............................................................................................ 22 
16. 
Risk to Participants ........................................................................................................ 22 
17. 
Potential Benefits to Participants ................................................................................... 22 
18. 
Compensation to Participants ......................................................................................... 22 
19. 
Data Analysis, Management and Confidentiality ........................................................... 23 
20. 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................... 25 
21. 
Provisions to Protect the Privacy Interest of Participants ................................................ 26 
22. 
Economic Burden to Participants ................................................................................... 26 
23. 
Informed Consent .......................................................................................................... 26 
24. 
Setting ........................................................................................................................... 27 
25. 
Resources Available ...................................................................................................... 27 
26. 
References ..................................................................................................................... 28 
 
 
 
 
 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
B6) 
 
 
 
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1. Study Summary 
 
Study Title 
Brothers Building Brothers by Breaking Barriers for 
Telehealth Delivery (tele-B6) 
Study Design 
Three phases: 
Phase I: Adaptation and Modification of Intervention  
Phase II: Pilot RCT 
Phase III: Community Implementation 
Primary Objective 
To adapt B6 for telehealth delivery, conduct a pilot randomized 
controlled trial to evaluate feasibility, acceptability, and safety 
of the tele-B6 intervention, and evaluate the process of 
implementing tele-B6 within the context of a community-based 
organization. 
Research 
Intervention(s)/Interactions 
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 
Study Population 
18–29-year-old Black, gay, bisexual, and other men who have 
sex with men living with HIV in the Atlanta Metro area. 
Sample Size 
Phase I: N=6 for convenience sample, pilot run through 
Phase II: N=60, with 30 randomized to each group (waitlist 
control and intervention) 
Phase III: N=15 staff members/volunteers 
Study Duration for 
individual participants 
Phase I: 5-week intervention period only 
Phase 2: 6 months  
Phase 3: 2 years 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
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Funding Source (if any) 
NIH  
External Collaborators 
The University of Michigan will not directly enroll or perform 
intervention on participants at their own site, and will not have 
access to any identifiable data collected during the study. 
 is a clinical psychologist and public health professor 
with extensive experience in community-engaged intervention 
development among sexual minority youth. 
has worked 
closely with Hussen for over eight years, including on the 
development of B6. He will attend study team meetings to 
advise on intervention adaptation, study protocols, trouble-
shooting, and qualitative analyses. 
 will not interact 
directly with any research participants or raw data. 
 is a social psychologist with substantial experience 
in community-engaged intervention development with people 
living with and at-risk for HIV, and has served as the lead 
quantitative data analyst for several NIH-funded pilot 
intervention studies. She will be the lead biostatistician on the 
study but will work exclusively with de-identified data. 
 
 
2. Objectives 
Our 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, we 
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.  
 
Specific Aims: 
 
Aim 1: To adapt B6 for telehealth delivery, in collaboration with YB-GBMSM, community 
partners, and an advisory panel of subject matter experts. We will translate our culturally-
grounded, theory-based content into a series of synchronous videoconference discussions with 
accompanying online resources, using the ADAPT-ITT framework.43  
 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
B6) 
 
 
 
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Aim 2: To conduct a pilot randomized controlled trial to evaluate feasibility, acceptability, 
and safety of the tele-B6 intervention among YB-GBMSM living with HIV in Atlanta. We 
will recruit N=60 YB-GBMSM (randomized to intervention or waitlist control groups) into a 
pilot trial and utilize a mixed-methods approach to examine feasibility, acceptability, and safety 
of tele-B6. We will also explore evidence of preliminary intervention effects on identity beliefs, 
social capital, stigma, and HIV-CoC engagement.  
 
Aim 3: To evaluate the process of implementing tele-B6 within the context of a community-
based organization. We will draw on the Consolidated Framework for Implementation 
Research to analyze staff effort and intra-organizational processes relating to tele-B6 
implementation within our partner CBO. 
 
3. Background 
HIV continues to disproportionately impact young Black gay, bisexual, and other men who have 
sex with men (YB-GBMSM) at staggering rates; by age 30, an estimated 40% will be living with 
HIV.47 Thirty-six percent of Black GBMSM diagnosed with HIV in 2016 were aged 13-24 years; 
39% were aged 25-34.11 Although current HIV treatments effectively prevent morbidity and 
mortality, YB-GBMSM are at high risk for disengagement across the HIV Continuum of Care 
(HIV-CoC), leading to lower rates of engagement including linkage to care, retention in care, 
medication adherence, and viral suppression12 relative to other demographic groups.13-16 
YB-GBMSM encounter multiple barriers to engaging in HIV care, as a direct result of racism, 
homonegativity, and HIV stigma operating at structural, interpersonal and intrapersonal levels.1-9 
Despite these known disparities, there are few evidence-based approaches for improving care 
engagement with people living with HIV, and very few have specifically addressed the social, 
cultural, and developmental contexts of living with HIV for YB-GBMSM.17 There is an urgent 
need for evidence-based interventions designed specifically for YB-GBMSM living with HIV, to 
improve HIV-CoC outcomes and ultimately reduce morbidity, mortality, and HIV transmission. 
The few existing interventions to improve HIV-CoC outcomes for youth, while useful, often 
target individual-level behavior change without addressing the psychosocial mechanisms through 
which larger social contexts influence clinical outcomes.18, 19 Resilience, at both individual and 
community levels, can buffer the negative effects of structural racism, homonegativity, and HIV 
stigma on HIV-CoC outcomes.20, 21 Individual-level resilience processes include affirming 
identity beliefs relating to one’s own race, sexuality, and HIV status; these can enhance care 
engagement among youth living with HIV.22-24 Community-level resilience processes that 
improve HIV care engagement include the utilization of social capital, defined as the sum of 
resources that can be gained from a person’s social network.25-27  
 
Brothers Building Brothers By Breaking Barriers (B6), designed with and for YB-GBMSM 
living with HIV, is an acceptable, culturally-specific intervention designed to build resilience 
processes through intersectional identity affirmation and enhancement of social capital. Using 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
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a community-based participatory research (CBPR) approach, we initially developed B6 as an in-
person intervention.28 We conducted a pilot trial with N=72 participants; N=48 were assigned to 
the B6 intervention and N=24 underwent a comparison intervention (matched for time and 
attention) that did not focus on identity or social capital. B6 was delivered in a single day 
intensive session and included 14 interactive modules addressing a host of issues including Black 
gay identity, understanding and improving social capital, and navigating logistical barriers to 
HIV care. Our initial pilot found: 
1) The intervention was highly acceptable to YB-GBMSM living with HIV. Participants 
described specific benefits of B6, including bolstered self-acceptance of gay identity, 
improved communication with family and partners, and lasting social connections.  
 
2) We have preliminary evidence of favorable effects of B6 on participants’ self-reported 
HIV stigma, internalized homonegativity, and engagement in HIV care. Our pilot trial 
was not powered for efficacy; however, effect size analyses suggest several positive results 
of the intervention. Three months after participation, B6 intervention participants had lower 
reported HIV stigma and internalized homonegativity, and fewer missed HIV care 
appointments than at baseline; these effects were stronger in B6 than in comparison group 
participants.  
 
