Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
Phase: NA
Conditions: HIV Infections, Alcohol Abuse
Sponsor: Brown University

STATISTICAL ANALYSIS PLAN 
Title: Brief Electronic Intervention for Heavy Drinking and Sex Risk Among Men who have sex with Men 
Seeking HIV Testing 
NCT#: NCT03435783 
Date of document: Last reviewed and approved by Brown IRB on 7/21/17 

 
 
C.   DESCRIPTION OF THE STUDY 
 
(C.1) Significance and Specific Aims of Project 
(C.2) Participant Population 
(C.3) Recruitment Procedures 
(C.4) Design and Methods 
 
C.1  Significance and Specific Aims of Project 
The annual rate of new HIV infections among men who have sex with men (MSM) in the 
United States continues to grow rapidly, despite stability or decline among other groups1. 
Population-level HIV prevalence among MSM in North America is estimated at 15.4%2, far and 
away the highest of any group. These data reflect the pressing need to continue developing and 
testing new tools for prevention among MSM that are well-positioned to reach those at highest 
risk. Responding to these risks is also consistent with goals identified in the US National 
Strategy on AIDS aimed at reducing new infections and overall health disparities among MSM3. 
Although a number of sex risk reduction interventions exist for MSM, barriers to dissemination 
and/or implementation limit their reach, and they fail to address pivotal factors that lead to high-
risk behavior, such as alcohol use4; 5. Alcohol has been referred to as ‘the forgotten drug in 
HIV/AIDS”6, and reviews of the HIV epidemiology literature have highlighted the role of alcohol 
in fueling HIV transmission among MSM7. To date, only 7 interventions have been rigorously 
tested for efficacy in reducing heavy alcohol use among MSM8, and all involve lengthy treatment 
protocols that present substantial barriers to their widespread use.  
 
We propose a three-year study to develop and pilot test a brief, combined behavioral 
prevention intervention to reduce heavy drinking and unprotected anal intercourse (UAI) among 
HIV-negative MSM who are seeking HIV testing services offered in community settings. 
Individual-level behavioral interventions (BIs) can often be administered in a single session and 
offer a potentially effective solution for both providing prevention services in resource-
constrained contexts and reaching MSM at highest risk for HIV acquisition9; 10. Brief BIs have 
been independently shown to be effective in reducing HIV risk in MSM and in reducing 
hazardous alcohol use in other populations. Our preliminary research supports the efficacy of a 
combined intervention for heavy drinking and sex risk, guided by the principles of motivational 
interviewing (MI), among HIV+ MSM and other high-risk groups. As such, combining existing 
interventions into a multi-component BI could yield robust prevention outcomes, particularly in 
MSM, among whom both behaviors are prevalent2; 11. Moreover, adapting each of these 
approaches into a technology-based format and optimizing them for use with tablet computers 
could leverage existing technology in order to maximize the reach and impact of the intervention 
on this priority population, one that eludes traditional public health and clinical interventions.  
 
The proposed research has two phases: Phase 1 involves an iterative development 
process, based on qualitative research, that focuses on: (a) adapting existing combined, MI-
based alcohol and sex risk intervention components to a technology-based format, and (b) 
understanding and addressing challenges in implementation, feasibility, and acceptability with 
high-risk MSM in community settings. Initial versions of the intervention (pre-alpha and alpha 
versions) created during Phase 1 will be heavily informed by Co-PIs, consultants, and 
developers. Subsequent (beta) versions will be informed by Phase 1 research, using focus 

 
groups, individual interviews, and theatre tests with high-risk MSM and other stakeholders. 
Phase 2 entails conducting a randomized-controlled pilot test of the intervention to explore its 
effects on HIV-risk behavior and alcohol use among MSM seeking testing in community-based 
outreach venues.  
Proposed Study and Specific Aims  
 
Specific Aim 1: Adapt existing protocols for MI-based combined BIs – which have 
previously been shown to reduce unsafe sex and heavy drinking – for use on tablet computers 
with MSM in community settings.  This will be accomplished in an iterative developmental 
process using qualitative methodologies with target group members and local stakeholders to 
produce a feasible and acceptable brief, technology-based intervention program for pilot testing 
in Phase 2.  
 
 
 
Specific Aim 2: Conduct a small randomized-controlled pilot study (N = 40) examining the 
preliminary effects of an adapted and integrated tablet-based BI, compared against an attention-
matched control, in reducing sexual risk and alcohol use among a sample of high-risk MSM 
seeking HIV testing in a community venue. We will evaluate our primary HIV-related outcomes 
(sexual risk behavior and alcohol use) at 1-, 3-, and 6-month follow-ups and conduct process 
evaluation to examine implementation procedures. Quantitative and qualitative data will be used 
to inform any further modifications that might be necessary for conducting a larger, randomized 
controlled trial of the intervention. 
 
 
 Overall, this research will produce the first known combined, theory-based, technology-
adapted intervention for alcohol and HIV risk among high-risk MSM in community settings. Use 
of a tablet-based, portable platform for intervention delivery is a particularly innovative feature 
that offers a number of important advantages over traditional intervention approaches. Should 
pilot data provide initial evidence of efficacy, this research will provide the groundwork for a 
future full-scale randomized controlled trial that tests the effects of this intervention on co-
occurring HIV and alcohol risk behaviors and biological indicators of risk in MSM. 
 
