Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of California, San Francisco

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LETSYNC STUDY PROTOCOL NCT04951544 
 
TABLE OF CONTENTS 
 
SECTION 1: OVERVIEW ................................................................................................................................. 4 
1.1 Study Rationale .................................................................................................................................. 4 
1.2 Study Aims .......................................................................................................................................... 4 
1.3 Timeline .............................................................................................................................................. 5 
SECTION 2: PARTICIPANT SELECTION AND SCREENING ............................................................................... 8 
2.1 Study Population ................................................................................................................................ 8 
2.2 Eligibility Criteria ................................................................................................................................ 8 
2.3 Eligibility Exceptions ........................................................................................................................... 8 
2.4 Sample Size ......................................................................................................................................... 8 
2.5 Recruitment ........................................................................................................................................ 9 
2.5.1 Recruitment Strategy .................................................................................................................. 9 
2.5.2 Recruitment Log .......................................................................................................................... 9 
2.6 Screening ............................................................................................................................................ 9 
2.7 Interview scheduling ........................................................................................................................ 10 
2.7.1 Reminder Calls ........................................................................................................................... 10 
2.7.2 Confirming interview location space ......................................................................................... 10 
SECTION 3: AIM 1 PROCEDURES ................................................................................................................. 12 
3.1 Interview Checklist ........................................................................................................................... 12 
3.2 Consent Process ............................................................................................................................... 12 
3.3 Enrollment ........................................................................................................................................ 13 
3.4 Interview Procedures ....................................................................................................................... 13 
3.4.1 Interview Procedures ................................................................................................................ 13 
3.4.2 Post-interview checklist ............................................................................................................. 14 
3.5 Participant Reimbursement ............................................................................................................. 14 
SECTION 4. AIM 2 PROCEDURES ................................................................................................................. 16 
4.1. 
LetSync CAC ............................................................................................................................... 16 
4.1.1 LetSync v1.0 development: ....................................................................................................... 16 
4.1.2. Draft of intervention protocol and procedures: ....................................................................... 16 
4.2. 
Mini-pilots and Interviews ........................................................................................................ 16 
4.3. 
Study Procedures, Materials, and Potential Risks ..................................................................... 17 
4.3.1.  
CAC Procedures ................................................................................................................ 17 
4.3.2. 
Mini Pilot and Interview Procedures .................................................................................... 17 
Participant Tracking ................................................................................................................................ 18 
SECTION 5: AIM 3 PROCEDURES ................................................................................................................. 19 
3.1. Overview of study design/procedures: ............................................................................................... 19 
3.2. Recruitment procedures. .................................................................................................................... 20 
3.3. Screening and enrollment. .................................................................................................................. 21 
SECTION 6: PARTICIPANT BREAK-UP PROTOCOL ....................................................................................... 31 
6.1 Breakups during Aim 1 ..................................................................................................................... 31 
6.2 Breakups during Aim 2 ..................................................................................................................... 31 
6.3 Breakups during Aim 3 ..................................................................................................................... 31 
SECTION 7: PARTICIPANT CRISES PROTOCOL ............................................................................................. 33 
7.1 Protection of Participants ................................................................................................................. 33 
June 25, 2020
LetSync: Pilot Test of Mobile Health (mHealth) Intervention

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7.2 Clinician Availability .......................................................................................................................... 33 
7.3 Protocol for Suicide Risk ................................................................................................................... 33 
7.3.1 Suicidal Comments Should Always Be Explored ........................................................................ 33 
7.3.2 Assess the Imminence ............................................................................................................... 33 
7.3.3 Look for an Obstacle or Hook .................................................................................................... 34 
7.3.4 Emergency Actions .................................................................................................................... 34 
7.3.5 Non-Emergency Actions ............................................................................................................ 34 
7.3.6 Document all actions taken ....................................................................................................... 35 
7.3.7 A Delicate Balance ..................................................................................................................... 35 
7.3.8 Useful Phone Numbers .............................................................................................................. 35 
7.4 Protocol for Homicidal Ideation ....................................................................................................... 35 
7.4.1 Tips for gathering information .................................................................................................. 36 
7.4.2 Useful Phone Numbers: ............................................................................................................. 36 
7.5 Protocol for Grave Disability ............................................................................................................ 37 
7.6 Protocol for Suspected Child and Elder/Dependent Adult Abuse .................................................... 37 
7.6.1 Useful Phone Numbers: ............................................................................................................. 37 
7.7 Protocol for Intimate Partner Violence ............................................................................................ 37 
SECTION 8: DATA MANAGEMENT .............................................................................................................. 38 
8.1 Participant ID Assignment ................................................................................................................ 38 
8.2 Study Tracking .................................................................................................................................. 38 
8.2.1 Recruitment activities ................................................................................................................ 38 
8.2.2 Screening form log .................................................................................................................... 38 
8.2.3 Interview scheduling tracker ..................................................................................................... 39 
8.2.4 Contact tracking ........................................................................................................................ 39 
8.3 Qualitative interview data procedures ............................................................................................. 39 
8.3.1 Post-interview procedures for interviewer ............................................................................... 39 
8.3.2 Interview transcription .............................................................................................................. 39 
8.3.3 Qualitative Coding and Analysis ................................................................................................ 40 
8.4 Data Storage/Maintaining confidentiality ........................................................................................ 41 
SECTION 9: QUALITY ASSURANCE .............................................................................................................. 41 
9.1 Staff Training and Certifications ....................................................................................................... 41 
9.1.1 Interview Training ...................................................................................................................... 41 
9.1.2 Staff Certification ....................................................................................................................... 41 
9.2 Qualitative Data Quality Assurance .................................................................................................. 41 
SECTION 10: OFFICE PROCEDURES ............................................................................................................. 42 
10.1 Petty Cash ....................................................................................................................................... 42 
10.1.1 Tracking Petty Cash Flow ......................................................................................................... 42 
10.2 Storage of participant forms .......................................................................................................... 42 
10.2 Printing of study documents .......................................................................................................... 42 
10.3 Project Management File ............................................................................................................... 42 
10.3 Reporting requirements ................................................................................................................. 43 
10.3.1 Research Performance Progress Report (RPPR) ...................................................................... 43 
10.3.2 Recruitment Milestone Reporting (RMR) ................................................................................ 43 
SECTION 11: HUMAN SUBJECTS ................................................................................................................. 44 
11.1. Potential Risks to Subjects ............................................................................................................. 44 
11.2 Adequacy of Protection against Risks ............................................................................................. 44 
11.2.1 Informed consent and assent .................................................................................................. 44 

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11.2.2 Protections Against Risk .......................................................................................................... 44 
11.2 Potential benefits of the proposed research to participants and others ....................................... 46 
11.3 Adverse Event Reporting ................................................................................................................ 46 
SECTION 13: CHANGE HISTORY .................................................................................................................. 49 
 
 
 

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SECTION 1: OVERVIEW 
 
1.1 Study Rationale  
For LetSync to come to fruition so that it can be tested by a largescale randomized controlled trial, 
further developmental work to address a number of critical issues is required, which will be addressed in 
this study. First, in order to design LetSync to motivate, facilitate, and target dyadic processes in HIV care 
engagement, we must have a deeper, more contextualized understanding than we have currently of the 
potential mechanisms by which couple’s resilience drive the capacity and opportunities for engaging in 
dyadic HIV care engagement.10,11 Although the formative work has illuminated the potential role of black 
men who have sex with men (BMSM) couple’s resilience in dyadic care engagement, the necessary next 
step for informing LetSync designs includes exploring how couple’s resilience fosters joint problem-
solving, and identifying successful joint problem-solving strategies and dyadic-coordination 
opportunities. Second, developing an mHealth intervention for successful adoption takes considerable 
time and resources during the design process.75-77 mHealth intervention development requires that the 
research and design processes occur in tandem to allow the science and the designs to mutually inform 
each other—the definition of “iterative user-centered design.”75-77 Third, once a full version of LetSync is 
developed, it will need to be pilot-tested to examine its acceptability and feasibility, and to determine if 
it appears likely to be efficacious. Thus, this developmental R01 is needed for iterative mHealth 
development given the considerable time and resources necessary to develop and pilot LetSync to 
prepare it for a full efficacy trial.  
 
1.2 Study Aims 
Aim 1: Explore dyadic processes in retention in care and ART adherence. To inform mHealth 
components, we will also obtain feedback on app wireframes.  
 
Aim 2: Develop and refine LetSync using an iterative process, drafting and refining wireframes based on 
feedback from the CAC.  
 
AIM 3: Conduct a pilot RCT of LetSync to assess acceptability, feasibility, and preliminary efficacy using a 
waitlist control design. 

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1.3 Timeline 
 
 
 

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1.4 A Useful Overview of Research 
 
• 
Who is a research participant? 
o A research participant used to be referred to as a human subject. Human subjects are 
providers of information (i.e., data) that is used to advance scientific knowledge about a 
particular problem or research question. A research participant has rights beyond those 
of the private citizen that are stipulated in documents including the Belmont Report, 
which was part of the response to the atrocities and misconduct of scientists in 
“studies” involving Nazi prisoners, Tuskegee airmen and their families, Henrietta Lacks, 
to name just a few.  
o Here is a typical research protocol involving a research participant:  
1. Screening/intake 
2. Research informed consent and enrollment into the study as a research 
participant 
3. Research activities (e.g., participating in interviews, focus groups, surveys, blood 
draws) 
4. [For a community-based research project:] Involving the participants in the 
analyses of the data collected, sharing interim findings 
5. Publishing and disseminating study findings back to the community from which 
they came ß This is often the part that researchers do not always do and 
therefore destroy any subsequent relationship and trust from the community, 
and rightfully so. 
 
• 
What is informed consent? 
o A research participant must give informed consent prior to participation. Giving 
informed consent means that they have been informed of their rights, the way the data 
will be collected and used, and what is offered in exchange for their participation. Their 
consent, in the form of verbal or written assent, MUST BE RECORDED AND 
DOCUMENTED.  
• 
Who is a researcher? 
o A researcher is a person with a question about the world and then tries to find the 
answer following a set of rules, called the scientific method. Each and every one of you 
is a researcher if you have a question you want to find answers to. 
• 
What is research?  
o Research is the situation set up by the researcher to be able to carry out to scientific 
method to find the answers to a question. Research involves articulating a research 
question, hypotheses, and the design of the research so that if X happens, we know that 
Y must be true under the conditions we set up. 
• 
What are research data? 
o Research data are information donated by the research participant to answer a research 
question that solves a societal problem. In a utopian world where no one is arbitrarily 
privileged over another (e.g., based on one’s skin color), research participation is never 
compensated, because information is donated and the research participant is 
“compensated” by participating in advancing knowledge for the good of everyone. This 
may seem trivial at first glance, but some of the biggest advancements in HIV, cancer, 

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and many many other diseases are due to these donated, volunteered information in 
the form of blood specimen, tissue, thoughts, beliefs, attitudes, feelings, etc. 
• 
What are research incentives? 
o Commonly referred to as stipends or compensation, incentives for research 
participation have taken the form of money and data are assigned monetary value. 
There is nothing wrong with this, since we do not live in a utopian society but a real 
society that inherently disadvantages some at the expense of others and meritocracy is 
mostly a myth. 
o However, research incentives fundamentally introduces a problem because it changes 
the relationship between participant and researcher into that of supplier and 
consumer, where the participant supplies data and the researcher consumes it. This is 
problematic for obvious reasons.  
o Nevertheless, people have bills to pay, and when they offer their insights and time, they 
need to be protected, and a way researchers show appreciation is by giving a research 
incentive, a monetary token of appreciation, to incentivize and facilitate the act of 
donating and volunteering private information. 
o In donating a part of themselves, a research participant is no longer in control of how 
their donation is used. This is another reason why we give research incentives. This is 
also why it is critical for researchers to disseminate the research findings back to the 
community from which they came. 
o Over time, researchers have conflated and muddied up these important distinctions. 

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SECTION 2: PARTICIPANT SELECTION AND SCREENING 
 
2.1 Study Population 
BMSM couples who meet the inclusion and exclusion criteria will be eligible for participation in this 
study.  
 