3) The feasibility of conducting the intervention in-person was limited by challenges with 
recruitment and retention. Recruitment and retention of participants were significant 
barriers to intervention feasibility. Although we were able to identify YB-GBMSM living 
with HIV who initially expressed interest and agreed to participate, show rates on the actual 
day of intervention were suboptimal. Previously confirmed individuals often mentioned 
transportation or work commitments as barriers to participation in the full-day, in-person 
intervention. To enhance feasibility and scalability of B6, we will therefore need to establish 
the effectiveness of alternative delivery methods such as telehealth delivery and/or delivery 
within the context of community-based organizations (CBOs). 
 
Overall, in our initial pilot trial of B6 as an in-person intervention, we found high levels of 
acceptability and satisfaction, as well as preliminary evidence for favorable effects on 
internalized homonegativity, HIV stigma, and HIV care engagement. However, we encountered 
limitations to feasibility with the in-person format.  
 
Telehealth delivery of interventions is scalable, feasible, and acceptable to youth living with 
HIV. Nearly 100% of US youth aged 18-29 own a mobile phone, and 96% own a smartphone.85 
Researchers have increasingly turned to digital health approaches, including development of 
mobile apps, social media campaigns, and telehealth to deliver youth-focused interventions 
targeting engagement across the HIV-CoC.86-91 Telehealth, referring simply to the use of 
electronic communication technologies to support health interventions over a distance,96 has 
been scaled rapidly in medical settings in the wake of the COVID-19 pandemic, including 
among youth living with and at risk for HIV.97-99 Telehealth also has demonstrated acceptability 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
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for behavioral intervention delivery in prior studies with these populations.100-102These studies 
suggest that telehealth is a potentially efficacious, acceptable and scalable strategy for 
intervention delivery to YB-GBMSM. 
 
Our scientific premise is that telehealth delivery and CBO-based implementation of a resilience-
focused intervention will enhance social capital, affirm identity beliefs, and ultimately improve 
engagement across the HIV-CoC for YB-GBMSM. 
4. Study Endpoints 
Primary Outcomes: Acceptability, feasibility, and safety. To assess acceptability, we will 
modify previous intervention satisfaction evaluation surveys and administer them at the end of 
each group discussion. We will also assess acceptability using data on participants’ reactions to 
various program components gathered from the facilitators’ intervention logs. Finally, we will 
conduct exit interviews with selected participants at the end of the six-week intervention period, 
in order to gather qualitative feedback about the structure, content, and experience of the 
intervention. To assess feasibility, we will monitor rates of outreach, recruitment, eligibility, 
enrollment, attendance, retention, and assessment completion. Based on calculations for 
enrollment and participation above, our recruitment goal will be to identify at least 13 eligible 
YB-GBMSM per month, to achieve intervention completion rates of >80% of group sessions 
completed, to maintain high intervention fidelity (goal: > 90% fidelity on checklists), and to 
ensure adequate retention across the follow-ups (goal: > 80%). Fidelity assessments will also be 
an important part of feasibility assessments: tele-B6 facilitators will complete a structured 
intervention log after each session to assess fidelity to intervention, time needed, and feasibility 
of delivering the intervention curriculum as designed. To assess safety, we will monitor adverse 
events, including psychological or physical events occurring over the course of intervention 
participation. 
 
Exploratory Outcomes. Although the primary aims of this study are to assess acceptability and 
feasibility, we will also assess HIV-CoC outcomes, as well as key mediators that are being 
targeted in tele-B6. Selection of measures will be guided by the relevant literature and our 
preliminary studies. Our eventual target outcome (in our subsequent, fully-powered study), HIV 
Care Engagement will be measured in terms of viral load suppression (defined as viral load 
measurement below 200 copies/mL at the most recent measurement before baseline, and at a 
data abstraction point at least 6 months post enrollment) and retention in HIV care, measured by 
missed visits before and after intervention participation. Missed visits are a validated measure of 
retention;148 additionally, we will not be able to use the Department of Health and Human 
Services (DHHS) retention measure (> 2 visits in 12 months, at least 3 months apart)149 due to 
the limited follow-up period. We will use previously validated scales with excellent documented 
reliability among our study population to measure key constructs in our conceptual model 
(structural racism and discrimination, logistical barriers, intersectional stigma, minority stress) 
and the resilience processes (identity affirmation and social capital) targeted in tele-B6. The 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
B6) 
 
 
 
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aforementioned qualitative exit interviews will also include domains assessing model constructs 
and resilience processes in addition to acceptability and satisfaction.  
 
5. Study Intervention/Design  
The study will involve three distinct phases, each corresponding to one of the research aims.  
Phase I: we will adapt the original B6 intervention for telehealth delivery, based on the ADAPT-
ITT framework and with the input of the YAB, THRIVE SS, and EAP. The goal of this phase is 
to convert our B6 content into a telehealth intervention (“tele-B6”) that can be delivered 100% 
remotely, while still retaining the personal connections and group engagement of the original in-
person intervention.  
Phase II: we will conduct a pilot randomized controlled trial with goal enrollment N=60 (with 30 
subjects in each group, intervention and waitlist control) to evaluate feasibility, acceptability, and 
safety of the adapted tele-B6 intervention. We will also conduct in-depth interviews (IDIs) with a 
subset of participants.  
Phase III: we will evaluate the process of implementing tele-B6 within the context of a 
community-based organization, THRIVE SS. 
 
6. Procedures Involved 
Phase I (adapt B6 for telehealth delivery, in collaboration with a youth advisory board 
(YAB), community advisors (THRIVE SS), and an advisory panel of subject matter experts 
(EAP). 
Adaptation Process. We will draw on Wingood and DiClemente’s ADAPT-ITT framework43 to 
guide intervention modifications (Table 1). ADAPT-ITT generally describes the process of 
adapting interventions for new populations – here, the target population will remain unchanged; 
however, the study settings and intervention delivery methods will change. We have already 
begun first two Steps (Assessment of population priorities and Decisions about what content to 
adapt), and will also work in a collaborative and participatory manner with our YAB to decide 
on further modifications. In the next step (Administration of the intervention), we will pilot 
individual tele-B6 modules with the YAB. We will then Produce a draft of the intervention 
manual and solicit feedback from our Topical experts (the EAP). We will Integrate this feedback 
into the adapted intervention and re-present the newest version to our YAB, THRIVE SS and the 
EAP for feedback. At this point, we will have completed the adaptation process and will Train 
study staff in implementation in preparation for Testing (Aim 2).  

