Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening
Phase: NA
Conditions: Sexually Transmitted Diseases, Gonorrhea, Chlamydia, Syphilis, HIV
Sponsor: University of Michigan

Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial 
Sexually Transmitted Infection Screening 
NCT Number: NCT06100250 
University of Michigan Health Sciences and Behavioral Sciences Institutional 
Review Board (IRB-HSBS) ID: HUM00240181 
Study Protocol and Statistical Analysis Plan Approval Date: 4/30/2024 

1 
 
SCIENTIFIC PROTOCOL 
____________________________________________________________________________ 
 
Study Title 
Zenyth 
 
Full Study Title 
Zenyth – Feasibility and Acceptability of an MI-based Telehealth Intervention for Bacterial STI 
Screening 
 
Principal Investigator 
Akshay Sharma, MBBS, MPH, PhD 
Assistant Professor 
Department of Health Behavior and Biological Sciences 
University of Michigan School of Nursing 
akshaydr@umich.edu 
 
Co-Investigator 
Erin Bonar, PhD 
Associate Professor 
Department of Psychiatry 
University of Michigan Medical School 
erinbona@umich.edu 
 
Sponsoring Agency 
National Institutes of Health (NIH) – National Institute of Allergy and Infectious Diseases (NIAID) 
____________________________________________________________________________ 

2 
 
Section 1. Introduction 
 
a. Background 
 
In the United States (US), gay, bisexual, and other men who have sex with men living with HIV 
(GBMSM-LWH) bear a heavy burden of bacterial sexually transmitted infections (STIs) such as 
gonorrhea (GC), chlamydia (CT), and syphilis.1 National surveillance data for 2020 from the 
Centers for Disease Control and Prevention (CDC) indicate that among GBMSM-LWH who 
presented for HIV medical care during the height of the COVID-19 pandemic, GC positivity was 
14.2% (vs. 9.8% for GBMSM without HIV) and CT positivity was 6.5% (vs. 7.0% for GBMSM 
without HIV).1 Additionally, 10.4% of GBMSM-LWH were diagnosed with primary and secondary 
syphilis (vs. 5.5% of GBMSM without HIV).1 Left untreated, bacterial STIs may lead to serious 
health complications such as epididymitis, orchitis, prostatitis, seminal vesiculitis, and proctitis.2-4 
Inflammatory and ulcerative STIs can also facilitate the onward sexual transmission of HIV in the 
presence of inadequate viral suppression.5-10 For example, new syphilis infections can increase 
HIV viral loads and decrease CD4 cell counts and syphilitic ulcers can aid the passage of HIV.10 
Therefore, the acquisition of bacterial STIs by GBMSM-LWH has profound individual and public 
health implications, underscoring the need for early diagnosis and treatment. 
 
Sexually active GBMSM-LWH are recommended to be tested for GC, CT, and syphilis at least 
annually and at 3-6 month intervals if at elevated risk.11 However, bacterial STI screening rates in 
GBMSM-LWH are suboptimal.12-14 Data from the Medical Monitoring Project have revealed 
gradual increases in yearly testing for GC, CT, and syphilis among GBMSM-LWH engaged in HIV 
medical care,15 but a 2020 study reported that only 49% had been tested for GC or CT and 68% 
had been tested for syphilis.16 GC and CT infections at pharyngeal and rectal sites are often 
asymptomatic and remain undiagnosed.17-21 Urine-only GC and CT testing can miss 70-75% of 
extra-urethral GC infections and 85-89% of extra-urethral CT infections.22, 23 Recent estimates for 
the proportions of GBMSM-LWH being tested for extra-urethral GC or CT annually during routine 
clinic visits have ranged from 4-20%.16, 24 Provider-related barriers to offering testing include 
limited time, fear of appearing judgmental, discomfort around discussing sexual behaviors, and 
being unsure of current testing guidelines.25, 26 Patient-related barriers include perceptions of low 
risk for bacterial STIs, being unaware of the importance of triple-site GC and CT testing (i.e., using 
urine samples, throat swabs, and rectal swabs), fear of stigmatization by providers, and concerns 
about privacy and confidentiality.27-29 Novel approaches are needed to reduce impediments to 
bacterial STI screening experienced by GBMSM-LWH in the US. 
 
Home specimen self-collection has increasingly been used to test for bacterial STIs in studies 
conducted with diverse populations.30-39 Self-collected specimens for bacterial STI screening are 
equally valid and reliable as those collected by a clinician.40-53 Telehealth has also demonstrated 
promise in managing mental health54, 55 and increasing antiretroviral therapy (ART) adherence in 
people living with HIV.56-61 Only few studies have combined home specimen self-collection with 
live audio/video (AV) conferencing, all of which have been restricted to people without HIV.62-67 
None have focused on GBMSM-LWH or incorporated motivational interviewing (MI), a client-
centered, strengths-based counseling approach that seeks to support individuals towards positive 
behavioral change.68, 69 Integrating home specimen self-collection from different anatomical sites 
of possible exposure with MI delivered via live AV conferencing might offer a unique solution to 
engage GBMSM-LWH in bacterial STI screening. MI-guided discussions have the potential to 
increase participants’ knowledge of bacterial STIs, enhance their intrinsic motivation to protect 
themselves and their sex partners, improve their self-efficacy for specimen self-collection, and 
problem-solve barriers to seeking treatment (if warranted) and repeat testing. 
 

3 
 
b. Objectives 
 
To investigate the feasibility and acceptability of a novel MI-based telehealth intervention to 
engage GBMSM-LWH in GC, CT, and syphilis testing, we propose to conduct a 2-year sequential 
explanatory mixed-methods study.70, 71 Our intervention is a package of 3 components: (i) a pre-
test live AV conferencing session involving an MI-guided discussion to elicit awareness of 
bacterial STIs and fill any knowledge gaps, bolster the perceived importance of regularly testing 
for GC, CT, and syphilis, and improve self-efficacy for specimen self-collection, (ii) self-collecting 
at home and returning by mail a urine sample (for GC and CT testing), a throat swab (for GC and 
CT testing), a rectal swab (for GC and CT testing), and a finger-stick blood sample (for syphilis 
testing), and (iii) a post-test live AV conferencing session involving an MI-guided discussion to 
prepare participants for receiving test results and formulate personalized action plans for seeking 
treatment (if warranted) and repeat testing. Potential increases in participants’ knowledge of GC, 
CT, and syphilis will be assessed by comparing their responses to the same set of questions on 
these STIs included in the baseline survey (to be administered before intervention delivery) and 
the satisfaction survey (to be administered after intervention delivery). 
 
c. Specific aims 
 
Guided by the main constructs of the Information-Motivation-Behavioral skills (IMB) model72, 73 
and the Theoretical Framework of Acceptability (TFA) of health interventions,74 our specific aims 
are as follows: 
 
Aim 1: Explore the feasibility and acceptability of a telehealth intervention for bacterial STI testing 
among 75 GBMSM-LWH in the US involving (i) a pre-test MI-guided live AV conferencing session, 
(ii) home specimen self-collection and return for GC, CT, and syphilis testing, and (iii) a post-test 
MI-guided live AV conferencing session. 
 
Aim 2: Elucidate attitudes, facilitators, and barriers related to engaging in each intervention 
component via in-depth interviews with a purposive subsample of 20 participants who complete 
progressively smaller subsets of the pre-test session, specimen return for bacterial STI testing, 
and the post-test session to refine the intervention. 
____________________________________________________________________________ 
 
Section 2. Participant recruitment 
 
a. Sample size 
 
Pilot studies are well-suited to conducting exploratory research,75, 76 for which sample sizes 
between 25 to 150 have been recommended.77, 78 In Phase 1, we will enroll 75 GBMSM-LWH to 
collect data on the feasibility and acceptability of the intervention. Sample sizes between 10 to 30 
have been recommended for in-depth interviews.79, 80 In Phase 2, we estimate that collecting 
qualitative data on attitudes, facilitators, and barriers from a subsample of 20 participants will be 
sufficient to reach information power81 and thematic saturation.82 
 
b. Primary recruitment strategy – Social media advertising 
 
Participants will primarily be recruited via social media advertising. According to a 2021 survey 
by the Pew Research Center, 7 in 10 Americans use social media.83 Current internet usage is at 
93% for non-Hispanic whites, 91% for non-Hispanic blacks, and 95% for Hispanics.84 Smartphone 
usage has also increased, with 85% of non-Hispanic whites, 83% of non-Hispanic blacks, and 

4 
 
85% of Hispanics owning a smartphone in 2021.85 Given the common use of social media by 
GBMSM to find sex partners,86-91 we will enroll 75 GBMSM-LWH via advertisements placed on 
mobile dating apps (e.g., Grindr, Scruff) and social networking sites (e.g., Facebook, Instagram) 
to receive the intervention. Our goal is to enroll 25 non-Hispanic black participants, 20 Hispanic 
participants, 25 non-Hispanic white participants, and 5 participants of other races/ethnicities, 
mirroring the current racial/ethnic distribution of GBMSM-LWH in the US.92 Our advertisements 
will include our study’s name and logo, the University of Michigan logo, images of racially and 
ethnically diverse men holding hands, cuddling, or kissing, and call-to-action text. Similar to PI 
Sharma’s recently completed Project Caboodle (HUM00153673), which successfully enrolled a 
diverse sample of GBMSM from across the US,93-96 we will monitor the racial/ethnic distribution 
of our sample on an ongoing basis and tailor our advertising efforts to achieve our goal of diversity. 
For example, if we need to recruit additional non-Hispanic black participants, we will focus our 
social media advertising in US metropolitan areas that have large black populations (e.g., Atlanta, 
Chicago, Philadelphia). 
 
Individuals who click on our social media advertisements will be directed to our study’s landing 
page programmed in Qualtrics that will provide a brief overview of the intervention. Those who 
are not interested can exit by closing their browser. Those who are interested can click on a link 
to the informed consent form that will include a detailed description of all study activities including 
(i) completing an eligibility screener, (ii) providing contact information to receive study 
communications and a specimen self-collection box if eligible, (iii) completing a baseline survey, 
each intervention component, and a satisfaction survey in Phase 1, and (iv) completing an in-
depth interview in Phase 2 if selected. Individuals will have the option to download a copy of the 
informed consent form for their records. Because they will be using their own computers, tablets, 
or smartphones, informed consent will be obtained by them clicking on “I understand what this 
research study is about, and my questions so far have been answered. I agree to participate in 
this study” or “I do not wish to participate in this research study”. The consent response, date, and 
IP address of the device will be recorded in Qualtrics. To minimize the potential for fraudulent 
activity, we will include a CAPTCHA verification question, enable the feature to prevent multiple 
submissions from the same IP address, and manually review the IP addresses on a regular basis 
to ensure that they are located within the US. 
 
Individuals who do not consent will be directed to a terminal page with a link to the CDC’s website 
on STIs so that they can learn more about protecting themselves and their sex partners. Those 
who consent will proceed to an eligibility screener that will assess whether they meet our study’s 
inclusion criteria. Individuals who are not eligible will be directed to a terminal page with a link to 
the CDC’s website on STIs so that they can learn more about protecting themselves and their sex 
partners. Those who are eligible will proceed to a contact information form that will request them 
to provide their full name, email address, and mobile phone number to receive study 
communications and their mailing address to receive a specimen self-collection box. Individuals 
who do not provide their contact information will be directed to a terminal page with a link to the 
CDC’s website on STIs so that they can learn more about protecting themselves and their sex 
partners. Those who provide their contact information will be informed that a study team member 
will contact them to verify their full name, email address, mobile phone number, and mailing 
address. Individuals who do not provide valid contact information will be excluded from further 
consideration and their personally identifiable information will be deleted within 4 weeks. 
Individuals who cannot read English will be informally excluded. 
 
Note: Qualtrics is approved by the University of Michigan (UM) Information and Technology 
Services (ITS) for sensitive identifiable human subjects research data regulated by the Federal 
Policy for the Protection of Human Subjects (“Common Rule”). Access to the Qualtrics account is 

5 
 
protected with a sufficiently complex password and requires Duo two-factor authentication for 
login. The data collected via the eligibility screener and the contact information form will be 
downloaded to a secure UM server. Only IRB-approved study team members, all of whom will 
have completed trainings on human subjects research protections offered by the UM Program for 
Education and Evaluation in Responsible Research and Scholarship (PEERRS), will have access 
to participants’ data on an as-needed basis. 
 
c. Inclusion criteria 
 
(i) 
Individual self-reports identifying as a man (regardless of their sex assigned at birth) 
in the eligibility screener. 
(ii) 
Individual self-reports residing in a US state or territory in the eligibility screener. 
(iii) 
Individual self-reports being physically located in a US state or territory when 
completing study activities in the eligibility screener. 
(iv) 
Individual self-reports being ≥18 years of age in the eligibility screener. 
(v) 
Individual self-reports being of legal age to provide consent for research participation 
in their US state or territory of residence in the eligibility screener. 
(vi) 
Individual self-reports having been diagnosed with HIV in the eligibility screener. 
(vii) 
Individual self-reports having any kind of condomless sex (e.g., oral, anal) with ≥2 men 
in the past year in the eligibility screener. 
(viii) 
Individual self-reports being willing to provide their contact information (full name, 
email address, mobile phone number, and mailing address) in the eligibility screener. 
(ix) 
Individual self-reports being able to participate in live AV conferencing sessions using 
an internet-connected device (e.g., computer, tablet, smartphone) in the eligibility 
screener. 
(x) 
Individual self-reports being willing to receive a box that contains kits to self-collect a 
urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing 
in the eligibility screener. 
(xi) 
Individual provides valid contact information (full name, email address, mobile phone 
number, and mailing address). 
(xii) 
Individual completes the baseline survey in order to receive the intervention. 
 
d. Exclusion criteria 
 
(i) 
Individual self-reports not identifying as a man (regardless of their sex assigned at 
birth) in the eligibility screener. 
(ii) 
Individual self-reports not residing in a US state or territory in the eligibility screener. 
(iii) 
Individual self-reports not being physically located in a US state or territory when 
completing study activities in the eligibility screener. 
(iv) 
Individual self-reports not being ≥18 years of age in the eligibility screener. 
(v) 
Individual self-reports not being of legal age to provide consent for research 
participation in their US state or territory of residence in the eligibility screener. 
(vi) 
Individual self-reports not having been diagnosed with HIV in the eligibility screener. 
(vii) 
Individual self-reports not having any kind of condomless sex (e.g., oral, anal) with ≥2 
men in the past year in the eligibility screener. 
(viii) 
Individual self-reports not being willing to provide their contact information (full name, 
email address, mobile phone number, and mailing address) in the eligibility screener. 
(ix) 
Individual self-reports not being able to participate in live AV conferencing sessions 
using an internet-connected device (e.g., computer, tablet, smartphone) in the 
eligibility screener. 