C.2 Participant Population 
 
Across all phases of the research, data will be collected from two groups: (1) Key 
informants (including health/social service providers, volunteer testing staff, and commercial sex 
venue staff; for Focus Groups, Phase 1a) and (2) high-risk MSM attending local commercial sex 
venues. Thus, 24 key informants, and 75 high-risk MSM participants (Individual interviews, N = 
35; Pilot study, N =40) will be recruited as a part of this research. Key informants will be 
recruited based upon existing community contacts and referrals. High-risk MSM participants will 
be recruited from the target venues after they have completed HIV testing and they report non-
reactive results. All participants will be individuals aged 18 and older. The use of participants 
older than 18 is appropriate to ensure applicability of findings to adult populations of men who 
have sex with men (MSM) at risk for HIV infection. No special or vulnerable populations, as 
defined by 45 CFR Part 46 (e.g., prisoners, pregnant women, fetuses) are involved.  
 
High-risk MSM participants will be recruited through their indication of interest in 
participating in a research study on a standard “exit” assessment form that is collected by AIDS 
Project Rhode Island (APRI) after conducting rapid oral HIV testing and counseling at the 
venues. To ensure anonymity during the testing procedure, participants will only be approached 
by research staff after all standard HIV testing and counseling procedures are completed, and 
after APRI staff and participants verbally confirm a negative HIV testing result. This procedure 

 
will ensure both that the anonymity of testers is maintained and that only those that are HIV-
negative are recruited. Given that those seeking testing from these settings come from diverse 
racial/ethnic backgrounds, we expect that the proposed research will be capable of recruiting a 
similarly diverse sample.  
 
Inclusion criteria for the research (Phases 1 and 2) are as follows: 
1. Biologically male 
2. Aged 18 or older 
3. Fluent English speaker 
4. Unprotected anal sex with a casual male partner at least once in the past 3 months  
5. Heavy alcohol use during the past 2-weeks (>14 drinks per week, or at least one 
occasion of 5+ drinks on a given occasion) 
6. Breath alcohol concentration (BrAC) of .000 at the time of enrollment 
7. No history of complex alcohol withdrawal 
8. Score of <4 for methamphetamine and <3 for cocaine and heroin/opiates on the SDS 
9. HIV-negative 
 
Exclusion criteria: 
1. Individuals who are HIV-positive 
2. Individuals who participated in other phases of the research 
3. Individuals who report being coerced to participate 
 
 
C.3  Recruitment Procedures 
 
 
 
We will recruit participants who have sought and consented to voluntary, rapid oral-swab 
HIV counseling and testing (VCT) and subsequently test negative. Testing is free, anonymous, 
and conducted by APRI at two sites from which we will recruit: (1) AIDS Project Rhode Island 
offices and (2) a local Providence, RI bathhouse (Megaplex). See Appendix C for consent 
documents for individual interview participants. See Appendix D for consent documents for pilot 
study participants. Staff at both venues have arranged for private, quiet spaces in the venue that 
allow patrons to enter and complete testing anonymously. After testing, standard APRI protocol 
involves administration of a brief, anonymous questionnaire regarding testers’ risk behavior and 
other concerns. An item inquiring about participants’ potential interest in participating in the 
study will be added to this questionnaire and will signal to the APRI tester to refer the patron to 
study staff. Research staff, after confirming a negative HIV-test, will enter the private testing area 
and discuss the research with the participant in further detail. Upon consenting and enrolling in 
the research, research staff will collect minimal identifying data for the purposes of scheduling an 
interview session (Phase 1-b, individual interviews) or contact to encourage retention and 
provide payment (Phase 2, pilot study), including names, telephone numbers, and e-mail 
addresses. These data will be stored according to protocols for handling sensitive information, 
and we will destroy all identifying information after the study is completed. Study participants 
will be reimbursed for participation. Reimbursement amounts are determined according to the 
amount of time involved in each phase of research, and are consistent with standard 
reimbursement amounts for research involvement at the Center for Alcohol and Addiction 
Studies and Center for AIDS Research at Brown, thus posing little risk of coercion. Those 

 
participating in Phases 1-b (individual interviews) will be paid $50, and those in Phase 1-c 
(theatre testing) will be paid $30. Those participating in Phase 2 will receive $50 for completing 
the baseline session (consisting of the intervention and baseline assessment), and $50 for each of 
the 1-, 3-, and 6-month follow-ups, with an extra $50 bonus for completing all three assessments. 
Phase 2 participants will be paid in cash after each follow-up appointment, with a bonus payment 
added after the 6-month appointment is complete  
 
C.4  Design and Methods 
 
PHASE 1: INTERVENTION DEVELOPMENT/REFINEMENT 
 
C.4.1. Initial Development (α-version). Phase 1 will begin with the study team meeting to 
identify the core components of MI-based alcohol and sex risk interventions and developing an 
initial flow of the intervention content. These discussions will guide the construction of feature 
sets, wireframes, and flows to provide to web developers to aid them in creating a preliminary 
version of the intervention’s components. This process will result in production of a preliminary 
-version of the tablet-based intervention. 
 
BI for sex risk reduction. Brief BIs for reducing HIV-risk behavior based on principles of 
MI focus on exploring current behavior and its consequences, and examining whether this 
behavior is congruent with one’s goals. Based upon these goals, the intervention then provides a 
menu of options available for behavior change, and discusses various ways of initiating that 
change and reducing harm based on personal goals. PCC9; 10, one of the only brief BIs for 
reducing HIV-risk among MSM to date, involves exploring the motivational, interpersonal, and 
behavioral precursors and effects of a specific unsafe sex episode, and whether these factors 
contribute to behaviors that are commensurate with one’s goals. To facilitate this, PCC uses a 
uses a questionnaire to guide later education, feedback, and risk reduction planning tailored 
specifically to participant responses, and thus is highly algorithm-based. As such, elements of 
PCC are highly amenable to computerization, while achieving optimal relevance to individual 
participants (see 3C.6. Pilot Data, for more detail about our preliminary adaptation of PCC 
components). Rather than incorporating all components of PCC (which may result in an overly 
long intervention), we will incorporate those aspects of PCC that are most consistent with an MI-
focus, using these components to support participants’ identification/monitoring of factors that 
contribute to behavior that is discrepant with their goals.  
 