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Intervention Format and 
Content. Table 2 depicts an 
overview of existing B6 content 
and proposed modifications for 
tele-B6. Whereas the original B6 
intervention was delivered in 
person over a single day, the 
main content in tele-B6 will be 
delivered via a series of six 
videoconference group 
discussions (two-hour sessions 
delivered weekly for six weeks), 
accompanied by intervening 
communication and brief, self-
paced activities to be completed 
by participants on their own 
time. We have found this format 
to be engaging and feasible in 
ongoing work with our YAB 
through the COVID-19 
pandemic. This modification is 
based on feedback from original 
B6 participants who expressed 
the desire for continued engagement, as well as prior research suggesting that increasing 
intervention intensity (i.e., length and frequency of engagement) has the potential to increase 
efficacy.135 We will add a password-protected section to the THRIVE SS website 
(www.thrivess.org), including: (1) Links to password-protected Zoom (or similar platform) 
sessions for weekly synchronous, online discussions; (2) educational resources (videos, 
infographics, case scenarios) for asynchronous content delivery between weekly sessions; (3) 
online discussion forums to facilitate communication between participants and with study staff; 
(4) links to community resources.  
Table 2. Intervention Content with Proposed Adaptations from Original In-Person B6 to Tele-B6 
Timing 
Target 
Construc
ts 
Module Title  
(in original 
B6) 
Module Goals  
(from original B6) 
Potential Adaptations in 
tele-B6 
(subject to change) 
Week 1: 
Introductio
ns  
 
Set the Stage 
Introduce facilitators and 
participants, set expectations and 
create a safe space 
Convert to online group 
discussion (synchronous) 
Table 1. Adaptation Process for Creation of Tele-B6 intervention 
ADAPT-ITT 
Steps 
Timing 
Methodology 
1) Assessment of 
priorities 
Preliminary 
Studies  
(pre-
proposal) 
Reviewed extensive preliminary 
data on social capital, identity, 
resilience, and HIV care 
engagement; key informant 
interviews 
2) Decisions 
about content 
to adapt 
Begun pre-
proposal, 
Months 1-3 
B6 intervention already created. 
Will convene YAB for iterative 
feedback sessions re: modifications. 
3) Administration Months 1-3 
Pilot testing individual modules with 
the YAB to inform decisions 
4) Produce 
Months 3-6 
Revise current manual, produce 
supplementary online materials  
5) Topical 
Experts 
Months 6-9 
Individual and group meetings with 
YAB, THRIVE SS and the EAP 
6) Integrate 
Feedback 
Months 9-
12 
Analyze feedback from YAB, 
THRIVE SS, and EAP; revise 
manual 
7) Train Study 
Staff 
Months 9-
12 
Practice sessions with YAB & pre-
RCT full pilot with convenience 
sample. 
8) Test 
Years 2-3  
Pilot RCT (Aim 2) 

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Social 
Capital  
Introduction 
to Social 
Capital 
Explain the theoretical foundation 
of the intervention to participants 
Convert to group discussion 
and create infographics for 
website. 
Identity 
Affirmati
on  
Who am I? 
Multiple 
Identities 
Identify the ways in which 
multiple identities (e.g., gay 
identity, Black identity, HIV-
positive identity) interact 
Convert to online group 
discussion (synchronous) 
Week 2: 
Exploring 
Self  
Social 
Capital  
Breaking 
Communicati
on Barriers 
Reflect on personal 
communication styles and any 
barriers to effective 
communication 
Convert to educational 
materials for posting on 
website, create pre-/post- 
quiz 
Coping 
with 
Minority 
Stress 
Critical self-
reflection and 
coping skills 
Reflect on how individual actions 
impact others; discuss common 
stressors and positive coping 
strategies 
Convert to online group 
discussion (synchronous) 
Week 3: 
Building 
Bonds 
Identity 
Affirmati
on  
Black Gay 
Slay: A 
History 
Gain appreciation for the 
historical contributions of Black 
gay men in society 
Create educational 
materials (e.g., brief video) 
to post online 
Social 
Capital 
Black Gay 
Community 
Explore perceptions, stereotypes 
and diversity within the Black 
gay community 
Convert to online group 
discussion (synchronous) 
Week 4: 
Building 
Bridges 
Part 1 
Social 
Capital 
Navigating 
Family  
Gain tools to develop healthier 
relationships with family (birth or 
choice) 
Convert to online group 
discussion (synchronous) 
Coping 
with 
Racism/
Discrimi
nation 
Navigating 
Professional 
Spaces 
Build skills for succeeding in 
professional arenas and 
cultivating relationships with 
colleagues and supervisors 
Convert to online group 
discussion (synchronous), 
post case studies on website  
Week 5: 
Building 
Bridges 
Part 2 
Coping 
with 
Racism/
Discrimi
nation 
Navigating 
Clinical 
Spaces 
Enhance skills for navigating 
healthcare settings, share 
strategies for communicating 
effectively with providers 
Convert to online group 
discussion (synchronous), 
post case studies on website 
Social 
Capital 
Navigating 
Intimate 
Relationships 
Reflect on intimate relationships; 
learn strategies to improve partner 
communication. 
Convert to online group 
discussion (synchronous), 
post case studies on website 
Week 6: 
Sustaining 
Connection
s 
Individua
l 
Resilienc
e 
Individual 
Goal Setting 
Set short and long-term goals for 
career, relationships, health.  
Create educational 
materials (e.g., worksheet) 
to post online 
Social 
Capital 
Community 
Action 
Learn strategies for activism and 
formulate community action 
plans.  
Convert to online group 
discussion (synchronous) 

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Conclusions 
Closing ceremony, distribution of 
a compilation of community 
resources 
Create list of community 
resources to post on website  
 
Iterative CBPR Modification Process. Throughout the ADAPT-ITT process, we will use an 
iterative participatory process whereby study staff will deliver each module to the YAB, 
followed directly by a collaborative session where they will solicit feedback and re-design 
recommendations for that specific module’s content and format. The potential strategies for 
adapted intervention delivery depicted in Table 2 are subject to change. YAB members will be 
encouraged to take notes during the administration of each module in order to provide detailed 
and specific feedback. Jones and Newman will also use Zoom’s shared screens and annotation 
functions to record concerns and recommendations during the collaborative feedback and re-
design sessions. These sessions will also be audio-recorded for further potential review. Field 
notes (with both observational and interpretive elements) will be taken during the course of each 
feedback and re-design session by research assistants observing these sessions. At the end of 
each session, Jones, Newman and the research assistants will engage in a process of critical 
reflection regarding the group, and develop combined reflection notes based on these 
conversations. Once all modules have been reviewed using this process, the study team will meet 
to make final decisions about modifications. We will then create the new intervention manual, 
and work with the YAB to create new online content. The YAB, EAP and members of THRIVE 
SS will review the tele-B6 manual, and make recommendations for changes during individual 
and group feedback meetings. Prior to commencement of the RCT, we will also recruit a 
separate convenience sample to conduct a pre-RCT pilot test of the intervention, so as to uncover 
potential implementation challenges and make any necessary modifications to prior to the RCT. 
Facilitator Training. Jones and Newman will be the two lead facilitators of tele-B6 (subject to 
change; any facilitators would be trained extensively prior to the intervention). Although they 
are intimately familiar with the original intervention content, training will be needed to 
standardize approach between the two facilitators, and to practice intervention delivery via 
videoconference. Jones and Newman will practice delivering modules with the YAB, and also 
during facilitation of the pre-RCT pilot referenced above. During this time, other team members 
will observe and note differences to be resolved prior to the RCT. During these observation 
sessions, we will refine an intervention log (a checklist modified from original B6) that we will 
use to measure fidelity during the RCT.  
 