6 
 
(x) 
Individual self-reports not being willing to receive a box that contains kits to self-collect 
a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI 
testing in the eligibility screener. 
(xi) 
Individual does not provide valid contact information (full name, email address, mobile 
phone number, and mailing address). 
(xii) 
Individual does not complete the baseline survey in order to receive the intervention. 
 
e. Secondary recruitment strategy – Peer referral 
 
Individuals will be requested to share the link to our study’s landing page with anyone in their 
social network who they believe might be interested in participating. The link will be provided at 
the end of the contact information form (which will be viewed by those who consent, are eligible, 
and provide their contact information) and on the terminal page (which will be viewed by those 
who do not consent, are not eligible, or do not provide their contact information). 
____________________________________________________________________________ 
 
Section 3. Phase 1 procedures 
 
a. Baseline survey 
 
Individuals whose contact information has been verified will be assigned a randomly generated 
participant ID number (e.g., ZEN618) and be sent a link to the baseline survey programmed in 
Qualtrics (with the participant ID number included as a metadata element) that will include 
questions on the following: 
 
(i) 
Sociodemographics: Age, race and ethnicity, educational level, employment status, 
income level, health insurance coverage, sexual orientation, gender identity, sex 
assigned at birth, and relationship status.97 
(ii) 
Bacterial STI-related knowledge: 22-item scale to assess participant’s knowledge of 
GC, CT, and syphilis.98 
(iii) 
Awareness and use of home STI tests and commercial telehealth services: Binary 
measures of whether the participant has heard of and used home STI tests sold online 
by companies and commercial telehealth services that offer STI treatment. 
(iv) 
Attitudes around “safer” sex: 13-item subscale from the Sexual Risks Scale to assess 
the participant’s attitudes around “safer” sex.99 
(v) 
Perceived risk of bacterial STIs: Risk perception ruler from 1 (Extremely unlikely) to 10 
(Extremely likely) to assess the participant’s perceived likelihood of contracting a 
bacterial STI in the next 12 months.98 
(vi) 
“Safer” sex self-efficacy: 7-item scale to assess the participant’s confidence in 
practicing “safer” sex.100 
(vii) 
Specimen self-collection self-efficacy: 5-point Likert items to assess the participant’s 
perceived ease of self-collecting each type of specimen. 
(viii) 
History of HIV testing and management: Timing of first positive HIV test, location of 
test, receipt of HIV medical care, ART use, HIV viral load, and CD4 count.97, 101-103 
(ix) 
History of bacterial STI testing and management: Frequency of testing for GC, CT, 
and syphilis, timing of latest tests, location of latest tests, types of specimens provided, 
test results, and receipt of treatment. 
(x) 
Relationship and partner characteristics: Relationship duration and type, partner’s HIV 
status and use of ART or pre-exposure prophylaxis (PrEP), and partner’s history of 
testing for GC, CT, and syphilis. 

7 
 
(xi) 
Sexual behaviors: Engagement in oral, anal, and vaginal or frontal sex in the past 12 
months, and condom use. 
(xii) 
History of substance use: Tobacco, alcohol, prescription medication, and other 
substance use using NIDA’s TAPS screening tool.104 
 
The baseline survey should take approximately 1 hour to complete, and it will allow participants 
to skip questions or indicate that they prefer not to answer a question. If participants do not 
complete the baseline survey within 1 week, up to 7 reminders will be sent at regular intervals 
over the next 7 weeks. The reminders will inform participants that non-completion of the baseline 
survey by the end of 8 weeks suggests that they are no longer interested and that they will not be 
able to proceed in the study after that time has elapsed (unless they request an extension). 
Participants who do not complete the baseline survey by the end of 8 weeks will be excluded from 
further consideration and their personally identifiable information will be deleted within 4 weeks. 
Those who complete the baseline survey will receive a $40 Amazon e-gift card and be considered 
“fully enrolled” participants (i.e., they will proceed to receive the intervention). 
 
Note: Qualtrics is approved by the UM ITS for sensitive identifiable human subjects research data 
regulated by the “Common Rule”. Access to the Qualtrics account is protected with a sufficiently 
complex password and requires Duo two-factor authentication for login. The data collected via 
the baseline survey will be downloaded to a secure UM server. Only IRB-approved study team 
members, all of whom will have completed trainings on human subjects research protections 
offered by the UM PEERRS, will have access to participants’ data on an as-needed basis. 
 
b. Intervention component I – Pre-test MI-guided live AV conferencing session 
 
Once participants complete the baseline survey, they will be contacted to schedule a 30 min pre-
test session to be conducted over Zoom with an interventionist who will have received training 
from PI Sharma and Co-I Bonar. Time slots will be offered in all US time zones and be flexible to 
meet their individual circumstances. If participants do not schedule a session within 1 week, up 
to 7 reminders will be sent at regular intervals over the next 7 weeks. The reminders will inform 
participants that not scheduling a session by the end of 8 weeks suggests that they are no longer 
interested and that they will not be able to proceed to the next intervention component (unless 
they request an extension). Once a time is confirmed, participants will be sent a password-
protected Zoom link. They will be advised to join the session from a private location and be offered 
the option to reschedule if the original time no longer works or if they anticipate being in a situation 
where their privacy may be compromised. 
 
Pre-test sessions will be conducted from a private location and participants will have the option 
to mute their own video (i.e., use only audio from their end) if they prefer to remain discreet. 
Sessions will be audio-recorded using a digital voice recorder to allow for the ongoing monitoring 
of intervention fidelity. No audio or video will be recorded in Zoom. The audio recordings will be 
transferred to a secure UM server immediately after the session, and then deleted from the digital 
voice recorder. The recordings will not be transcribed, but IRB-approved study team members 
will listen to them on an ongoing basis to identify and discuss areas of potential improvement. 
The recordings will be deleted from the UM server upon study completion (i.e., when all study-
related data have been collected and checked for accuracy and completeness). During the 
session, the interventionist will follow procedures described in the pre-test intervention outline. 
The session will begin with a conversation to initiate a collaborative partnership and build rapport 
(MI process: Engaging). Next, the interventionist will elicit participants’ awareness of the 
epidemiology and transmission of bacterial STIs among GBMSM-LWH, provide new information 
to fill any knowledge gaps or address misconceptions around triple-site GC and CT or syphilis 

8 
 
testing, and elicit reactions to this new information. Open-ended questioning and reflective 
listening will be used to gain a better understanding of participants’ perspectives on their own 
sexual risk and protective behaviors (MI process: Focusing). Subsequently, the interventionist will 
explore their history of bacterial STI testing, their motivations for testing or reasons for not testing, 
and their perceived benefits and challenges of regular testing (MI process: Evoking). To improve 
self-efficacy for specimen self-collection, the interventionist will demonstrate the contents of the 
specimen self-collection box, review step-by-step instructions for self-collecting each type of 
specimen, and address any questions or concerns. Participants who express an intent to test with 
their own provider or at a clinic will be encouraged to pursue that route. The session will end by 
summarizing the participants’ strengths and goals with respect to protecting their own and their 
partners’ sexual health and discussing their plans to test for GC, CT, and syphilis over the next 
month (MI process: Planning). 
 
Participants who do not schedule or attend the pre-test session will be deemed not interested in 
this intervention component (unless they have contacted us to reschedule). Those who complete 
the session will proceed to the next intervention component. Although participants who express 
an intent to test with their own provider or at a clinic will be encouraged to pursue that route, they 
will still proceed to the next intervention component (i.e., they will be shipped a specimen self-
collection box) upon completing the pre-test session unless they choose to withdraw from the 
study. 
 
Note: Zoom is approved by the UM ITS for sensitive identifiable human subjects research data 
regulated by the “Common Rule”. Access to the Zoom account is protected with a sufficiently 
complex password and requires Duo two-factor authentication for login. Only IRB-approved study 
team members, all of whom will have completed trainings on human subjects research protections 
offered by the UM PEERRS, will have access to participants’ data on an as-needed basis. 
 
c. Intervention component II – Home specimen self-collection and return 
 
Once participants complete the pre-test session, they will be shipped a box in plain, unmarked 
packaging that contains kits to self-collect a urine sample, a throat swab, a rectal swab, and a 
finger-stick blood sample. Boxes will be assembled at the University of Michigan School of 
Nursing (UMSN) using specimen self-collection kits supplied by the Emory University Clinical 
Virology Research Lab (CVRL) located at Woodruff Memorial Research Building Room 7007, 101 
Woodruff Circle, Atlanta, Georgia, 30322. CVRL has conducted HIV, GC, CT, or syphilis testing 
for >12 national studies with GBMSM,105 including PI Sharma’s recently completed Project 
Caboodle (HUM00153673).93-96 The shipment and delivery of boxes to participants will be tracked 
by a study team member on a regular basis. Each box will include the following: 
 
(i) 
General information sheet: This sheet will provide participants with a brief description 
of the box contents and information on how to package and return their self-collected 
specimens to CVRL in Atlanta, Georgia. It will also instruct participants to not include 
any sort of personally identifiable information (e.g., full name, mailing address) on the 
lab requisition form. 
(ii) 
Urine sample self-collection kit: This kit will include materials for participants to self-
collect a urine sample of 3 milliliters (which is less than 1 teaspoon of urine). These 
include a collection cup, a transfer pipette, and a transport tube containing a buffer to 
stabilize DNA until specimen preparation. The transport tube will be affixed with a 
unique specimen ID number (e.g., URN327) to enable specimen identification upon 
return and to document GC and CT test results. The kit will also include written 
instructions with color images and a QR code that links to video instructions. 

9 
 
Participants will be instructed to not urinate for at least 1 hour before urine collection, 
collect the first part of their urine stream into the collection cup up to the marked line, 
use the transfer pipette to transfer urine from the collection cup to the transport tube 
and fill it between the minimum and maximum lines, secure the lid of the transport 
tube, place the transport tube in the plastic biohazard bag, and dispose of the 
collection cup and the transfer pipette in their home garbage. 
(iii) 
Throat swab self-collection kit: This kit will include materials for participants to self-
collect a throat swab. These include a sterile specimen collection swab and a transport 
tube containing a buffer to stabilize DNA until specimen preparation. The transport 
tube will be affixed with a unique specimen ID number (e.g., THR327) to enable 
specimen identification upon return and to document GC and CT test results. The kit 
will also include written instructions with color images and a QR code that links to video 
instructions. Participants will be instructed to open their mouth wide in front of a mirror, 
wipe the specimen collection swab along the back of their throat on both sides several 
times and then remove, insert the swab into the transport tube and break off its top 
portion, secure the lid of the transport tube, place the transport tube in the plastic 
biohazard bag, and dispose of the swab wrapper and the unused portion of the swab 
in their home garbage. 
(iv) 
Rectal swab self-collection kit: This kit will include materials for participants to self-
collect a rectal swab. These include a sterile specimen collection swab, two lubricant 
packets, and a transport tube containing a buffer to stabilize DNA until specimen 
preparation. The transport tube will be affixed with a unique specimen ID number (e.g., 
REC327) to enable specimen identification upon return and to document GC and CT 
test results. The kit will also include written instructions with color images and a QR 
code that links to video instructions. Participants will be instructed to lubricate their 
rectum, gently insert the specimen collection swab into their rectum about 1.5 inches, 
gently move the swab in a circular motion and then remove, insert the swab into the 
transport tube and break off its top portion, secure the lid of the transport tube, place 
the transport tube in the plastic biohazard bag, and dispose of the swab wrapper and 
the unused portion of the swab in their home garbage. 
(v) 
Finger-stick blood sample self-collection kit: This kit will include materials for 
participants to self-collect a finger-stick blood sample of 500 microliters (which is equal 
to 10 drops of blood). These include an alcohol wipe, two safety lancets, two gauze 
pads, two bandages, and a transport tube containing a buffer to stabilize DNA until 
specimen preparation. The transport tube will be affixed with a unique specimen ID 
number (e.g., BLD327) to enable specimen identification upon return and to document 
syphilis test results. The kit will also include written instructions with color images and 
a QR code that links to video instructions. Participants will be instructed to clean their 
middle or ring finger from their non-dominant hand using the alcohol wipe, stimulate 
blood flow by shaking their hand below their waist, prick their finger using the safety 
lancet, massage from the base of their finger using a squeeze-release motion, wipe 
away the first drop of blood with the gauze pad, wipe subsequent drops of blood onto 
the inside of the transport tube and fill it to top line, wipe the remaining blood off their 
finger using the gauze pad, apply the bandage, secure the lid of the transport tube, 
gently mix the blood in the transport tube by inverting it and moving it around, place 
the transport tube in the plastic biohazard bag, and dispose of the alcohol wipe, the 
gauze pad(s), and the wrappers in their home garbage. The Occupational Safety and 
Health Administration’s Bloodborne Pathogens Standard (29 CFR 1910.1030(b)) as 
amended pursuant to the 2000 Needlestick Safety and Prevention Act defines 
regulated waste as “liquid or semi-liquid blood or other potentially infectious materials 
(OPIM); contaminated items that would release blood or OPIM in a liquid or semi-liquid 

10 
 
state if compressed; items that are caked with dried blood or OPIM and are capable 
of releasing these materials during handling; contaminated sharps; and pathological 
and microbiological wastes containing blood or OPIM”. The amount of blood or OPIM 
released from a finger-stick is not enough to saturate the gauze pads to the point of 
caking them or releasing these materials if compressed during handling. Unsaturated 
gauze pads do not meet the definition of regulated waste and can therefore be placed 
in one’s home garbage for disposal. The safety lancets being provided to participants 
are sterile, contact-activated, single-use devices that enable the collection of up to 500 
microliters of blood from a single puncture. Their contact-activation design facilitates 
a consistent puncture depth and minimizes the likelihood of having to repeat the 
puncture. They consist of a stainless-steel needle/blade in a thick plastic casing that 
retracts automatically and permanently after the puncture. Participants will be 
instructed to follow procedures described by SafeNeedleDisposal.org, the nation’s 
leading information resource for home-generated medical sharps disposal, to safely 
dispose of their used lancet(s) in their locality. 
(vi) 
Plastic biohazard bag: This bag will be used by participants to enclose the transport 
tubes containing their self-collected specimens. 
(vii) 
Lab requisition form: This form will be used by participants to write down the date on 
which they self-collected their specimens and the unique specimen ID numbers affixed 
to the transport tubes. 
(viii) 
Prepaid bubble mailer with a category B sticker: This bubble mailer will be used by 
participants to return their self-collected specimens and the completed lab requisition 
form to CVRL. 
 
