Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care
Phase: NA
Conditions: Alcohol Drinking, HIV
Sponsor: Brown University

 
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Study Protocol and Statistical Analysis Plan 
 
Behavioral Interventions to Reduce Heavy Drinking Among 
MSM in HIV Primary Care 
 
 
NCT02709759 
 
April 2, 2024 
 
 
 

 
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Description and Purpose of the Project 
The purpose of this project is to conduct a randomized clinical trial in which 224 heavy drinking 
men who have sex with men (MSM), who receive their HIV primary care at Fenway Health or other 
health care facilities in the greater Boston area or Jackson Memorial Hospital Medical Center or other 
health care facilities in Miami (N = 112 per site), are randomly assigned in a 2 X 2 X 2 design to receive 
either (1) Brief Advice about their drinking (BA) or Motivational Interviewing (MI) with personalized 
normative feedback specific to their drinking and HIV. Participants will also be assigned to receive 
either (2) an interactive text messaging (ITM) system that facilitates behavioral self-monitoring versus 
no ITM and (3) a standard (1-month) vs. an extended intervention (9 months; EI). BA and MI will be 
delivered by interventionists at Brown University using a webcam-enabled telemedicine system, as well 
as over the phone. Both BA and MI will involve one individual session of up to an hour, conducted 
using videoconferencing, and a follow-up counseling session delivered over the phone a month later that 
can last up to 20 minutes (5-10 minutes for BA, 10-20 minutes for MI). BA will involve counseling 
patients that they are drinking more than recommended limits for safe consumption and that staying 
below these limits is important for those with HIV. The MI intervention involves a more in-depth 
discussion of alcohol use, including providing feedback on health indicators and alcohol and other 
substance use. The ITM program involves sending/receiving text messages about participants’ drinking 
daily for 30 days. The EI conditions involve extended versions of either counseling approach (BA vs. 
MI) and the ITM program. Beyond the “standard” counseling participants receive, those in the EI 
conditions will receive additional 5-20 minute phone-based counseling sessions at 3- and 9- months, and 
participate in an additional 5-20 minute videoconference session at 6 months. Those in the EI+ITM 
condition will participate in an extended version of the ITM program that provides interactive text 
messages each week for 8 additional months after the initial 30 days (months 2-9).  
 
The primary aims of the study are as follows:  
Aim 1: To test the hypothesis that MI compared to BA, ITM compared to no ITM, and EI 
compared to no EI, will result in significantly greater reductions in (1) the number of alcoholic drinks 
consumed and (2) the number of heavy drinking days at 6- and 12-month follow ups.  
Aim 2: To test the effects of MI, ITM, and EI on engagement in unprotected anal intercourse, 
ART adherence and viral suppression.  
 
Procedures 
A number of procedures will mirror many of those previously approved. There will only be slight 
changes made to the explanation of the study in the study screener (see attached) with the primary 
change being the addition of text messaging, delivery of intervention by videoconferencing, and 
inclusion of at least minimal counseling for all participants. New consent forms are attached that reflect 
those changes.  We will recruit heavy drinking HIV-infected MSM receiving primary care at Fenway 
Health or other health care facilities in the greater Boston, Massachusetts area and at Jackson Memorial 
Hospital Medical Center or other health care facilities in Miami, Florida.  Participants will be recruited 
through fliers posted throughout the clinics and at HIV support groups and on community bulletin 
boards, as well as through proactive screening and recruitment during primary care visits at Fenway 
Health and at outside organizations that cater to HIV+ individuals.  Screening procedures at outside 
organizations will only take place in either private rooms, hallways, or corners of rooms that are all out 
of the earshot of others.  Study recruiters at Fenway Health will work closely with providers and CFAR 
Network of Integrated Clinical Systems (CNICS) staff to identify patients who would be eligible and 
interested in participating in this study. We will also advertise the study on social media websites like 
Facebook and Tumblr, online community bulletin boards like Craigslist, as well as on location-based, 
sex-seeking websites/apps (e.g. Grindr and SCRUFF) to further assist us with recruitment efforts.  The 
online advertisement will include a link to a secure REDCap form that will request only the interested 

 
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individual’s contact information so that the study team could then reach out to the person (instead of 
requiring him/them to initiate contact).  The REDCap form describes the main details of the study at the 
top of it.  The REDCap form will not request an individual’s protected health information and the form 
and its associated database will not have “HIV” or “Alcohol” in their names.  Participants will be 
randomly assigned to one of each of three conditions in a 2 X 2 X 2 between-subjects design (BA vs. 
MI, ITM vs. no ITM, and EI vs. standard intervention) and followed for 12 months.  
 