Phase II (a pilot randomized controlled trial (RCT) to evaluate feasibility, acceptability and 
safety of the tele-B6 intervention among YB-GBMSM living with HIV in Atlanta.) 
Study Design. We will conduct a pilot RCT, where upon enrollment participants will be 
randomized to either the intervention or to a wait-list control condition, in which participants will 

Protocol Title: Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (tele-
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also receive the intervention after 
a four-month waiting period 
(Figure 2). We chose 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. Rolling 
enrollment of 60 participants will take place over an 
estimated 14-month time period; group assignment will 
occur as soon as sufficient participants are enrolled for two 
groups. As described above, the tele-B6 intervention 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). The second phase of the study, the 
delayed intervention (waitlist control) phase, provides an opportunity for the control arm to 
receive the intervention and simultaneously to (1) follow intervention arm participants for a 
further 2 months to assess the persistence of intervention effects, and (2) replicate main trial 
findings utilizing wait-list control data. Wait-list control participants will be assigned to a group 
for initiation of the full intervention beginning at month 2 after their enrollment (i.e., beginning 
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 (pre-intervention), and 6 months (immediate post-
intervention). 
Participant Experience. We will obtain electronic informed consent in one-on-one meetings 
conducted either via videoconference or in person prior to the first intervention visit. Participants 
will then complete the baseline REDCap survey and be provided with the schedule of tele-B6 
sessions and instructions on how to log on to the videoconference meeting at the pre-specified 
time. On the days of the tele-B6 sessions, we expect that most will log in from home; however, 
THRIVE SS has also agreed that participants can use their facilities for computer and/or wifi 
access if needed. YB-GBMSM 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, after which they will receive a $25 
electronic gift card. In the intervening week between sessions, participants will be asked to view 
additional resources and activities housed on the website in preparation for the following week. 
They will also have the opportunity to chat with each other and with facilitators on online 
discussion forums hosted on the website – these will be unstructured but moderated by study 
staff to ensure that there is no inappropriate content (i.e., bullying, harassment). Participants will 
retain access to the website after tele-B6 completion, and will also be formally linked to 
1
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18 months
Receiving intervention
Enrolled as control
Completing follow-up assessments
INTERVENTION 
GROUPS
WAITLIST 
CONTROL 
GROUPS
Figure 2. Waitlist Control Study Design

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THRIVE SS for additional support if they are not already members. The participants will then be 
emailed/texted links to follow-up REDCap surveys to complete follow-up assessments. 
Evaluation Strategy. We will utilize a mixed-methods approach to evaluate our intervention and 
assess our primary and exploratory outcomes (Table 3 below). Data sources will include 
intervention logs, adverse event reports, periodic electronic surveys, qualitative exit interviews, 
and electronic medical record (EMR) data. 
Table 3. Aim 2 Measurement Priorities 
 
 
Constructs 
Assessment 
Strategy 
Measures (where 
applicable) 
Timing 
Primary 
R34 
Outcomes 
Acceptability 
Qualitative 
Interviews 
Open-ended questions 
adapted from original B6 
exit interview guide 
Exit 
interviews 
Surveys 
Post-session eval forms 
(adapted from original B6) 
After each 
group session 
Feasibility 
Recruitment 
rates 
Rates of participation from 
screened and eligible 
participants 
Continuous 
Retention 
Attendance logs 
Continuous 
Intervention 
Fidelity 
Structured intervention 
logs (adapted from original 
B6) 
Continuous 
Safety 
Adverse Events  Adverse event tracking 
forms 
Continuous 
Model 
Constructs 
Structural 
Racism and 
Discrimination 
Surveys 
Measures of 
socioeconomic status, 
demographics 
Material resources scale142 
0, 2, 4, 
6months 
Intersectional 
Stigma 
Surveys 
Everyday Discrimination 
Scale143 
HIV Stigma Scale144 
Internalized 
Homonegativity 
Inventory145 
0, 2, 4, 
6months 
Qualitative 
Interviews 
Open-ended questions 
adapted from original B6 
exit interview guide 
Exit 
interviews 
Logistical 
Barriers 
Surveys 
Zip code to derive 
neighborhood measures 
0, 2, 4, 
6months 
Qualitative 
interviews 
Open-ended questions 
adapted from original B6 
exit interview guide 
Exit 
interviews 

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Data Collection Procedures - Surveys. We will use REDCap to create and administer baseline 
and follow-up surveys of participants. Surveys will be administered at baseline, 2-, 4-, 6-  month 
timepoints. Reminders to complete surveys will be sent via text message where needed. Survey 
Procedures: Surveys will primarily be conducted remotely, but can also be done in person at 
THRIVE SS or Emory if a participant prefers. We estimate that the surveys will take 30 minutes 
to complete. Best practices for web-based data collection will be employed to detect suspicious 
response patterns.150  
Data Collection Procedures - Qualitative Interviews. To evaluate B6 feasibility and 
acceptability, as well as descriptive accounts of any impact on resilience processes and/or 
conceptual model constructs, we will conduct qualitative exit interviews with a subset of 
participants (planned n=20 interviews). We will conduct these in-depth interviews (IDIs) with a 
purposively selected sample of participants, including both participants who maintained high 
levels of engagement and those with lower levels of engagement. Interviews will focus on 
experiences with the B6 intervention, and recommended improvements. IDI Procedures: IDIs 
will be conducted by trained study staff via Zoom. We will have participants interviewed by the 
staff member who was not their tele-B6 facilitator, in order to provide space for criticism if 
Individual 
Resilience 
Process: Identity 
Affirmation 
Surveys 
Multidimensional Model 
of Black Identity146 
Lesbian, Gay and Bisexual 
Identity Scale147 
0, 2, 4, 
6months 
Qualitative 
interviews 
Open-ended questions 
adapted from original B6 
exit interview guide 
Exit 
interviews 
Community 
Resilience 
Process: Social 
Capital 
Surveys 
Personal Social Capital 
Scale26 
0, 2, 4, 
6months 
Qualitative 
interviews 
Open-ended questions 
adapted from original B6 
exit interview guide 
Exit 
interviews 
Minority Stress 
Surveys 
Mental health measures 
including: 
Depression (CES-D) 
General Well-Being 
(GWB) 
0, 2, 4, 
6months 
Qualitative 
interviews 
Open-ended questions 
adapted from original B6 
exit interview guide 
Exit 
interviews 
Clinical 
Outcomes 
HIV Care 
Engagement 
Electronic 
Medical 
Record (EMR) 
abstraction  
HIV viral load 
Retention in Care (missed 
visits) 
0 and 6 
months 
 