Participants will be requested to self-collect their specimens, enclose the transport tubes in the 
plastic biohazard bag, complete the lab requisition form, place the bag and the form in the prepaid 
bubble mailer, and return the bubble mailer to CVRL. Specimen return will be voluntary, and 
participants can choose to return all, some, or none of the four specimens. However, if no 
specimens have been received by CVRL within 3 weeks of box delivery (which will be confirmed 
by contacting lab personnel at CVRL and providing them the unique specimen ID numbers), up 
to 5 reminders will be sent at regular intervals over the next 5 weeks. The reminders will inform 
participants that not returning any specimens by the end of 8 weeks suggests that they are no 
longer interested and that they will not be able to proceed to the next intervention component 
(unless they request an extension). The reminders will also inform participants that any specimens 
received by CVRL after 8 weeks will not be tested and will be destroyed (unless they have 
requested an extension). 
 
Urine samples, throat swabs, and rectal swabs returned by participants will be tested for GC and 
CT using the Abbott Real Time PCR Assay. Finger-stick blood samples returned by participants 
will be tested for syphilis using the ASI rapid plasma reagin (RPR) Card Test reported as a titer 
of antibodies. If the screening test for syphilis is reactive (i.e., a titer of ≥1:8), it will be followed by 
a confirmatory test (i.e., a treponemal enzyme immunoassay to detect IgG antibodies) at the 
Emory Medical Laboratory (EML) which is located in the same building as CVRL. Both CVRL and 
EML are certified under CLIA (Clinical Laboratory Improvement Amendments). CLIA regulations 
establish quality standards for lab testing performed on specimens from humans. Any specimens 
returned by participants within 8 weeks will be destroyed immediately after lab testing. Any 
specimens returned after 8 weeks will be destroyed without being tested (unless they are from 
participants who have requested an extension). Lab personnel at CVRL or EML will only be able 
to connect the participants’ test results to the unique specimen ID numbers affixed to the different 
transport tubes. They will not have access to either the participant ID numbers or to the 
participants’ contact information (full name, email address, mobile phone number, and mailing 

11 
 
address). Only IRB-approved study team members at the UM will have access to the data on 
which unique specimen ID numbers are assigned to a particular participant ID number, and which 
participant ID number corresponds to a particular participant’s contact information. These data 
will be stored in a password-protected file on a secure UM server. Before sending a link to the 
baseline survey to an individual whose contact information has been verified, a study team 
member will update the file containing participants’ contact information with a corresponding 
participant ID number (e.g., ZEN618). Before shipping a specimen self-collection box to this 
participant, a study team member will further update the file with information on which unique 
specimen ID numbers affixed to the different transport tubes (e.g., URN327, THR327, REC327, 
BLD327) are assigned to their participant ID number. This file will be deleted from the UM server 
upon study completion (i.e., when all study-related data have been collected and checked for 
accuracy and completeness). GC, CT, and syphilis test results will be shared with us by lab 
personnel at CVRL via a secure Dropbox folder and will be stored on a secure UM server. Once 
we receive all the test results, lab personnel at CVRL will no longer have access to the folder. 
 
Participants who do not return any specimens by the end of 8 weeks will be deemed not interested 
in this intervention component (unless they have requested an extension). Those who return 
some or all specimens within 8 weeks will proceed to the next intervention component. 
 
Note: Dropbox is approved by the UM ITS for sensitive identifiable human subjects research data 
regulated by the “Common Rule”. Access to the Dropbox account is protected with a sufficiently 
complex password and requires Duo two-factor authentication for login. Only IRB-approved study 
team members, all of whom will have completed trainings on human subjects research protections 
offered by the UM PEERRS, will have access to participants’ data on an as-needed basis. 
 
d. Intervention component III – Post-test MI-guided live AV conferencing session 
 
Once we receive participants’ GC, CT, and syphilis test results back from CVRL (approximately 
2 weeks after they return their specimens), they will be contacted to schedule a 30 min post-test 
session to be conducted over Zoom with the same interventionist who conducted the pre-test 
session, whenever possible. Time slots will be offered in all US time zones and be flexible to meet 
their individual circumstances. If participants do not schedule a session within 1 week, up to 7 
reminders will be sent at regular intervals over the next 7 weeks. The reminders will inform 
participants that not scheduling a session by the end of 8 weeks suggests that they are no longer 
interested (unless they request an extension). Once a time is confirmed, participants will be sent 
a password-protected Zoom link. They will be advised to join the session from a private location 
and be offered the option to reschedule if the original time no longer works or if they anticipate 
being in a situation where their privacy may be compromised. 
 
Post-test sessions will be conducted from a private location and participants will have the option 
to mute their own video (i.e., use only audio from their end) if they prefer to remain discreet. 
Sessions will be audio-recorded using a digital voice recorder to allow for the ongoing monitoring 
of intervention fidelity. No audio or video will be recorded in Zoom. The audio recordings will be 
transferred to a secure UM server immediately after the session, and then deleted from the digital 
voice recorder. The recordings will not be transcribed, but IRB-approved study team members 
will listen to them on an ongoing basis to identify and discuss areas of potential improvement. 
The recordings will be deleted from the UM server upon study completion (i.e., when all study-
related data have been collected and checked for accuracy and completeness). During the 
session, the interventionist will follow procedures described in the post-test intervention outline. 
The session will incorporate the four MI processes of Engaging, Focusing, Evoking, and Planning. 
It will begin with a conversation to initiate a collaborative partnership and build rapport. The 

12 
 
interventionist will discuss the meaning of negative and positive bacterial STI test results and 
assess participants’ emotional response to each possible outcome via open-ended questioning 
and reflective listening. Test results will be delivered via screen sharing the lab test results form 
(that will only include the unique specimen ID numbers and corresponding test results). The 
interventionist will have completed online training courses on GC, CT, and syphilis offered by the 
Michigan Department of Health and Human Services (MDHHS). For participants receiving 
negative GC, CT, and syphilis test results, the interventionist will use affirmations to acknowledge 
their engagement in protective behaviors and jointly formulate a plan to prevent the acquisition of 
bacterial STIs. For participants receiving a positive GC, CT, or syphilis test result, the 
interventionist will offer emotional support, discuss the benefits of timely antibiotic treatment, and 
jointly formulate a linkage to care plan. Barriers to accessing treatment (e.g., lack of insurance, 
limited personal transportation, reluctance to visit one’s own provider) will be elicited and the 
interventionist will work with participants to find practical solutions. For example, if someone lacks 
insurance, screen sharing will be used to give information on local STI clinics that provide free or 
low-cost services identified using site locators on the CDC’s “GetTested: National HIV, STD, and 
Hepatitis Testing” and Planned Parenthood’s “STD Testing, Treatment & Vaccines” websites. If 
someone has limited personal transportation, the interventionist will assist in creating a commute 
plan that uses public transportation options. If someone is reluctant to visit their own provider, the 
interventionist will assist in finding other STI clinics or identifying commercial telehealth services 
that offer STI treatment (e.g., GoodMDs, PlushHealth, CallonDoc). Participants will be 
encouraged to notify their sex partners of their positive test results so that they can seek testing. 
Open-ended questioning and reflective listening will be used to engage them in a discussion on 
sexual risk reduction. Next, elicit-provide-elicit will be used to find out what participants already 
know about the current national recommendations for bacterial STI testing among GBMSM and 
to fill any knowledge gaps or address misconceptions around the recommended frequency of 
testing. The interventionist will also explore whether and how home STI tests sold online by 
companies (e.g., NURX, myLAB Box, LetsGetChecked) might fit into the participants’ testing 
routines. The session will end by reviewing the participants’ personalized action plans formulated 
based on their test results and summarizing their strengths and goals with respect to reducing 
sexual risk behaviors and regularly testing for bacterial STIs. After the session, a copy of the lab 
test results form will also be shared with participants via a secure Dropbox folder that is only 
accessible to them and the study team members. The folder will also include a supplemental 
information sheet on using site locators on the CDC’s “GetTested: National HIV, STD, and 
Hepatitis Testing” and Planned Parenthood’s “STD Testing, Treatment & Vaccines” websites to 
identify local STI clinics to seek treatment (if warranted) and repeat testing. The link to the folder 
will expire after 4 weeks and the folder will be deleted, following which participants will need to 
contact us to obtain a new link. 
 
For participants receiving a positive GC, CT, or syphilis test result, a study team member will 
review their state and local statutory reporting requirements and procedures and make up to 3 
attempts to notify the relevant public health authorities. Reporting of these bacterial STIs can be 
performed without providing isolates. Participants’ contact information will be reported. This 
notification may result in participants being contacted by their public health authorities for follow 
up and possible contact tracing. A study team member will also follow up via phone at 2 weeks 
and at 4 weeks to determine their treatment status. During each of these interactions, the study 
team member will complete a case report form programmed in Qualtrics documenting whether 
the participant has initiated treatment, completed treatment, has not yet initiated treatment but 
has made an appointment with a provider, or has not yet made an appointment with a provider. 
Those who have not yet made an appointment with a provider will be encouraged to do so as 
soon as possible and offered additional assistance as requested. The data entered into the case 
report forms will be downloaded to a secure UM server. 

13 
 
 
Participants who do not schedule or attend the post-test session will be deemed not interested in 
this intervention component (unless they have contacted us to reschedule). However, a copy of 
the lab test results form and the supplemental information sheet on using site locators to identify 
local STI clinics will be shared with these participants via a secure Dropbox folder that is only 
accessible to them and the study team members. The link to the folder will expire after 4 weeks 
and the folder will be deleted, following which participants will need to contact us to obtain a new 
link. 
 
Note: Qualtrics, Zoom, and Dropbox are approved by the UM ITS for sensitive identifiable human 
subjects research data regulated by the “Common Rule”. Access to the Qualtrics, Zoom, and 
Dropbox accounts is protected with a sufficiently complex password and requires Duo two-factor 
authentication for login. Only IRB-approved study team members, all of whom will have completed 
trainings on human subjects research protections offered by the UM PEERRS, will have access 
to participants’ data on an as-needed basis. 
 
e. Satisfaction survey 
 
Upon completion of the intervention delivery, all 75 “fully enrolled” participants (regardless of their 
level of engagement in the pre-test session, specimen return for bacterial STI testing, and the 
post-test session) will be sent a link to the satisfaction survey programmed in Qualtrics (with the 
participant ID number included as a metadata element) that will include questions on the following: 
 
(i) 
Pre-test live AV conferencing session experience: 4-item subscale from the Telehealth 
Usability Questionnaire to assess the participant’s quality of interaction with the 
interventionist,106 12-item Counselor Rating Form Short to assess the participant’s 
perceptions of the interventionist,107 5-point Likert items to assess the participant’s 
satisfaction with, willingness to repeat, and likelihood to recommend the session. 
(ii) 
Urine sample self-collection experience: 5-point Likert items to assess the participant’s 
experience with, willingness to repeat, and likelihood to recommend self-collection.66 
(iii) 
Throat swab self-collection experience: 5-point Likert items to assess the participant’s 
experience with, willingness to repeat, and likelihood to recommend self-collection.66 
(iv) 
Rectal swab self-collection experience: 5-point Likert items to assess the participant’s 
experience with, willingness to repeat, and likelihood to recommend self-collection.66 
(v) 
Finger-stick blood sample self-collection experience: 5-point Likert items to assess the 
participant’s experience with, willingness to repeat, and likelihood to recommend self-
collection.66 
(vi) 
Specimen packaging and return experience: 5-point Likert items to assess the 
participant’s experience with packaging and returning specimens. 
(vii) 
Post-test live AV conferencing session experience: 4-item subscale from the 
Telehealth Usability Questionnaire to assess the participant’s quality of interaction with 
the interventionist,106 12-item Counselor Rating Form Short to assess the participant’s 
perceptions of the interventionist,107 5-point Likert items to assess the participant’s 
satisfaction with, willingness to repeat, and likelihood to recommend the session. 
(viii) 
Bacterial STI-related knowledge: 22-item scale to assess the participant’s knowledge 
of GC, CT, and syphilis98 for comparison with the baseline survey responses. 
(ix) 
Likelihood of testing for bacterial STIs in the future: 5-point Likert items to assess the 
participant’s likelihood of testing for bacterial STIs at least annually and likelihood of 
using home STI tests sold online by companies. 
 

14 
 
The satisfaction survey should take approximately 30 min to complete, and it will allow participants 
to skip questions or indicate that they prefer not to answer a question. If participants do not 
complete the satisfaction survey within 1 week, up to 7 reminders will be sent at regular intervals 
over the next 7 weeks. The reminders will inform participants that non-completion of the 
satisfaction survey by the end of 8 weeks suggests that they are no longer interested (unless they 
request an extension). Those who complete the satisfaction survey will receive a $20 Amazon e-
gift card. 
 
Note: Qualtrics is approved by the UM ITS for sensitive identifiable human subjects research data 
regulated by the “Common Rule”. Access to the Qualtrics account is protected with a sufficiently 
complex password and requires Duo two-factor authentication for login. The data collected via 
the satisfaction survey will be downloaded to a secure UM server. Only IRB-approved study team 
members, all of whom will have completed trainings on human subjects research protections 
offered by the UM PEERRS, will have access to participants’ data on an as-needed basis. 
____________________________________________________________________________ 
 
Section 4. Phase 2 procedures 
 
To gain a deeper understanding of attitudes, facilitators, and barriers related to engaging in each 
component of the intervention, we will conduct in-depth interviews with a subsample of 20 
participants. Purposive sampling will be used to select a mix of participants who complete 
progressively smaller subsets of the pre-test session, specimen return for bacterial STI testing, 
and the post-test session.108  
 
Participants will be contacted to schedule a 1-hour interview with a study team member to be 
conducted over Zoom or phone (depending upon their preference). Time slots will be offered in 
all US time zones and be flexible to meet their individual circumstances. If participants do not 
schedule an interview within 1 week, up to 7 reminders will be sent at regular intervals over the 
next 7 weeks. The reminders will inform participants that not scheduling an interview by the end 
of 8 weeks suggests that they are no longer interested (unless they request an extension). 
Participants who prefer being interviewed over Zoom will be sent a password-protected Zoom 
link. They will be advised to join the interview from a private location and be offered the option to 
reschedule if the original time no longer works or if they anticipate being in a situation where their 
privacy may be compromised. 
 
Interviews will be conducted from a private location and participants on Zoom will have the option 
to mute their own video (i.e., use only audio from their end) if they prefer to remain discreet. 
Interviews will be audio-recorded using a digital voice recorder to allow for verbatim transcription. 
No audio or video will be recorded in Zoom. The audio recordings will be transferred to a secure 
UM server immediately after the interview, and then deleted from the digital voice recorder. During 
the interview, the study team member will ask participants open-ended questions outlined in the 
semi-structured in-depth interview guide. Informed by the TFA of health interventions74, the 
interviews will focus on a range of participants’ experiences including factors influencing their 
attendance (e.g., discuss specimen self-collection procedures, receive bacterial STI test results) 
or non-attendance (e.g., concerns about session length, scheduling conflicts) of the pre-test or 
the post-test sessions, and reasons for returning specimens (e.g., confirm bacterial STI status, 
limited access to testing) or choosing not to return specimens (e.g., lack of confidence, preference 
for clinic-based testing). The audio recordings will be transcribed by IRB-approved study team 
members, all of whom will have completed trainings on human subjects research protections 
offered by the UM PEERRS. Each transcript will only be connected to the participant ID number 
and saved on a secure UM server. The recordings will be deleted from the UM server upon study 

15 
 
completion (i.e., when all study-related data have been collected and checked for accuracy and 
completeness). Only IRB-approved study team members will have access to participants’ data on 
an as-needed basis. 
 