In addition to content related to reducing sex risk behavior, the intervention will also be well-
positioned for facilitating patrons’ connection with other existing prevention resources (e.g., 
PrEP, STI screening, further testing). As such, based on the respondents’ individual risk profile 
and previous engagement with these services, additional information will be provided concerning 
how and where specific resources can be located (see Appendix F for info card).  
 
BI for alcohol use. Personalized feedback interventions (PFIs) involve delivering feedback 
on a range of data including comparisons of one’s drinking with that of relevant proximal norms, 
challenging personally-relevant alcohol-related expectancies, conducting decisional balances 
related to use, presentation of practical use consequences (e.g., time and money spent, calories 
consumed), as well as strategies for harm reduction47. PFIs are frequently delivered electronically 
and used in conjunction with motivational interviewing (MI)48. These interventions can be 
readily tailored to MSM-specific needs and integrated with sex risk reduction components in an 
MI-consistent manner. Dr. Kahler’s clinical trial with HIV-infected MSM uses this approach. 

 
Table 1. Proposed Initial Intervention Components  
Alcohol use 
1.) Profile and norms 
2.) Practical costs/consequences & gains 
from change 
3.) Challenging alcohol-related 
expectancies  
4.) Decisional balance (Pros and cons) 
5.) Menu of options for changing drinking 
and plan for change 
HIV risk reduction 
1.) Profile and norms 
2.) Decisional balance 
3.) Feedback about sex risk reduction 
motivation and goal choice 
4.) Factors contributing to past sex risk 
5.) Risk reduction planning 
 
 
Combined BI. The proposed combined BI would utilize aspects of existing evidence-based 
BIs for alcohol use and HIV-risk behavior, and integrate their components to discuss the 
relationships between the two behaviors, including how engaging in alcohol use can potentiate 
HIV-risk behavior and how beliefs and attitudes about alcohol can affect this relationship. 
Combined BIs can also address how one’s goals (e.g., health) and change efforts can be relevant 
to both behaviors. Table 1 presents an initial, brief outline of possible intervention components. 
The intervention will first involve a brief assessment completed via tablet, which will ask briefly 
about sex risk behavior, motivation for reduce drinking and sexual risk (including “stage of 
change”), collect a 30-day Timeline Follow-Back91 of alcohol use and sexual behavior, and ask 
about engagement with other biomedical prevention activities (e.g., PrEP, STI screening). These 
items will be used to both determine eligibility and inform the content of the intervention. 
Although the intervention components are separated into discrete topic areas (alcohol use vs. 
HIV-risk), each component provides an opportunity to present content about how these behaviors 
intersect.  For example, the expectancies module can address alcohol-related sex expectancies, 
which may promote both drinking and sex risk among MSM29. See Appendix A for additional 
detail. This process of development will result in a single-session BI, lasting approximately 50 
minutes (based on our initial timing of several components; see 3C.3).  
Technical development. The 
intervention components will be 
presented via a web application 
(hosted on Brown University’s web 
servers), and will be designed to be 
engaging, visually-appealing, and 
entertaining. The application will be 
dynamically optimized for tablet, 
mobile, or desktop-based delivery 
based on data from the device’s web 
browser. Study-specific logins will be 
used to access the program from 
tablets at the study site. Participants 
can then use the application to 
navigate through the BI’s components, 
including introduction, initial 
assessment, each module, and follow-
up. User-provided data will be 
collected via baseline assessments, 
interactive modules during the 
intervention, and items within each component. These data will be used to tailor the intervention 
content to each participant, and will be accomplished using MySQL. To ensure that the 
application is entertaining and engaging, an animated cartoon “doctor” will guide participants 
through the assessment and intervention components, using humor where appropriate. Consistent 
with the spirit of MI, this character’s narration will also involve a non-confrontational, non-
judgmental tone, and will be specifically tailored to the needs of MSM. Interactive graphics, 
charts, videos, and “games” will also be used throughout. All animation and interactive web 
components will be produced using HTML5.  

 
 
C.4.2.1. Procedures for Refinement. After the α-version is produced, we will use qualitative 
methods to elicit narrative feedback from key informants (focus groups; Phase 1a), individual 
interviews with MSM testing in these settings (clinic/bathhouse; Phase 1b) and from a small 
sample of theatre testers, who will use the software at the proposed study site (Phase 1c). These 
data will provide rich contextual information on key issues relevant to conducting interventions 
with high-risk MSM, the cultural appropriateness of the α-version intervention, conducting 
prevention activities in a community/outreach-based context. These data will also provide initial 
ratings of satisfaction, feasibility, and acceptability. We anticipate that several areas will need to 
be adapted based on this formative research, including: (1) use of relevant, local 
behavioral/social terminology, (2) adapting core components to match those identified as 
important by interviewees, (3) adjusting particular components (voice of the narrator, visual aids, 
etc.) based on logistical issues identified, (4) reviewing applicability of evaluation measures, (5) 
identifying strategies to enhance recruitment, follow-up, and retention, (6) altering the program to 
fit within the existing community setting-based VTC protocol, and (7) optimizing the methods 
for delivering summary feedback at the conclusion of the intervention (e-mail vs. hardcopy print-
out). Based on this formative research and precise timing of the intervention components in 
Phase 1, we will also cut back on intervention content in order to arrive at a 50-minute BI, 
consistent with a standard clinical hour. After analyzing Phase 1 data, the study team will suggest 
revisions to the intervention based on our findings, and meet with developers in order to 
incorporate the recommended changes. This process will ultimately result in production of a -
version with all features integrated that will then be used for Phase 2 pilot testing.  
 