2.2 Eligibility Criteria 
Inclusion Criteria (Index partner) 
1. Self-identify as BMSM 
2. HIV-positive or the primary partner of a Black man who is HIV-positive (HIV+) 
3. Have a primary relationship partner, defined as someone to whom the participant is committed 
above anyone else for three or more months 
4. Age 18 or older 
5. English-speaking 
6. Willing and able to provide informed consent 
7. Use and own a personal Smartphone (Aim 2 and 3 only) 
 
Inclusion Criteria (Primary partner) 
For primary partners, eligibility will be determined using identical criteria, except for the following: 
1. In serodiscordant couples, the primary partner will be HIV-negative (HIV-) 
2. Primary partners may be of any race or ethnicity, or may be a trans male or female 
 
Participants in earlier aims of the study may also participate in later aims of the study, except as 
described in the exclusion criteria section below.  
 
Exclusion Criteria 
1. Report fear of intimate partner violence (IPV) resulting from participation as assessed at 
screening 
2. Unwilling or unable to disclose HIV status to primary partner 
3. Present evidence of severe cognitive impairment that would prevent comprehension of study 
procedures assessed during informed consent 
 
Additional Exclusion Criteria, Aim 3 
1. HIV+ individuals who are unable or unwilling to provide small hair samples will be excluded   
4. Couples who participated in the Aim 2 mini-pilot will be ineligible for Aim 3 
 
2.3 Eligibility Exceptions 
Exceptions to Eligibility      
1. Dyad with family ID 885 has one smartphone between the 2. Both are African American/Black 
and HIV positive. They are allowed to participate with one smart phone and 2 accounts if 
randomized into the intervention arm.  
 
2.4 Sample Size 
Aim 1 
We will conduct onetime individual interviews with 48 BMSM from 24 couples (12 seroconcordant-
positive, 12 serodiscordant). To explore emergent couple-level themes from the individual interviews, 

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we will also conduct couple interviews with 12 couples where both partners will be present (6 
seroconcordant-positive and 6 serodiscordant). 
 
Aim 2 
We will establish the LetSync CAC by recruiting 10-12 HIV-positive BMSM who are in couples using the 
same eligibility criteria and recruitment procedures. We will strive for diversity among CAC members in 
terms of age, relationship length, and socioeconomic status. 
 
To obtain feedback on LetSync v0.5 features, functionality, and usability, as well as to pilot-test 
intervention protocols and procedures, we will recruit 10 BMSM couples (n=20) (can be recruited from 
Aim 1) and give them LetSync v0.5 to download and use for 1 week. 
 
Aim 3 
Using a waitlist control design, 110 couples will be randomized to either the intervention or waitlist 
control conditions (N=220). 
 
2.5 Recruitment  
2.5.1 Recruitment Strategy 
For all three aims, we will develop and implement a multipronged recruitment strategy, as follows: 
1. Advertisements and outreach: These will include print and online advertisements, dating apps, 
word-of-mouth referrals, organization listservs, and the creation of social media presence. The 
trained study recruiters will post study promotional materials and conduct in-person outreach at 
community-based organizations (CBOs; e.g., churches, AIDS-service organizations, single-room 
occupancy, etc.), bars, and spaces where black men socialize, as well as clinics that provide 
HIV/STI testing. 
2. Established relationships with CBOs: Through CAPS Community Engagement Core, we will 
contact CBOs throughout the Bay Area and meet with care providers and CBO leaders to inform 
them of the study. 
3. UCSF Clinical and Translational Science Institute (CTSI) Recruitment Service: We will use this 
service, which will search for and mail letters to UCSF patients found eligible by inclusion criteria 
in the electronic medical record.  
4. For Aims 2 and 3, couples who participated in earlier aims of the study and selected “willing to 
be contacted for future research” on their consent forms may be invited to participate, except 
as described above in the exclusion criteria (Section 2.2). 
 
2.5.2 Recruitment Log 
Study staff will keep track of site visits and recruitment activites in the recruitment log (excel sheet tab 
inside of the Study Log, saved in the Box folder “Study Logs and Trackers”). The log will include the 
names of organizations contacted, contacts at these organizations, dates of contact, updates, and action 
items. The log will be completed by all staff members completing recruitment activities. 
 
2.6 Screening  
Participants who are interested will call the study line or express interest via the study website. The 
Recruitment Coordinator and Study Recruiter(s) will check the study website daily and update the phone 
screen “to call” list. All tracking attempts will be noted in the database.  
 
Eligibility will be determined when individuals contact the study via a dedicated phone line. Upon 
establishing eligibility, study staff will collect contact information for the participant and his primary 

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partner. We will instruct the index partner to have his primary partner call the study line so that we can 
determine his eligibility and to verify partnership status. If the primary partner does not call within 3 
days, we will call the index partner back to remind them. 
 
HIV status will be verified at the first in person meeting during the consent visit by a letter of diagnosis, 
copy of pharmacy ART prescription, or a recent ART pill bottle with the participant’s name on it.  
 
Participant IDs (PIDs) will be assigned while completing the phone screen questionnaire. Everyone who 
completes the phone screen, even if they are not eligible, will receive a PID. See section 4.1, Participant 
ID Assignment, for information on how ID numbers are assigned.  
 
Update August 2020: Due to privacy concerns, participants will no longer be asked to verify their HIV 
status. 
 
The Phone Script for the Screening call may be found in Appendix A as well as in the Box “Protocol” 
folder. 
 
The Screener Questionnaire may be found in Appendix B as well as in the Box “Screening Forms” folder. 
 
2.7 Interview scheduling 
Aim 1 
Once both partners are confirmed eligible, the team member will attempt to schedule the interview 
with Partner #2 over the phone. If Partner #2 would like to discuss times with Partner #1 before 
scheduling, give them a call back the next day to check in and see if they have come up with an available 
day and time and preferred location (Oakland or San Francisco).   
 
Both the individual and couple interviews will be scheduled for a day and time when both members of 
the couple are available to come to the interview site for a period of 1.5-2 hours.  
 
Scheduled interviews will be tracked in the study calendar maintained by the study coordinator.  
 
When the interview time and location are scheduled, the interviewer will email, text, or give over-the-
phone instructions to the participant (as per their preference) the interview location address, time and 
date, and directions. 
 
2.7.1 Reminder Calls 
Interviewers will text and/or call the participant 3 days before and 1 day before the scheduled interview 
to remind and confim the location, date, and time of the interview. During this call, the interviewer will 
also remind the participant that both partners need to arrive at the same time in order for the interview 
to occur, as well as remind any HIV-positive participants to bring in their HIV status verification 
materials.  
 
The interviewer will also re-send directions to the interview location to the participant at this time. 
 
2.7.2 Confirming interview location space 
The lead recruiter will work with the interview locations to keep an updated schedule of interview room 
availability to ensure that participant scheduling flows smoothly. When interviews are scheduled, s/he 
will contact the interview location to let them know as well as confirm availability.  

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SECTION 3: AIM 1 PROCEDURES  
 
3.1 Interview Checklist 
The day before the interview, the interviewer will check/confirm the following:  
• 
Test recording equipment and check batteries 
• 
Calculate time to arrive at interview location and review directions 
• 
Consider bringing backup recording equipment 
• 
Room availability at the interview location 
• 
Participant availability via phone call or text 
 
The interviewer will bring the following items to the interview: 
• 
Recording equipment, extra batteries, and charger (ensure is charged, functioning, and has 
enough room to record the interview) 
• 
Consent forms  
• 
Interview guide 
• 
Petty cash for participant reimbursement 
• 
Receipt forms 
• 
Writing pad and pen to take notes 
• 
Participant contact info  
• 
Clear directions to place of interview 
• 
Snacks/refreshments 
 
3.2 Consent Process 
Individual Interviews, IN PERSON 
The written consent process will occur during the first in-person meeting with the participant, right 
before the scheduled interview. The team member will hand the participant a copy of the consent form 
if they want to read or look at it and verbally review the consent form with the participant. Once this is 
completed, the team member will then briefly discuss it with and answer any questions from the 
participant, as well as ask a few questions of the participant to make sure that the consent form and 
study are understood.  
 
The interviewer will always bring 2 copies of the consent form with them: one for the participant to take 
if they choose, and one for the study to keep. Any copies kept by the study or taken by the participant 
must be signed and dated by both the team member and participant.  
 
Participants will all be consented separately and privately, in private rooms. 
 
Individual Interviews, REMOTE 
Due to SIP mandates caused by COVID-19, all consent procedures will occur remotely. UCSF IRB has 
authorized studies to acquire consent online through Qualtrics. 
 
Once interviews have been scheduled with the participant, the Coordinator will send the link to the 
online Qualtrics consent form and questionnaire to the email address provided. The participant will be 
asked to read it in its entirety and contact study staff should any questions arise.  
 
Participants will be asked to give consent by indicating ‘Yes’ or ‘No’ on the Qualtrics form. 
 

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3.3 Enrollment 
After participants consent to participate in the study and sign the consent form, interviewers will ask 
them to complete a contact form to assist study staff with contacting partcipants for follow up. Not all 
sections of the contact form are required to be completed; just as much as the participant is able and 
willing to complete.  
 
The interviewer will then hand the participant a tablet with the demographics questionnaire loaded up, 
which the participant will complete. The interviewer will have already entered in the PID into the survey 
for the participant.  
 
Both partners will need to sign the consent forms and complete the questionnaire in order for 
enrollment to be considered complete. 
 
Both the contact form and demographics questionnaire will be completed in the separate, private 
rooms in which the consent process occurred. Once these are completed, interviewers will then conduct 
the interview as described below. 
 
For Aim 3 only, participants will also be randomized to their pilot RCT group during this time. 
 
3.4 Interview Procedures 
Two research staff will be at the interview location to complete the separate participant processes.  
 
3.4.1 Interview Procedures  
Individual Interviews, IN PERSON 
Participants will arrive at the predetermined and scheduled interview site. Study staff will greet the 
participant and accompany them to the private interview room. Staff will offer the participant 
refreshments. If one partner shows up before the other partner arrives, they will be instructed to wait 
until they are both there. 
 
Participants will be placed in separate rooms so that staff can review the consent with them individually. 
Study staff will explain the overall study objectives, the participant’s rights of as a research subject 
(including the right to stop participation at any time), answer any questions the participant has, and give 
a consent form approved by the UCSF IRB for him to read with ample time. Staff will then obtain a 
written informed consent. After both individuals consent to the study, study staff will conduct the 
interview privately with each individual at the same time.  
 
The interviewer will set up the recorder by recording both voices and playing back to make sure both 
voices record.  
 
S/he will record the ID number of the participants and date at the beginning of the recording.  
 
Individual Interviews, REMOTE 
Participants will complete the interview either over the phone or over Zoom, depending on their 
preference and capability. The same procedures apply for checking that recorders are functioning 
appropriately. 
 

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Field notes: Interviewers must take notes during the interview about their observations, interesting 
ideas the participant mentioned, new probes, and/or questions for the PI. This consists of jotting down 
key phrases as the participants mention them, new areas of inquiry or related ideas that come up during 
the conversation, as well as questions or probes that don’t work or fail to elicit rich data. Remember 
that the most important thing is to maintain rapport, so note-taking must be brief and the participants 
should be aware that you are going to be writing things down during the interview itself so this does not 
come as a surprise to them. Keeping the flow of the interview, maintaining warmth, eye contact, and 
connection all are more important than taking thorough notes. 
 
Once the interview is completed, the interviewer will turn off the recorder, reimburse the participant for 
any travel, collect receipts, and thank the participant for his time.  
 
Couples Interviews 
The Couples interviews will follow the same consent procedures as described above (e.g., partners are 
consented separately). Participants will arrive at UCSF Mission Hall or the alternative interview site, and 
study staff will accompany them to the private interview room. Study staff will explain the interview 
topics and answer any questions from the couple before commencing the interview. 
 
The interview guides may be found in Appendix C, as well as in the “Interview Guides” folder in Box. 
 