 
Participant population 
 
Inclusion criteria: For inclusion, subjects must: (1) be at least 18 years of age; (2) drink heavily at 
least once per month on average (≥5 drinks) or have drunk more than 14 drinks per week over the past 3 
months; (3) have a confirmed diagnosis of HIV with a documented viral load test result drawn within six 
months of the date of screening; (4) receive HIV clinical care at Fenway Health or other health care 
facilities in the greater Boston area; (5) be a biological male who identifies as male; (6) report having 
had sex (oral or anal) with a male partner in the past 12 months and/or identify as gay or bisexual. For 
those on ART, they must be on the same ART regimen for at least 3 months prior to study enrollment, 
with the exception of patients who switch from one medication to another medication that shares the 
same active moiety. Additionally, prospective participants who, at the time of the baseline visit, have the 
results of a viral load test completed in the last seven months, but not the past six months, may be 
allowed to enroll in the study with the approval of a Principal Investigator or co-Investigator provided 
they are willing to complete a viral load test at the time of the baseline visit. 
Exclusion criteria: Participants will be excluded if they: (1) reported past 3 month intravenous 
drug use; (2) are currently psychotic, suicidal, or manic; (3) are currently being treated or have been 
treated in the past 3 months for an HIV-related opportunistic infection; or (4) are currently receiving 
treatment for an alcohol or drug problem. We will allow those in maintenance methadone or Suboxone 
programs to enroll provided that they have been using the medication for at least one year and are not 
receiving counseling in conjunction with the treatment. We also will exclude participants who have 
characteristics that might make supervised alcohol detoxification necessary, specifically, having a 
history of severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens. 
Withdrawal symptoms will be assessed using the Clinical Institute Withdrawal Assessment for Alcohol, 
revised (CIWA-Ar) 1, and those with scores over 7 will be excluded. Participants must abstain from 
alcohol the night before the baseline assessment and have a BrAC of 0.00 g/dl. Participants reporting 
psychosis or suicidality, or who have CIWA-Ar scores greater than 7, will be referred to appropriate 
treatment. Participants must agree to be available for 12 months. Participants will not be asked to refrain 
from seeking treatment for an alcohol problem during the study if they decide to do so, and treatment 
utilization during follow-up will be assessed. We will also maintain a list of local addictions and mental 
health treatment resources (both Fenway Health and JMHMC have in-house substance abuse treatment 
programs), and any participant requesting referral to drug, alcohol, or other mental health treatment at 
any point during the study will be provided the referral list. Participants are not required to use text 
messaging to participate as lack of text messaging is an occasional limitation to the approach that should 
not be eliminated when testing its potential impact. Participants will be randomized to ITM vs. no-ITM 
without regard for whether they have access to text messaging on their phones. Subjects reporting 
substance dependence, psychosis, or suicidality or who have CIWA-Ar scores greater than 7 will be 
referred to appropriate treatment.  
 
Inclusion of Women, Minorities, and Children. 
This research will involve youth between the ages of 18 and 20 inclusive. Youth in this age range 
have been included in numerous clinical trials of brief alcohol interventions for heavy drinkers.  
HIV-infected MSM who receive care in Boston or Miami were chosen as the focus of this study because 
of high rates of HIV-infection and co-occurring elevated alcohol use and heavy drinking among this 

 
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population, and the elevated risk of unprotected sexual encounters while under the influence of alcohol.  
We did not include women or heterosexual men in the current study because the intervention approach 
may vary in different communities.  
 
Recruitment Procedures 
Prospective participants at both sites will be screened during HIV primary care visits or by phone if 
responding to a study advertisement. Patients at Fenway Health and JMHMC are given a Notice of 
Privacy Practices which informs them that their protected health information may be utilized for 
research when the research proposal is approved by the IRB and conducted in accordance with 
established rules on privacy and confidentiality (i.e. Health Insurance Portability and Accountability Act 
of 1996 -HIPAA).  Under HIPAA, as employees of the covered entities (Fenway Health/JMHMC), the 
study staff may utilize the medical records to identify potential participants and flag their providers to 
alert them to the study.  Providers will work closely with the study staff to gauge their client’s interest 
for participation during the next scheduled visits. If patients are interested, they will be referred to the 
study staff during the clinic visits.  For potential study participants who receive their HIV care 
elsewhere, we will require them to confirm their HIV diagnosis with a documented viral load lab drawn 
within six months of the date of screening.  Potential participants have the option to request that 
information on their own from their providers and bring it with them to the baseline visit or study staff 
could request that information from their medical providers with their authorization by having them sign 
a medical records release form.  If a participant plans to bring documentation of the viral load test to the 
study visit, it must include the participant’s name and date of birth, the name of medical provider who 
ordered the test, the viral load lab value and the date of the blood draw, and a logo or letterhead or 
something identifying the health care facility or lab where the test was performed.  Once they are 
enrolled in the study at the baseline visit, we will ask all participants who receive care outside of 
Fenway Health to sign what will for some be a second medical records release form to allow us to 
access their medical information.  We will ask permission to access their medical records from one year 
before the scheduled study visit through one year after their study visit. If the participant agrees, we will 
request medical information from the medical record concerning treatment for HIV and other conditions, 
such as hepatitis. This medical information will not be shared with anyone outside of our research team. 
The participant’s name and other identifying information will not be associated with the information 
from the medical record. Once we receive the medical information, it will be coded and stored with a 
code number instead of the participant’s name in order to maintain confidentiality.  
  