Phase 1a: Key informant focus groups. We plan to conduct three focus groups (N=8) with 
key informants, including health/social service providers, volunteer testing staff, commercial sex 
venue staff, and community leaders. Eligibility criteria will include being 18 years or older, with 
a qualified understanding of local MSM community needs. Participants will be recruited from 
organizations or groups that work within MSM communities, identified through referrals and 
existing relationships. Focus groups will be digitally recorded, facilitated by a senior investigator 
(Dr. Operario), and attended by a member of the research staff, who will take notes. Focus 
groups will take place in private research rooms to maximize confidentiality, will last roughly 2 
hours, and members will receive $50 for participating, an amount consistent with similar 
research studies conducted in Providence. Focus group members will involve both general 
discussion about HIV-risk behavior in MSM and the role of alcohol in this process, as well as 
provide specific feedback about each component of the - version BI.  
 
Phase 1b: MSM individual interviews. We will also recruit a sample of 25 MSM from 
within the Providence bathhouse to participate in individual qualitative interviews. Individual 
interviews will inform the further refinement of the intervention, and provide preliminary data on 
acceptability and feasibility. Eligibility criteria will include being (1) male, (2) 18 years or older, 
(3) fluent in English, (4) HIV-negative, (5) residing in the greater Providence, RI area, and (6) 
reporting unprotected anal sex with a casual male partner at least once in the past 3 months12. In 
these interviews, a semi-structured protocol will first guide participants through the α-version 
intervention and ask them to comment on each of the core intervention components, with a 
particular eye on optimally adapting existing protocols to the realities of high-risk MSM. In 
addition, interviews will ask participants about their perceptions of prevention efforts conducted 
in bathhouses and other MSM-oriented venues (bars, nightblubs, adult bookstores), and ask them 

 
to reflect on specific challenges that might affect the uptake of risk reduction efforts in the target 
settings (e.g., ability to attend, overall length). Interviews will last 2 hours, and participants will 
receive $50 for their participation.  
 
Phase 1c: Theatre testing of BI alpha-version. We will recruit a sample of 10 MSM, using 
the eligibility criteria from Phase 1b, to conduct a “theatre test” of the BI. MSM who participated 
in earlier phases will be excluded to provide different perspectives. Participants who are seeking 
HIV testing at the target venues will be recruited using a screening item concerning their interest 
in the study that will be included on the standard post-test assessment, and their participation will 
be anonymous. Interested participants will simply wait in the testing room for study staff after 
VCT is complete. Staff will then provide them with a tablet and headphones in order to complete 
the full intervention. Afterward, participants will complete a brief questionnaire and interview 
about their perceptions of the acceptability and feasibility of delivering a BI in this environment, 
as well as comments they have about each BI component. Participants will receive $30 for 
completing the theatre test.  
 
Qualitative analysis. Recordings of all focus groups and interviews will be transcribed via 
commercially available software. Data will be analyzed using modified grounded theory 
methods90, with two independent coders arriving at a consensus on major themes identified. This 
qualitative data will allow us to refine the assessment instruments and BI components for 
population sensitivity. As such, the study team will review the analysis, and assess the 
strengths/weaknesses of each of the components based on these findings.  
 
C.4.2. PHASE 2: PILOT TESTING 
 
Specific Aim 2 is to conduct a pilot randomized controlled trial of our BI, and explore 
preliminary evidence of its efficacy for reducing sexual risk and alcohol use among a sample of 
high-risk MSM seeking HIV testing in community venues.  As such, we will randomize 40 MSM 
who receive HIV testing at the identified venues to either the standard VCT group + attention-
matched control (AC), or the VCT + Intervention (BI) group. We will test the hypothesis that 
those in the BI group will report reductions in sex risk outcomes, sex under the influence of 
alcohol, and alcohol use at 1-, 3-, and 6-month follow-ups compared to the VCT+AC group.  
C.4.2.1. Methods 
 
Eligibility. Criteria for inclusion in this portion of the study are: (1) Male, (2) age 18 or 
older, (3) fluent in English, (4) self-reported unprotected anal sex with a casual male partner at 
least once in the past 3 months12, (5) heavy alcohol use during the past 2-weeks (>14 drinks per 
week, or at least one occasion of 5+ drinks)13, (6) register a breath alcohol content of .000 upon 
recruitment, (7) no history of complex alcohol withdrawal, (8) scoring < 4 on severity of 
dependence scale (SDS) for methamphetamine14, and < 3 on the SDS for cocaine and 
heroin/opiates15; 16, (9) HIV-negative as indicated during their preliminary HIV testing, and (10) 
willing to provide phone and email contact information (see Design Considerations section 
below for further detail). Participants who test HIV+, score highly on the SDS, or participated in 
Phase 1 of the research will be excluded from participation. Those testing HIV+ will be referred 
to a comprehensive care clinic at the Miriam Hospital for treatment, as per the standard protocol 
of our collaborating agency. Those with high SDS scores will be provided with lists of local 
MSM-friendly drug treatment providers.  
 
Recruitment. We will recruit participants from among those seeking HIV testing at the 
identified community-based venues. Patrons who are interested in participating indicate this on 

 
their standard HIV testing “exit” form, which is anonymous. After APRI staff deliver negative 
results, participants will remain in a private room, where our research study staff will enter and 
provide further information about the study.  
 