3.4.2 Post-interview checklist 
After the interview is completed, the interviewer will complete the following steps:  
 
• 
After the interview and before leaving space, transfer the audio file to a password-protected 
laptop and upload the audio file to an encrypted transcription service website (HomeRow).  
• 
Label the file with Participant ID number(s) and date. Each file will be kept in the appropriate 
Box folder. 
• 
If the interview did not record, sit down immediately and write up everything s/he can recall 
about the interview. 
• 
Review field notes and add anything missing. 
o Create a summary of the interview. This includes the manner of the participants (i.e., 
were they on time, did they seem comfortable, etc), developing rapport, key themes 
that emerged during the interview, areas that were particularly rich (i.e., provider 
relationships, or couple dynamics) and also particular areas that should be explored in 
future interviews (noting any dynamics that are based on sero-status concordancy will 
be key). These field notes can almost be thought of as a diary for the interviewer, and 
will be used as a starting point for the analysis. These should be completed directly after 
the interview if possible, but no later than within 24 hours of the interview.  
o Save the field notes to the Box “Field Notes” folder. Make sure the file does not contain 
identifiable information. Save the file as “PID_Individual Interview Field 
Notes_Date.docx”. 
• 
After the recorded file is downloaded and backed up (double check that they backed up before 
completing this step), the interviewer deletes the file from the recorder. 
 
3.5 Participant Reimbursement  
Each participant will receive $60 cash per individual interview and $60 each per couple interview. The 
interviewer will fill out the receipt and have the participant sign that they received the payment. At least 

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once per week at UCSF Mission Hall, the interviewers will review their petty cash stock and receipts with 
the study petty cash handler to update and verify the petty cash balance.   
 
Should it be deemed necessary to pay participants with gift cards, use National Gift Card Group, found in 
BearBuy. Log into MyAccess, then, under the search bar, click on Browse: Suppliers. Jump to page 6 
(approximately) and select National Gift Card. Select the cards or e-cards you want to purchase and add 
to cart. Please note, if the denomination is not listed, email customerservice@ngc-group.com and 
request they add the denomination you need. It can take up to 30 days to get that added, so plan in 
advance.  When checking out, if needed, ask Emelyn Ponce to change the delivery address if cards need 
to be send to someone’s home. 
 
 

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SECTION 4. AIM 2 PROCEDURES  
 
 
4.1. 
LetSync CAC 
 
We will strive for diversity among CAC members in terms of age, relationship length, and socioeconomic 
status. Sessions will be audio-recorded and transcribed. 
 
 
 
4.1.1 LetSync v1.0 development:  
 
The CAC will engage in three sessions. 
 
In Session 1, we will present potential intervention targets and mHealth approaches based on a 
synthesis of the prior K01 mHealth designs with Aim 1 findings. We will solicit the CAC’s input on 
intervention targets and mHealth approaches. 
 
Based on Session 1, we will work with School of Medicine Tech Services (SOM Tech) and Wow 
Labz (see Letters of Support) to incorporate the CAC’s feedback and our observations in drafting 
wireframes to present in Session 2. 
 
Based on CAC feedback in Session 2, we will refine wireframes and present them for final 
feedback in Session 3 to produce LetSync v0.5 for mini-pilots. The CAC will be able to view emergent 
intervention targets and approaches on a large TV screen during these sessions. The team will take 
notes during the sessions, adding any new constructs and approaches that emerge to inform the app 
designs.  
 
 
 
4.1.2. Draft of intervention protocol and procedures: 
 
In tandem with the app development, we will draft the pilot RCT procedures and protocol. We 
will also draft a script for the brief (5-minute) “User’s Guide” video with instructions to using app 
features. It will automatically play when the app is first launched and may be re-watched anytime. We 
will present protocols, procedures, and User’s Guide script in the CAC Session 2 and make revisions 
according to feedback. We will then also produce the video with a video production team.  
 
 
4.2. 
Mini-pilots and Interviews 
 
To obtain feedback on LetSync v0.5 features, functionality, and usability, as well as to pilot-test 
intervention protocols and procedures, we will recruit 10 new BMSM couples (n=20) and give them 
LetSync v0.5 to download and use for 1 week. 
 
We will interview each couple to explore their perspectives on the product usability; ways in which 
they liked or disliked the prototype and the intervention framework; and ways in which they would 
customize them. We will also explore the extent to which men liked their information linked and 
accessible to each other. 
 

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We will show a rough cut of the User’s Guide during the interview for feedback. Finally, we will ask 
how they would like to access and receive the app, i.e., whether they would like it prescribed by their 
provider, referred by friends, or simply via GooglePlay or iTunes. 
 
Based on the couple interviews, we will work with SOM Tech/Wow Labz improve upon LetSync v0.5 
to finalize LetSync v1.0 and the intervention protocol. We will also work to finalize the User’s Guide 
video. Interviews will last 1-1.5 hours and will be audio-recorded and transcribed.  
 
We will collect self-reported information from participants using questionnaires administered via 
computer-assisted self-interview (CASI) on encrypted and password protected tablets (i.e., iPads). We 
will collect demographic information such as age, gender, sexual orientation, highest education level 
attained, and race/ethnicity. We will also ask about incarceration history and experience in the foster 
care system, as these variables explain differences in outcomes related to health among BMSM. 
Validated survey measures will be administered pertaining to self-reported clinical outcomes of 
adherence to ART, retention in care, and viral suppression. In addition, we will ask for verification of HIV 
status via a letter of diagnosis from the participant’s provider or a pill bottle. Other validated measures 
will pertain to psychosocial variables (e.g., stigma, stress, social support, experiences with racism, 
relationship satisfaction, social identity, minority stress) and app acceptability and usability.  
 
 
 
4.3. 
Study Procedures, Materials, and Potential Risks 
 
 
 
4.3.1.  CAC Procedures 
 
Individuals interested in the CAC will call a dedicated study phone line to a trained research staff. 
We will give an overview of the study before conducting a screening over the phone to determine 
eligibility. Upon determining eligibility, we will obtain informed consent individually using the same 
procedures in Aim 1. 
 
We will enroll the participant as a member of the study’s CAC comprising of 10 – 12 members. Three 
CAC sessions will be scheduled and will take place remotely – or, if/when it is safe to meet in person, 
take place at UCSF or APEB. CAC sessions will last three hours each and will involve guided group 
discussions that will include members’ reactions and feedback to presented research material. Through 
an iterative development process, the mHealth intervention will be developed and revised based on 
feedback obtained from these CAC sessions. There will be three CAC sessions convened, and new 
materials and prototypes modified based on feedback from the last session, will be presented for 
feedback at a subsequent session. Each CAC member will receive a $120 cash card at the end of each 
session, and refreshments will be served at all sessions. 
 
 
 
4.3.2. Mini Pilot and Interview Procedures 
 
Individuals interested in the mini pilot will call a dedicated study phone line to a trained 
research staff. We will give an overview of the study before conducting a screening over the phone to 
determine eligibility. Upon determining eligibility, we will obtain informed consent individually using the 
same procedures in Aim 1. We will instruct the index partner to have his primary partner call the study 
line so that we can determine his eligibility and to verify partnership status. If the primary partner does 
not call within 3 days, we will call the index partner back to remind them. 

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Each participant in the couple’s interview will receive $100 cash card as a thank-you; the amount 
of is higher because it takes greater effort for couple members to coordinate their respective schedules 
for the same appointment time. 
 
 
Participant Tracking 
Study staff will keep track of site visits and recruitment activities in the recruitment log (excel sheet tab 
inside of the Study Log, saved in the Box folder “Study Logs and Trackers”). The log will include the 
names of organizations contacted, contacts at these organizations, dates of contact, updates, and action 
items. The log will be completed by all staff members completing recruitment activities. 
 
Participants who are interested will call the study line or express interest via the study website. The 
Recruitment Coordinator and Study Recruiter(s) will check the study website daily and update the phone 
screen “to call” list. All tracking attempts will be noted in the database.  
 
Eligibility will be determined when individuals contact the study via a dedicated phone line. Upon 
establishing eligibility, study staff will collect contact information for the participant and his primary 
partner.  
 
HIV status will be verified at the first in person meeting during the consent visit by a letter of diagnosis, 
copy of pharmacy ART prescription, or a recent ART pill bottle with the participant’s name on it.  
 
Participant IDs (PIDs) will be assigned to newly screened participants while completing the phone screen 
questionnaire. Everyone who completes the phone screen, even if they are not eligible, will receive a 
PID. PID assignment procedures will be the same as Aim 1 in that the Index will have a suffix of “01” and 
the partner will have a suffix of “02”. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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SECTION 5: AIM 3 PROCEDURES  
 
3.1. OVERVIEW OF STUDY DESIGN/PROCEDURES: 
This study proposes to develop and refine the LetSync app, protocol, and intervention procedures with 
110 couples (n= 220) where at least one partner is living with HIV, a Black/African American cisgender 
man or a transgender woman. The goal of this pilot RCT is to assess acceptability, feasibility, and 
preliminary evidence of efficacy to impact ART adherence as measured by ARV concentrations in dried 
blood spots. We will also explore the acceptability of remote dipstick urinalysis and hair collection in 
addition to remote DBS. We will iteratively develop the app, revise protocol and procedures based on 
participant feedback, in a 8-month pilot trial using an RCT design. We will then: 
1. Randomly assign 55 couples to the intervention arm and 55 couples to the control arm. Those in 
the intervention arm will receive LetSync v1.0 for 8 months while those in the control arm will 
not use the app. Participants in both arms will be assessed at baseline (T0 or Month 0). 
2. Between T0 (Month 0) and T1 (Month 4), we will check in with participants in both arms. With 
the Intervention participants, we will troubleshoot any app-related issues and confirm their 
most up-to-date contact information. With the Control participants, we will confirm their 
contact information. 
3. Participants in both arms will be assessed at T1 (Month 4) and T2 (Month 8).  
4. We will collect biosamples every two months from participants (Baseline, Month 2, Month 4, 
Month 6, Month 8). 
1. We will collect dried blood samples from all participants, including those who are HIV 
negative. Hair and urine will be optional. 
In preparation for the full-scale RCT, we will also pilot-test the protocol and procedures for data 
collection. Measures/instruments will be collected via questionnaires and DBS/urine/hair samples at 
baseline, T1, and T2. 
 
Dried blood spot (DBS) samples will be self-collected by participants at home, mailed to a third-party lab 
we enter an agreement with, and analyzed at said lab. Dipstick urinalysis will be done by participants at 
home, in which they will insert a dipstick in their urine that indicates the presence (e.g., positive result) 
or absence (e.g., negative result) of ARV in their urine. Hair samples will be self-collected by participants 
at home, mailed to UCSF, and analyzed at UCSF Hair Analysis Lab (HAL) for levels of ARVs indicative of 
adherence to ART.  
 
If possible to gather samples in person (e.g., if participant lives in Bay Area),  we will conduct baseline 
assessment in person if COVID guidelines and scheduling allow; if it is not possible to conduct baseline 
assessments in person, we will mail detailed video instructions and materials to the participant. 
 
Consistent with study goals to evaluate feasibility and acceptability as primary outcomes, all participants 
will be asked to participate in a 45 to 60-minute exit interview at T2 to evaluate their experience in the 
study and identify areas for improvement. A draft of the interview guide is attached as Appendix. 
 
 
 
 

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3.2. RECRUITMENT PROCEDURES. 
Recruitment efforts will take place remotely (e.g., via online advertisements). Depending on COVID-19 
guidelines, in-person recruitment efforts may or may not resume. We will target the San Francisco Bay 
Area and other U.S. cities with highest prevalence of HIV among racial/ethnic SGM. These cities will be 
identified using the latest data from the Centers of Disease Control and Prevention (CDC). 
• 
Online recruitment 
o 
We will place targeted advertisements on social media platforms (e.g., Facebook, 
Instagram), dating apps (e.g., Grindr, Jack'd), and/or online newspaper and magazines. 
o 
Study staff will attend virtual webinars or events hosted by community-based 
organizations serving racial/ethnic and/or sexual minority communities impacted by 
HIV/AIDS. We will focus on organizations that serve Black MSM and/or trans women 
living with HIV. 
• 
In-person recruitment 
o 
Study staff will contact community-based organizations to schedule a visit date. They 
will drop off study materials (e.g., flyers) for participants to take. They will also attend 
community events when appropriate (e.g., LGBTQ health-geared events). 
• 
Other methods 
o 
We will utilize UCSF Recruitment Letter Services and contact participants of other UCSF 
studies who gave consent to be contacted. 
 