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needed. Verbal consent will be obtained prior to each IDI, and participants will receive a $25 
electronic gift card upon completion. All interviews will be digitally recorded and uploaded to a 
secure server for professional transcription and analysis. Interviewers will record field notes, 
documenting salient themes to be explored in subsequent IDIs. 
Data Collection Procedures - Clinical EMR data abstraction. To measure preliminary efficacy 
of tele-B6 for improving engagement in care (defined using exploratory endpoints of care 
retention and viral suppression), we will abstract clinical data from the EMR. We will compare 
retention and viral suppression outcomes pre- and post- B6, and compare the intervention and 
control groups. At baseline and 6 months later, we will abstract viral load measurements as well 
as missed, scheduled, and attended appointments. Data will be entered into a secure REDCap 
database by trained abstractors (graduate research assistants), using standardized abstraction 
forms and manuals.151 For the first three months of abstraction, EMR data will be abstracted by 
two study team members in parallel and examined for inter-coder reliability. Differences will be 
discussed, and forms and manuals revised until inter-coder reliability is adequate (kappa > 0.80). 
 are experienced in training teams on EMR abstraction for HIV-
CoC outcomes.32, 152  
 
Phase III (evaluation of implementing tele-B6 within the context of a community-based 
organization.)  
Phase 3 seeks to answer the question, “How can we best facilitate future implementation of tele-
B6 via CBOs such as THRIVE SS?” To begin to address this question, we will conduct a mixed-
methods assessment guided by the Consolidated Framework for Implementation Research 
(CFIR),169 which synthesizes multiple theories to provide a “menu of constructs” associated 
with effective implementation. CFIR domains include: (1) Intervention Characteristics (i.e., 
perceptions of tele-B6); (2) Outer Setting (economic, social and political context surrounding the 
CBO); (3) Inner Setting (structural and cultural features within the CBO); (4) Characteristics of 
Individuals (staff who would implement tele-B6), and (5) Process (steps needed to implement 
tele-B6). We will develop brief surveys and interview guides to assess CFIR constructs (Table 
4).  

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Table 4. Consolidated Framework for Implementation Research (CFIR)- guided 
Assessment Strategy 
CFIR Construct 
Description 
Assessment 
Methods 
Specific scales from which 
survey items will be 
derived; or qualitative 
domains where applicable 
Intervention Characteristics 
Relative Advantage 
Perceptions of 
advantage of 
implementation 
Qualitative 
IDIs 
Open-ended questions about 
whether tele-B6 is perceived 
as beneficial by THRIVE SS 
staff 
Complexity 
Perceived difficulty of 
implementation 
Qualitative 
IDIs 
Open-ended questions about 
perceived difficulty of 
implementing tele-B6 
Staff effort 
Electronic 
Logs 
THRIVE SS staff working on 
the project will be asked to 
record time spent doing tele-
B6 related activities. 
Outer Setting 
Client Needs and 
Resources 
Client needs; barriers 
& facilitators for 
meeting them 
Qualitative 
IDIs 
Open-ended questions about 
barriers and facilitators to 
HIV CoC among YB-
GBMSM 
Surveys 
Study team to create items 
External Policy and 
Incentives 
Policies that could 
help/ hinder 
implementation 
Qualitative 
IDIs 
Open-ended questions about 
perceived barriers and 
facilitators to tele-B6 
implementation 
Inner Setting 
Networks and 
Communications 
Nature and quality of 
communication within 
the organization 
Surveys 
Study team to create items 
Qualitative 
IDIs 
Open-ended questions 
soliciting detailed 
descriptions of referral and 
communication processes 
Organizational 
culture 
Norms, values of the 
specific clinic setting 
Qualitative 
IDIs 
Open-ended solicitation of 
description of organizational 
culture, descriptions of how 
initiatives are implemented 
Leadership 
engagement 
Commitment, 
involvement of 
THRIVE SS 
leadership 
Surveys 
Selected items: 
Implementation Leadership 
Scale (ILS)170 
Characteristics of Individuals 
Knowledge & 
beliefs 
Familiarity with tele-
B6 
Surveys 
Study team will create items 
specific to tele-B6. 
Self-efficacy 
Individual belief in 
own capability to 
implement new 
Surveys 
Study team will modify items 
from the general self-efficacy 

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This assessment will run in parallel with the pilot RCT procedures described for Aim 2, such that 
implementation challenges and successes can be identified in real-time. 
 
Surveys. We will administer brief electronic surveys to THRIVE SS staff in order to assess CFIR 
constructs relating to implementing tele-B6. Surveys will be conducted every 6 months, 
beginning halfway through Year 1 (i.e. 6 months prior to initial tele-B6 implementation, and then 
every 6 months until the end of the project period). Sample size for this portion of the study will 
be based on feasibility of recruitment (any staff or general members involved with the project 
will be invited to join); we estimate that we can enroll approximately 15-20 individuals. As in 
Aim 2, we will use REDCap to create and administer surveys, which will take an estimated 20 
minutes to complete. Participants will have the option of completing surveys in-person or 
remotely. Upon completion of each survey, respondents will receive a $25 electronic gift card. 
 
Qualitative interviews. To evaluate implementation in real time, we will conduct prospective, 
linked qualitative IDIs with THRIVE SS staff depending on their involvement with the project. 
All THRIVE SS members who participate in the scheduled surveys will be asked to consent to 
be contacted for potential qualitative surveys as well. Based on Kvale’s estimate that 15 +/-5 
individuals is sufficient to reach theoretical saturation,172 we expect this to be an adequate 
sample size; particularly for the small scale implementation assessment being conducted here. In 
addition to interviewing members at times of heavier involvement, we will also strive to 
interview different types of stakeholders (e.g., leadership, paid staff, and/or highly involved 
members who are involved in the ongoing tele-B6 trial in any capacity) – although we will likely 
not be able to draw comparisons with this small sample size, we will still strive for 
representation of these different categories of individuals. We will create a semi-structured 
interview guide based on the CFIR, and follow procedures for remote and/or in person 
interviewing similar to those outlined in Aim 2. Interviews are expected to last 30-45 minutes, 
and stakeholders will also receive an additional $25 electronic gift card for any qualitative 
interviews that they participate in. Some individuals may participate in more than one interview 
(for example, we expect that the computer specialist who updates the website will have heavy 
involvement necessitating multiple interviews).  
 
Synthesis of Implementation Findings. Given that this assessment is still occurring within the 
context of a pilot trial, it will not completely predict “real-life” implementation experiences. 
However, these assessments will alert us to potential challenges (for example, if effort for the 
THRIVE SS computer specialist is higher than anticipated) that will need to be addressed prior 
to the next study. Additionally, documentation of the steps needed for implementation from the 
CBO side will inform development of an implementation manual – a guide that we will create 
based on the CFIR-guided assessment – that will be used in the follow-up trial. 
interventions at 
THRIVE SS 
scale171 to measure efficacy 
for implementing tele-B6 
Process 
Planning, Engaging, 
Executing and 
Evaluation 
Analysis of steps taken 
to implement an 
intervention 
Qualitative 
IDIs 
Recommendations for future 
implementation processes 
and how B6 integration 
might fit into organizational 
flow. 