Baseline Assessment. All assessments will be completed on the tablet and administered by a 
research assistant that is blind to experimental condition. Study staff will first acquire informed 
consent and deliver the tablet to begin collecting baseline/screening measures. While ineligible 
participants will be informed of this on the assessment screen, eligible participants will then 
proceed directly to complete other baseline measures. Participants will receive $50 for the 
baseline session, which may take up to 90 minutes.  
 
Randomization/Design. Participants will be randomly assigned to either the control or 
intervention groups by the software. Those randomized to the BI condition will complete the 
intervention, which will be delivered on a Windows tablet (with noise-cancelling headphones). 
Those randomized to the AC group (attention control) will watch a set of videos on the tablet on 
improving dietary and exercise habits. At the end of their session, participants in both groups will 
complete brief exit interviews and confirm contact information.  
 
Follow-up Assessments. Follow-up assessments will be conducted at 1-, 3-, and 6-months 
following the intervention session. At each of these intervals, study staff will call participants and 
ask to schedule an appointment to come to the research offices. At these 45-minute 
appointments, participants will complete an assessment battery delivered on a tablet. Participants 
will receive $50 for each assessment appointment, plus a $50 bonus for completing all follow-up 
assessments.  
 
C.4.2.2. Measures (see Appendix E) 
 
Baseline/Eligibility Assessments. The SDS17 will be used to assess symptoms of substance 
dependence for methamphetamine, cocaine, heroin/opiates, and alcohol. The SDS has 
demonstrated good validity and excellent reliability with respect to these drugs (α=0.80-0.85)14; 
15; 17. In addition, a 30-day Timeline Follow Back (TLFB)18; 19, administered online, will be used 
to assess alcohol use and sexual behavior during that period. The TLFB presents a calendar of 
each recall period, and participants respond by clicking on a box that represents a given day, 
answering several questions about that day. Questions will assess the number of standard drinks 
consumed on that day, the number of hours over which these drinks were consumed, the total 
number of sex partners, their relationship with each (e.g., steady vs. casual), the HIV status of 
each (e.g., HIV+, HIV-, or unknown), whether they asked about their partner’s HIV/STI status or 
the last time they were tested, sex acts performed with each, condom use for each act, and 
whether sexual activity took place while under the influence of alcohol. Meta-analyses have 
shown that TLFBs for assessing alcohol use and sex behavior are reliable when administered 
electronically and online20. Other studies explicitly comparing online vs. in-person TLFBs for 
sexual behavior21, and comparing the TLFB to biological measures for alcohol use22 have 
confirmed the validity of online TLFBs. TLFB data will be used to determine participants’ 
drinking eligibility, while single items will assess all other eligibility criteria. Finally, stages of 
change will be assessed using the Stages of Change (Short Form)23 and a 4-item stages of change 
measure for HIV-risk24-26.  
 
Efficacy outcomes. Our primary outcomes will be the number of unprotected anal sex 
events, number of sex events under the influence of alcohol, frequency of drinking, and the 

 
number of heavy drinking days over the past month. Outcomes will be assessed via 30-day 
Timeline Follow Back (TLFB)91; 93 at each follow-up.  
Secondary outcomes. We will also assess whether participants talked to their partners about 
their HIV/STI status and recent testing, and whether during each follow-up window, participants 
engaged in self-initiated HIV testing, sought STI screening, or sought information about pre-
exposure prophylaxis. Change motivation and stages will also be explored as secondary 
outcomes.  
Exploratory Mediators. As exploratory measures, we will include brief measures of 
possible mediators of the intervention effect, based on mediators identified in the original BIs. 
These will include HIV-related knowledge, perceived risk for HIV, peer safe sex norms, and safe 
sex behavioral skills (e.g., condom negotiation, partner communication skills, self-efficacy)27-29.  
General participant characteristics. Participants will also provide information about 
general demographic characteristics (e.g., age, ethnicity, income, educational level); general 
health; current relationship status and relationship history; self-reported history of other sexually 
transmitted infections (chlamydia, genital warts, gonorrhea, herpes, syphilis, trichomoniasis, 
Hepatitis B, Hepatitis C); drug use behaviors (SDS), and utilization of other health and social 
services. We will also administer the Client Satisfaction Questionnaire, a brief 8-item measure 
assessing satisfaction with services95. 
  
C.4.2.2. Data Analysis Plan 
 
Descriptive/Exploratory analyses. Behavioral data (e.g., alcohol use and sex risk behaviors) 
will be tabulated using contingency tables within each condition at baseline and for each follow-
up period. We will examine study retention rates at each follow-up and generate a CONSORT 
flow-diagram.  
 
Primary analyses. Our hypotheses related to Specific Aim 2 are that participants in the 
intervention group will report (1) fewer unprotected anal sex events, (2) fewer events involving 
sex while under the influence of alcohol, and (3) lower frequency of drinking and a reduced 
number of heavy drinking days versus the control group. These hypotheses will be evaluated 
using an intention-to-treat comparison of the rates of our primary outcomes at 1-, 3-, and 6-
month follow-ups, using a incidence rate ratio (IRR) and 95% CI. Given the count nature of the 
data, we will use a Poisson regression covarying for key baseline covariates, and compare IRRs 
across the two treatment conditions at each time point. As conclusions about statistical 
significance will be limited due to the small sample, clinically meaningful differences in the 
pattern of IRRs and means (for alcohol use variables) across groups will be used to evaluate our 
hypotheses. However, if available data produce stable results, generalized estimating equations 
(GEEs) using binomial distributions and logit-link functions will also be used to explore 
differences in these outcomes across time and treatment condition. We will also explore the 
potential influence of the intervention on secondary outcomes and exploratory mediators. IRRs 
and descriptive data will be used to compare the groups in terms of their frequency of talking to 
partners about their status, whether they sought additional HIV testing, STI screening or 
information about PrEP. Descriptive mean comparisons and linear regressions controlling for 
baseline values will be used to compare whether HIV knowledge and perceived risk, peer safe 
sex norms, and safe sex behavioral skills differ across the groups. 
 