 

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3.3. SCREENING AND ENROLLMENT.  
3.3.1. Screening 
We will enroll 55 SGM seroconcordant-positive couples and 55 SGM serodiscordant couples. Individuals 
interested in the study will call a dedicated study phone line to a trained research staff. The staff 
member will give an overview of the study before conducting a screening over the phone to determine 
eligibility. We will screen participants based on the inclusion and exclusion criteria. 
We will use customer relationship management (CRM) platforms to communicate with participants and 
manage participant data. Ripple Science (www.ripplescience.com) will be used to manage participant 
data. Ripple Science is HIPAA-compliant and has undergone IT Risk Assessment with UCSF. 
Targeted online advertisements will link to an online pre-screener hosted by UCSF Qualtrics or Ripple 
that interested individuals can take to see if they qualify. The pre-screener will be used to identify only 
those who are potentially eligible to avoid a large backlog of candidates to contact. 
Update X/X/XXXX: During Phase 1, the team screened a handful of Black trans women living 
with HIV that would have been eligible to participate had it not been a requirement to identify 
as a cisgender Black man. The PI applied for an administrative supplement to include 30 couples 
in which at least one person identifies as a Black transgender woman living with HIV.  
Update 8/4/2022: We will do away with the pre-screener and have candidates complete a full 
screener online/asynchronously. The team noticed it was difficult getting pre-screened 
candidates to complete the full screener and was playing phone tag trying to make this happen. 
To simplify the process, we will now link online ads to the FULL screener which candidates can 
complete online and asynchronously.  
Only those who are potentially eligible, based on screener responses, will be contacted by study 
staff. Ineligible responses will be recorded along with the reasons why someone may be 
ineligible (e.g., not living with HIV, not in a relationship with a cis-gender man or transgender 
woman). Participants will be asked to send a photo of state-issued identification, along with 
proof of HIV status (e.g., letter of diagnosis, pill bottle of their ART) bearing their name, to the 
UCSF-managed study email 
Update 9/20/2022: The team has been getting more fraudulent responses. To determine the 
legitimacy of couples, relationship status will be verified at screening (as opposed to 
Enrollment) using the couple verification screening instrument and protocol (see Appendices). 
Partners’ responses to a series of questions (e.g., “What is your employment status? What is 
your partner’s employment status?”) will be compared for consistency. Upon establishing 
eligibility, contact information will be collected for the participant and his primary partner. In 
person, project staff will explain the study, answer questions, and obtain informed consent from 
each participant separately.  
 
If candidates decline to participate but are otherwise eligible, we will ask them if they’re willing to speak 
with the Principal Investigator to share why they declined to participate. The Principal Invesitgator will 
ask participants reasons why they chose to decline.  
 

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Unresponsive or potentially fraudlent candidates will be flagged for review by other team members. For 
candidates who are consistently unresponsive, different staff members should take turns contacting 
them in case this gets the candidates’ attention.  
 
After every contact attempt, staff members should create a task in Ripple to contact the candidate in the 
future. The goal is for no “dead ends” to be present.   
 
Update 7/12/2022: 3.3.1.1. Atypical Couples + Interviews 
 
We have been encountering individuals who are eligible to participate, but otherwise cannot because 
their partner is not interested in doing the study with them. We’ve also encountered folks who are not 
in a formal relationship, but are involved with someone (much like a situationship).  
 
At the same time, we’re learning it’s been difficult to convince Black gay couples to participate, 
especially because Black gay couples may define relationships differently from a White lens.  
 
 We’re finding that queer couples define relationships much differently. Definitions of relationships are 
different by those communities. We may benefit from more qualitative research to understand how 
relationships are defined. As such, couples’ research is very complicated for LGBTQ+ folks of color.  As 
such, we began exploring the idea of conducting supplemental interviews with these flagged folks that 
explores this topic further.  
 
If we encounter folks who are not in a formal relationship but say they are involved with someone, staff 
will begin asking them how involved they are in each others’ healthcare. Candidates will be presented to 
the PI on case by case basis to see if they are deemed eligible to participate. For example, if the 
“friend”/couple who is living together know about each others’ health very well and are sexually 
involved and have on-going whatever kind of relationship, they can still qualify. 
 
We will also begin conducting individual interviews with these candidates to learn more about how they 
define relationships and how they are involved in each other’s care. 
 
 
3.3.2. Eligibility 
 
Eligibility criteria will be similar as Aims 1 and 2. 
 
At least one member of the couple must: 
• 
Iidentify as Black/African American 
• 
Identify as cis man OR transgender woman 
• 
Be living with HIV. 
 
As long as at least one member of the couple meets these criteria, the race and HIV status of the partner 
does not matter.  
 
However, BOTH members of the couple must: 
• 
Be assigned male at birth 

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• 
Be 18 years old or over 
 
Update 7/2/2022:  Cindy and Sam will serve as second line for flagged participants. If Jovon flags 
someone, our job is to check flagged people to see how we can resolve them. Figure out how to 
look for flagged people and how often. If time allows for it, for pre-screeners that seem 
ineligible (e.g., if someone says they’re not in relationship), we will still contact people in case 
they answered incorrectly.  
 
Update 11/4/2022: The team has experienced difficulties pertaining to the recruitment of 
romantic couples where at least one partner is Black/African American, living with HIV, AND a cis 
man or trans woman. To address these challenges to launching the pilot RCT, we will implement 
the following: 
 
1. App: We aim for the app to go live by December 20th 2022. If this is not achieved and the 
pilot trial is not launched by January 14th, we will be ready to launch the app outside of the 
App Store/Google Play environments, i.e., statically, in the same way that we have tested 
mini beta-versions of the app by January 15th. 
2. Recruitment: The LetSync app and trial are focused on supportive dyadic relationships. Thus, 
we will start engaging dyads where there are dynamics to be targeted by the LetSync app 
intervention, focusing on Black/African American sexual and gender minority dyads. Based 
on our current recruitment numbers, we are confident that this expansion will allow us to 
meet our enrollment target by trial start date. We will open up eligibility criteria to any 
non-White person of color cis man, trans woman, or non-binary individual who is living 
with HIV and in a relationship. 
 
Update 11/4/2022: Due to feedback from Co-I’s around the measures around dyadic 
coordination and relationship outcomes, we will still limit eligibility to romantic couples. 
 
3.3.3. HIV status verification. At the time of screening, study staff will ask for HIV-status verification by 
showing a letter of diagnosis or ART pill bottle with their name on it via videoconference (e.g., Zoom). 
An alternative is sending a digital photo to our UCSF-encrypted email address and server. Digital photos 
will be destroyed upon verification. 
Update 9/20/2022: We will now verify HIV information AT CONSENT/ENROLLMENT. This is due 
to staff members noticing that couples would visibly balk at this request and becoming hard to 
reach after requesting this. 
Update 12/21/2022: We will re-instate verifying HIV information at SCREENING again. The 
team, with the help of Co-Investigators, decided on 12/20 that it may be more efficient use of 
our time doing this at screening instead of waiting at consent/enrollment.  
On Ripple, we will document what was used to verify HIV status. Staff should also follow the 
below guidelines on how to verify HIV status. 
• 
If they are on PrEP: 

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o Vial or prescription that has the name TRUVADA (Tenofovir disoproxil fumarate 
+ emb), DESCOVY (tenofovir alefenamide + emb), APRETUDE (cabotegravir) 
o No possibility for letter of dx for someone taking PrEP. 
• 
If they are on HIV medications, ONE of the following: 
o Any antiretroviral medications (need to cross-reference with a list) 
§ 
This CANNOT be JUST Truvada or JUST Descovy. If they show us these, 
we need to ask for another medication. 
o Letter of dx with name, medication 
§ 
Needs to look official (ex. with letterhead, name of provider, etc.) 
o Lab results with name, “HIV viral load”, or “HIV PCR”, or “HIV RNA” 
• 
Parya’s suggestion 
o Pre-enrollment visit: Ask for HIV, relationship, and age verification via email or 
text, then send scheduling info once we receive verification, then actually enroll. 
• 
What happens if they fail verification? How many times will we allow re-verification? 
o For participants we might personally know, we will take what we already know 
about them into consideration 
3.3.4. Randomization. We will assign each couple a unique study ID and randomly assign couples into 
intervention and control arms based on couple serostatus. Randomization will be conducted using an 
online randomization plan generator (www.randomization.com) that allows for stratification. 
Update 5/18/2022: We will use a randomization scheme spreadsheet generated by our 
statistician, Lance Pollack, to randomize couples according to serostatus and gender 
composition (ex. MSM, trans woman). 
Update 9/20/2022: If couples break up AFTER randomization, we will still keep them in the 
study as long as they want to still participate (intention to treat analysis). Excluding their data 
after they’ve been randomized is a HUGE no-no in randomized control trials. We’d be 
introducing non-randomization here. 
3.3.5. Enrollment/Consent.  
Pre-Enrollment Visit 
Scheduling. We will schedule an enrollment visit over Zoom with each member of the couple 
SEPARATELY. To minimize phone tag, we will use a scheduling platform (ex. Calendly) to let couples 
choose from available dates.  
We will conduct the enrollment visit over Zoom. Participants will be instructed to join the call from a 
QUIET space free of distractions (ex. they cannot be in the middle of walking, driving, in a loud place 
such as the gym, etc.).  
Prior to the visit, staff will email a copy of the informed consent via DocuSign, and study handouts such 
as the activity/incentive schedule. 1 day prior to the visit, we will send reminders with instructions (join 
call from quiet space if needed, if couples scheduled visit together please join separately) 

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Staff will also instruct particpants to come prepared with documentation of their HIV status if needed 
(letter of diagnosis or medication bottle).  
During Enrollment Visit 
Overview. We will give an overview of the call: HIV status verification, review ICF, inform them of 
randomization status, administer baseline survey, and walk through study activities (if randomized to 
Intervention, administer app download and walk through. 
Review ICF. We will review the ICF with the participant. Participants will give consent by signing via 
DocuSign in real time. 
We will also obtain contact information of at least three other individuals (ex. friends, family), along with 
the participant’s social media info, to use in case we cannot reach the participant. 
We will also confirm their most up-to-date address to send materials to. 
Explain activities and incentive. Once the baseline is complete, we will walk through the study activities 
and incentive schedules.  
Baseline survey. Once ICF has been signed, the staff will send the unique Qualtrics baseline survey link 
to the participant. Staff will stay with them on the call until the survey is complete. If participants cannot 
stay online for the whole time, then they should contact the staff when they have completed the survey 
at a later time.  
After Enrollment Visit 
Send baseline survey and signed ICF. Staff will prepare unique baseline survey links for each participant 
on Qualtrics and email them to participant, along with copy of signed ICF. 
Mail study materials. Staff will mail biomarker collection kits and ClinCard to participants’ mailing 
address. We will mail materials using tracked USPS shipping. Staff must pay attention to expected 
delivery date and contact the participant when it has arrived.  
Randomization. Both members of the couple must finish their baseline survey to be randomized. Staff 
will use the randomization scheme spreadsheet created by Lance Pollack to determine which group the 
participant will be randomized to. 
Once a participant has completed a survey, we will get an email notification sent to letsync@ucsf.edu. 
Staff will enter the participant’s ID and name IN THE ORDER ASSIGNED to the spreadsheet. Staff will call, 
text, or email the couple to inform which group they’ve been assigned to. 
Track when biosamples have been finished. DBS sample must be completed by X date (2 weeks from 
when pt gets kit) for them to get the bonus incentive in addition to the regular incentive. Return 
package must be postmarked by Y date (4 weeks from when pt gets kit) to get incentive in general.The 
ABSOLUTE LATEST someone can mail back samples is 6 months. 

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The following is an overview of the research activities for in-person and remote study visits by 
intervention and control arms. REFLECTS MOST UP-TO-DATE IRB STUDY APPLICATION. 
Update 5/27/2022: We will no longer collect hair samples from participants due to low 
acceptability and feasibility. This was determined after a meeting with the LetSync Dyadic 
Advisory Board on 5/27/2022 when we ran by different modalities of biosample collection to get 
their feedback on. We will collect DBS in lieu of hair after having seen other studies that 
measure adherence to ARV and PrEP successfully collect these. 
 