Prior to screening, the study staff will explain the study and obtain consent for completing the 
screening questionnaire. No identifying information will be collected on the screening questionnaire. 
Those who appear eligible based on their responses will be invited to participate in the study and asked 
to schedule a baseline (intake) appointment at Fenway Health/JMHMC within the next one to two 
weeks, which would last up to 4 hours: up to three hours are for the assessment and up to one hour is for 
counseling.  This visit can be completed in one or two days. 
 
Intake visit 
At the baseline interview, participants will first complete informed consent. Subjects will be asked to 
abstain from alcohol for 24 hours before this assessment, and an alcohol breathanalysis will be 
conducted. Those with a positive breath alcohol concentration (BrAC >.00 g/dl) will not be assessed and 
will be asked to re-schedule their baseline assessment. Then subjects will complete a limited battery of 
other assessments, including having blood drawn, completing a urine drug screen, and completing a few 
questionnaires and interviews and will be interviewed and screened as to exclusion criteria using the 
MINI 7.0 and the CIWA-Ar. Subjects who appear eligible based on the interview will complete 

 
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additional questionnaires, interviews, and neurocognitive assessments. Interview assessments will be 
audio recorded for training purposes. 
We aim to randomize 112 participants at each site using block randomization (16 per block) to 
ensure an equal number of participants in each of the treatment cells. Participants will receive their first 
session of MI/BA videocounseling immediately upon completion of the baseline interview. Research 
staff will share with the interventionist participant’s information that is necessary for conducting the 
counseling session (drinking level, viral load, etc.) by uploading a report to a restricted and secure folder 
on the Brown server. Participants will be seated in a private room in the clinic that is equipped with a 
computer, speakers, a microphone, and a webcam. Research staff will instruct participants about how to 
use the videoconferencing tool on this computer. The videoconferencing software provides a secure, 
HIPAA compliant connection with the study’s interventionists, who will be housed at Brown University.  
The software also allows secure sharing of the conferencing patient’s medical information, which allows 
video counselors to share, present, and discuss this information, as relevant to the conversation. Each 
session conducted will be audio recorded for research and training purposes. 
After the videoconference, participants in all conditions will be informed that they will be contacted 
by this same counselor by phone in 1 month, and that they will come back in for in-person interviews 
and questionnaires in 6 and 12 months. Those in the EI condition will be informed that they will receive 
an additional phone call from their counselor at 3 months, meet again with their counselor during their 6 
month appointment, and then receive a final phone call at 9 months. Those in the ITM conditions will 
also be informed that they should expect to receive daily text messages beginning the next day. Those in 
the EI+ITM group will be told to expect the frequency of these messages to be reduced to weekly after 
the first 30 days.  
 
Brief Intervention 
Counselors. Counseling sessions will be delivered by master's-level interventionists. Detailed 
treatment manuals will be used at all times to ensure standardization of treatment delivery. Drs. Kahler 
and Mastroleo will provide interventionists extensive training in treatment protocols and motivational 
interviewing including readings and role-playing exercises, and conduct weekly clinical supervision 
along with Drs. Pantalone and Hernandez. Interventionist training also includes education about HIV, 
medication adherence, and high-risk sexual behaviors, which will be led by Drs. Mayer and Pantalone. 
Dr. Mastroleo will review session recordings on a weekly basis and provide detailed feedback to 
interventionists; Dr. Hernandez will provide feedback on sessions conducted in Spanish. For emergent 
psychosocial problems such as family conflict, unemployment, or loss of residence, a brief problem-
solving discussion will be conducted in session and referrals to relevant local agencies and community 
therapists will be provided, including services available at Fenway Health and JMHMC. Interventionists 
will intervene immediately in the event that participants are an immediate threat to themselves or others 
and will discuss any cases of clinical deterioration with Drs. Mastroleo, Pantalone or Kahler (licensed 
clinicians) in order to determine whether more intensive treatment is required. 
Brief Advice – Session 1 (Video conferencing): Brief advice entails a largely scripted intervention 
lasting 5-10 minutes (see attached script). The interventionist will inform the participant that he is 
drinking more than the recommended limits for safe consumption and that staying below these limits is 
particularly important for those with chronic health conditions such as HIV. The interventionist will then 
gauge readiness to change drinking. For those willing to change, the interventionist will help them 
choose a change goal, will send educational materials to their home address, and offer to provide local 
referrals (both Fenway Health and JMHMC have substance abuse treatment programs), including 
recommending (a) 12-step programs for those willing to quit drinking or (b) discussing alcohol 
pharmacotherapy with the participant’s HIV care provider. At the end of BA, the interventionist will 
inform participants assigned to ITM about the text messaging program, initiating a text at that time to 
ensure that the participant receives the message and texts back in the appropriate way to complete 