C.4.3. Recruitment 

 
We will recruit participants who have sought and consented to voluntary HIV counseling 
and testing (VCT) with APRI on-site at outreach venues, and subsequently test negative. The 
staff at both settings (APRI offices/bathhouse) have arranged for private, quiet spaces in the 
venues that allow patrons to enter and complete testing anonymously. After testing, standard 
APRI protocol involves administration of a brief, anonymous questionnaire regarding testers’ 
risk behavior and other concerns. An item inquiring about participants’ potential interest in 
participating in the study will be added to this questionnaire and will signal to the APRI tester to 
refer the patron to study staff. Research staff, after confirming a negative HIV-test, will enter the 
private testing area and discuss the research with the participant in further detail. Upon 
consenting and enrolling in the research, research staff will collect minimal identifying data for 
the purposes of scheduling an interview session (Phase 1-b, individual interviews) or contact to 
encourage retention and provide payment (Phase 2, pilot study), including names, telephone 
numbers, and e-mail addresses. These data will be stored according to protocols for handling 
sensitive information, and we will destroy all identifying information after the study is 
completed. Study participants will be reimbursed for participation. Reimbursement amounts are 
determined according to the amount of time involved in each phase of research, and are 
consistent with standard reimbursement amounts for research involvement at the Center for 
Alcohol and Addiction Studies and Center for AIDS Research at Brown, thus posing little risk of 
coercion. Those participating in Phases 1-b (individual interviews) will be paid $50, and those in 
Phase 1-c (theatre testing) will be paid $30. Those participating in Phase 2 will receive $50 for 
completing the baseline session (consisting of the intervention and baseline assessment), and $50 
for each of the 1-, 3-, and 6-month follow-ups, with an extra $50 bonus for completing all three 
assessments. Phase 2 participants will be paid in cash after each follow-up appointment, with a 
bonus payment added after the 6-month appointment is complete. Recruitment and 
reimbursement procedures will follow protocols approved by the Brown University Research 
Protections Office IRB.  
 
C.4.4. Human Subjects Involvement, Characteristics, and Design 
 
Across all phases of the research, data will be collected from two groups: (1) Key 
informants (including health/social service providers, volunteer testing staff, and commercial sex 
venue staff; for Focus Groups, Phase 1a) and (2) high-risk MSM seeking test at one of the 
community-based outreach venues. Thus, 24 key informants, and 75 high-risk MSM participants 
(Individual interviews, N = 25; Theatre testing, N = 10; Pilot study, N =40) will be recruited as a 
part of this research. Key informants will be recruited based upon existing community contacts 
and referrals. High-risk MSM participants will be recruited from among those seeking HIV 
testing at APRI offices and a local bathhouse. All participants will be individuals aged 18 and 
older. The use of participants older than 18 is appropriate to ensure applicability of findings to 
adult populations of men who have sex with men (MSM) at risk for HIV infection. No special or 
vulnerable populations, as defined by 45 CFR Part 46 (e.g., prisoners, pregnant women, fetuses) 
are involved.  
 
High-risk MSM participants will be recruited through their indication of interest in 
participating in a research study on a standard “exit” assessment form that is collected by AIDS 
Project Rhode Island (APRI) after conducting rapid oral HIV testing and counseling at APRI 
offices/the bathhouse. To ensure anonymity during the testing procedure, participants will only 
be approached by research staff after all standard HIV testing and counseling procedures are 

 
completed, and after APRI staff verbally confirm a negative HIV testing result. This procedure 
will ensure both that the anonymity of testers is maintained and that only those that are HIV-
negative are recruited. Given that those seeking testing in these settings come from diverse 
racial/ethnic backgrounds, we expect that the proposed research will be capable of recruiting a 
similarly diverse sample.  
 
Inclusion criteria for the research (Phases 1-b, 1-c and 2) are as follows: 
10. Biologically male 
11. Aged 18 or older 
12. Fluent English speaker 
13. Unprotected anal sex with a casual male partner at least once in the past 3 months  
14. Heavy alcohol use during the past 2-weeks (>14 drinks per week, or at least one 
occasion of 5+ drinks on a given occasion) 
15. Breath alcohol concentration (BrAC) of .000 at the time of enrollment 
16. No history of complex alcohol withdrawal 
17. Score of <4 for methamphetamine and <3 for cocaine and heroin/opiates on the SDS 
18. HIV-negative 
 
Exclusion criteria: 
4. Individuals who are HIV-positive 
5. Individuals who participated in other phases of the research 
6. Individuals who report being coerced to participate 
 
Types of Data. This study will involve collecting four types of data:  
1. Focus groups (N = 24) in Phase 1-a, generating written notes, digital recordings, and 
transcripts. 
2. Qualitative process interviews for both individual interviews (Phase 1-b, N = 35), 
generating written notes, digital recordings, and transcripts, written, open-ended 
questionnaire data.  
3. Quantitative data on clinical outcomes for the pilot sample (Phase 2, N = 40), 
obtained via electronically-administered questionnaires. 
 
All study procedures, including data collection, will be conducted by either the Contact 
PI/Project Director (Dr. Wray), Co-PIs (Drs. Operario and Kahler) or a Research Assistant. 
Research Assistants will receive intensive training in all study procedures from Dr. Wray and 
other PIs. Procedures for assigning individual participants to trial arms in Phase 2 will be based 
on a computer-generated randomization sequence that is completed automatically by the 
software. A randomized design is appropriate for our goal of pilot testing a behavioral 
intervention.  
 