Intervention arm (LetSync v1.0) 
1. At T0 (baseline) – remote OR in-person:  
a. Intervention arm participants will be scheduled to do the study initiation visit remotely 
or in-person at UCSF Mission Bay. We will offer the option of remote or in-person visits, 
depending on COVID-19 guidelines.  
1. Remote visit procedures 
1. Prior to the teleconference (e.g., Zoom) study visit, study staff will 
contact the participant, give an overview of the study, answer any 
questions, and obtain informed consent.  
2. Participants will be mailed a dried blood spot (DBS) collection kit and be 
instructed to complete a Baseline questionnaire of psychosocial and 
clinical self-report measures administered via Qualtrics. The 
questionnaire will collect demographic information such as age, gender, 
sexual orientation, highest education level attained, and race/ethnicity; 
self-reported clinical outcomes of adherence to ART, retention in care, 
and viral suppression; and psychosocial variables (e.g., stigma, stress, 
social support, experiences with racism, relationship satisfaction, social 
identity, minority stress). 
3. Participants will also be mailed a take-home urine test and materials to 
complete.  
4. Study staff will give participants an overview of the study and answer 
any questions. They will also give participants an overview of how to 
collect and mail dried blood spot (DBS) samples, and (if willing) hair 
and/or urine.  
5. Study staff will walk through how to install an Android or iOS version 
of LetSync 1.0 on their mobile Smartphone devices.  
6. Participants’ ClinCards will be loaded with $10 for completing the 
Enrollment visit and another $30 for completing the Baseline 
assessment.  
2. In-person visit procedures 
1. Prior to the study visit: 
1. Study staff will contact the participant, give an overview of the 
study, answer any questions, and obtain informed consent.  

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2. Participants will complete a Baseline questionnaire of 
psychosocial and clinical self-report measures administered via 
Qualtrics.  
2. During the study visit: 
1. Staff will collect a dried blood spot (DBS) sample from 
participants. 
2. As part of our new exploratory aim to assess the acceptability of 
remote dipstick urinalysis and hair collection, participants will 
be asked if they are willing to provide dipstick urinalysis and/or 
hair samples.  
1. If participant is willing to provide dipstick urinalysis 
sample: Staff will provide a cup and dipstick for 
participants to use. Staff will instruct participants how 
to use the dipstick. Participants will provide the dipstick 
to the staff. 
2. If participant is willing to provide hair: Staff will 
demonstrate how to collect, label, and securely store a 
small hair sample (30-40 strands) for ARV level analysis. 
3. Study staff will walk through how to install an Android or iOS 
version of LetSync 1.0 on their mobile Smartphone devices.  
4. Participants’ ClinCards will be loaded with $10 for completing 
the Enrollment visit and another $30 for completing the 
Baseline assessment.  
2. T1 (Month 2) – remote: 
a. Participants will collect and return a dried blood spot (DBS) sample using the kit 
delivered to their mailing address with necessary supplies and a prepaid return 
envelope. 
1. Upon successful receipt of the sample, participants will receive $30. Participants 
will receive a $10 bonus if the sample is post-marked within 7-10 days of 
requested due date. 
b. Participant will perform dipstick urinalysis using a kit delivered to their mailing address 
with necessary supplies. They will send a photo of the results, either by texting or 
emailing, to the study team. Participants will receive $15 for texting/emailing us a photo 
of their urine sample.  
c. Study staff will check in with participants via text, call, or email. We will ask participants 
about their experiences using the app, troubleshoot any issues, and confirm that we 
have their most up-to-date contact information.  
3. At T2 (Month 4) – remote or in person: 
a. Intervention arm participants will continue using LetSync v1.0. 
1. Remote visit procedures 
1. Participants will collect and return a dried blood spot (DBS) sample 
using the kit delivered to their mailing address with necessary supplies 
and a prepaid return envelope. 

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1. Upon successful receipt of the sample, participants will receive 
$30. Participants will receive a $10 bonus if the sample is post-
marked within 7-10 days of requested due date. 
2. Participant will perform dipstick urinalysis using a kit delivered to their 
mailing address with necessary supplies. They will send a photo of the 
results, either by texting or emailing, to the study team. Participants will 
receive $15 for texting/emailing us a photo of their urine sample.  
3. Participants will complete an online questionnaire that will be available 
during a window of time. After 3 days of non-response to the 
questionnaire, we will remind participants via an E-mail or call from the 
research staff. 
4. Online questionnaire will include validated usability and acceptability 
measures in addition to those on the Baseline questionnaire. 
2. In-person visit procedures 
1. Staff will collect a dried blood spot (DBS) sample from the participant. 
Participants will receive $40 for the sample. 
2. Staff will collect a dipstick urinalysis test. Participants will receive $15 
for the completed urine test.  
3. Participants will complete an online questionnaire that will be available 
during a window of time. After 3 days of non-response to the 
questionnaire, we will remind participants via an E-mail or call from the 
research staff. 
4. Online questionnaire will include validated usability and acceptability 
measures in addition to those on the Baseline questionnaire. 
Participants will receive $40 for completing the survey. 
4. At T3 (Month 6) – remote: 
a. Procedures will be similar to those at T1 (Month 2). 
5. At T4 (Month 8) – remote or in person: 
a. Intervention arm participants will continue using LetSync v1.0. We will conduct an Exit 
Interview in-person or remotely depending on COVID-19 guidelines. Interviews will be 
audio-recorded and transcribed for analysis. The digitally recorded audio file will be 
transferred immediately following the interview onto a password-protected laptop and 
then uploaded to an encrypted transcription service website prior to being permanently 
deleted on the audio-recorder and laptop. Any personally identifying information will be 
redacted from the transcripts.  
1. Remote visit procedures 
1. Procedures for biospecimen collection and online survey completion 
will be the same as T2 (Month 4).  
1.  
2. Staff will conduct the Exit Interview over teleconference (e.g., Zoom) or 
phone. 
2. In-person visit procedures 
1. Procedures for biospecimen collection and online survey completion 
will be the same as T2 (Month 4).  

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2. Staff will conduct the Exit Interview in person.  
b. Participants will receive a $20 cash card for completing the Exit Interview, and an 
additional $50 as a study completion bonus. 
 
Control arm  
1. At T0 (baseline) – remote:  
a. Participants randomized to the control arm will be informed of the study objectives and 
timeline. They will be informed that they can use the app once the study is over. 
b. Participants will be mailed a dried blood spot (DBS) collection kit and be instructed to 
complete a Baseline questionnaire of psychosocial and clinical self-report measures 
administered via Qualtrics. The questionnaire will collect demographic information such 
as age, gender, sexual orientation, highest education level attained, and race/ethnicity; 
self-reported clinical outcomes of adherence to ART, retention in care, and viral 
suppression; and psychosocial variables (e.g., stigma, stress, social support, experiences 
with racism, relationship satisfaction, social identity, minority stress). 
c. As part of our new exploratory aim to assess the acceptability of remote dipstick 
urinalysis and hair collection, participants will be asked if they are willing to provide 
urine and/or samples. If so, participants will be mailed a remote urine and/or hair 
collection kit at no cost to them. The kit will contain materials and instructions on how 
to send samples back. 
d. Study staff will give participants an overview of the study and answer any questions. 
They will also give participants an overview of how to collect and mail dried blood spot 
(DBS) samples, and (if willing) hair and/or urine.  
e. Study staff will walk through how to install an Android or iOS version of LetSync 1.0 on 
their mobile Smartphone devices.  
f. Participants will receive a $66 cash card for completing the Baseline assessment. 
2. At T1 (Month 2) – remote: 
3. At T2 (Month 4) – remote:  
a. Procedures for T2 will be the same as those for participants in the intervention arm at 
T2. 
4. At T3 (Month 6) – remote: 
a. Procedures for T3 will be the same as those for T2. 
5. At T4 (Month 8) – remote: 
 
a. T2 procedures will be identical in both intervention and control arms. At the T2 visit, we 
will conduct an in-person or remote exit interview to gather qualitative data for 
evaluating the acceptability of our methodology, including of the remote dried blood 
spot (DBS), dipstick urinalysis, and/or hair collection. In the exit interview, we will ask 
participants about the acceptability of sample collection. Participants will receive a $90 
cash card for completing the Exit Interview. 
 
We will interact with participants at Baseline, T1, and T2 via in-person visits, phone calls, postal mail, 
and E-mails. We will contact study participants to remind them of their scheduled visits, hair sample due 
dates, and to obtain information on acceptability of app and its use. 

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Follow-up/retention in study. We will collect at least three methods of personal contact, such as their 
social media handles and additional phone numbers, at the time of enrollment. We will also obtain 
contact information to three of the participant’s close friends and/or family that we will contact only if 
we cannot reach the participant (see LetSync Secondary Contact Script, attached). We will also maintain 
regular contact with participants by sending reminders about virtual check-ins, about sending in hair 
samples, and asking about any app-related issues. In every contact, we will request information on 
changes in contact information. 
 
Incentives. Incentives will be given to participants in the form of cash or gift cards. 
 
Update 8/15/2022: To encourage participation in a longitudinal study, the study team and co-
investigators, namely Lance Pollack, agreed that we should make the incentive structure 
graduated, i.e. increase over time. We will tie an incentive amount to EACH study activity. 
 
We previously discussed awarding “on-time” bonuses to reward participants who complete 
activities on time. There was some disagreement with this among the co-investigators, because 
any unused on-time bonuses could have gone towards increasing incentive amounts for study 
activities overall and encouraging participation in them.  
 
We will also now pay participants via ClinCard, as the team agreed this is the best alternative to 
paying participants via apps such as Venmo and CashApp (which the university is not supporting 
at the moment). Participants have historically requested cash, and due to this being a remote 
study it will not be possible to pay everyone with cash. 
 
Update 2/21/2023: We will re-instate “on-time” bonuses for DBS samples to encourage participants 
to mail them back on a timely basis, and with all the considerations the staff realized such as time it 
takes for pts to complete DBS sample, mailing it back, and freezing it to ensure limited degradation. 
We will try this structure out and re-visit if needed (ex. if we don't see pts mailing back samples).  
 
 

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SECTION 6: PARTICIPANT BREAK-UP PROTOCOL 
 
Participants will be screened and enrolled in the study as an intact couple. Participants will be informed 
at the time of phone screening and consent that this research is a couple’s study. However, in the event 
that an enrolled couple breaks up, the Participant Break-Up Protocol will be followed based on the time 
point when the break-up occurred and the randomization status of the couple.  
 
6.1 Breakups during Aim 1 
• 
Between Phone Screening and Consent: 
o Participants will be informed that they are no longer eligible for the study due to not 
being in a couple, and their scheduled interview will be cancelled.  
o Participants will be informed that if and when participants enter into a new primary 
relationship and meet eligibility and inclusion criteria, they and their new primary 
partner may enroll as a new couple in a subsequent study (e.g., the pilot trial). 
• 
Between Consent and Couple Interview (if not scheduled on the same day as the individual 
interviews): 
o Participants will be informed that they are no longer eligible for the study due to not 
being in a couple, and their couple interview, if scheduled, will be cancelled.  
o Participants will be informed that if and when participants enter into a new primary 
relationship and meet eligibility and inclusion criteria, they and their new primary 
partner may enroll as a new couple in a subsequent study (e.g., the pilot trial). 
• 
Both participants will be offered referrals for support and a list of other UCSF CAPS studies (See 
Appendix XXX). 
 