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7. Data Specimen Banking 
 
Does not apply. 
 
8. Sharing of Results with Participants 
There are no individual results that would be shared with participants during the course of the 
study. In aggregate, dissemination of the results in the scientific and local community is a 
critically important part of this process. We plan a three-pronged approach that includes: (1) 
Community meetings at the midway point and at the end of the project. At these meetings (which 
we also plan to stream as a webinar), we will invite community members to hear about the status 
of our project, to ask questions and to provide feedback on next steps. We will invite all of the 
key informants from Phase 1 to these meetings and enlist the help of the YCAB in advertising to 
the audience who would find it most relevant. (2) Scientific publications: We will publish 
interim and final results of each phase in peer-reviewed publications. Where possible, we will try 
to publish in open-access journals to facilitate dissemination to those outside of academic 
institutions. (3) Presentations at Scientific meetings: We will also present interim and final 
results at national and international meetings such as the American Public Health Association 
and International AIDS Society meetings. 
 
9. Study Timelines 
Activity 
Pre-
Award 
Year 1 
Year 2 
Year 3 
Year 4 
Research Activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Team consolidation, hiring new staff, 
planning 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Development of project guidelines/SOPs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
IRB review: Emory, Grady 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
IRB review/project determination review: 
CDC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Qualitative interview guide development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 1: Adaptation with YAB 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 1: Adaptation with THRIVE SS, EAP  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 1: Facilitator Training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 2:  Recruitment and enrollment of 
intervention arm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 2:  Enrollment and follow-up of 
waitlist control arm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 2: Intervention and survey collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 2: IDIs with participants 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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Study Participants Recruitment and Participation Timeline. We would conservatively estimate 
that it will take 15.7 months to identify 204 eligible participants, of whom 60 would actually 
attend tele-B6. We will be continuously recruiting and enrolling for the study, beginning 2 
months prior to planned commencement of the first baseline group. Surveys will be administered 
to participants at baseline, 2-, 4-, 6-  month timepoints after the intervention as outlined above. 
Reminders to complete surveys will be sent via text message where needed. 
 
10. Inclusion and Exclusion Criteria 
Eligibility Criteria for Phases I and II will include, by self-report:  
(1) Black race, inclusive of multiracial identities;  
(2) male gender, inclusive of transgender men;  
(3) self-identification as gay, bisexual, or another non-heterosexual orientation, and/or 
any history of consensual anal or oral sex with men;  
(4) HIV-positive serostatus;  
(5) age 18-29 years inclusive;  
(6) residence in the Atlanta Metropolitan Statistical Area;  
(7) available and interested to meet for two hours weekly over a six week period.  
Eligibility will be assessed via a brief web-based screening survey administered either remotely 
or in person on a tablet.   
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 criteria for enrollment in other 
phases  
 
For Phase III, eligibility criteria will include: 
Aim 2:  Data analysis from pilot 
intervention/follow up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 3: Implementation guide 
development  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 3: Surveys and IDIs with 
implementation CBO 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Aim 3: Data analysis from implementation 
data and interviews 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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(1) Paid staff or volunteer at THRIVE SS 
(2) Willing and able to complete surveys and interviews about implementation experience 
(3) Age 18 and above 
 
11. Population 
We are focusing exclusively on Atlanta-area YB-GBMSM in this study due to the 
disproportionate impact of HIV in this population, as detailed in the literature review above. We 
are aiming to develop an intervention that is culturally and developmentally appropriate, and as 
such are limiting our enrollment to this target population. 
External collaborators at University of Michigan will not enroll subjects or participate directly in 
protocol interventions. The protocol will take place exclusively at Emory University in Atlanta, 
GA, except for statistical analyses which will be completed virtually through a de-identified, 
secure database by 
 at the University of Michigan. 
12. Vulnerable Populations 
We will not be working with vulnerable populations. 
13. Local Number of Participants 
Phase I: 6 participants 
Phase II: 60 participants 
In Phase III: 15 participants 
14. Recruitment Methods 
Our multi-pronged outreach strategy will target YB-GBMSM at varying levels of engagement 
with HIV clinical and community organizations: (1) Clinic-based recruitment: The main clinical 
recruitment site will be the Grady Infectious Disease Program clinic (IDP) in downtown Atlanta. 
 have strong track records of both clinical practice and research 
based at the IDP.9,24,93,96,97 (2) Research-based recruitment: We will also recruit from existing 
research projects (our own and others – with support from the Emory Center for AIDS Research 
[CFAR] Clinical Core) in which participants have expressed interest in being contacted for 
future studies. (3) CBO recruitment: We will ask for referrals from THRIVE SS as well as other 
Atlanta CBOs that work with Black GBMSM living with HIV. We will post flyers in CBO 
offices and other community locations as recommended by our advisors. (4) Online recruitment: 
We will recruit on social networking apps and websites (e.g., Facebook, Jack’d) shown to be 
high-yield for recruitment of sexual minority men in research;138 and post advertisements in 
online support groups and email listservs. We have found these strategies to be effective and 
acceptable in our prior work.28, 32, 139 
It will be important to make efforts to enhance retention and participation, while also not creating 
undue burden that could not be replicated during real-world implementation. Facilitators will 
utilize automated text message software (e.g., Twilio) to send periodic reminders and check-ins 

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(e.g., “time to log on to Zoom for B6!”; “Don’t forget to check out the case studies on 
www.thrivess.org”), as a low-intensity strategy for maintaining engagement. Text message 
reminders have been shown to enhance retention of Black GBMSM in prior intervention 
research.141 
 
15. Withdrawal of Participants 
Participants may withdraw from the study at any time. Once they have withdrawn, we will not 
collect any further data from these individuals. 
 
16. Risk to Participants 
Risks to participants from a physical standpoint are minimal, as there are no medical procedures 
being conducted in this study. There are risks from a social and/or psychological standpoint, 
primarily related to the potential for a breach of privacy which could lead to inadvertent 
disclosure of HIV status or sexuality. One source of such a breach could be study records; we 
will take the necessary precautions to prevent this including password protection of all 
participant records and de-identification of datasets before analysis. A second source of such a 
breach is other participants, as the activities include involvement in a group project with other 
YB-GBMSM living with HIV. We will make sure to explicitly discuss privacy concerns and 
instruct participants not to disclose others’ participation and/or HIV status; however this will be 
impossible for us to enforce. We will ensure that participants are aware of this potential risk in 
the informed consent process. 
There is a risk of uncovering information about psychological distress during the qualitative 
interviews, as questions about social support networks (or lack thereof) and coping with HIV can 
be sensitive topics for some. Prior to beginning the study, research staff will receive sensitivity 
training from mental health providers on the study team, in order to be knowledgeable of 
psychological occurrences that require intervention by a mental health professional. Any 
assessment of a potential psychological emergency during the course of the trial will result in the 
patient being transported to the Crisis Intervention Service unit at Grady Hospital, a 24-hour 
psychiatric emergency service with the ability to evaluate and stabilize patients. If less emergent 
emotional distress is noted, staff will be equipped with pamphlets listing mental health resources 
in the community and will assist with referrals as needed.  
 