C.4.4.1. Sources of Materials 
 
In Phase 1a, we will collect data directly from informants using focus group 
methodology. These methods will produce qualitative data in the form of digital recordings 
(which will be recorded using a digital voice recorder [DVR]) and transcripts for analysis. Focus 
groups will be moderated by Dr. Operario and will generate data in the form of written notes, 
which will contain no individual participant identifiers. We will use the Phase 1a data to adapt 

 
intervention protocols for use with the target populations and settings.  
 
In Phase 1b, we will collect qualitative data in the form of digital recordings (recorded 
using DVR), transcripts for analysis, and open-ended, paper-and-pencil questionnaires. These 
interviews will be conducted by a trained RA, with PIs providing comprehensive training and 
supervision. Interviews will also generate data in the form of written notes, which will contain no 
individual participant identifiers. We will also collect discussion data directly from participants 
by asking them to comment and “think aloud” in response to the elements presented to them as 
they navigate the intervention; these discussions will also be digitally recorded and transcribed. 
Analyses of these qualitative data will be used to refine the intervention protocol.   
 
In Phase 2, we will collect quantitative data directly from participants using computer-
delivered assessments at baseline, 1-month, 3-months, and 6-months. These assessments will 
produce data on alcohol use and sexual risk behavior during the follow-up periods, and as such, 
participants will be provided with private spaces within the research offices to complete these 
measures. All staff members will receive training on ethical follow-up contact and retention 
strategies. This data will be used as a preliminary evaluation of the intervention on relevant 
outcomes.  
 
Throughout the study, all procedures and data collection undertaken in face-to-face 
format will take place in locations that are convenient and private. APRI has arranged for private 
space to be available for the purposes of conducting the research in both venues. For data 
collected via computerized assessments, participants will be given privacy to complete these 
measures. For Phases 1-b and 2, participant contact information will be collected in order to 
arrange for study sessions, allow contact for any follow-ups, and encourage retention. 
Confidentiality of participants in these phases will be maintained by assigning them each a 
unique code number that will be associated with their identifying information in an electronic 
database that will itself be password-protected and stored on encrypted, secure Brown University 
servers. Only essential study staff will have access to this file. Participants in Phase 1-c will 
participate anonymously. Data collected and stored on physical mediums (written notes, digital 
recordings, written questionnaire data) will be kept in locked file cabinets at Brown University. 
All personal identifying information collected over the course of the research will be destroyed 
after the study is completed.  
 
 
D. RISKS/BENEFITS OF PARTICIPATION 
Participation in this study involves no physical risk above those ordinarily encountered in daily 
life. However, there may be several non-physical risks: 
 
1. There is a small risk of loss of privacy and confidentiality of data, including data that 
is sensitive (sexual risk-taking, alcohol and drug use, psychological characteristics). 
We take this risk seriously, and will take steps to protect participants’ confidential 
data and anonymity, as detailed in Section E. We will ensure that personal identifiers 
are removed from the data and any publications arising from the study. Informed 
consent documents will bring confidentiality risks to participants’ attention.  
 
2. Participants may also experience psychological discomfort while completing the 
intervention procedures and some of the quantitative assessment measures, since 

 
these involve discussion and disclosure of sexual behavior and alcohol/drug use. We 
will take steps to minimize this discomfort by framing intervention messages as 
sensitively and non-directively as possible. Research staff will also be trained in a 
prepared crisis management protocol and have access to additional supervision from 
Dr. Kahler, who is a licensed psychologist. Research staff will also have lists of 
referrals to local agencies to address potential psychological problems that may arise 
in study participants.  
 
D.1. Adequacy of Protection Against Risk 
We will make every attempt to minimize risks to participants throughout the study 
protocol, including loss of privacy or confidentiality and psychological discomfort.  
D.1.1. The risk of loss of privacy will be controlled (as described above) by using 
unique participant ID numbers on all data, rather than participant names. Transcription will be 
performed by study staff, who will be trained to maintain the confidentiality of interview data by 
omitting any identifying information when storing data. Only essential staff members will have 
access to data and research files. Specific forms of data will be protected as follows: 
Digital Audio Recordings and Transcripts. Focus groups and interviews in Phases 1a-c 
will be recorded using digital voice recorders (DVRs). After each day of recording, the Research 
Assistant will transfer all new recordings from the DVRs to a password-protected computer in a 
locked project office. They will label files with the number of each focus group (for focus 
groups) or the Study ID of the individual participant (for participants in the individual interview 
phase, 1-b). They will listen to the recording in the digital file, and will use audio editing 
software to edit out any names or identifying information that may appear in the recordings. To 
store these data, the Research Assistant will then burn these edited files onto a data CD, which 
will be kept in a locked cabinet in a locked office (which is in a locked suite in a building with a 
security guard). After burning the voice recording onto these two data CDs, they will delete the 
original recording from the DVRs. The DVRs will always be kept in the locked cabinet in the 
RAs office when they contain original recordings. All original recordings will be removed from 
the recorders before starting a new interview or focus group, and no recording will remain on the 
DVR for longer than three days. Transcript files will be encrypted and stored securely in a 
password-protected file, on the password-protected computer in the Contact PI's locked office. 
Data CDs will be destroyed at the conclusion of the study, once transcription is complete and 
there is no longer any need for a physical copy of the recording. 
 
Paper-and-pencil Questionnaire Data and Notes. Physical versions of qualitative data 
collected via handwritten notes taken by research staff  and open-ended questionnaire responses 
(Phases 1a-c) will be labeled with study IDs only, and no identifying information will be 
recorded. Hard copies of these documents will be stored in locked file cabinets located in Brown 
University research facilities as long as the study is ongoing, but destroyed upon completion of 
the research.  
 
