Game Plan: Testing the Efficacy of a Brief, Web-based Intervention in Reducing Heavy Drinking and Reducing Sexually-transmitted Infections Among High-risk Men Completing Self-testing
Phase: NA
Conditions: Sexually Transmitted Diseases, Bacterial, Alcohol; Harmful Use
Sponsor: Brown University

Official Title of Study: Brief, web-based intervention to reduce heavy drinking and encourage 
prevention among high-risk men completing HIV/STI self-testing 
NCT Number: ID Not Yet Assigned 
Date of document: 5/29/2020 
 
 

3.C.3. Randomized Controlled Effectiveness Trial 
 
3.C.3.1. Recruitment Areas and Methods. After start-up, we will recruit 360 heavy 
drinking, high-risk MSM from several gay-oriented smartphone dating applications (e.g., Grindr, 
Jack’d, Scruff) and social networking sites (e.g., Facebook, Instagram, Twitter) in five major US 
cities: Atlanta, Los Angeles, Miami, 
New Orleans, and Washington 
D.C./Baltimore. We chose these 
areas due to their high HIV 
prevalence, MSM living with 
undiagnosed HIV, and substantial 
populations of African American 
and Hispanic/Latino MSM (see 
Table 3). Each of the identified 
advertising platforms allows 
researchers to focus their ads toward users in specific cities (e.g., < 30 miles of city center), and 
we will adjust our ad strategy as needed to recruit as evenly across each area as possible. We 
have been using a similar approach in several ongoing studies in other cities and have pre-
screened 5,135 MSM over 4 years (see §3.C.6. for feasibility details). See Table 5 (Forms E, 
§2.7) for recruitment timeline.  
 3.C.3.2. Participants. Eligible participants will be (1) assigned male sex at birth, (2) currently 
male gender, (3) 18+ years old, (4) HIV-negative or unknown status, (5) able to speak and read 
English or Spanish fluently, and report (6) drinking heavily within the past month, defined 
according to NIAAA guidelines as having drank >5 drinks on a single occasion at least once or 
an average of >14 drinks in a given week127. Participants will also report (7) not being currently 
prescribed or taking PrEP and (8) having met at least one of three HIV-risk-related PrEP 
eligibility criteria in the last 6 months128, which include: (a) having been diagnosed with an STI, 
(b) currently having regular anal sex with a man who is HIV-positive, or (c) having had anal sex 
without a condom with a man outside of the context of a sexually exclusive relationship with a 
single partner who has been recently tested and is HIV-negative. We elected to recruit those not 
currently on PrEP given that Game Plan involves content explicitly intended to encourage users 
to seek a consultation about PrEP and beginning a PrEP regimen is a key risk-reduction 
outcome (see §3.A.4.2.). Participants will be ineligible if they report injection drug use within the 
past year, given that these individuals are likely to struggle with more severe dependence than 
can be addressed with a brief web-based intervention.  
 3.C.3.3. Measures. After enrolling, participants will complete a baseline questionnaire 
assessing demographics, HIV/STI testing history , recent sexual behavior129-136, alcohol/drug 
use130; 137, the Readiness to Change Questionnaire138; 139, health empowerment140, sexual 
motives for drinking141, and other constructs.  
 3.C.3.3.1. Measures of app engagement. Several measures of app engagement will be 
collected as participants use Game Plan, including modules entered and completed, as well as 
dwell time and scroll depth on each screen142. Although the app stores no identifiable data, 
participants will use a unique study ID number on the “onboarding” screens to access content. 
This allows us to export all data entered via the command line on the server in order to link it 
with the participant database or other web applications using its Application Programming 
Interface (API). These data will be used to address some implementation outcomes in Aim 3, 
including adoption and engagement (see §3.C.4.).   
 3.C.3.3.2. Quarterly online questionnaires. Participants will also complete follow-up surveys 
online each quarter during the 12-month study period. Alcohol and drug use in the past 30 days 
will be assessed in these surveys using an online Timeline Followback (TLFB)137; 143; 144. In this 
task, participants are first presented with a calendar of the past 30 days, and are asked to 
identify days on which they drank alcohol. For each day identified, a day-level “detail view” 
TABLE 3. Estimates of relevant participant 
characteristics in each geographic area 
 