Participants who do not schedule or attend the interview will be deemed not interested (unless 
they have contacted us to reschedule). Those who attend the interview will receive a $40 Amazon 
e-gift card. 
____________________________________________________________________________ 
 
Section 5. Data analyses 
 
a. Phase 1 analyses 
 
Descriptive statistics (e.g., means, medians and ranges for continuous variables, counts and 
proportions for categorical variables) and progression ratios (i.e., proportions who sequentially 
progress through different intervention components) will be calculated using software for 
quantitative data analysis (e.g., SAS, Excel). Intervention feasibility outcomes include the number 
of participants who (i) schedule a pre-test session, (ii) join the pre-test session within 15 min of 
the start time, (iii) return each type of specimen, (iv) provide specimens of adequate quality for 
lab testing, (v) schedule a post-test session, and (vi) join the post-test session within 15 min of 
the start time. Intervention acceptability outcomes include (i) satisfaction with the different 
intervention components, (ii) willingness to repeat the different intervention components, (iii) 
willingness to recommend the different intervention components to friends or sex partners, (iv) 
quality of interactions with and perception of the interventionist, and (v) comparison of bacterial 
STI testing experience in the study with the last testing experience. Potential impact of the 
intervention on IMB model constructs will be assessed by calculating (i) improvement in bacterial 
STI-related knowledge, (ii) willingness to test for bacterial STIs at least annually, and (iii) 
improvement in self-efficacy for specimen self-collection. Because our study is inherently 
exploratory, we do not plan on using probability-based statistical inference techniques in line with 
current best practices.109, 110 Instead, potential variations in our intervention’s feasibility and 
acceptability across selected participant characteristics, and its potential impact on IMB model 
constructs will be numerically summarized and graphically visualized (e.g., side-by-side boxplots, 
scatter plots), as recommended for exploratory data.111, 112 Proportions of participants who test 
negative or positive for GC, CT, and syphilis (using our specimen self-collection kits or with their 
own provider or at a clinic), and proportions who initiate treatment (with their own provider or at a 
clinic or via commercial telehealth services) within 2 weeks or 4 weeks of receiving a positive test 
result will also be calculated. 
 
b. Phase 2 analyses 
 
In-depth interview transcripts will be imported into software for qualitative data analysis (e.g., 
NVivo, Dedoose). Thematic analysis will be used to identify, analyze and report patterns in the 
qualitative data.113-116 This approach is being chosen as it allows for flexibility within both post-
positivist and constructivist paradigms, which is consistent with mixed-methods research.116 We 
will follow Braun & Clarke’s 6 stages of thematic analysis: (i) becoming familiar with the data, (ii) 
generating initial codes, (iii) searching for themes, (iv) reviewing themes, (v) defining and naming 
themes, and (vi) writing up the results.116 Trustworthiness and authenticity of the qualitative 
analysis will be enhanced through multiple mechanisms, including double coding a subset of 
transcripts independently, regular meetings among the study team members to discuss and 
resolve discrepancies, and maintaining documentation for auditing purposes.  
 

16 
 
c. Integration of quantitative and qualitative data117 
 
Integration at the design level will be achieved by our use of a sequential explanatory mixed 
methods design wherein we will first collect quantitative data on the feasibility and acceptability 
of our intervention, and then collect qualitative data on attitudes, facilitators, and barriers related 
to engaging in different intervention components. Integration at the methods level will be achieved 
via (i) connecting (i.e., when one form of data links with the other form through the sampling frame) 
as we will select a purposive subsample of 20 participants for the qualitative phase from 75 
participants in the quantitative phase, and (ii) building (i.e., when results from the first phase inform 
data collection in the second phase) as we will use information on participants’ level of 
engagement in different intervention components to guide our in-depth interviews. Integration at 
the interpretation level will be achieved through a comparison of our quantitative findings (i.e., 
potential variations in our intervention’s feasibility and acceptability across selected participant 
characteristics) with our qualitative findings (i.e., themes describing attitudes, facilitators, and 
barriers related to engaging in each intervention component), including a consideration of how 
results from each study phase converge, diverge, and expand our understanding of these issues. 
Integration at the reporting level will be achieved by representing comparisons through combined 
written descriptions of the quantitative and qualitative data (e.g., statistics-by-themes) and visual 
representations (e.g., joint displays). Results from our study will be contextualized by and 
compared to the extant literature on home specimen self-collection and telehealth-delivered MI in 
other sexual and gender minority populations in the US. 
____________________________________________________________________________ 
 
Section 6. Human subjects protections 
 
a. Potential risks 
 
Our study poses no more than minimal risk to participants. The risks that could arise are detailed 
as follows: 
 
Participants may have concerns about the risk of disclosure of their participation in our study: 
Some participants may be concerned that their participation in our study could be disclosed if 
someone else reads our emails or texts or opens the specimen self-collection box when it arrives 
in the mail. 
 
Participants may feel uncomfortable when answering sensitive survey questions: Our baseline 
survey includes questions on history of HIV testing and management, history of bacterial STI 
testing and management, sexual behaviors, and history of substance use. Because these topics 
are of a sensitive nature, some participants may feel uncomfortable. 
 
Participants may feel uncomfortable revealing their faces over Zoom during the pre-test or the 
post-test sessions, or during the in-depth interview: The pre-test and the post-test MI-guided live 
AV conferencing sessions in Phase 1 will be conducted over Zoom. The in-depth interviews in 
Phase 2 will be conducted with a purposive subsample of participants over Zoom or phone 
(depending upon their preference). The prospect of revealing their faces over Zoom could make 
some participants feel uncomfortable. 
 
Participants may experience mild physical discomfort when self-collecting some specimens: Our 
intervention involves self-collecting at home and returning by mail a urine sample (for GC and CT 
testing), a throat swab (for GC and CT testing), a rectal swab (for GC and CT testing), and a 
finger-stick blood sample (for syphilis testing). Although self-collecting a urine sample of 3 

17 
 
milliliters (which is less than 1 teaspoon of urine) is not expected to cause any physical discomfort, 
self-collecting a throat swab and a rectal swab may cause mild physical discomfort. Self-collecting 
a finger-stick blood sample by pricking one’s own finger to obtain 500 microliters (which is equal 
to 10 drops of blood) can also cause some physical discomfort. However, the risks associated 
with this procedure are minimal (e.g., mild bruising at the puncture site). 
 
Participants who test positive for one or more bacterial STIs may experience emotional distress 
after learning of their health condition: The receipt of one or more positive bacterial STI test results 
may cause emotional distress in some participants, especially if they were expecting all of their 
test results to be negative. 
 
Participants may have concerns about a breach of confidentiality: Because participants will be 
providing their contact information (full name, email address, mobile phone number, and mailing 
address) as well as quantitative and qualitative data during Phases 1 and 2 of our study, some 
may be concerned that the details they share could be unintentionally disclosed to someone who 
is not authorized to access the data. 
 
b. Protections against risks 
 
The procedures that we will undertake to protect participants in our study against risks are detailed 
as follows: 
 
Protections during recruitment: Participants will be recruited via social media advertising and peer 
referral. Our study’s landing page will provide a brief overview of the intervention. Individuals who 
are interested can click on a link to the informed consent form that will include a detailed 
description of all study activities including (i) completing an eligibility screener, (ii) providing 
contact information to receive study communications and a specimen self-collection box if eligible, 
(iii) completing a baseline survey, each intervention component, and a satisfaction survey in 
Phase 1, and (iv) completing an in-depth interview in Phase 2 if selected. The informed consent 
form will be in plain English and use simple, non-technical terms. It will describe the expectations 
of participation, the voluntary nature of participation, and the potential risks and benefits of 
participation, such that individuals are fully aware of the nature of our study. It will also provide 
the study team members’ contact information to discuss any questions or concerns prior to 
deciding on participation. Individuals will have the option to download a copy of the informed 
consent form for their records. 
 
Protections against the risk of disclosure of participation in our study: To minimize the risk of 
disclosure of participation (i) none of the study communications will make any reference to the 
nature of our study, (ii) participants will be encouraged to delete any emails, call logs, or texts 
received as part of our study, and (iii) the specimen self-collection box will be shipped in plain, 
unmarked packaging with no reference to the nature of its contents to the mailing address 
provided by participants in the contact information form. 
 
Protections against potential discomfort when answering sensitive survey questions: To reduce 
potential discomfort when answering questions on sensitive topics (e.g., history of HIV testing and 
management, history of bacterial STI testing and management, sexual behaviors, history of 
substance use) in the baseline survey, these data will be collected via a self-completed survey 
programmed in Qualtrics that will allow participants to skip questions or indicate that they prefer 
not to answer a question. 
 

18 
 
Protections to safeguard participants’ privacy during the pre-test and the post-test sessions, and 
during the in-depth interviews: Participants will be sent password-protected Zoom links and be 
advised to join the pre-test and the post-test sessions, and the in-depth interview from a private 
location. They will also be offered the option to reschedule if the original time no longer works or 
if they anticipate being in a situation where their privacy may be compromised. The pre-test and 
the post-test sessions, and the in-depth interviews will be conducted from a private location and 
participants on Zoom will have the option to mute their own video (i.e., use only audio from their 
end) if they prefer to remain discreet. 
 
Protections to aid the proper self-collection and safe return of specimens: To assist participants 
in correctly self-collecting a urine sample, a throat swab, a rectal swab, and a finger-stick blood 
sample, and appropriately packaging them for return by mail, the interventionist will demonstrate 
the contents of the specimen self-collection box, review step-by-step instructions, and address 
any questions or concerns during the pre-test session to be conducted over Zoom. The specimen 
self-collection box shipped to participants will include a general information sheet that will provide 
participants with a brief description of the box contents and information on how to package and 
return their specimens to CVRL in Atlanta, Georgia. It will also instruct participants to not include 
any sort of personally identifiable information (e.g., full name, mailing address) on the lab 
requisition form. Each specimen self-collection kit included in the box will include written 
instructions along with color images and a QR code that links to video instructions. Participants 
will be requested to enclose the transport tubes containing their self-collected specimens in the 
plastic biohazard bag, complete the lab requisition form, place the bag and the form in the prepaid 
bubble mailer, and return the bubble mailer to CVRL. Specimen return will be voluntary, and 
participants can choose to return all, some, or none of the four specimens. 
 
Protections to ensure the quality of specimen testing: CVRL is one of two primary labs of the 
Virology and Molecular Biomarkers Core of the Emory University Center for AIDS Research 
(CFAR). Urine samples, throat swabs, and rectal swabs returned by participants will be tested for 
GC and CT using the Abbott Real Time PCR Assay. This test targets a region of the Opa gene of 
Neisseria gonorrhea and a region of the cryptic plasmid of Chlamydia trachomatis. It can also 
detect the Sweden (nvCT) variant strain. For GC, its sensitivity is 97.5% and its specificity is 
99.7%. For CT, its sensitivity is 95.2% and its specificity is 99.3%.  
 
Finger-stick blood samples returned by participants will be tested for syphilis using the ASI RPR 
Card Test reported as a titer of antibodies. This is a semiquantitative nontreponemal flocculation 
test to detect reagin antibodies in human serum and plasma with a sensitivity of 97.7% and a 
specificity of 99.5%. If the screening test for syphilis is reactive (i.e., a titer of ≥1:8), it will be 
followed by a confirmatory test (i.e., a treponemal enzyme immunoassay to detect IgG antibodies) 
at EML which is located in the same building as CVRL. EML is a fully accredited and licensed 
clinical lab operating within the Emory Healthcare Department of Pathology & Laboratory 
Medicine. Both CVRL and EML are certified under CLIA. CLIA regulations establish quality 
standards for lab testing performed on specimens from humans. The physical and environmental 
conditions of the labs are adequate and appropriate for the types of testing performed. Extensive 
safety and biohazard requirements are followed at CVRL and EML to keep lab personnel safe 
from physical, chemical, and biological hazards. Lab personnel wear appropriate personal 
protective equipment such as gloves, goggles, and masks, and follow practices to reduce their 
risk of exposure (e.g., handling all blood and other body fluids as if they are infectious, being 
cautious of exposure to mucous membranes such as the eyes, nostrils, and mouth, disposing of 
any used sharps properly in puncture-proof sharps containers, participating in trainings related to 
infection prevention). During the testing process, the biohazard bags and sharps containers used 
for disposal of contaminated materials are as close to the immediate testing area as possible, 

19 
 
kept upright throughout use, replaced routinely, and prevented from being overfilled. Containers 
for contaminated waste are constructed to contain all contents and prevent leakage of fluids 
during handling, storage, and transport, are labeled or color-coded to indicate biohazard material, 
and are closed prior to removal to prevent spillage or protrusion of contents during handling. Lab 
personnel at CVRL and EML are appropriately educated, experienced, and trained to perform lab 
tests and report test results in accordance with written duties and responsibilities. 
 
Protections to securely return test results to participants: Once we receive participants’ GC, CT, 
and syphilis test results back from CVRL (approximately 2 weeks after they return their 
specimens), they will be scheduled for a post-test session to be conducted over Zoom with the 
same interventionist who conducted the pre-test session, whenever possible. The interventionist 
will discuss the meaning of negative and positive bacterial STI test results and assess 
participants’ emotional response to each possible outcome via open-ended questioning and 
reflective listening. Test results will be delivered via screen sharing the lab test results form (that 
will only include the unique specimen ID numbers and corresponding test results). The 
interventionist will have completed online training courses on GC, CT, and syphilis offered by the 
MDHHS. After the session, a copy of the lab test results form will also be shared with participants 
via a secure Dropbox folder that is only accessible to them and the study team members. The 
folder will also include a supplemental information sheet on using site locators on the CDC’s 
“GetTested: National HIV, STD, and Hepatitis Testing” and Planned Parenthood’s “STD Testing, 
Treatment & Vaccines” websites to identify local STI clinics to seek treatment (if warranted) and 
repeat testing. The link to the folder will expire after 4 weeks and the folder will be deleted, 
following which participants will need to contact us to obtain a new link. Participants who do not 
schedule or attend the post-test session will also be provided a copy of the lab test results form 
and the supplemental information sheet on using site locators to identify local STI clinics via a 
secure Dropbox folder that is only accessible to them and the study team members. 
 