17. Potential Benefits to Participants 
If our intervention is effective, it will provide direct benefits to the participants in terms of 
improved social support, social capital and HIV related outcomes. Those in the waitlist control 
arm will also receive the benefits of the intervention after a brief “waitlist” period.  
 
18. Compensation to Participants 
Phase I pilot participants will receive a $25 electronic gift card after each of the six intervention 
sessions. 

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Phase II RCT participants will be asked to complete a brief session evaluation form at the end of 
each videoconference session, in which they will rate the content, facilitation and overall 
experience for the week; after each of these intervention sessions and evaluation forms they will 
receive a $25 electronic gift card. Participants will also complete more in-depth surveys at 
varying intervals (0, 2, 4, 6 months for intervention and 0, 2, 4, 6, 8 for controls); upon 
completion of each, they will receive a $25 electronic gift card. Participants who choose to 
additionally complete an in-depth interview will receive a $25 electronic gift card upon 
completion. As such, participants can earn up to $300 over the course of Phase II participation. 
Phase III THRIVE SS staff will also be administered electronic surveys every 6 months through 
REDCap to assess implementation of tele-B6 in a community setting. At the completion of the 
survey, staff participants will receive a $25 electronic gift card. We will also conduct 
prospective, linked qualitative IDIs with selected THRIVE SS staff, after which they will receive 
an additional $25 electronic gift card. 
 
19. Data Analysis, Management and Confidentiality 
All survey and clinical data will be entered into a password protected, HIPAA compliant RedCap 
database. The database will be accessible only to the study team. Any subsequent datasets that 
are exported for analysis will be stripped of identifying information and will only be linked by a 
participant ID number. 
In terms of identifying discrepancies, some of this will be done prospectively by building quality 
checks into the Redcap data collection system—for example, if certain data do not line up 
between the baseline and follow up surveys (e.g. participant’s date of birth), participants will be 
prompted to re-enter their answers to that question. Once per month, data will be reviewed in 
more detail for potential errors. We will ask our biostatistician to conduct descriptive analyses in 
order to help us identify outliers and return to the original data source as needed to confirm 
outlying values.  
Qualitative interviews will be transcribed verbatim. Identifying information (names) will be 
taken out at the time of transcription. Files will be kept in a secured shared drive (Emory Box or 
equivalent) for access by study staff only. 
Phase II: Randomized Control Trial 
Statistical Analysis. Co-investigator 
 will lead all quantitative analyses. Our primary 
outcome is focused on descriptive analyses of the acceptability, feasibility and safety indices. We 
will assess intervention target outcomes (i.e., retention in care and viral suppression), 
hypothesized mediators (e.g., social capital, intersectional stigma), and background variables. 
These measures will be used to assess feasibility and acceptability (e.g., acceptability of items, 
length of time to complete surveys) of data collection.  
 

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Acceptability, feasibility, and safety: primary analyses. To evaluate acceptability of the 
intervention, quantitative analyses of the intervention data will be descriptive and concentrate on 
tabulating and summarizing post-session satisfaction survey measures. As described below, will 
also qualitatively analyze exit interviews conducted to assess acceptability and to identify any 
necessary modifications needed before a full trial. To evaluate feasibility of the intervention, we 
will monitor rates of recruitment and effort required (e.g. number of staff hours), number of 
screenings conducted and proportion eligible and agreed to enroll. Facilitators will complete a 
structured “intervention log” after each session, documenting level of fidelity to the curriculum. 
We will record number of rescheduled, cancelled and missed sessions and assessment visits to 
inform estimation of staffing needs and retention protocols for a subsequent full trial. We will 
also assess feasibility of verifying retention in care and viral load data by obtaining releases from 
participants to contact their provider and/or clinic by monitoring rates of verifiable EMR reports. 
To assess safety, we will tabulate and describe any reported adverse events that occurred during 
study participation. 
 
Hypotheses and methods for exploratory analyses. Exploratory hypotheses will be evaluated as 
part of the feasibility assessment process. For example, we expect that intervention participants 
compared to those in the waitlist control condition will have H1: higher mean count of medical 
appointments attended, H2: higher probability of viral suppression, and H3: higher mean social 
capital scores. Means and proportions will be plotted from baseline to follow-ups to enable 
descriptive evaluation of overall patterns of change across time. As a data analysis feasibility 
check, we will use generalized linear mixed models (GLMM) for dichotomous variables (e.g., 
viral load) and semi-continuous count data (e.g., number of appointments attended) and linear 
mixed models (LMM) for continuous outcomes (e.g., social capital) to evaluate the proposed 
preliminary hypotheses. GLMMs fitted to count outcomes will use the best-fitting distribution 
from the Poisson family (e.g., Poisson, negative binomial; zero-inflated Poisson; zeroinflated 
negative binomial) with the log link function.167 All mixed models will be estimated via 
maximum likelihood and will be fitted to ensure that all requisite information is available in the 
data to perform the types of analyses typically undertaken in a larger, formal RCT of the 
intervention's efficacy. Due to the modest sample size, significance testing will be de-
emphasized. Similarly, although the modest sample size precludes investigating mediation 
formally, we will employ the LMM and GLMM approaches described as described above 
compare changes over time on the mediators listed in Table 7. We will follow an intent-to-treat 
design. Comparisons of characteristics of participants lost to follow-up to those who participate 
will be conducted to assess systematic patterns that could influence results. 
Qualitative Analysis. Exit interviews will be digitally recorded, de-identified and transcribed 
verbatim. To support rigorous and reproducible qualitative analysis, 
 will lead 
team coding and analysis utilizing a pragmatic thematic analysis approach.168Analytic steps will 
include: (1) after each interview, interviewers will document field notes including emerging 
topic areas for subsequent exploration; (2) transcripts will be entered into MAXQDA qualitative 

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software for coding and analysis; (3) we will develop a preliminary codebook to include pre-
determined deductive codes related to theoretical domains of interest (e.g., constructs from the 
conceptual model) and inductive codes that emerge from the data; (4) Analysts will code a subset 
of transcripts and compare coding, with differences discussed in team meetings until consensus 
is reached; (5) similarities and differences across transcripts will be examined, and codes and 
themes revised accordingly. We will cease developing new codes when no new themes are seen; 
(6) properties and dimensions of salient themes will be summarized and interpreted in detailed 
analytic memos (“thick descriptions”). 
Phase III: Implementation 
Data Analysis. Quantitative data analysis: Analyses of implementation measures will be 
descriptive, including summaries of survey responses to the scales measuring CFIR constructs. 
The small sample size will preclude further comparative analyses; however, these assessments 
will give a brief window into implementation and also afford us an opportunity to pilot our 
instruments ahead of a larger trial. Qualitative data analysis: will follow thematic analysis 
procedures described above in Phase II.  
 