Computerized assessment data. Screening data will be collected during Phase 1b, and 
consist of a small pool of items assessing study inclusion criteria. Quantitative data collected in 
Phase 2 will be more extensive, and assess screening criteria, responses to items during the 
intervention, and assessments administered during follow-ups. Screening, intervention-based, 
and baseline session assessment data will be gathered via online assessments delivered over the 
tablet. Follow-up assessments will be completed during in-person appointments conducted at the 

 
Brown University research offices. However, all assessments will be delivered via computer, 
either via Qualtrics® online survey tools (which stores data securely) or via items built-in to the 
study’s custom software. This data will be identified by participants’ study IDs only, and will be 
downloaded weekly and stored in password-protected files on Brown University’s servers, which 
are encrypted. This data will be kept in a separate location from files that link participants’ 
identifying information with their unique study IDs.  
 
Monitoring. The PIs will provide ongoing supervision and training to essential study staff 
at weekly meetings, which will also ensure continued compliance with data safety protocols. The 
PIs will also discuss human subjects issues at weekly meetings. Participants in human subjects 
research inevitably give up some privacy to share data about their individual experiences. 
However, we believe our data safety and monitoring plan will minimize the risks of any breach 
of privacy or confidentiality. The PIs will be responsible for ensuring that study protocols for 
maintaining confidentiality are followed.  
Adverse Events. If an Adverse Event is reported, the Contact PI (Dr. Wray) will complete 
an Adverse Events form and report the event to The Brown University IRB and the NIH funding 
institute within 24 hours. The Contact PI will gather any information needed to investigate the 
event and to determine subsequent action. The Contact PI will document and report any 
subsequent action to institutional IRBs and the NIH program officer. DSMBs will also be 
informed of any adverse events and remedial actions needed. The Contact PI will also generate a 
brief report of adverse events for the study record each year, and we will forward the report to the 
institutional IRBs and the NIH funding institute. 
 
D.1.2. The risk of psychological discomfort will be controlled by providing research 
staff with training on crisis management. Dr. Kahler, a licensed psychologist, will also be 
available to provide supervision. We will also identify MSM-friendly professional clinical and 
counseling services that can provide urgent services if needed, and will establish a Memorandum 
of Understanding with these agencies. During the informed consent process, we will clearly 
describe the nature of the intervention to participants, which includes discussion of alcohol/drug 
use and sexual behavior. We will closely monitor any indication of adverse events that might 
arise from participation in the intervention, and will respond promptly and appropriately by 
notifying the Brown University IRB.  
 
 
D2. Potential Benefits  
 
There are no direct benefits to study participants in Phase 1; possible indirect benefits for 
participants include learning about HIV prevention, testing, and treatment, and having 
opportunities to discuss their experiences and feelings regarding HIV prevention with 
investigators. In Phase 2, direct benefits may include opportunities to reflect on HIV risk and 
drinking behavior with the intervention and receive linkage to further preventive care. However, 
the MSM community as a whole will likely benefit from the development of the first brief tools 
for reducing heavy drinking and sex risk. We have instituted multiple procedures to minimize the 
risks associated with the loss of confidentiality and any discomfort during the study processes. 
These risks substantially outweigh the potential benefits of the proposed research. 
The study will fill critical gaps in the research on interventions for reducing sex risks and 
related risk factors (heavy drinking) for MSM by providing the first, brief intervention that is 

 
adapted for use in community-based settings. As such, our study will provide important insight 
into the feasibility and appropriateness of behavior change interventions delivered via tablet in 
MSM. To our knowledge, no known studies have tested a brief, combined heavy drinking and 
sex risk reduction intervention in MSM, nor has any published study described the potential for 
delivering these interventions in a technology-assisted format that can be delivered outside of 
healthcare settings. As such, this research will result in the development of the first highly 
disseminable and scalable tool for reducing heavy drinking and sex risk in high-risk MSM. 
 
 
E. Informed Consent 
The informed consent process will be conducted by trained staff members that possess 
research experience working with the target populations and who are also trained in the ethical 
treatment of human subjects. Staff members will also be trained in more advanced research 
topics, such as protocol adherence, quality assurance, data management, and so on. The process 
of informed consent involves presenting a detailed verbal description of the study as it is 
described on the printed, IRB-approved consent forms (Appendices C & D). Staff will emphasize 
that participation is voluntary, and that participants can refuse to answer any question and/or can 
discontinue participation at any time without penalty. Interviewers will ask whether participants 
have experienced any coercion to take part in the study; those that describe any pressure or 
coercion to participate will be excluded. Potential subjects receive an item-by-item reading of the 
consent form by the study interviewer. Participants will be informed of the procedures for 
ensuring their confidentiality, including: the use of unique non-personally identifying ID numbers 
instead of names on research materials, and maintenance of data in locked computer databases 
and in locked filing cabinets in locked rooms. Compensation for participation will be explained. 
All participants will be given the contact numbers of the Principal Investigators and IRB Chairs 
to answer questions about the study or one’s rights as a human subject as well as a research site 
contact number. All consenting participants will be offered a copy of the informed consent form. 
 
Appendices 
 
Appendix 
Content 
A 
Feature Set and Wireframes for Experimental Intervention Content 
B 
Attention Matched Control Content  
C 
Informed Consent Document (Individual Interview participants) 
D 
Informed Consent Document (Pilot study participants) 
E 
Study Measures 
F 
Follow-up Resources Info Card 
G 
Protocol Checklist & Submission Procedures 
 

 
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