6.2 Breakups during Aim 2 
• 
Between Phone Screening and the 3rd CAC Session 
o Participants will be informed that they are no longer eligible for the study due to not 
being in a couple, and their scheduled session will be cancelled. 
o Participants will be informed that if and when participants enter into a new primary 
relationship and meets eligibility and inclusion criteria, they and their new primary 
partner may enrol as a new couple in a subsequent study (e.g., the pilot trial). 
• 
Between Consent and mini-pilot 
o Participants will be informed that they are no longer eligible for the study due to not 
being in a couple, and their scheduled session will be cancelled.  
o Participants will be informed that if and when participants enter into a new primary 
relationship and meets eligibility and inclusion criteria, they and their new primary 
partner may enrol as a new couple in a subsequent study (e.g., the pilot trial). 
• 
Both participants will be offered referrals for support and a list of other UCSF CAPS studies 
located at https://prevention.ucsf.edu/join-study 
 
6.3 Breakups during Aim 3 
• 
Between Consent and Randomization 
o Participants will be informed that they are no longer eligible for the study due to not 
being in a couple, and their scheduled baseline appointment will be cancelled.  
• 
After Randomization  

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o Study staff will contact both participants and explain to them that they may use the app 
and participate in the T1, T2, T3, and T4 surveys, and hair self-collection (if HIV+) as 
scheduled throughout the rest of the study.  
• 
Between T1 and T4 
o Study staff will contact both participants and explain to them that they may use the app 
and participate in the remaining surveys and hair self-collection (if HIV+) as scheduled 
throughout the rest of the study.  
• 
Throughout the Pilot Trial 
o Participants will be asked whether they are still together with their original partner at 
each time point. 
o If a couple breaks up, study staff will contact both participants to confirm their current 
contact information, if changed as a result of the break-up. The Tracking Database will 
be updated with the correct information to ensure continued contact with each 
participant.  
o The staff member who identified the break-up will communicate this information to the 
study coordinator and PI via email. 
o In the event that a couple breaks up and then gets back together, the study staff will 
meet as a team to discuss the situation and determine the most appropriate way to 
proceed. 
 
 
 
 
 

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SECTION 7: PARTICIPANT CRISES PROTOCOL 
 
7.1 Protection of Participants 
Remember: Our utmost concern is protecting the safety and welfare of participants. Given the nature of 
our research project and population, it's possible that during an interview or study visit a participant 
may make suicidal comments or indicate that they are experiencing significant distress or depression. 
We've created the following procedures as a safeguard.  
 
Initial Impressions  
As you greet and orient participants, look for indications of distress. Address any concerns you have 
according to the protocol below.  Ones that need extra attention are: 
• 
Suicidal Ideation 
• 
Homicidal Ideation 
• 
Grave disability  
• 
Child, Elder and Dependent Adult Abuse  
• 
Intimate Partner Violence 
• 
Emotional Distress 
 
7.2 Clinician Availability  
Clinically trained staff members are always available to interviewers.  Be familiar with your team’s 
contact information and list of people who should be contacted in case of an emergency. The Principal 
Investigator and/or Study Coordinator are generally onsite during interviewing hours. Be aware, on a 
daily basis, of staff availability for clinical and crisis consultation. As a back-up, there will always be a 
licensed clinician with a cell phone to contact in emergencies. You should always have easy access to 
these team members and phone numbers. Judy and the Clinical Supervisor (TBD) are ok with calls or 
texts. 
• 
Clinical Supervisor, TBD cell: (XXX) XXX-XXXX   
• 
Principal Investigator, Dr. Judy Tan’s cell: (917) 838-0698 
 
7.3 Protocol for Suicide Risk 
7.3.1 Suicidal Comments Should Always Be Explored   
It is a myth that talking about suicide to people increases the chances of them actually doing it.  A 
participant's comments could be direct, (e.g., "I want to die," "I'm thinking of killing myself," or "I don't 
want to go on any more."). They can also be more indirect, such as "Life isn't worth living alone, without 
my partner." 
 
If you are concerned that the participant is at risk of harm, and if you are a trained clinician, begin a 
suicide assessment (see Suicide Risk Protocol below). If you are not a trained clinician, involve an 
available staff clinician with the participant’s consent. 
 
7.3.2 Assess the Imminence  
If there is evidence that the participant is significantly distressed and suicide may be imminent, take 
steps to establish contact between the participant and a referral source. Action is imperative when a 
person meets the following criteria: 
• 
Has a plan, 
• 
Has the means to carry out the plan (i.e., has the medication or weapon), 

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• 
Has intent to complete suicide in immediate or near future, 
• 
Has little that they are planning to do in the future, 
• 
Has attempted to commit suicide in the past (approximately 5% of those who attempt but do 
not complete suicide, do commit at a later date), 
• 
Has not told others about the plans out of a concern that they will try to intervene, and 
• 
Talks about events and close people as though the suicide has already occurred. 
• 
Has given away valuable and sentimental items.  
 
7.3.3 Look for an Obstacle or Hook  
Listen for the participant to mention something that would keep them from committing suicide either 
immediately or in the future. This is the "hook." It might be an upcoming event that the participant 
would not want to miss. It might be a promise the participant made to a partner. It might be a spiritual 
belief or a commitment to friends. Listen for this carefully as you are showing your concern and 
empathy for the participant. If a "hook" is found, mention it to the participant to see if they responds 
positively. For example, they might say, "You're right, I really did make a promise and I can't go back on 
that," or "I'm not going to even think about it until after I go back East for the holidays to see our 
friends...that's something we were planning for a long time." The presence of a hook can usually be used 
to extract a commitment from the participant that they will not take any immediate action to hurt 
himself. This is, in essence, a good sign. 
 
7.3.4 Emergency Actions 
Ask the participant direct questions and get answers to criteria 1–8 above. If, based on the answers, you 
believe that risk of harm is imminent, you must next decide if it is an emergency. If you believe that they 
may take an action between now and a few days from now, the situation is considered an emergency. If 
this is the case, do not let the participant leave.  Contact the Principal Investigator or the Study 
Coordinator. If they cannot be contacted, persuade the participant to come with you to talk with 
someone about the suicide now and take the participant in a cab to a nearby ER or call a 24-Hour Suicide 
Prevention Hotline and ask them to talk to the participant. Don't leave the participant until the situation 
is resolved with your having a firm commitment from the participant that they is not going to take any 
action to hurt himself until after a future date. 
 
What to say 
• 
"This is such an important decision.  It's so final.  It's really important that you talk with someone 
about this, and I am not the best person." 
• 
“The fact that you told me about this means that you may want to talk it through first.  It's 
important that you talk with someone about your feelings." 
 
7.3.5 Non-Emergency Actions  
If you determine that there is risk, but that it is not imminent (for example, the participant is thinking 
about suicide but has no plan, or there is a plan but the participant is definite about not wanting to do 
anything until after an upcoming event), talk to the participant about obtaining counseling and make a 
referral. You should also seek consultation from a clinically trained person while the participant is still 
present. The focus during this consultation call is on reviewing the imminence, and then developing a 
plan for support and referral. Work with the participant to devise a plan for getting in touch with the 
designated referral source. Refer to Appendix A for a list of resources. 
 

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7.3.6 Document all actions taken 
Write a summary email to the Project Director, print a copy for documentation in the participant's file, 
briefly summarize in the database, and inform other staff members on a “need to know” basis. Follow 
up any referrals with a phone call within the next 24-48 hours. 
 
Interview Protocol for Non-Suicidal Distress.  
 
7.3.7 A Delicate Balance   
Keep in mind that while participant safety is our primary concern, it's also important to consider 
balancing your response to the participants' needs with unbiased data collection. Although suicidal 
comments and indications of distress must always be explored, it may be possible to complete the 
interview before conducting a full risk assessment. This is preferable from a research perspective 
because the data is collected before attempting any type of intervention, which could bias the 
participant's responses.   
 
Example Situation: If, during informed consent, the participant indicates recent significant depression, 
then: 
• 
Briefly acknowledge their response in order to determine the severity of depression and suicide 
risk.  Then, if risk of harm does not seem imminent and if the participant seems comfortable, 
continue with the interview. 
• 
Complete the interview, and then revisit the response by saying, "When I asked earlier how you 
were feeling, you stated that you felt life is not worth living.   Will you please tell me more about 
that?" 
 
To determine the level of risk gather specific information by asking each of the following probes: 
• 
How are you feeling now? 
• 
Are you receiving any type of counseling? 
• 
(If in counseling): When is your next appointment? 
• 
Have you had any counseling in the past? 
• 
Are you taking any medication to help you handle ______? 
• 
Do you have a friend or family member that you can turn to when you are feeling down like 
this? 
• 
What do you feel you need now? 
• 
Would you like to talk with someone about ______? (Referral) 
• 
(If possibly suicidal): Have you thought about what you might do? 
 
7.3.8 Useful Phone Numbers 
• 
Suicide Hotline: (415) 781-0500 
• 
Mobile Crisis: (415) 255-3610 
• 
Psychiatric Emergency Services (SFGH) 206-8125 
 
7.4 Protocol for Homicidal Ideation 
If a participant makes any comments about wanting to hurt or kill another person, or presents with 
unusually strong rage towards another person, the interviewer needs to assess for potential risk of harm 
to other people.  If there is  
 

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• 
Intent to harm an identifiable victim, and unable to clearly state they have no intent to act on 
these thoughts  (Tarasoff situation - duty to warn enacted and police and intended victim must 
be warned)  
• 
Participant feels out of control or unable to manage angry feelings (should be treated the same 
way as suicidality, with problem solving, contracting and potential referrals to a mental health 
provider, Mobile Crisis Team or Psychiatric Emergency Services).  
 
In either of these cases a clinically trained staff member should be alerted immediately to help assess 
the situation and level of risk. 
 
7.4.1 Tips for gathering information 
Suggested Interviewer Style: Friendly (compassionate, warm, concerned, supportive, client-centered), 
Frank (direct, candid, unafraid to ask or talk about risks plainly), and Firm (asking in a confident tone and 
insisting that this discussion is essential, imperative, and necessary). These help establish therapeutic 
trust, clear expectations, and relational honesty.  
 
Is there homicidal ideation (Normalize): When someone feels as upset as you do, they may have 
thoughts about hurting the person who has upset or hurt them. 
What thoughts have you had like this?  
 
Is there a Plan (Means) 
If you decided to try to hurt ________, how would you do it?  
Tell me about the plans you’ve made.  
 
Is there Access to Means  
You mentioned that if you were to hurt __________, you’d probably do it by (describe method). How 
easy would it be for you to do this?  
 
Are there any protective factors? (Normalize): People often have very mixed feelings about harming 
other people.  
What are some reasons that would stop you or prevent you from trying to hurt ________? What is it 
that most holds you back from actually doing this?  
 
What about past experiences? (History of violence) What have been your past experiences related to 
hurting people who have hurt you?  
 
Future Expectations  
What are some of the things happening in your life or likely to happen in your life right now that would 
either make you more or less likely to want to hurt_______?  
How do you think people who know you would react if you actually did this?  
What would they say, think, or feel?  
What would be some of the consequences? 
 
7.4.2 Useful Phone Numbers: 
Police Liaison: (415) 255-3727 
 

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7.5 Protocol for Grave Disability  
Although unlikely, participants may develop a significantly impaired mental state at some point during 
the intervention, i.e. evident upon arrival for an interview or during the course of an interview. This 
could be caused by acute psychosis, mania, substance use or withdrawal, or acute or progressive 
medical illness. If the participant is too disorganized or confused to continue the interview, evaluate 
whether the participant is going to be able to get home safely. If it appears that the participant is no 
longer able to care for them self, the interviewer should take the steps listed under Emergency Actions 
and consult with an available supervisor.  
 
7.6 Protocol for Suspected Child and Elder/Dependent Adult Abuse 
The LetSync team is required to report any cases of suspected child, elder (65 or older), and dependent 
adult abuse. If participant mentions knowledge of a current abuse situation, the project is required to 
notify the appropriate agency within the required time period. 
 
• 
Children under 18: Call Child Protective Services as soon as possible and follow up with written 
report within 36 hours 
• 
Adults: Call Adult Protective Services and follow up with written report within 2 working days 
 
If a participant reports past abuse, the interviewer should assess whether or not the perpetrator is still 
in contact with children. If they are either living with children or being left unsupervised with children, 
the project is required to file a report with CPS. If clinically appropriate, the participant should be 
involved in the reporting process.  
 
When in doubt about whether a report is required, staff at CPS/APS are available for consultation. 
Always remember to get the name of the person you spoke with and document the conversation in the 
participant’s file.  
 
The interviewer should always discuss the situation with a supervisor and decide together whether as 
report needs to be filed.  
 
7.6.1 Useful Phone Numbers: 
Adult Protective Services: 557-5230 
Child Protective Services:  558-2650, or 1-800-856-5553 
 
7.7 Protocol for Intimate Partner Violence 
LetSync is not mandated to report domestic violence and staff are not allowed to break the participant’s 
confidentiality to report battering unless the victim is over 65 or considered a dependent adult (disabled 
in a wheel chair, unable to physically care for self, etc.). 
 