Protections to safeguard participants who test positive for one or more bacterial STIs and link 
them to medical care: For participants receiving a positive GC, CT, or syphilis test result, the 
interventionist will offer emotional support, discuss the benefits of timely antibiotic treatment, and 
jointly formulate a linkage to care plan during the post-test session to be conducted over Zoom. 
Barriers to accessing treatment (e.g., lack of insurance, limited personal transportation, reluctance 
to visit one’s own provider) will be elicited and the interventionist will work with participants to find 
practical solutions. For example, if someone lacks insurance, screen sharing will be used to give 
information on local STI clinics that provide free or low-cost services identified using site locators 
on the CDC’s “GetTested: National HIV, STD, and Hepatitis Testing” and Planned Parenthood’s 
“STD Testing, Treatment & Vaccines” websites. If someone has limited personal transportation, 
the interventionist will assist in creating a commute plan that uses public transportation options. 
If someone is reluctant to visit their own provider, the interventionist will assist in finding other STI 
clinics or identifying commercial telehealth services that offer STI treatment (e.g., GoodMDs, 
PlushHealth, CallonDoc). Participants will be encouraged to notify their sex partners of their 
positive test results so that they can seek testing. Open-ended questioning and reflective listening 
will be used to engage them in a discussion on sexual risk reduction. A study team member will 
follow up via phone at 2 weeks and at 4 weeks to determine participants’ treatment status. During 
each of these interactions, the study team member will complete a case report form programmed 
in Qualtrics documenting whether the participant has initiated treatment, completed treatment, 
has not yet initiated treatment but has made an appointment with a provider, or has not yet made 
an appointment with a provider. Those who have not yet made an appointment with a provider 
will be encouraged to do so as soon as possible and offered additional assistance as requested. 
 

20 
 
Protections to safeguard confidentiality: To minimize risks to confidentiality, we will provide all of 
the appropriate protections to participants’ data collected as part of our study. UM has signed 
Business Associate Agreements with Qualtrics, Zoom, and Dropbox. These resources are 
approved by the UM ITS for sensitive identifiable human subjects research data regulated by the 
“Common Rule”. Access to the Qualtrics, Zoom, and Dropbox accounts is protected with a 
sufficiently complex password and requires Duo two-factor authentication for login. Duo protects 
applications by using a second source of validation, like a phone or token, to verify user identity 
before granting access. Individuals whose contact information has been verified will be assigned 
a randomly generated participant ID number to be included as a metadata element in subsequent 
baseline and satisfaction surveys programmed in Qualtrics. Participants’ contact information (full 
name, email address, mobile phone number, and mailing address) will be kept separate from the 
quantitative and qualitative data collected during Phases 1 and 2 of our study in a password-
protected file stored on a secure UM server. Only IRB-approved study team members, all of whom 
will have completed trainings on human subjects research protections offered by the UM 
PEERRS, will have access to participants’ data on an as-needed basis. Any specimens returned 
by participants within 8 weeks will be destroyed immediately after lab testing. Any specimens 
returned after 8 weeks will be destroyed without being tested (unless they are from participants 
who have requested an extension). Lab personnel at CVRL or EML will only be able to connect 
the participants’ test results to the unique specimen ID numbers affixed to the different transport 
tubes. They will not have access to either the participant ID numbers or to the participants’ contact 
information. Only IRB-approved study team members at the UM will have access to the data on 
which unique specimen ID numbers are assigned to a particular participant ID number, and which 
participant ID number corresponds to a particular participant’s contact information. The data 
collected via the eligibility screener, contact information form, baseline survey, case report form, 
and satisfaction survey will be deleted from Qualtrics upon study completion (i.e., when all study-
related data have been collected and checked for accuracy and completeness). The audio 
recordings from our pre-test sessions, post-test sessions, and in-depth interviews will be deleted 
from the UM server upon study completion (i.e., when all study-related data have been collected 
and checked for accuracy and completeness). The file containing participants’ contact information 
will also be deleted from the UM server upon study completion (i.e., when all study-related data 
have been collected and checked for accuracy and completeness). All other data collected as 
part of our study (i.e., survey responses, case report form data, in-depth interview transcripts) will 
be stored on a secure UM server for subsequent analyses and reporting, and the only link 
between them will be the participant ID numbers (i.e., none of the files will contain any sort of 
personally identifiable information except ZIP code). Results from our study will be described in a 
manner such that no individual participants can be identified. Our study is funded by the NIH and 
holds a Certificate of Confidentiality. 
 
c. Potential benefits 
 
Participants in our study may benefit from having the opportunity to learn more about bacterial 
STIs during the pre-test and the post-test live AV conferencing sessions and receiving free 
specimen self-collection kits to test for GC or CT at three different anatomical sites of possible 
exposure and for syphilis. Others may benefit because our study will provide new information on 
the feasibility and acceptability of a novel MI-based telehealth intervention to engage sexually 
active GBMSM-LWH in bacterial STI screening. Our potentially scalable intervention is unique in 
integrating home specimen self-collection and return for GC, CT, and syphilis testing with MI-
guided discussions over live AV conferencing and has a high likelihood of advancing the field in 
an area of critical need. 
 
d. Importance of the knowledge to be gained 

21 
 
 
GBMSM-LWH bear a heavy burden of GC, CT, and syphilis. Left untreated, bacterial STIs may 
lead to serious health complications. Inflammatory and ulcerative STIs can also facilitate the 
onward sexual transmission of HIV in the presence of inadequate viral suppression. Timely 
diagnosis and treatment are key to prevention. Sexually active GBMSM-LWH engaged in HIV 
medical care are not being tested for GC, CT, and syphilis at least annually, as recommended by 
the CDC. Home specimen self-collection has increasingly been used to test for bacterial STIs in 
studies conducted with diverse populations. Telehealth has also demonstrated promise in 
managing mental health and increasing antiretroviral therapy adherence in people living with HIV. 
Only few studies have combined home specimen self-collection with live AV conferencing, all of 
which have been restricted to people without HIV. None have focused on GBMSM-LWH or 
incorporated MI, a client-centered, strengths-based counseling approach that seeks to support 
individuals towards positive behavioral change. Integrating home specimen self-collection from 
different anatomical sites of possible exposure with MI delivered via live AV conferencing might 
offer a unique solution to engage GBMSM-LWH in bacterial STI screening. Our sequential 
explanatory mixed-methods study seeks to explore the feasibility and acceptability of a novel MI-
based telehealth intervention to engage GBMSM-LWH in GC, CT, and syphilis testing. Our 
intervention is a package of 3 components: (i) a pre-test live AV conferencing session involving 
an MI-guided discussion to elicit awareness of bacterial STIs and fill any knowledge gaps, bolster 
the perceived importance of regularly testing for GC, CT, and syphilis, and improve self-efficacy 
for specimen self-collection, (ii) self-collecting at home and returning by mail a urine sample (for 
GC and CT testing), a throat swab (for GC and CT testing), a rectal swab (for GC and CT testing), 
and a finger-stick blood sample (for syphilis testing), and (iii) a post-test live AV conferencing 
session involving an MI-guided discussion to prepare participants for receiving test results and 
formulate personalized action plans for seeking treatment (if warranted) and repeat testing. Our 
study advances multiple goals of the 2021-2025 STI National Strategic Plan for the United States 
(prevent new STIs, accelerate progress in STI research, technology, and innovation, and reduce 
STI-related health disparities). Data on attitudes, facilitators, and barriers related to engaging in 
each intervention component from in-depth interviews will guide refinements to our intervention 
prior to assessing its impact in improving GC, CT, and syphilis testing rates among sexually active 
GBMSM-LWH in a future study. 
____________________________________________________________________________ 
 
Section 7. Researchers’ qualifications 
 
a. Akshay Sharma, MBBS, MPH, PhD 
 
PI Sharma is an Assistant Professor in the Department of Health Behavior and Biological 
Sciences at the UMSN. He is educated as a physician, an infectious disease epidemiologist, and 
an HIV prevention counselor. He has extensive experience in conducting online studies with 
GBMSM118-128 and in research methods.129-134 He was recently the PI of an NIH-funded sequential 
explanatory mixed-methods study evaluating the return of 5 self-collected specimens for HIV, GC, 
CT, and potential PrEP adherence testing among GBMSM without HIV (Project Caboodle)93-96 
and a Co-I on telehealth studies among transgender youth without HIV62-64 and seroconcordant 
HIV-negative male couples.65-67 
 
b. Erin Bonar, PhD 
 
Co-I Bonar is an Associate Professor in the Department of Psychiatry at the UM Medical School. 
She is a licensed clinical psychologist with experience in both quantitative and qualitative 
research.135-141 She has expertise in telehealth142-144 and MI (e.g., MI Network of Trainers trained) 

22 
 
and has led MI training, fidelity, and supervision on several collaborative trials focused on HIV 
and substance use prevention.145-155 She is the PI of multiple NIH-funded studies to evaluate 
interventions to reduce substance use and concomitant sexual risk behaviors in vulnerable 
populations, all of which deliver MI via telehealth. Several of these studies pair in-depth interviews 
with quantitative data to inform implementation. 
____________________________________________________________________________ 
 
Section 8. References 
 
1. 
CDC. Sexually transmitted disease surveillance 2021. 2023 [07/10/2023]. Available 
from: https://www.cdc.gov/std/statistics/2021/default.htm. 
2. 
Workowski K. Chlamydia and gonorrhea. Annals of Internal Medicine. 2013;158(3):ITC2. 
3. 
Read P, Donovan B. Clinical aspects of adult syphilis. Internal Medicine Journal. 
2012;42(6):614-20. 
4. 
Benson CA, Brooks JT, Holmes KK, Kaplan JE, Masur H, Pau A. Guidelines for 
prevention and treatment opportunistic infections in HIV-infected adults and adolescents: 
Recommendations from CDC, the National Institutes of Health, and the HIV Medicine 
Association/Infectious Diseases Society of America. MMWR Recommendations and Reports. 
2009;58:1-207. 
5. 
Galvin SR, Cohen MS. The role of sexually transmitted diseases in HIV transmission. 
Nature Reviews Microbiology. 2004;2(1):33-42. 
6. 
Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and 
practice: The contribution of other sexually transmitted diseases to sexual transmission of HIV 
infection. Sexually Transmitted Infections. 1999;75(1):3-17. 
7. 
Ward H, Rönn M. The contribution of STIs to the sexual transmission of HIV. Current 
Opinion in HIV and AIDS. 2010;5(4):305. 
8. 
Bernstein KT, Marcus JL, Nieri G, Philip SS, Klausner JD. Rectal gonorrhea and 
chlamydia reinfection is associated with increased risk of HIV seroconversion. JAIDS. 
2010;53(4):537-43. 
9. 
Menza TW, Hughes JP, Celum CL, Golden MR. Prediction of HIV acquisition among 
men who have sex with men. Sexually Transmitted Diseases. 2009;36(9):547. 
10. 
Buchacz K, Patel P, Taylor M, Kerndt PR, Byers RH, Holmberg SD, Klausner JD. 
Syphilis increases HIV viral load and decreases CD4 cell counts in HIV-infected patients with 
new syphilis infections. AIDS. 2004;18(15):2075-9. 
11. 
CDC. Sexually transmitted diseases treatment guidelines, 2015. MMWR 
Recommendations and Reports. 2015;64(3). 
12. 
Berry SA, Ghanem KG, Page KR, Thio CL, Moore RD, Gebo KA. Gonorrhoea and 
chlamydia testing rates of HIV-infected men: Low despite guidelines. Sexually Transmitted 
Infections. 2010;86(6):481-4. 
13. 
Flagg EW, Weinstock HS, Frazier EL, Valverde EE, Heffelfinger JD, Skarbinski J. 
Bacterial sexually transmitted infections among HIV-infected patients in the United States: 
Estimates from the Medical Monitoring Project. Sexually Transmitted Diseases. 2015;42(4):171-
9. 
14. 
Baffi CW, Aban I, Willig JH, Agrawal M, Mugavero MJ, Bachmann LH. New syphilis 
cases and concurrent STI screening in a southeastern US HIV clinic: A call to action. AIDS 
Patient Care and STDs. 2010;24(1):23-9. 
15. 
Mattson CL, Bradley H, Beer L, Johnson C, Pearson WS, Shouse RL. Increased STD 
testing among sexually active persons receiving medical care for HIV infection in the United 
States, 2009–2013. Clinical Infectious Diseases. 2017;64(5):629-34. 