Undiagnosed 
HIV per 100 
MSM rate115 
Est. male 
same sex 
couples116 
% of 
population126 
AA 
H/L 
Atlanta 
1.62 
107,312 
28.9 
6.5 
Los Angeles 
0.71 
241,370 
7.6 
40.3 
Miami 
1.35 
116,308 
20.4 
40.3 
New Orleans 
2.08 
21,162 
37.5 
4.4 
D.C./Baltimore 
1.03 
159,598 
26.2 
6.4 

allows participants to report how many standard drinks they consumed (standard drink = 12 oz. 
beer, 5 oz. wine, and 1 oz. of liquor; a graphic “key” is provided to assist), how many hours they 
drank, and what their peak level of intoxication was ([1] not at all to [10] extremely) each day. 
Participants are then asked to identify days on which they used drugs, and for each day, which 
drugs they used (8 possible classes; e.g., marijuana, cocaine, prescription stimulants, etc.), and 
how high they were ([1] not at all to [10] extremely). Sexual behavior will be assessed using this 
same TLFB. Participants first identify days on which they had oral, anal, or vaginal sex. A “detail 
view” then guides them in reporting the number of sex partners they had on each day (up to 4), 
as well as each partner’s gender, whether they were a new partner, were an exclusive/non-
exclusive partner, whether they asked about each partner’s HIV status or the last time they 
tested, and if so, what their status was, whether their partner was on PrEP, and whether they 
asked about PrEP directly prior to sex. They are then asked to report which sex acts they 
engaged in with each partner (oral, insertive anal, receptive anal, vaginal sex) and whether they 
used a condom for each act. Past studies show that online TLFBs are reliable and valid for 
assessing alcohol use, drug use, and sex144-148.  
 Quarterly surveys will also involve detailed assessment of participants’ receipt of HIV/STI 
testing (aside from study-provided kits), risk reduction counseling, and alcohol/drug treatment 
since their last survey. These surveys will also ask participants about whether they sought 
consultation with a healthcare provider about starting PrEP and whether they received a PrEP 
prescription and are taking it. For those who reported taking PrEP since the last survey, the 
TLFB will also assess daily adherence over the past month. Although we are aware that self-
report measures of PrEP adherence have clear limitations149; 150, these reports will primarily be 
used to explore possible secondary analyses of how well those on PrEP fare across the two 
conditions. Finally, quarterly surveys will also assess alcohol- and drug-related problems, using 
the AUDIT151 and Drug Abuse Screening Test (DAST-10)152-154, respectively. Among 
participants who were assigned to receive access to Game Plan and used it, 3-month surveys 
will also assess implementation outcomes of satisfaction (using the Client Satisfaction 
Questionnaire-8155, and acceptability and appropriateness, using scales adapted from past 
studies156; 157 and recommended by Proctor et al.117. 
 
3.C.3.3.3. HIV/STI testing. Study staff will mail CareKits to each participant at baseline, 6-
months, and 12-months. CareKits are prepared by the Emory University CFAR’s Prevention 
Science Core and, and they provide these kits and lab testing at cost to NIH-funded studies. 
The kits contain a urine collection cup, throat swab, rectal swab, and capillary blood collection 
tube, and all other supplies needed to collect valid samples (e.g., alcohol pads, lancets, etc.). 
An OraSure OraQuick® Rapid HIV 1/2 Antibody test is also provided to facilitate HIV testing. 
Each sample container is labelled with a barcode that is associated with that participant’s 
unique study ID. Participants can also register their kits with a provided Box ID. Detailed 
instructions explaining how each sample should be collected, stored, and shipped are also 
included and presented in multiple formats (graphic, text, videos). For pharyngeal CT/GN 
testing, participants will be instructed to swab their tonsils and throat using a 6” sterile swab, 
and to seal it in a provided culture tube. For rectal CT/GN testing, they will be instructed to dab 
a small amount of provided lube onto a polyester swab and insert at least an 1.5 in. into their 
rectum and swab in a circle before sealing in a culture tube. Finally, participants will be 
instructed to lance their fingertip and provide about 200 mL (6-12 drops) of blood into a capillary 
blood collection tube. All kit contents will be shipped in provided biohazard containers via FedEx 
to Emory’s laboratories (Atlanta, GA) to perform testing. Abbott RealTime assays will be used to 
test rectal, throat, and urine samples for CT/GN158, and “classical” testing algorithms (non-
treponemal, then treponemal tests) for Syphilis159. Once testing has been completed, results will 
be provided to study staff, who will then contact participants via phone within 24 hours to deliver 
their results.  Similar to previous studies100; 101, staff will provide a secure link and password 
which participants can use to access or print their certified test results and a list of local 