If a participant reports that there is physical violence or feels increasingly at risk of violence in a 
relationship, the counselor will want to help the participant develop a safety plan. This may include 
referrals to shelters, problem-solving places to go (family, friend’s house, hotels), or finding ways for 
participant to keep themselves safe at home.  
 
7.8 Protocol for Emotional Distress 

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If a participant is under clear emotional distress (e.g., crying, yelling), take the time to figure out if the 
participant is in a clear headspace to do the interview. It may also be that the interview questions can be 
triggering. 
 
Let the participant know that you can tell they are feeling distressed from their words and intonation of 
voice. Ask if they would like to re-schedule the interview on another day and time, which they can do 
with no penalty to them. It may also be appropriate to refer them to services they clearly mention need 
of (e.g., psychological counselling, housing assistance, food banks). 
 
SECTION 8: DATA MANAGEMENT  
 
8.1 Participant ID Assignment  
After interested individuals are screened and determined to be eligible, they will be assigned a 
participant ID number. The number will consist of 4 digits (XXXX). The first three digits will refer to the 
couple, and the last digit will refer to the individual within the partnership. For example:  
 
• 
1011, 1012 
• 
1021, 1022 
• 
1031, 1032 
• 
etc.  
 
The index partner in the relationship (the HIV-positive, cis-gendered black man) will always be assigned 
the individual digit of “1”, while the primary partner will receive the individual digit of “2”. This is not to 
be confused with the “Partner 1” and “Partner 2” on the screening form, which only refers to the order 
in which the partners call to be screened.  
 
8.2 Study Tracking  
8.2.1 Recruitment activities  
Any study staff conducting recruitment activities (see Section 2.4 Recruitment) will, within 24 hours of 
the activity, add a row to the “Recruitment Activities” tab in the “Study Log” file within the “Study Logs 
and Trackers” folder in Box.  
 
8.2.2 Screening form log 
The “Screening Form Log” tab of the “Study Log” file will be updated within 24 hours of each participant 
call-in and phone screener questionnaire completion. The staff member who completes the 
questionnaire will ideally also enter the information into the Screening Form Log.  
 
Each person who calls in and completes a phone screening questionnaire will be entered into this form, 
regardless of eligibility.  
 
This will be verified weekly by both a recruiter and the study coordinator.  
 
Updating dropdown lists 
If changes to answer choices in each column are needed, they can be edited in the “SFL answer options” 
tab (currently hidden) in the same excel file. If answer choices need to be added, the team member will 
need to change the data selection range in the “Screening Form Log” tab. To do this:  
 

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1. Highlight the appropriate column in the “Screening Form Log” for which you need to update the 
drop down list.  
2. Choose “Data validation” from the “Data” menu. 
3. Choose “List” for the “Allow” section under “Settings”. 
4. Make sure “In-cell dropdown” is checked. 
5. In “Source”, choose the cells you would like to be included in the dropdown list. Drag to 
highlight the cells you want.  
6. You can also edit the message you see when you hover over the column, as well as the type of 
Error Alert here as well.  
7. Click OK.  
 
8.2.3 Interview scheduling tracker 
Once both partners confirm eligibility and interest and the interview is scheduled, the staff member who 
scheduled the interview will complete a row for the appropriate participants.  
 
This will be verified weekly by both a recruiter and the study coordinator in conjunction with the PI.  
 
8.2.4 Contact tracking 
Whenever a participant is contacted, the study team member who contacts said participant will enter 
the PID, Date, contact method, and notes regarding the call.  
 
This will be verified weekly by both a recruiter and the study coordinator.  
 
8.3 Qualitative interview data procedures  
8.3.1 Post-interview procedures for interviewer  
1. After completing the interview, the interviewer will review the audio recording to ensure it was 
properly recorded.  
2. The interviewer will review their field notes for clarity and accuracy and summarize the 
interview while it is still fresh in their mind.   
3. Right after the interview, or within 24 hours, the interviewer will type up his/her field notes 
onto their laptop and upload them to the Field Note folder in UCSF Box. The notes will be 
labeled with participant ID number(s) and date of interview. Any identifying information will be 
removed. 
 
8.3.2 Interview transcription  
Interview audio files will be sent to a transcription service (e.g., HomeRow) to be transcribed. The study 
coordinator or PI will send the audio files to the transcription service within 24 hours of interview 
completion. Interviews will be transcribed verbatim. The interviews are expected to be transcribed 
within 7 business days of the transcription service receiving them.  
 
When the transcriptions are received from the transcription service, the study coordinator will upload 
the transcriptions to the UCSF Box Interview Transcription folder and label them with Participant ID 
number(s) and interview date.  
 
The interviewer will then be told that the transcript is available, and they will need to access the file and 
ensure that the written version is accurate.  The interviewer will listen to the audio recording and make 
necessary corrections and will remove identifying information.  The clean version will be saved as 
“0101.clean, 0102.clean, etc.” These clean files will be loaded into the analytic program to be coded. 

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The study coordinator will also upload the transcription into DeDoose in the file folder for LetSync (may 
still need to be set up). 
 
The study coordinator will update the PI about uploaded transcripts on a weekly basis and will track of 
the status of interview completion and transcription under the Interview Tab in the LetSync Study Log.  
 
8.3.3 Qualitative Coding and Analysis 
The team will use DeDoose to code and analyze the interviews.  
 
Couples’ Interview Transcripts 
The team, trained by Drs. Arnold and Tan, will conduct couple-level analysis of the individual interview 
transcripts first, using both a deductive and inductive approach. The team will read all individual 
transcripts and develop a codebook based on the interview guides, the theoretical framework, and 
emergent themes.  Taking a subset of interviews, the team will read and re-read the transcripts to gain 
familiarity with the major themes within the data.  They will then develop a preliminary codebook, 
which will contain parent and child codes designed to capture and describe the data.  Using the 
preliminary codebook, the team will then collaboratively code 2-3 transcripts, openly discussing the 
rationale behind code application and chunking particular segments of data.  Once the team has 
reached a shared understanding for code application, they will separately code 1-2 transcripts, with Dr. 
Arnold measuring the level of coding agreement between different coders and providing training and 
feedback to the team members until all coders reach a coder agreement threshold of 90 percent.  Once 
coder agreement has been achieved, the team will be assigned transcripts to code in Dedoose and will 
convene on a weekly basis to discuss analysis and particular narratives, patterns, and emergent findings.  
 
The team will compare and contrast each transcript from individual interview with that of the partner to 
discover overlaps between narratives and to identify points of corroboration and contradiction. With the 
couple as the unit of analysis, we will cross-analyze significant statements, formulating themes based on 
both partners’ perspectives on their relationship, resiliency, dyadic coordination around health and care 
engagement, and respective roles in their own and each other’s healthcare. Comparing both partners’ 
perspectives will allow triangulation to derive a fuller, more contextualized understanding of the nature 
of dyadic processes in HIV care engagement in the context of social and structural challenges and 
barriers to care.  
 
Individual Interview Transcripts 
After dyadic analysis, we will conduct individual-level analyses. We will develop the codebook by reading 
all transcripts and iteratively generating and revising codes based on discussions of major themes that 
are linked to our theoretical framework and that emerge from our data. After several sessions of 
simultaneously applying codes to 3 transcripts (2 individual and 1 couple interview) as a team and 
discussing the coding system, we will use 1 couple’s individual and couple interview transcripts to verify 
consistency in code application between coders. We will revise the codebook and repeat this process 
until reaching 90% agreement. Thereafter, we will independently code and create analytic memos based 
on our conceptual framework and emergent findings.  
 
 
 
 
 

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8.4 Data Storage/Maintaining confidentiality 
All electronic data will be stored via password-protected laptops in UCSF Box, Qualtrics, or DeDoose. 
 
All hard copies of forms with data (e.g., consent forms, etc.) will be stored in a locked file cabinet in the 
UCSF Mission Hall office. Only the study coordinator and PI will have access to the cabinet, and other 
team members may request access when needed. 
 
Any hard copies of forms that are scanned and uploaded to Box will be deidentified and labeled with 
Participant ID. 
 
If confidential data must be sent from one UCSF entity to another, the email will be labeled “SECURE” in 
accordance with UCSF IT policy to ensure confidentiality of information. 
 
 
SECTION 9: QUALITY ASSURANCE  
 
9.1 Staff Training and Certifications  
9.1.1 Interview Training 
Study staff will be trained in interviewing by the PIs (Judy Tan and Emily Arnold). This will include:  
• 
Practice interviewing with UCSF staff 
• 
PI review of and feedback on transcripts  
 
Each interviewer must review the separate protocols for emergency reporting procedures and intimate 
partner violence procedures. 
 
9.1.2 Staff Certification 
The Study Coordinator will ensure that all study staff are up-to-date on CITI training requirements and 
upload the certificates to the appropriate study folder.  
 
The Study Coordinator will ensure that the petty cash handler and any other study staff needing petty 
cash certification for any reason maintain certification. The Study coordinator will upload the certificate 
to the appropriate study folder.  
 
9.2 Qualitative Data Quality Assurance 
The investigators will regularly review the interview transcripts to ensure that all topic areas are being 
discussed with participants and data are collected.  They will also review summaries as they become 
available.  In instances where topics are not investigated, training will be offered to interviewers to 
ensure that study data are collected appropriately across the entire sample. 
 
PI Judy Tan (917-838-0698) and Co-I Emily Arnold (personal cell phone number: TBD) will be available for 
calls from staff (interviewers) or participants around difficult issues in experienced in the field. 
 
 

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SECTION 10: OFFICE PROCEDURES 
 
10.1 Petty Cash 
Project staff requesting petty cash will meet with the petty cash custodian on a weekly basis to log 
receipts and petty cash requests.  
 
The petty cash custodian is in charge of the petty cash lockbox, tracking, and reporting as per UCSF 
requirements. 
 
10.1.1 Tracking Petty Cash Flow 
Using the “LetSync Petty Cash Tracking” file located within the “Admin” > “Petty Cash”folder in Box, the 
petty cash custodian will fill in a new row for any petty cash transation that s/he initiates. This includes 
collection of receipts.  
 
• 
When giving petty cash to interviewers, the petty cash custodian will note this amount in the 
“Amount Given to Staff” column. The petty cash custodian will note this amount in the petty 
cash tracking log immediately after giving petty cash to study team members.  
• 
When receiving receipts for participant transactions from interviewers, the petty cash custodian 
will note this amount in the “Receipts Received from Staff in Current Transaction” column.  
• 
The “Cumulative Total of Receipts” column will automatically add the receipts of all 
transactions. DO not edit this.  
 
All petty cash receipts will be stored in a designated folder in a locked file cabinet at the petty cash 
custodian’s desk. 
 
Once per month, the petty cash custodian will meet with the PI to verify that petty cash transactions 
add up. 
 
Update 2/7/2022: Twice a year, the petty cash custodian will meet with the department head to verify 
amount of petty cash in hand. 
 
10.2 Storage of participant forms 
Forms with participant information on them will be kept in participant-designated file folders in a locked 
cabinet of the study coordinator.  
 
10.2 Printing of study documents 
The study coordinator, with help from team members, will keep track of the number of forms that are 
available as hard copies (e.g., consent forms, questionnaires, interview guides, etc.) and print new 
copies when needed. 
 
10.3 Project Management File 
The study coordinator will keep the Project Management excel file (found in the “Admin” folder) 
updated. This includes:  
• 
Login credentials for any study-related websites or other apps 
• 
Study phone information 
• 
Required reporting dates 

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• 
Other pieces as necessary 
 
10.3 Reporting requirements 
10.3.1 Research Performance Progress Report (RPPR) 
The study coordinator will keep track of the variables needed to be included in the RPPR forms sent to 
the NIH at the end of each project year. The study coordinator will assist the PI in completing the RPPR 
to be submitted.  
 
The study coordinator will make sure that the necessary reporting items are being tracked in the study 
logs, which are the following: 
 
• 
Age (in years) 
• 
Race 
• 
Ethnicity 
• 
Gender 
 
10.3.2 Recruitment Milestone Reporting (RMR) 
The study coordinator will keep track of the recruitment numbers needed to be included in the RMR 
forms sent to the NIH. The study coordinator will send this to the PI so she can submit to the NIH. 
 