23 
 
16. 
Weiser J, Tie Y, Beer L, Pearson WS, Shouse RL. Receipt of prevention services and 
testing for sexually transmitted diseases among HIV-positive men who have sex with men, 
United States. Annals of Internal Medicine. 2020;173(2):162-4. 
17. 
Fuchs W, Kreuter A, Hellmich M, Potthoff A, Swoboda J, Brockmeyer N, Wieland U. 
Asymptomatic anal sexually transmitted infections in HIV‐positive men attending anal cancer 
screening. British Journal of Dermatology. 2016;174(4):831-8. 
18. 
Rieg G, Lewis RJ, Miller LG, Witt MD, Guerrero M, Daar ES. Asymptomatic sexually 
transmitted infections in HIV-infected men who have sex with men: Prevalence, incidence, 
predictors, and screening strategies. AIDS Patient Care and STDs. 2008;22(12):947-54. 
19. 
Jones MLJ, Chapin-Bardales J, Bizune D, Papp JR, Phillips C, Kirkcaldy RD, Wejnert C, 
Bernstein KT, Khuwaja S, Lopez Z. Extragenital chlamydia and gonorrhea among community 
venue-attending men who have sex with men - Five cities, United States, 2017. MMWR. 
2019;68(14):321. 
20. 
Sultan B, White J, Fish R, Carrick G, Brima N, Copas A, Robinson A, Gilson R, Mercey 
D, Benn P. The “3 in 1” study: Pooling self-taken pharyngeal, urethral, and rectal samples into a 
single sample for analysis for detection of Neisseria gonorrhoeae and Chlamydia trachomatis in 
men who have sex with men. Journal of Clinical Microbiology. 2016;54(3):650-6. 
21. 
Keaveney S, Sadlier C, O’Dea S, Delamere S, Bergin C. High prevalence of 
asymptomatic sexually transmitted infections in HIV-infected men who have sex with men: A 
stimulus to improve screening. International Journal of STD and AIDS. 2014;25(10):758-61. 
22. 
Patton ME, Kidd S, Llata E, Stenger M, Braxton J, Asbel L, Bernstein K, Gratzer B, 
Jespersen M, Kerani R. Extragenital gonorrhea and chlamydia testing and infection among men 
who have sex with men—STD Surveillance Network, United States, 2010–2012. Clinical 
Infectious Diseases. 2014;58(11):1564-70. 
23. 
Abara WE, Llata EL, Schumacher C, Carlos-Henderson J, Peralta AM, Huspeni D, 
Kerani RP, Elder H, Toevs K, Pathela P. Extragenital gonorrhea and chlamydia positivity and 
the potential for missed extragenital gonorrhea with concurrent urethral chlamydia among men 
who have sex with men attending sexually transmitted disease clinics—sexually transmitted 
disease surveillance network, 2015–2019. Sexually Transmitted Diseases. 2020;47(6):361-8. 
24. 
Dean BB, Scott M, Hart R, Battalora L, Novak RM, Durham MD, Brooks JT, Buchacz K, 
Investigators HOS. Sexually transmitted disease testing of human immunodeficiency virus–
infected men who have sex with men: Room for improvement. Sexually Transmitted Diseases. 
2017;44(11):678-84. 
25. 
Barbee LA, Dhanireddy S, Tat SA, Marrazzo JM. Barriers to bacterial STI testing of HIV-
infected men who have sex with men engaged in HIV primary care. Sexually Transmitted 
Diseases. 2015;42(10):590. 
26. 
Carter Jr JW, Hart-Cooper GD, Butler MO, Workowski KA, Hoover KW. Provider barriers 
prevent recommended sexually transmitted disease screening of HIV-infected men who have 
sex with men. Sexually Transmitted Diseases. 2014;41(2):137-42. 
27. 
Landovitz RJ, Gildner JL, Leibowitz AA. Sexually transmitted infection testing of HIV-
positive Medicare and Medicaid enrollees falls short of guidelines. Sexually Transmitted 
Diseases. 2018;45(1):8. 
28. 
Lutz AR. Screening for asymptomatic extragenital gonorrhea and chlamydia in men who 
have sex with men: Significance, recommendations, and options for overcoming barriers to 
testing. LGBT Health. 2015;2(1):27-34. 
29. 
Heijman T, Zuure F, Stolte I, Davidovich U. Motives and barriers to safer sex and regular 
STI testing among MSM soon after HIV diagnosis. BMC Infectious Diseases. 2017;17(1):1-11. 
30. 
Tobin K, Edwards C, Flath N, Lee A, Tormohlen K, Gaydos CA. Acceptability and 
feasibility of a Peer Mentor program to train young Black men who have sex with men to 
promote HIV and STI home-testing to their social network members. AIDS Care. 
2018;30(7):896-902. 

24 
 
31. 
Grov C, Cain D, Whitfield TH, Rendina HJ, Pawson M, Ventuneac A, Parsons JT. 
Recruiting a US national sample of HIV-negative gay and bisexual men to complete at-home 
self-administered HIV/STI testing and surveys: Challenges and opportunities. Sex Res Soc 
Policy. 2016;13(1):1-21. 
32. 
Grov C, Cain D, Rendina HJ, Ventuneac A, Parsons JT. Characteristics associated with 
urethral and rectal gonorrhea and chlamydia diagnoses in a US national sample of gay and 
bisexual men: Results from the One Thousand Strong panel. Sexually Transmitted Diseases. 
2016;43(3):165. 
33. 
McRee AL, Esber A, Reiter PL. Acceptability of home‐based chlamydia and gonorrhea 
testing among a national sample of sexual minority young adults. Perspectives on Sexual and 
Reproductive Health. 2015;47(1):3-10. 
34. 
Fisher M, Wayal S, Smith H, Llewellyn C, Alexander S, Ison C, Parry JV, Singleton G, 
Perry N, Richardson D. Home sampling for sexually transmitted infections and HIV in men who 
have sex with men: A prospective observational study. PLOS ONE. 2015;10(4):e0120810. 
35. 
Odesanmi TY, Wasti SP, Odesanmi OS, Adegbola O, Oguntuase OO, Mahmood S. 
Comparative effectiveness and acceptability of home-based and clinic-based sampling methods 
for sexually transmissible infections screening in females aged 14-50 years: A systematic 
review and meta-analysis. Sexual Health. 2013;10(6):559-69. 
36. 
Götz HM, Wolfers ME, Luijendijk A, van den Broek IV. Retesting for genital Chlamydia 
trachomatis among visitors of a sexually transmitted infections clinic: randomized intervention 
trial of home-versus clinic-based recall. BMC Infectious Diseases. 2013;13(1):239. 
37. 
Reagan MM, Xu H, Shih SL, Secura GM, Peipert JF. A randomized trial of home versus 
clinic-based STD screening among men. Sexually Transmitted Diseases. 2012;39(11):842. 
38. 
Xu F, Stoner BP, Taylor SN, Mena L, Tian LH, Papp J, Hutchins K, Martin DH, 
Markowitz LE. Use of home-obtained vaginal swabs to facilitate rescreening for Chlamydia 
trachomatis infections: Two randomized controlled trials. Obstetrics and Gynecology. 
2011;118(2):231-9. 
39. 
Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with 
clinic-based screening for sexually transmitted infections: A randomized controlled trial. 
Obstetrics and Gynecology. 2010;116(6):1311. 
40. 
Shafer M-A, Moncada J, Boyer CB, Betsinger K, Flinn SD, Schachter J. Comparing first-
void urine specimens, self-collected vaginal swabs, and endocervical specimens to detect 
Chlamydia trachomatis and Neisseria gonorrhoeae by a nucleic acid amplification test. Journal 
of Clinical Microbiology. 2003;41(9):4395-9. 
41. 
Hernandez BY, Wilkens LR, Unger ER, Steinau M, Markowitz L, Garvin K, Thompson 
PJ, Shvetsov YB, O’Dillon K, Dunne EF. Evaluation of genital self-sampling methods for HPV 
detection in males. Journal of Clinical Virology. 2013;58(1):168-75. 
42. 
Read TR, Hocking JS, Vodstrcil LA, Tabrizi SN, McCullough MJ, Grulich AE, Garland 
SM, Bradshaw CS, Chen MY, Fairley CK. Oral human papillomavirus in men having sex with 
men: Risk-factors and sampling. PLOS ONE. 2012;7(11):e49324. 
43. 
Ogilvie G, Taylor D, Achen M, Cook D, Krajden M. Self-collection of genital human 
papillomavirus specimens in heterosexual men. Sexually Transmitted Infections. 
2009;85(3):221-5. 
44. 
Chin-Hong PV, Berry JM, Cheng S-C, Catania JA, Da Costa M, Darragh TM, Fishman F, 
Jay N, Pollack LM, Palefsky JM. Comparison of patient-and clinician-collected anal cytology 
samples to screen for human papillomavirus-associated anal intraepithelial neoplasia in men 
who have sex with men. Annals of Internal Medicine. 2008;149(5):300-6. 
45. 
Hernandez BY, McDuffie K, Goodman M, Wilkens L, Thompson P, Zhu X, Wong W, 
Ning L. Comparison of physician-and self-collected genital specimens for detection of human 
papillomavirus in men. Journal of Clinical Microbiology. 2006;44(2):513-7. 

25 
 
46. 
Lampinen TM, Chan K, Anema A, Kornegay J, Hogg RS, Coutlée F. Self-screening for 
rectal sexually transmitted infections: Human papillomavirus. Clinical Infectious Diseases. 
2006;42(2):308-9. 
47. 
Dize L, Barnes Jr P, Barnes M, Hsieh Y-H, Marsiglia V, Duncan D, Hardick J, Gaydos 
CA. Performance of self-collected penile-meatal swabs compared to clinician-collected urethral 
swabs for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas 
vaginalis, and Mycoplasma genitalium by nucleic acid amplification assays. Diagnostic 
Microbiology and Infectious Disease. 2016;86(2):131-5. 
48. 
Soni S, White JA. Self-screening for Neisseria gonorrhoeae and Chlamydia trachomatis 
in the human immunodeficiency virus clinic - High yields and high acceptability. Sexually 
Transmitted Diseases. 2011;38(12):1107-9. 
49. 
Freeman AH, Bernstein KT, Kohn RP, Philip S, Rauch LM, Klausner JD. Evaluation of 
self-collected versus clinician-collected swabs for the detection of Chlamydia trachomatis and 
Neisseria gonorrhoeae pharyngeal infection among men who have sex with men. Sexually 
Transmitted Diseases. 2011;38(11):1036-9. 
50. 
van der Helm JJ, Hoebe CJ, van Rooijen MS, Brouwers EE, Fennema HS, 
Thiesbrummel HF, Dukers-Muijrers NH. High performance and acceptability of self-collected 
rectal swabs for diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in men who 
have sex with men and women. Sexually Transmitted Diseases. 2009;36(8):493-7. 
51. 
Moncada J, Schachter J, Liska S, Shayevich C, Klausner JD. Evaluation of self-collected 
glans and rectal swabs from men who have sex with men for detection of Chlamydia 
trachomatis and Neisseria gonorrhoeae by use of nucleic acid amplification tests. Journal of 
Clinical Microbiology. 2009;47(6):1657-62. 
52. 
Alexander S, Ison C, Parry J, Llewellyn C, Wayal S, Richardson D, Phillips A, Smith H, 
Fisher M. Self-taken pharyngeal and rectal swabs are appropriate for the detection of 
Chlamydia trachomatis and Neisseria gonorrhoeae in asymptomatic men who have sex with 
men. Sexually Transmitted Infections. 2008;84(6):488-92. 
53. 
Wayal S, Llewellyn C, Smith H, Hankins M, Phillips A, Richardson D, Fisher M. Self-
sampling for oropharyngeal and rectal specimens to screen for sexually transmitted infections: 
acceptability among men who have sex with men. Sexually Transmitted Infections. 
2009;85(1):60-4. 
54. 
Drummond KL, Painter JT, Curran GM, Stanley R, Gifford AL, Rodriguez-Barradas M, 
Rimland D, Monson TP, Pyne JM. HIV patient and provider feedback on a telehealth 
collaborative care for depression intervention. AIDS Care. 2017;29(3):290-8. 
55. 
McKinney EN, Heckman D, Bernadette H, Lauckner D, Ford DC, Cooper J, editors. 
Project MIGHT: Mental Health Intervention for Georgians with HIV/AIDS using Telehealth. 6th 
Annual Rural HIV Research and Training Conference; 2018. 
56. 
Mulawa MI, LeGrand S, Hightow-Weidman LB. eHealth to enhance treatment adherence 
among youth living with HIV. Current HIV/AIDS Reports. 2018;15(4):336-49. 
57. 
Navarra A-MD, Gwadz MV, Whittemore R, Bakken SR, Cleland CM, Burleson W, 
Jacobs SK, Melkus GDE. Health technology-enabled interventions for adherence support and 
retention in care among US HIV-infected adolescents and young adults: An integrative review. 
AIDS Behav. 2017;21(11):3154-71. 
58. 
Jongbloed K, Parmar S, van der Kop M, Spittal PM, Lester RT. Recent evidence for 
emerging digital technologies to support global HIV engagement in care. Current HIV/AIDS 
Reports. 2015;12(4):451-61. 
59. 
Young JD, Patel M. HIV subspecialty care in correctional facilities using telemedicine. 
Journal of Correctional Health Care. 2015;21(2):177-85. 
60. 
Saberi P, Yuan P, John M, Sheon N, Johnson MO. A pilot study to engage and counsel 
HIV-positive African American youth via telehealth technology. AIDS Patient Care and STDs. 
2013;27(9):529-32. 

26 
 
61. 
Ohl M, Dillon D, Moeckli J, Ono S, Waterbury N, Sissel J, Yin J, Neil B, Wakefield B, 
Kaboli P. Mixed-methods evaluation of a telehealth collaborative care program for persons with 
HIV infection in a rural setting. Journal of General Internal Medicine. 2013;28(9):1165-73. 
62. 
Stephenson R, Metheny N, Sharma A, Sullivan S, Riley E. Providing home-based HIV 
testing and counseling for transgender youth (Project Moxie): Protocol for a pilot randomized 
controlled trial. JMIR Research Protocols. 2017;6(11). 
63. 
Sharma A, Kahle E, Todd K, Peitzmeier S, Stephenson R. Variations in testing for HIV 
and other sexually transmitted infections across gender identity among transgender youth. 
Transgender Health. 2019;4(1):46-57. 
64. 
Stephenson R, Todd K, Kahle E, Sullivan SP, Miller-Perusse M, Sharma A, Horvath KJ. 
Project Moxie: Results of a feasibility study of a telehealth intervention to increase HIV testing 
among binary and nonbinary transgender youth. AIDS Behav. 2020;24(5):1517-30. 
65. 
Stephenson R, Freeland R, Sullivan SP, Riley E, Johnson BA, Mitchell J, McFarland D, 
Sullivan PS. Home-based HIV testing and counseling for male couples (Project Nexus): A 
protocol for a randomized controlled trial. JMIR Research Protocols. 2017;6(5). 
66. 
Sullivan SP, Sullivan PS, Stephenson R. Acceptability and feasibility of a telehealth 
intervention for STI testing among male couples. AIDS Behav. 2021:1-15. 
67. 
Sharma A, Kahle E, Sullivan S, Stephenson R. Relationship characteristics associated 
with perceptions of partners’ HIV testing behavior among male couples. AIDS Behav. 
2020;24(2):516-31. 
68. 
Rollnick S, Miller WR. What is motivational interviewing? Behavioural and Cognitive 
Psychotherapy. 1995;23(4):325-34. 
69. 
Miller WR, Rollnick S. Motivational interviewing: Helping people change: Guilford press; 
2012. 
70. 
Ivankova NV, Creswell JW, Stick SL. Using mixed-methods sequential explanatory 
design: From theory to practice. Field Methods. 2006;18(1):3-20. 
71. 
Bryman A. Integrating quantitative and qualitative research: how is it done? Qualitative 
Research. 2006;6(1):97-113. 
72. 
Fisher JD, Fisher WA, Shuper PA. The information-motivation-behavioral skills model of 
HIV preventive behavior. Emerging Theories in Health Promotion Practice and Research. 
2009;2:21-64. 
73. 
Fisher WA, Fisher JD, Harman J. The information-motivation-behavioral skills model: A 
general social psychological approach to understanding and promoting health behavior. Social 
Psychological Foundations of Health and Illness. 2003:82-106. 
74. 
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an 
overview of reviews and development of a theoretical framework. BMC Health Services 
Research. 2017;17(1):1-13. 
75. 
Tickle-Degnen L. Nuts and bolts of conducting feasibility studies. American Journal of 
Occupational Therapy. 2013;67(2):171-6. 
76. 
Lenth RV. Some practical guidelines for effective sample size determination. The 
American Statistician. 2001;55(3):187-93. 
77. 
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical 
Statistics. 2005;4(4):287-91. 
78. 
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a 
pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial 
for a continuous outcome variable. Statistical Methods in Medical Research. 2016;25(3):1057-
73. 
79. 
Dworkin SL. Sample size policy for qualitative studies using in-depth interviews. 
Springer; 2012. 
80. 
Crouch M, McKenzie H. The logic of small samples in interview-based qualitative 
research. Social Science Information. 2006;45(4):483-99. 