 
20. Provisions to Monitor the Data to Ensure the Safety of Participants 
Adverse Events. Study staff will be instructed to notify the PI immediately via phone or pager if 
there is any adverse event, whether or not they perceive it to be related to study 
participation. The PI will then take the responsibility of reporting to the Emory IRB within 24-48 
hours. Additionally, the project staff member who witnessed the event will complete an Adverse 
and Negative Events Form that includes the date, a description of the event, duration, severity, 
actions taken to remedy the negative event (including professional referrals).  
 
Information management and analysis software. Data will be collected and stored 
electronically using the RedCap (Research Electronic Data Capture) program. RedCap is a 
secure web application for building and managing online surveys and databases. It is compliant 
with the requirements of HIPAA and therefore ideal for the collection and storage of personal 
health information such as that which we will be collecting here. 
Software for data analysis will include statistical software (SAS, SPSS) as well as qualitative 
data management software (MaxQDa). We will de-identify all qualitative and quantitative 
datasets before beginning analyses and will only maintain the de-identified datasets once data 
collection is completed. 
 
Quality control/assurance. All data will be collected by trained staff members. 
 will 
assume primary responsibility for training and supervision of research staff administering the 
recruitment, informed consents, and Redcap online questionnaires. Staff will meet for weekly 
supervision with 
 and her mentors to discuss research protocol and logistical issues, as 
a way to allow for discussions of adverse events and promote maintenance of study integrity. 
Data will also be checked periodically for consistency and quality, as described in the Data 
entry, editing and management section above. 

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Bias in data collection, measurement and analysis. There is potential for bias in data collection, 
measurement and analysis in this study, which we will make every effort to curtail. Bias in data 
collection is the most likely to be a problem in our study. Selection bias in terms of our 
qualitative interviews (Phases II and III) and RCT participants could occur, as those YB-
GBMSM more interested in our project may already be likely to have higher levels of social 
capital and be more engaged in care. Given this concern, we propose to expand beyond 
recruiting at CBOs and in the clinic, and also recruit in more general community settings and 
online. In terms of measurement, our primary outcome will be measured using the modified 
social capital scale, which has only had limited use in the YB-GBMSM population. Although our 
preliminary analyses have shown good reliability in other YB-GBMSM samples, it will be 
important to continue to examine the performance of this measure in this population. Finally, in 
terms of analysis, the qualitative analysis is prone to bias given the inherent subjectivity in 
qualitative research. In order to counteract this, we will utilize a team approach to qualitative 
coding and interpretation, and we will undertake member checking with our YAB to ensure that 
our interpretation of our qualitative data is consistent with their general experiences. 
 
 
21. Provisions to Protect the Privacy Interest of Participants 
Breach of privacy is a concern in this study as identifying information/personal health 
information will be collected as part of the data collection process. Additionally, efforts to 
maximize retention will also include maintaining a database of participants’ phone numbers and 
email addresses. In order to minimize the risk of a privacy breach with any of these files, 
participants will be assigned a subject ID number which will be used to identify them in the 
database. Only one file will link the subject ID number to the participants’ medical record 
number, and all files will be password protected, kept on a secure server, and only accessible to 
the study team. Study files and consents will be kept in password protected files within HIPAA 
compliant shared drive folders only (e.g. Emory OneDrive, REDCap).  
 
22. Economic Burden to Participants 
The only potential cost of participation in the research study is the need for access to the internet 
to participate in the tele-B6 intervention; however, THRIVE SS has agreed to allow subjects to 
use computers with internet access to minimize this potential cost/barrier to participation. 
 
23. Informed Consent  
We will obtain electronic informed consent (including authorization for release of medical 
records for Phase II participants) using REDCap in one-on-one meetings conducted either via 
videoconference or in person prior to the first intervention session. This consent conversation 
will provide an opportunity to troubleshoot technical difficulties with the videoconference 
platform, orient participants to the THRIVE SS website, and complete the baseline REDCap 
survey. Consents will be signed and documented in REDCap with a copy sent to the participant 
after signing. Adequate time will be dedicated to the consent process to ensure full understanding 

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by participants and that all questions have been answered. Participants will receive contact 
information for study staff members and 
 for any questions or follow up concerns 
regarding the consent or study participation. 
We are requesting a waiver of written consent for the IDI participants, as their signing of the 
consent form would be the only written record of participation and therefore could increase 
potential for breach of confidentiality. There is precedent for such waivers in our prior research; 
furthermore, federal regulations state that the IRB may waive the requirement for written consent 
if this will be the only record linking the subject and the research, and the principal risk would be 
potential harm resulting from a breach of confidentiality (45 CFR 46.117(c)). Verbal consent 
will be obtained prior to each IDI.  
All study staff who have direct contact with participants will be trained in the process of both 
verbal and written consent administration by 
 This training will include instruction 
on the importance and critical elements of informed consent, as well as role-playing to 
demonstrate proper and improper consenting techniques. New research assistants will be 
supervised for at least the first three consents that they do in order to observe and provide 
feedback; once the trainer has determined that they are able to conduct the discussion 
independently, they will no longer be supervised. 
 
24. Setting 
The research will primarily take place in the virtual setting due to the nature of the study. In 
terms of recruitment, flyers will be posted for self-referral in the Grady IDP clinic, community-
based organizations, and other venues (e.g. coffee shops) as directed by our YAB. Additionally, 
participants may be referred from other studies. Participants will be residents of the greater 
Atlanta area—with no strict boundaries provided they are able to get back and forth from their 
homes to the intervention sites in Midtown Atlanta. The CAB will be comprised of key 
stakeholders working with our target population in Atlanta.  
 
25. Resources Available 
Given the non-invasive nature of this study, it is not expected that involvement in either the 
control or treatment arm would lead to any physical or psychiatric emergencies. However, were 
an emergency to occur during the course of involvement, study staff would be instructed to 
contact the PI immediately via cell phone or pager. Any assessment of a potential psychological 
emergency during the course of the trial will result in the patient being transported to the Crisis 
Intervention Service unit at Grady Hospital, a 24-hour psychiatric emergency service with the 
ability to evaluate and stabilize patients. If less emergent emotional distress is noted, staff will be 
equipped with pamphlets listing mental health resources in the community and will assist with 
referrals as needed, two of which are described below. 
 
THRIVE SS is a nonprofit organization created for and by people living with HIV, with the 
overarching goal of providing a range of support services to men and women of color in the 

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Atlanta metro area. Most of the members are Black gay and bisexual men– their current 
estimated membership is 945 individuals. THRIVE SS has a long history of close collaboration 
with researchers in varying capacities– including assisting with recruitment and retention, 
serving on community advisory boards, and providing technical assistance and trainings to staff 
members where needed. THRIVE SS has served on advisory committees for 
 
ongoing research in this area. Specifically for this protocol, THRIVE SS will serve to refer study 
participants and provide the physical space and internet (WiFi) to deliver our intervention to 
subjects who do not have another way to access tele-B6. Additionally, THRIVE SS staff and 
leadership will have the opportunity to respond to implementation surveys as study participants 
in Phase III of the protocol.  
 
 
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