treatment providers. Staff will monitor participants who have tested positive for any STI and 
follow-up with them periodically to ensure that they receive treatment. For more details on the 
delivery of HIV/STI results and treatment, see Human Subjects Protections, §1.b.1, 2.b.1.(4). A 
number of past studies show that HST is feasible, acceptable, and produces valid samples for 
testing16; 17; 99-101. In one study of MSM, 97% of genital and rectal samples collected were valid 
and returned to labs for analyses100; 101. 
 3.C.3.3.4. Phsophatidylethanol (PEth). PEth is a phospholipid that can appear on red blood 
cell membranes when an enzyme that assists in membrane trafficking (phospholipase D) reacts 
due to alcohol exposure160. As such, PEth has been used as a biomarker of recent alcohol use, 
since the quantity of PEth produced is directly proportional to the concentration of alcohol160. 
Since PEth has a 4-day half-life161, it may be most accurate in identifying binge drinking 
episodes that occur 1-4 days before sampling31. However, some studies have shown that PEth 
can accurately estimate frequent heavy drinking 2 weeks or more prior to sampling31; 160; 162. To 
facilitate PEth analysis, dried blood spot (DBS) cards will be prepared from provided capillary 
blood samples. DBS samples will be prepared by Emory CFAR lab staff by pipetting blood onto 
903 Protein Saver Cards (Whatman/GE Healthcare, Piscataway, NJ). Cards will be dried for a 
minimum of 4 hours before being transferred to plastic bags with desiccant packs and a 
humidity indicator. Samples will then be shipped directly to US Drug Testing Laboratories (Des 
Plaines, IL) for PEth analysis.  
 3.C.3.4. Conditions. After enrollment, participants will be block randomized by geographic 
area and high AUDIT (>8) scores 1:1 to two conditions. In one (1), participants will be 
encouraged to call a 24-hour helpline after testing that provides standard post-test counseling 
and referrals. In the other (2) participants will be encouraged to use the Game Plan app, but 
provided access to the 24-hour helpline as well. Through another project led by Dr. Wray 
(Contact PI; R01MH114891), we have established a 24-hour helpline of certified HIV phone test 
counselors that provides risk reduction counseling and referrals as part of another study 
involving home delivery of HIV self-tests. Risk reduction counseling provided during these calls 
is the same person-centered counseling approach provided in most HIV testing clinics19, and is 
based on CDC guidelines18. It involves providing education about risk, identifying specific 
behaviors that put callers at risk, and devising a specific, realistic plan for reducing risk. Those 
in the Game Plan condition will be provided with a link to the website as well as the helpline 
number. In both conditions, participants will be encouraged to use these services via a large 
postcard included in each test kit and via email, and so, can use them after each test.  
 3.C.3.4.1. Game Plan – Interactive text messaging. At the end of the Game Plan intervention, 
users can opt-into an interactive text messaging component (developed through TextIt) that 
conducts check-ins with users about their alcohol use and HIV risk behavior each week and 
provides feedback about whether rates of these behaviors reflect progress toward their chosen 
goals. As users receive feedback over time, they can elect to change their goals, select new 
ones, and ask to receive information about various services via text (responses provide links to 
the CDC’s HIV/STI testing and PrEP locator widgets). Although this program was designed to 
last 12 weeks, participants can elect to continue beyond this period or stop receiving messages 
at any time. This program is similar to that used in RC2 (REACH 2 & 3), which was in turn 
modeled from several previous studies of alcohol use and HIV risk behavior in MSM showing 
promising results163; 164 (see §C.7.b of RC2).  
 