27 
 
81. 
Malterud K, Siersma VD, Guassora AD. Sample size in qualitative interview studies: 
guided by information power. Qualitative Health Research. 2016;26(13):1753-60. 
82. 
Braun V, Clarke V. To saturate or not to saturate? Questioning data saturation as a 
useful concept for thematic analysis and sample-size rationales. Qualitative Research in Sport, 
Exercise and Health. 2021;13(2):201-16. 
83. 
Pew Research Center: Social media fact sheet. 2021 [07/10/2023]. Available from: 
https://www.pewresearch.org/internet/fact-sheet/social-media/. 
84. 
Pew Research Center: Internet/Broadband fact sheet. 2021 [07/10/2023]. Available 
from: https://www.pewresearch.org/internet/fact-sheet/internet-broadband/. 
85. 
Pew Research Center: Mobile fact sheet. 2021 [07/10/2023]. Available from: 
https://www.pewresearch.org/internet/fact-sheet/mobile/. 
86. 
Hirshfield S, Grov C, Parsons JT, Anderson I, Chiasson MA. Social media use and HIV 
transmission risk behavior among ethnically diverse HIV-positive gay men: results of an online 
study in three US states. Archives of Sexual Behavior. 2015;44(7):1969-78. 
87. 
Lewnard JA, Berrang-Ford L. Internet-based partner selection and risk for unprotected 
anal intercourse in sexual encounters among men who have sex with men: a meta-analysis of 
observational studies. Sexually Transmitted Infections. 2014;90(4):290-6. 
88. 
Landovitz RJ, Tseng C-H, Weissman M, Haymer M, Mendenhall B, Rogers K, Veniegas 
R, Gorbach PM, Reback CJ, Shoptaw S. Epidemiology, sexual risk behavior, and HIV 
prevention practices of men who have sex with men using Grindr in Los Angeles, California. 
Journal of Urban Health. 2013;90(4):729-39. 
89. 
Garofalo R, Herrick A, Mustanski BS, Donenberg GR. Tip of the iceberg: Young men 
who have sex with men, the internet, and HIV risk. American Journal of Public Health. 
2007;97(6):1113-7. 
90. 
Liau A, Millett G, Marks G. Meta-analytic examination of online sex-seeking and sexual 
risk behavior among men who have sex with men. Sexually Transmitted Diseases. 
2006;33(9):576-84. 
91. 
Bull SS, McFarlane M, Lloyd L, Rietmeijer C. The process of seeking sex partners online 
and implications for STD/HIV prevention. AIDS Care. 2004;16(8):1012-20. 
92. 
CDC. Estimated HIV incidence and prevalence in the United States 2014-2018. 2020 
[07/10/2023]. Available from: https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-
surveillance-supplemental-report-vol-25-1.pdf. 
93. 
Sharma A, Stephenson R, Sallabank G, Merrill L, Sullivan S, Gandhi M. Acceptability 
and feasibility of self-collecting biological specimens for HIV, sexually transmitted infection, and 
adherence testing among high-risk populations (Project Caboodle!): Protocol for an exploratory 
mixed-methods study. JMIR Research Protocols. 2019;8(5):e13647. 
94. 
Sharma A, Gandhi M, Sallabank G, Merrill L, Stephenson R. Study evaluating self-
collected specimen return for HIV, bacterial STI, and potential pre-exposure prophylaxis 
adherence testing among sexual minority men in the United States. American Journal of Men's 
Health. 2022;16(4). 
95. 
Sharma A, Gandhi M, Sallabank G, Merrill L, Stephenson R. Perceptions and 
experiences of returning self-collected specimens for HIV, bacterial STI and potential PrEP 
adherence testing among sexual minority men in the United States. AIDS Behav. 
2023;27(4):1091-105. 
96. 
Sallabank G, Stephenson R, Gandhi M, Merrill L, Sharma A. Lessons learned from the 
implementation of a pilot study on self-collected specimen return by sexual minority men 
(Project Caboodle!): Qualitative exploration. JMIR Formative Research. 2023;7:e43539. 
97. 
Paz-Bailey G, Raymond HF, Lansky A, Mermin J. Using the National HIV Behavioral 
Surveillance System to inform HIV prevention efforts in the United States. AIDS Behav. 
2014;18(3):233-6. 

28 
 
98. 
Balán IC, Lopez-Rios J, Dolezal C, Rael CT, Lentz C. Low STI knowledge, risk 
perception, and concern about infection among men who have sex with men and transgender 
women at high risk of infection. Sexual Health. 2019;16(6):580. 
99. 
DeHart DD, Birkimer JC. Trying to practice safer sex: Development of the sexual risks 
scale. Journal of Sex Research. 1997;34(1):11-25. 
100. 
Alvy LM, McKirnan DJ, Mansergh G, Koblin B, Colfax GN, Flores SA, Hudson S. 
Depression is associated with sexual risk among men who have sex with men, but is mediated 
by cognitive escape and self-efficacy. AIDS Behav. 2011;15(6):1171-9. 
101. 
Howarth A, Apea V, Michie S, Morris S, Sachikonye M, Mercer C, Evans A, Delpech V, 
Sabin C, Burns F. Associations with sub-optimal clinic attendance and reasons for missed 
appointments among heterosexual women and men living with HIV in London. AIDS Behav. 
2022;26(11):3620-9. 
102. 
Wilson IB, Lee Y, Michaud J, Fowler Jr FJ, Rogers WH. Validation of a new three-item 
self-report measure for medication adherence. AIDS Behav. 2016;20(11):2700-8. 
103. 
CDC. Medical Monitoring Project Fiedl Questionnaire Version 22.1. 2021 [07/10/2023]. 
Available from: https://www.cdc.gov/hiv/pdf/statistics/systems/mmp/cdc-hiv-mmp-questionnaire-
2021.pdf. 
104. 
NIDA. Screening and assessment tools chart. 2021 [07/10/2023]. Available from: 
https://nida.nih.gov/nidamed-medical-health-professionals/screening-tools-resources/chart-
screening-tools. 
105. 
Norelli J, Zlotorzynska M, Sanchez T, Sullivan PS. Scaling up CareKit: Lessons learned 
from expansion of a centralized home HIV and sexually transmitted infection testing program. 
Sexually Transmitted Diseases. 2021;48(8 Suppl):S66. 
106. 
Parmanto B, Lewis Jr AN, Graham KM, Bertolet MH. Development of the telehealth 
usability questionnaire (TUQ). International Journal of Telerehabilitation. 2016;8(1):3. 
107. 
Corrigan JD, Schmidt LD. Development and validation of revisions in the Counselor 
Rating Form. Journal of Counseling Psychology. 1983;30(1):64. 
108. 
Robinson OC. Sampling in interview-based qualitative research: A theoretical and 
practical guide. Qualitative Research in Psychology. 2014;11(1):25-41. 
109. 
Tong C. Statistical inference enables bad science; statistical thinking enables good 
science. The American Statistician. 2019;73(sup1):246-61. 
110. 
De Groot AD. The meaning of “significance” for different types of research [translated 
and annotated by Eric-Jan Wagenmakers, Denny Borsboom, Josine Verhagen, Rogier Kievit, 
Marjan Bakker, Angelique Cramer, Dora Matzke, Don Mellenbergh, and Han LJ van der Maas]. 
Acta Psychologica. 2014;148:188-94. 
111. 
Komorowski M, Marshall DC, Salciccioli JD, Crutain Y. Exploratory data analysis. 
Secondary Analysis of Electronic Health Records. 2016:185-203. 
112. 
DuToit SH, Steyn AGW, Stumpf RH. Graphical exploratory data analysis: Springer 
Science & Business Media; 2012. 
113. 
Braun V, Clarke V. One size fits all? What counts as quality practice in (reflexive) 
thematic analysis? Qualitative Research in Psychology. 2021;18(3):328-52. 
114. 
Clarke V, Braun V. Thematic analysis. The Journal of Positive Psychology. 
2017;12(3):297-8. 
115. 
Guest G, MacQueen KM, Namey EE. Applied thematic analysis: sage publications; 
2011. 
116. 
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in 
Psychology. 2006;3(2):77-101. 
117. 
Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs - 
Principles and practices. Health Services Research. 2013;48(6pt2):2134-56. 

29 
 
118. 
Wesolowski L, Chavez P, Sullivan P, Freeman A, Sharma A, Mustanski B, McNaghten 
A, MacGowan R. Distribution of HIV self-tests by HIV-positive men who have sex with men to 
social and sexual contacts. AIDS Behav. 2018:1-7. 
119. 
MacGowan RJ, Chavez PR, Gravens L, Wesolowski LG, Sharma A, McNaghten A, 
Freeman A, Sullivan PS, Borkowf CB, Owen SM. Pilot evaluation of the ability of men who have 
sex with men to self-administer rapid HIV tests, prepare dried blood spot cards, and interpret 
test results, Atlanta, Georgia, 2013. AIDS Behav. 2018. 
120. 
Sharma A, Kahle EM, Sullivan SP, Stephenson R. Birth cohort variations across 
functional knowledge of HIV prevention strategies, perceived risk, and HIV-associated 
behaviors among gay, bisexual, and other men who have sex with men in the United States. 
American Journal of Men's Health. 2018;12(6):1824-34. 
121. 
Freeman AE, Sullivan P, Higa D, Sharma A, MacGowan R, Hirshfield S, Greene GJ, 
Gravens L, Chavez P, McNaghten A. Perceptions of HIV self-testing among men who have sex 
with men in the United States: A qualitative analysis. AIDS Education and Prevention. 
2018;30(1):47-62. 
122. 
Sharma A, Sullivan SP, Stephenson RB. Detailed knowledge about HIV epidemiology 
and transmission dynamics and their associations with preventive and risk behaviors among 
gay, bisexual, and other men who have sex with men in the United States. JMIR Public Health 
and Surveillance. 2017;3(1). 
123. 
Sharma A, Chavez PR, MacGowan RJ, McNaghten A, Mustanski B, Gravens L, 
Freeman AE, Sullivan PS. Willingness to distribute free rapid home HIV test kits and to test with 
social or sexual network associates among men who have sex with men in the United States. 
AIDS Care. 2017;29(12):1499-503. 
124. 
Johnson BA, McKenney J, Ricca AV, Rosenberg ES, Liu C, Sharma A, Sullivan PS. Risk 
factors associated with pepeated HIV testing among internet-using men who have sex with 
men. AIDS Education and Prevention. 2016;28(6):511-23. 
125. 
Sharma A, Stephenson RB, White D, Sullivan PS. Acceptability and intended usage 
preferences for six HIV testing options among internet-using men who have sex with men. 
SpringerPlus. 2014;3(1):109. 
126. 
Sharma A, Sullivan PS, Khosropour CM. Willingness to take a free home HIV test and 
associated factors among internet-using men who have sex with men. JIAPAC. 2011;10(6):357-
64. 
127. 
Sharma A, Kahle E, Sullivan S, Stephenson R. Sexual agreements and intimate partner 
violence among male couples in the US: An analysis of dyadic data. Archives of Sexual 
Behavior. 2020:1-19. 
128. 
Sharma A, Paredes-Vincent A, Kahle EM. Awareness, utilization, and preferences for 
traditional and contemporary HIV prevention strategies among Facebook and Instagram-using 
MSM in the United States. Journal of the International Association of Providers of AIDS Care. 
2021;20:23259582211024770. 
129. 
Valencia R, Wang LY, Dunville R, Sharma A, Sanchez T, Rosenberg E. Sexual risk 
behaviors in adolescent sexual minority males: A systematic review and meta-analysis. The 
Journal of Primary Prevention. 2018. 
130. 
Sharma A, Wang LY, Dunville R, Valencia RK, Rosenberg ES, Sullivan PS. HIV and 
sexually transmitted disease testing behavior among adolescent sexual minority males: Analysis 
of pooled Youth Risk Behavior Survey data, 2005–2013. LGBT Health. 2017;4(2):130-40. 
131. 
Jenness SM, Sharma A, Goodreau SM, Rosenberg ES, Weiss KM, Hoover KW, Smith 
DK, Sullivan P. Individual HIV risk versus population impact of risk compensation after HIV 
preexposure prophylaxis initiation among men who have sex with men. PLOS ONE. 2017;12(1). 
132. 
Shah M, Perry A, Risher K, Kapoor S, Grey J, Sharma A, Rosenberg ES, Del Rio C, 
Sullivan P, Dowdy DW. Effect of the US National HIV/AIDS Strategy targets for improved HIV 
care engagement: A modelling study. The Lancet HIV. 2016;3(3):e140-e6. 