The study coordinator will make sure that the necessary reporting items are being tracked in the study 
logs. 
 

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SECTION 11: HUMAN SUBJECTS 
 
11.1. Potential Risks to Subjects 
A risk posed to participants will be loss of confidentiality. Mini-pilot participants risk losing 
confidentiality over unsecured transmission of private data. Another risk is the psychological discomfort 
due to unpleasant memories that the survey or interview questions may elicit. Although highly unlikely, 
there is a low risk of interpersonal disagreements during couple’s interviews that pose unpleasant 
interactions. Intimate partner violence (IPV) is common among same-sex gay couples. In any couples-
based research, in order to protect against the risks of IPV resulting from research participation of 
couples, researchers should inquire about IPV. The proposed research does not directly study IPV and 
thus will not involve content related to IPV. However, because we will be inquiring about IPV at 
screening, there is a risk of distress while revealing IPV experiences to investigators/research staff, fear 
of reprisal, and actual reprisal. 
 
11.2 Adequacy of Protection against Risks 
11.2.1 Informed consent and assent 
Written informed consent will be obtained from each subject at entry into the study. Informed consent 
is obtained by the following process: 
1. The subject will be asked to review the study consent form and will be given ample time to do 
so. The consent form will be at a 6th grade reading level. 
2. A member of the research team will meet with the subject to review the form, to confirm the 
subject’s understanding of the study, and to answer any questions the subject might have. Potential 
participants will be informed that their participation in the study is voluntary and that they may 
decline to participate for any reason without any negative consequences. We will inform 
individuals that they may refuse to answer any question, and that any information they provide 
will be strictly confidential. We will also inform individuals that the study is being conducted by 
our team at the University of California, San Francisco, and that its purpose is to examine issues 
of importance to BMSM living with HIV, including relationships, engagement in care and 
adherence to treatment, general health outcomes, and thoughts on HIV prevention programs. 
3. Once the subject demonstrates understanding of the study and agrees to participate in the 
study, the consent will be signed in the presence of the member of the research team. 
 
11.2.2 Protections Against Risk 
All study procedures will be submitted for approval at the Institutional Review Board (IRB) at UCSF.  
Protecting the identity and confidentiality of the participants will be a top concern for all involved in the 
project. To accomplish this, a number of steps will be taken:  
• 
All participants will be assigned a unique identification (ID) number. We will assign ID numbers 
to each survey record, so names will not be associated with individuals’ answers to the 
questions. All private identifiable information collected from participants will be stored 
separately from the participants’ research data, e.g., transcripts, hair samples, and 
questionnaire using a password-protected and encrypted laptop per UCSF minimum security 
standards. The key linking personally identifiable information to study ID will be stored 
separately under passcode. 
• 
We will regularly obtain up-to-date human subjects and ethics training certifications indicating 
that all investigators and key personnel have fulfilled all requirements for performing research 
involving human subjects, thereby meeting NIH policy. Research staff will receive regular 
“refresher” training on handling confidential information from participants. Staff who takes 

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notes on paper (e.g., at a CAC session) will document only the necessary information, will never 
list identifying information, and will destroy the notes by placing them in a secure shredder bin 
once they are transferred onto the study laptop. Any physical copy of study-related information 
will be handled in this way.  
• 
All data will be accessed and stored on UCSF-managed and serviced laptops and iPads and only 
on these devices. All data files containing participant information—even de-identified 
information—will be password-protected. All research laptops and iPads are password-
protected and secured with Duo two-factor authentication process and have installed on them 
Pulse Secure Virtual Private Network (VPN), which secures a user’s transactions. Any 
transmission of data will be encrypted across public networks as if it were directly connected to 
the UCSF network. UCSF provides a secure environment for all computing by protecting all 
computers and servers with anti-virus, anti-spyware, intrusion prevention, proactive threat 
scanning, and personal firewall for Windows computers. On OS X and Linux computers, UCSF 
provides anti-virus and anti-spyware. 
• 
UCSF’s Qualtrics software will be used to administer and store all self-administered surveys. 
Qualtrics is a web-based HIPAA-compliant and secure electronic data capture and storage for 
research studies. All Qualtrics web connections are secured with authentication and data 
logging.  
• 
Digital recording devices will be erased subsequent to interview transcription. Transmission of 
data will be done using via UCSF’s secure VPN. The qualitative interview transcriptionist service 
will transmit files over military grade 128-bit Secure Socket Layer (SSL) encryption security in 
transit and 256-bit AES encryption at rest. 
• 
All interviews, CAC sessions, and in-person visits will be conducted in a private space at CAPS or 
APEB, a HIPAA-compliant community-based primary care clinic. Audio files and transcripts will 
be labeled according to the unique ID number and the file will be password-protected.  
• 
We will supply all participants with a study phone number and email address where they can 
contact us for any questions or concerns. 
• 
Participants will be instructed to use the app on their private mobile phones in locations where 
their privacy is ensured, and will be informed about ways to help protect their privacy. Data 
collected via the study app will be securely captured and monitored using data confidentiality 
and authentication protocols, including a data encryption solution for mHealth (DE4MHA). Past 
research has shown that DE4MHA allows users to safely obtain and exchange health information 
with the data being transferred securely and managed internally using systems set up by the 
UCSF Information Technology Services. All tracking information will be destroyed after the 
completion of the study.  
 
To protect against the risk of interpersonal disagreements between couples or psychological discomfort: 
• 
We will emphasize that the participant may stop or terminate his participation at any time 
without negative consequences. 
• 
The interviewer will be trained by the PI to mitigate potential disagreements and psychological 
discomfort from occurring and to handle them if and when they do occur. In the event that the 
interviewer or staff observes the participant(s) experiencing psychological discomfort or having 
disagreements, the interviewer will pause and ask if participant(s) would like to continue. If the 
disagreements still continue, then the interviewer will end the interview. A protocol will be in 
place for reporting these as minor adverse events to the PI. 
 
To protect against the risk of IPV or related reprisal due to research participation: 

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• 
Exclusion criteria include participant reporting fear of IPV resulting from participation. We will 
evaluate fear of reprisal prior to enrollment in the study via a Yes/No question, “Are you fearful 
or in danger from your partner as a result of your participation in the study?” To maintain 
privacy, participants will be screened privately and separately from their partner. Suspected IPV 
will not be specifically listed as a reason for exclusion to the participant or his partner.  
• 
We will use the following IPV-research guidelines set forth by the World Health Organization 
(WHO) for ensuring participants’, including: 
o The safety of respondents and the research team is paramount and should infuse all 
project decisions.  
o Protecting confidentiality is essential to ensure both safety and data quality.  
o All research team members should be carefully selected and receive specialized training 
and ongoing support.  
o The study design must include a number of actions aimed at reducing any possible 
distress caused to the participants by the research.  
o Field workers should be trained to refer women requesting assistance to available 
sources of support. Where few resources exist, it may be necessary for the study to 
create short-term support mechanisms.  
o Researchers and donors have an ethical obligation to help ensure that their findings are 
properly interpreted and used to advance policy and intervention development.  
o Violence questions should be incorporated into surveys designed for other purposes 
only when ethical and methodological requirements can be met.  
• 
We will give all participants a detailed referral list that includes local counseling centers, 
community-based resources and services, and emergency shelters that will have been vetted 
and regularly updated. Study staff will call regularly to confirm that local hotlines provided on 
study information cards are still connected. 
• 
The PI, Dr. Tan, will meet with Bay Area community-based organizations and nonprofit advocacy 
groups that specifically serve the population to build rapport to help ensure that these 
supportive services will be prepared for any increase in help seeking that the study may 
generate.  
• 
If a participant becomes agitated or threatens violence while at the study offices, Dr. Hoff, a 
study consultant and Clinical Psychologist, will be called on her emergency phone line to 
intervene and prescribe follow-up procedures.  
 
11.2 Potential benefits of the proposed research to participants and others 
There are no direct benefits to individual participants in the study. Participants may gain knowledge and 
awareness from the incidental exposure to information about treatment information and referrals. They 
may derive satisfaction from contributing to research and advancing scientific knowledge for improving 
the health of their community. Finally, they may enjoy using the app individually and with their partner. 
 
11.3 Adverse Event Reporting 
An internal (on-site) adverse event that PI determines to be (1) definitely, probably or possibly related 
AND (2) serious or unexpected, will be reported to the UCSF IRB within 5 working days of UCSF PI 
awareness. 
 
Internal, related deaths and life-threatening events will be reported to the UCSF IRB immediately.   
 

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An external (off-site) adverse event that the PI determines (1) changes the study risks or benefits, OR (2) 
necessitates modification to the IRB-approved consent document(s), and/or the IRB-approved 
application/protocol, will be reported to the UCSF IRB within 10 working days of UCSF PI awareness. 
 
 

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SECTION 12: SURVEY 
 
On page 1 is ACEs. We changed the response format from yes/no to what you see 
because some of the investigators wanted to try and differentiate early childhood 
trauma from later trauma. 
  
On page 2 is an experience discrimination instrument. Perhaps this could be 
adapted to be a “stuff been through” instrument…”Have any of the following 
happened to either of you since you became a couple?” (excluding the 3rd item 
about being rejected by a partner). There is also a single item about break-ups that 
might be useful. 
  
On pages 3-6 are the substance use items they used. The primary sources were 
NIDA Assist and the AUDIT-C. The “window” was changed to 60 days for the 
purposes of the MP+ study (since they assessed sexual risk using a 60-day 
window). I would use the time windows suggested in the original instruments 
(probably 30 days). 
  
From page 7 onward is the mental health section from the actual survey. That 
section asked the full CES-D. There is a short form we could replace it with, but I 
lobbied for the full CES-D in MP+ because past research had shown that the 
positive and negative affect scores differentially impacted health care uptake. It is 
followed by the General Anxiety Disorder scale, and then questions about 
medications. So, the medication questions were “set up” by the fact that they ask 
about depression symptoms and anxiety symptoms first. In Philadelphia ACE they 
ask about depression in a single item. I adapted that to create an anxiety item as 
well using language from the GAD. For the purposes of this study single questions 
might be sufficient. 
 
 
 
 
 
 

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SECTION 13: CHANGE HISTORY 
 
Version 
Date 
Description of Change 
Other Documents 
Affected 
1.0 
10/1/2019 
New Document 
-- 
1.1 
8/18/2020 
Revised Interview procedures for in-person and 
remotely 
 
Added Protocol for Participants under Emotional 
Distress (Section 7.8) 
 
1.2 
10/6/2020 
Outlined procedures for Aim 2 
 
1.3 
2/17/2021 
Added which information is necessary for RPPR 
in Section 10.3 
 
Added Appendix B on write-out of methods for 
various procedures 
 
1.4 
4/17/2021 
Added information about secondary coding and 
process of writing memos in Appendix B 
 
1.5 
5/12/2021 
Added rationale and procedures for cognitive 
interviewing in Appendix B 
 
1.6 
6/15/2021 
Expanded on cognitive interviewing procedures  
in Appendix B as well as data analysis, assigning 
ratings to each item 
 
1.7 
9/9/2021 
Expanded on cognitive interviewing procedures 
in Appendix B, namely the second and third 
rounds of interviews 
 
1.8 
10/6/2021 
Expanded on Phase 1 recruitment methods in 
Appendix B 
 
1.9 
2/7/2022 
Expanded on Phase 2 and 3 methods in Appendix 
B 
 
2.0 
6/23/2022 
Revised study timeline and biosample collection 
modalities 
 
2.1 
8/15/2022 
Amended incentive structure to make it increase 
over time (i.e., follow a graduated schedule) 
 
2.2 
11/4/2022 
Amended Phase 3 eligibility criteria to expand it 
to DYADS of Black/African American sexual and 
gender minority folks living with HIV 
 
2.3 
2/27/2023 
Amended incentive structure, procedures for 
Intervention and Control to remove any mention 
of hair 
LetSync Study Activity 
Handout (changed from 
v3 à v4 with revised 
incentive structure)  
 
 
 
 
 
 
 
 
 

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