3.C.3.5. Procedures. Ads recruiting MSM for a study on home-based HIV/STI testing will be 
placed on several MSM-oriented smartphone dating apps (e.g., Grindr, Scruff, Jack’d) and 
general social media sites (e.g., Facebook, Instagram). These ads will display to users who log 
in within 30 miles of each designated metro area. Clicking on the ad will direct users to a landing 
page for the study, where they can view brief details about the study and its requirements. 
Interested users will complete a brief questionnaire to assess eligibility. Those eligible will then 
be directed to provide informed consent online, as well as basic contact information, and a 

baseline questionnaire (see Human Subjects Protections §2.a for details about online informed 
consent). Once users have consented and registered, staff will conduct a brief introductory call 
to verify their contact information, ensure their understanding of study requirements, and 
encourage adherence to follow-up procedures. After completing this call, study staff will mark 
these participants as ‘fully enrolled,’ activating them in the study database. Research staff will 
then prepare MyCare kits for each participant, log their PIN number and shipping information in 
the study database, and ship them to participants’ provided home addresses with a condition-
appropriate postcard (e.g., Game Plan vs. Helpline only). Email notifications will be 
automatically sent to participants after receiving their test kits to call or visit the website URL, as 
appropriate. Helpline counselors are bachelor’s-level staff who are certified as HIV test 
counselors and are trained in crisis intervention. A Spanish-speaking counselor is on-call at all 
times. Counselors will record data for each helpline  call in the study database. In both 
conditions, these procedures will be repeated for 6- and 12-month test kits.  
 
Quarterly online follow-up surveys will use REDCap165 and will be hosted on Brown 
University servers. On the date 
each survey is due, the study 
database will automatically 
send participants an email with 
language-specific instructions 
and links to the survey. 
Participants will be asked to 
complete these within two days, 
and reminder emails will be 
sent every other day for seven 
days after the due date. If 
participants have not completed the survey within a week of their due date, staff will contact 
participants by phone, text message, and email to encourage adherence. Those who fail to 
complete two consecutive quarterly assessments will be considered to have withdrawn from the 
study. Participant payments will be issued via a reloadable debit card mailed after participants 
are activated in the study. Participants will earn $20 for each of the five online surveys they 
complete over a year, plus $20 for completing each mailed HIV/STI test, with a bonus of $40 for 
completing all study procedures within a week of their due date, for a possible total of $200. See 
§3.C.6. for details about the feasibility of these procedures.  
 
3.C.3.5.1. In-depth individual qualitative interviews with Game Plan users. After completing 
their 12-month testing and follow-up survey, 30 participants who used Game Plan will be 
randomly selected to participate in an individual interview via videoconferencing in exchange for 
an additional $25 payment. These interviews will be focused on exploring key implementation 
questions posed in Aim 3 in greater detail. Specifically, these interviews will be focused on 
eliciting major themes that affected participants’ adoption, engagement, and satisfaction with 
Game Plan, and their sense of its appropriateness alongside HIV/STI self-testing. Facilitators 
will review Game Plan’s components and guide participants them in discussing the fit and utility 
of each with self-testing. Interviews will be led by Drs. Wray and Elwy (Research Methods Core 
faculty), following a semi-structured format, and will last about an hour. Interviews will be audio 
recorded and transcribed for analysis.  
 
3.C.3.5.2. Virtual focus groups with key stakeholders. Near the end of the effectiveness 
study, we will recruit 12 testing program decision-makers (i.e., from public health departments) 
who are considering or actively using home-based HIV/STI testing strategies in their 
communities from our existing contacts. In two virtual focus groups (N = 6 each), we will explore 
major implementation themes and anticipated barriers from the perspectives of stakeholders 
who would ultimately be responsible for integrating Game Plan into their testing programs. 
Facilitators will guide discussion on each of Proctor et al.’s117 implementation outcomes (e.g., 
Figure 3. Participant timeline over the study period.  
 

adoption, appropriateness, costs) and key concepts of the Dynamic Sustainability Framework121 
(e.g., how to achieve organizational support, long-term funding strategies, tracking program 
benefit) and use data collected from users during the effectiveness study to guide discussion. 
Facilitators will also review several of Powell’s categorization of implementation strategies166 to 
elicit feedback and help identify promising strategies. Finally, participants will also complete the 
Evidence-based Practice Attitudes Scale167. Focus groups will be led by Drs. Wray and Elwy, 
will follow a semi-structured format, will last about 90 minutes, and will be audio-recorded for 
later transcription. P Participants will be reimbursed $50 for their time.  
 