30 
 
133. 
Sharma A, Johnson BA, Sullivan PS. Evaluating interventions to promote routine 
preventive screenings: A comparison of analytical outcomes. Contemporary Clinical Trials. 
2015;41:152-9. 
134. 
Spaulding AC, Sharma A, Messina LC, Zlotorzynska M, Miller L, Binswanger IA. A 
comparison of liver disease mortality with HIV and overdose mortality among Georgia prisoners 
and releasees: A 2-decade cohort study of prisoners incarcerated in 1991. American Journal of 
Public Health. 2015;105(5):e51-e7. 
135. 
Bonar EE, Rosenberg H. Injection drug users’ perceived barriers to using self-initiated 
harm reduction strategies. Addiction Research and Theory. 2014;22(4):271-8. 
136. 
Bonar EE, Young KM, Hoffmann E, Gumber S, Cummings JP, Pavlick M, Rosenberg H. 
Quantitative and qualitative assessment of university students' definitions of binge drinking. 
Psychology of Addictive Behaviors. 2012;26(2):187. 
137. 
Philyaw-Kotov ML, Walton MA, Brenneman B, Gleckman-Krut M, Davis AK, Bonar EE. 
What undergraduates want in campus sexual assault prevention programming: Findings from a 
formative research study. Journal of American College Health. 2021:1-8. 
138. 
Thomas L, Bonar E, Hwa C, Coffin P, Bohnert A. Development of an evidence-based 
online toolkit to improve opioid safety. Injury Prevention. 2020;26(Suppl 1):A11-A2. 
139. 
Stein CH, Abraham KM, Bonar EE, McAuliffe CE, Fogo WR, Faigin DA, Raiya HA, 
Potokar DN. Making meaning from personal loss: Religious, benefit finding, and goal-oriented 
attributions. Journal of Loss and Trauma. 2009;14(2):83-100. 
140. 
Bonar EE, Ngo QM, Philyaw-Kotov ML, Walton MA, Kusunoki Y. Stealthing perpetration 
and victimization: prevalence and correlates among emerging adults. Journal of Interpersonal 
Violence. 2019. 
141. 
Bonar EE, Chapman L, McAfee J, Goldstick JE, Bauermeister JA, Carter PM, Young 
SD, Walton MA. Perceived impacts of the COVID-19 pandemic on cannabis-using emerging 
adults. Translational Behavioral Medicine. 2021;11(7):1299-309. 
142. 
Coughlin LN, Bonar EE, Bickel WK. Considerations for remote delivery of behavioral 
economic interventions for substance use disorder during COVID-19 and beyond. Journal of 
Substance Abuse Treatment. 2021;120:108150. 
143. 
Lin LA, Fernandez AC, Bonar EE. Telehealth for substance-using populations in the age 
of coronavirus disease 2019: recommendations to enhance adoption. JAMA Psychiatry. 
2020;77(12):1209-10. 
144. 
Bonar EE, Kidwell KM, Bohnert AS, Bourque CA, Carter PM, Clark SJ, Glantz MD, King 
CA, Losman ED, McCabe SE. Optimizing scalable, technology-supported behavioral 
interventions to prevent opioid misuse among adolescents and young adults in the emergency 
department: A randomized controlled trial protocol. Contemporary Clinical Trials. 
2021;108:106523. 
145. 
Bonar EE, Bauermeister JA, Blow FC, Bohnert AS, Bourque C, Coughlin LN, Davis AK, 
Florimbio AR, Goldstick JE, Wisnieski DM. A randomized controlled trial of social media 
interventions for risky drinking among adolescents and emerging adults. Drug and Alcohol 
Dependence. 2022. 
146. 
Bonar EE, Goldstick JE, Chapman L, Bauermeister JA, Young SD, McAfee J, Walton 
MA. A social media intervention for cannabis use among emerging adults: Randomized 
controlled trial. Drug and Alcohol Dependence. 2022;232. 
147. 
Bonar EE, Schneeberger DM, Bourque C, Bauermeister JA, Young SD, Blow FC, 
Cunningham RM, Bohnert AS, Zimmerman MA, Walton MA. Social media interventions for risky 
drinking among adolescents and emerging adults: Protocol for a randomized controlled trial. 
JMIR Research Protocols. 2020;9(5):e16688. 
148. 
Stephenson R, Bonar EE, Carrico A, Hunter A, Connochie D, Himmelstein R, 
Bauermeister J. Intervention to increase HIV testing among substance-using young men who 

31 
 
have sex with men: Protocol for a randomized controlled trial. JMIR Research Protocols. 
2018;7(4):e114. 
149. 
Bonar EE, Cunningham RM, Sweezea EC, Blow FC, Drislane LE, Walton MA. Piloting a 
brief intervention plus mobile boosters for drug use among emerging adults receiving 
emergency department care. Drug and Alcohol Dependence. 2021;221:108625. 
150. 
Chermack ST, Bonar EE, Goldstick JE, Winters J, Blow FC, Friday S, Ilgen MA, Rauch 
SA, Perron BE, Ngo QM. A randomized controlled trial for aggression and substance use 
involvement among Veterans: Impact of combining Motivational Interviewing, Cognitive 
Behavioral Treatment and telephone-based Continuing Care. Journal of Substance Abuse 
Treatment. 2019;98:78-88. 
151. 
Patrick ME, Boatman JA, Morrell N, Wagner AC, Lyden GR, Nahum-Shani I, King CA, 
Bonar EE, Lee CM, Larimer ME. A sequential multiple assignment randomized trial (SMART) 
protocol for empirically developing an adaptive preventive intervention for college student 
drinking reduction. Contemporary Clinical Trials. 2020;96:106089. 
152. 
Chermack ST, Bonar EE, Ilgen MA, Walton MA, Cunningham RM, Booth BM, Blow FC. 
Developing an integrated violence prevention for men and women in treatment for substance 
use disorders. Journal of Interpersonal Violence. 2017;32(4):581-603. 
153. 
Bonar EE, Walton MA, Barry KL, Bohnert AS, Chermack ST, Cunningham RM, Massey 
LS, Ignacio RV, Blow FC. Sexual HIV risk behavior outcomes of brief interventions for drug use 
in an inner-city emergency department: Secondary outcomes from a randomized controlled trial. 
Drug and Alcohol Dependence. 2018;183:217-24. 
154. 
Bauermeister J, Sullivan PS, Gravens L, Wolfe J, Countryman K, Smith-Bankhead N, 
Drab RA, Sallabank G, Helms JD, Khatibi K. Reducing HIV vulnerability through a multilevel life 
skills intervention for adolescent men (The iREACH Project): protocol for a randomized 
controlled trial. JMIR Research Protocols. 2018;7(7):e10174. 
155. 
Davis AK, Arterberry BJ, Bonar EE, Chermack ST, Blow FC, Cunningham RM, Walton 
MA. Predictors of positive drinking outcomes among youth receiving an alcohol brief 
intervention in the emergency department. Drug and Alcohol Dependence. 2018;188:102-8. 
____________________________________________________________________________ 
 
Ame00143150 
 
Section 1.b: We have made minor additions to the introduction section to clarify how the 
feasibility and acceptability of the intervention will be assessed. The amended text reads 
as follows: 
 
To investigate the feasibility and acceptability of a novel MI-based telehealth intervention to 
engage GBMSM-LWH in GC, CT, and syphilis testing, we propose to conduct a 2-year sequential 
explanatory mixed-methods study.70, 71 Our intervention is a package of 3 components: (i) a pre-
test live AV conferencing session involving an MI-guided discussion to elicit awareness of 
bacterial STIs and fill any knowledge gaps, bolster the perceived importance of regularly testing 
for GC, CT, and syphilis, and improve self-efficacy for specimen self-collection, (ii) self-collecting 
at home and returning by mail a urine sample (for GC and CT testing), a throat swab (for GC and 
CT testing), a rectal swab (for GC and CT testing), and a finger-stick blood sample (for syphilis 
testing), and (iii) a post-test live AV conferencing session involving an MI-guided discussion to 
prepare participants for receiving test results and formulate personalized action plans for seeking 
treatment (if warranted) and repeat testing. Feasibility will be assessed by documenting 
participants’ levels of engagement in the pre-test session, specimen return for bacterial STI 
testing, and the post-test session. Acceptability will be assessed by documenting overall 
intervention satisfaction, interventionist perceptions, usability of the pre-test and the post-test 

32 
 
sessions, willingness to repeat the intervention, and likelihood of recommending the intervention 
to friends or sex partners. Potential increases in participants’ knowledge of GC, CT, and syphilis 
will be assessed by comparing their responses to the same set of questions on these STIs 
included in the baseline survey (to be administered before intervention delivery) and the 
satisfaction survey (to be administered after intervention delivery). Potential increases in 
participants’ self-efficacy for specimen self-collection will be assessed by comparing their 
responses to similar sets of questions on the ease or difficulty of self-collecting each specimen in 
the baseline survey and the satisfaction survey. 
 
Section 5.a: We have made minor revisions to the description of outcome measures in the 
data analyses section to clarify which outcomes are primary and which outcomes are 
secondary, in alignment with the information registered on ClinicalTrials.gov. The 
amended text reads as follows: 
 
Descriptive statistics (e.g., means, medians and ranges for continuous variables, counts and 
proportions for categorical variables) and progression ratios (i.e., proportions who sequentially 
progress through different intervention components) will be calculated using software for 
quantitative data analysis (e.g., SAS, Excel). 
 
Primary outcome measures: 
 
Outcomes to measure the feasibility of our intervention include the following: 
(i) Number of participants that schedule a pre-test session. 
(ii) Number of participants that join the pre-test session within 30 min of the start time. 
(iii) Number of participants that return each type of specimen within 6 weeks of box delivery. 
(iv) Number of participants that provide specimens of adequate quality for lab testing. 
(v) Number of participants that schedule a post-test session. 
(vi) Number of participants that join the post-test session within 30 min of the start time. 
 
Outcomes to measure the acceptability of our intervention include the following: 
(i) Overall intervention satisfaction: Participants’ satisfaction with the pre-test session, urine 
sample self-collection, throat swab self-collection, rectal swab self-collection, finger-stick blood 
sample self-collection, and the post-test session will be assessed using six 5-point Likert items 
included in the satisfaction survey. Response values will be summed to obtain a total score 
ranging from 6-30, with higher scores indicating greater overall intervention satisfaction. 
(ii) Interventionist perceptions:  Participants’ perceptions of the interventionist conducting the pre-
test and the post-test sessions will be assessed using two 12-item Counselor Rating Form Short 
scales included in the satisfaction survey. Response values will be summed to obtain a total score 
ranging from 24-168, with higher scores indicating more positive interventionist perceptions. 
(iii) Usability of the pre-test and the post-test sessions: Participants’ usability of the pre-test and 
the post-test sessions will be assessed using two 4-item subscales from the Telehealth Usability 
Questionnaire on the quality of interactions with the interventionist during each session included 
in the satisfaction survey. Response values will be summed to obtain a total score ranging from 
8-56, with higher scores indicating greater usability of the pre-test and the post-test sessions. 
 
(iv) Willingness to repeat the intervention: Participants’ willingness to repeat the pre-test session, 
urine sample self-collection, throat swab self-collection, rectal swab self-collection, finger-stick 
blood sample self-collection, and the post-test session will be assessed using six 5-point Likert 
items included in the satisfaction survey. Response values will be summed to obtain a total score 
ranging from 6-30, with higher scores indicating greater willingness to repeat the intervention. 

33 
 
(v) Likelihood of recommending the intervention to friends or sex partners: Participants’ likelihood 
of recommending the pre-test session, urine sample self-collection, throat swab self-collection, 
rectal swab self-collection, finger-stick blood sample self-collection, and the post-test session to 
friends or sex partners will be assessed using six 5-point Likert items included in the satisfaction 
survey. Response values will be summed to obtain a total score ranging from 6-30, with higher 
scores indicating greater likelihood of recommending the intervention to friends or sex partners. 
 
Secondary outcome measures: 
 
Outcomes to measure the potential impact of our intervention on IMB model constructs include 
the following: 
(i) Improvement in STI-related knowledge: Potential increases in participants’ knowledge of GC, 
CT, and syphilis will be assessed by comparing responses to the same set of 22 items included 
in the baseline survey and the satisfaction survey. Response values will be summed to obtain 
separate total scores ranging from 0-22, with higher scores indicating greater STI-related 
knowledge. 
(ii) Likelihood of testing for bacterial STIs at least annually: Participants’ likelihood of testing for 
bacterial STIs at least annually will be assessed using a single 5-point Likert item included in the 
satisfaction survey. Response values will range from 1-5, with higher values indicating greater 
likelihood of testing for bacterial sexually transmitted infections at least annually. 
(iii) Improvement in self-efficacy for specimen self-collection: Potential increases in participants’ 
self-efficacy for urine sample self-collection, throat swab self-collection, rectal swab self-
collection, and finger-stick blood sample self-collection will be assessed by comparing responses 
to similar sets of four 5-point Likert items included in the baseline survey and the satisfaction 
survey. Response values will be summed to obtain separate total scores ranging from 4-20, with 
higher scores indicating greater self-efficacy for specimen self-collection. 
 
Outcomes to measure the prevalence of bacterial STIs and receipt of treatment include the 
following: 
(i) Number of participants that test negative or positive for GC, CT, and syphilis (using our 
specimen self-collection kits or with their own provider or at a clinic). 
(ii) Number of participants that initiate treatment (with their own provider or at a clinic or via 
commercial telehealth services) within 1 week of receiving a positive test result. 
 
Because our study is inherently exploratory, we do not plan on using probability-based statistical 
inference techniques in line with current best practices.109, 110 Instead, potential variations in our 
intervention’s feasibility and acceptability across selected participant characteristics, and its 
potential impact on IMB model constructs will be numerically summarized and graphically 
visualized (e.g., side-by-side boxplots, scatter plots), as recommended for exploratory data.111, 112 
____________________________________________________________________________ 
 
Ame00145753 
 
Instead of using a bubble mailer for participants to return their specimens, we will be using a 
shipping box made of cardboard as the outer shipping package. This change is to promote 
compliance with the Hazardous Materials Regulations for the safe transportation of hazardous 
materials, including Category B infectious substances, that recommend the use of "rigid outer 
packaging" (HMR; 49 CFR §173.199). To reflect this change, we have replaced the phrase 
"bubble mailer" with "shipping box" in the informed consent form and have updated the general 
information sheet that includes packaging instructions for participants. We have also included our 
contact details in the general information sheet and the supplemental information sheet so that 

34 
 
participants can readily contact us via phone or email if they have any questions. We have 
updated the lab test results form to include the Emory University Clinical Virology Research Lab's 
CLIA ID (11D1069803), so that participants can look up detailed information about the lab on the 
Centers for Medicare & Medicaid Services website. We have also changed the study's start date 
from 11/1/23 to 3/1/24. Per our correspondence with HSIP, we have checked the option for cash 
and unchecked the option for HSIP issued gift cards to disburse participant incentives. Study team 
members who have taken the TME103 training may pick up cash in the form of a prepaid Visa 
card from Wolverine Tower and use it to purchase e-gift cards from Amazon, which is an approved 
third-party vendor for HSIP. 
____________________________________________________________________________ 
 
Ame00147334 
 
In an effort to reach a greater number of potential participants, we will also place advertisements 
on Adam4Adam, Jack’d, and Sniffies. We have added their Web addresses (URLs) to the 
application. Our advertisements will include content that has been previously approved by the 
IRB. We have also checked the option for Study Coordinator/Research Assistant in the fields for 
who will provide study information and instructions to the participants beyond what is included in 
the informed consent form, obtain informed consent, and monitor subjects and identify adverse 
events. Additionally, we have added the names and areas of expertise of the Data and Safety 
Monitoring Board (DSMB) members and uploaded a copy of the signed DSMB charter. 
____________________________________________________________________________ 
 
Ame00147802 
 
To minimize the potential for fraudulent activity, we will schedule a 10 min live audio/video 
conferencing session over Zoom to verify a potential participant’s contact information. Time slots 
will be offered in all US time zones and be flexible to meet their individual circumstances. Once a 
time is confirmed, potential participants will be sent a password-protected Zoom link. They will 
need to keep their camera on during the session, but no audio or video will be recorded. During 
the session, a study team member will verify their full name, email address, mobile phone number, 
and mailing address. Based on a review of the baseline and satisfaction survey metadata in 
Qualtrics, we will undertake a similar verification process before disbursing participant incentives 
on as as-needed basis. To reflect these changes, we have added this information to the informed 
consent form, created a new Qualtrics survey to seek re-consent, and drafted correspondence 
scripts for scheduling a Zoom session and for re-consenting previously enrolled participants. 
____________________________________________________________________________