 
3.C.4. Planned Analyses. All analyses will be led by Dr. Chrysanthopoulou (Biostatistics 
faculty, Research Methods Core) and will be conducted in intent-to-treat fashion168. Missing data 
for all primary and secondary outcome variables will be addressed using multiple imputation169. 
Binge drinking (BD) will consist of the number of days on which > 5 standard drinks were 
consumed in the 30 days prior to each online follow-up. Average number of drinks per drinking 
day (ADPDD) will consist of the average number of standard drinks participants reported on 
days when they drank in the past 30 days before each follow-up. PEth, a secondary outcome, 
will consist of the quantity (ng/µL) detected in each DBS sample at each STI/HIV testing 
interval. To address Aim 1, we will (a) estimate a generalized estimating equation (GEE) with 
BD as an outcome and time, geographical area, condition (and their interactions), as well as 
problem drinking (AUDIT > 8 at baseline) and lifetime STI history as predictors. As BD is a 
“count” outcome, a Poisson distribution and log link function will be specified. A similar GEE 
model will be estimated with ADPDD, but with a normal distribution specified. Finally, we will 
estimate a similar GEE model with PEth as an outcome, specifically among those who reported 
an average of > 7 drinks/day per week or at least one BD day within 2 weeks prior to sampling, 
excluding undetectable samples. This will allow us to explore between-group differences in 
PEth, specifically among those whose PEth data are likely to be most accurate. To address Aim 
2, rates of new STI diagnoses will be coded as a binary variable that reflects whether any STI 
was detected during baseline, 6, and 12 month testing. We will then estimate a GEE model with 
a binomial distribution and logit link function, using STI rates at each time point as an outcome, 
and time, geographical area, lifetime STIs, and condition as predictors. Although we will 
similarly compare rates of new HIV infections across study conditions, we expect that this rate 
will be too low to afford meaningful comparisons. Sexual risk behavior, for the purposes of this 
study, will be considered any insertive or receptive anal sex with a non-exclusive partner or 
partner whose HIV status is uncertain without using a condom, or for those who have started 
PrEP, without reporting having taken a dose within 2 days of sex occurring. We chose to 
characterize this outcome so stringently in order to reflect sexual behavior that likely poses a 
risk specifically for HIV transmission. However, we will also explore condomless anal sex events 
with new or non-exclusive partners as a whole, since these acts are also likely to pose a risk of 
STI transmission. Between-group differences in PrEP uptake across the study period will be 
assessed using logistic regression with a binary variable representing whether participants 
started PrEP at any time across the year-long study as an outcome variable, and geographical 
area and condition as predictors. To address Aim 3, we will calculate descriptive data on Game 
Plan in-app use data to explore how many participants accessed it, used each module, and set 
behavior change goals as metrics of adoption and engagement. We will also calculate 
descriptive data for follow-up survey questions assessing participants’ perceptions of Game 
Plan’s appropriateness and satisfaction. Transcripts from both individual in-depth interviews and 
virtual focus groups will be analyzed using a directed content approach170. Using this approach, 
two independent raters (TW and RE) will review and code transcripts using NVivo, and then 
meet to review codes and develop a coding framework171. We will then use this framework to 
help arrive at consensus about major themes identified for each of the implementation 
outcomes that were addressed, first from the user (participant) perspective and then from the 

stakeholder perspective. Further data collection will be conducted if needed until few new codes 
or themes are identified in each topic area and saturation is likely172. Reports prepared on these 
analyses will follow COREQ guidelines for qualitative research173.