 
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initiation of the program. The interventionist will schedule a follow-up phone call 1 month later and 
inform the participant how many more conversations they will be having: for those not assigned to EI, 1 
phone call; for those in EI, 3 phone calls and 1 more videoconference at 6 months.  
Brief Advice – Follow-Up sessions. Follow-up session(s) entail a brief check in on progress towards 
reducing drinking, reinforcement for changes made, encouragement to make changes for those whose 
drinking has remained heavy, and offers of referral to treatment for those who have been unsuccessful in 
their efforts to change. All follow-up sessions of BA, regardless of assignment to ITM or EI, will last 5-
10 minutes. 
Motivational Intervention – Session 1 (Video Conferencing): MI follows the same intervention 
outline that we have utilized in the ongoing approved study with minor modifications to mention text 
messaging when appropriate. The intervention draws heavily from techniques of motivational 
interviewing intended to minimize resistance and support self-efficacy for change. Interventionists will 
provide feedback and advice in a non-confrontational manner that avoids labeling and stresses personal 
responsibility for change. This MI relies heavily on the impact of alcohol use on HIV-relevant outcomes 
in building motivation for change. The interventionist first asks participants to describe their current 
drinking patterns and its positive and potential negative aspects and how drinking relates to their HIV 
treatment. Participant statements supporting change in drinking are reflected and amplified. Personalized 
feedback is then presented on the person’s drinking level relative to norms from a national sample of 
urban MSM. Personalized feedback on viral and immune function, ART adherence, sexual risk 
behaviors, liver function, neurocognitive function, and other substance use is provided highlighting 
areas where the participant is currently doing well and where there may be concerns that are potentially 
related to drinking. These data are used to develop discrepancies between a goal of living successfully 
with HIV and continued heavy drinking. The interventionist provides a “grand summary” of the 
discussion, reflecting the participant’s stated pros and cons of drinking and the key feedback results. The 
interventionist will clearly state there is no known “safe” level of drinking for those with HIV and 
recommend reducing or avoiding alcohol use to the greatest extent possible, especially if there is 
hepatitis coinfection. The provider will ask participants to choose a drinking goal, providing a menu of 
alternative goals to those who have difficulty formulating a goal. The session then focuses on increasing 
self-efficacy for changing drinking and problem-solving regarding drinking goals, including identifying 
supportive people, addressing barriers to change, and engaging in alternative activities to drinking 
alcohol. As in BA, the interventionist will mail the participant the NIAAA self-help pamphlet “Tips for 
Cutting Down on Drinking,” and those indicating an intention to quit drinking or to stop drug use also 
will be provided referrals to AA and local addictions treatment programs if desired. Participants also 
will be directed to a website where they can view question and answer videos we have developed, which 
are tailored for MSM, focusing on alcohol, health, and HIV. 
Motivational interviewing (Follow-Up sessions). Follow-up session(s) begin with a brief summary 
of the prior session and discussion of their current drinking goal. Progress in making changes in drinking 
is reviewed and reinforced and barriers to changing drinking are discussed and addressed with problem 
solving discussions. Where relevant, the interventionist highlights potential benefits of reducing 
drinking, including benefits unrelated to HIV treatment such as saving money, improving energy levels, 
and enhancing productivity. As with BA, referral to additional treatment resources is provided in the 
event the participant has been unsuccessful in efforts to moderate or stop drinking. At the last session of 
MI (session 2 for those not in EI and session 5 for those in EI), there is a brief discussion of strategies 
for maintaining changes in drinking over the longer term. 
Interactive Text Messaging. The ITM program will be housed as Brown University and uses 
Qualtrics’TM text messaging program. In the first 30 days of the program, participants will receive daily 
texts that ask them to report the number of drinks they consumed in the prior day, whether they plan to 
drink that day, and how much they plan to drink. Tailored messages are used to reinforce abstinence and 
moderate drinking and drinking goals. At the end of each 7 days of ITM, the system will provide the 

 
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participant feedback on the number of drinks consumed during the week with a tailored message based 
on whether the participant has stayed under 15 drinks, avoided heavy drinking (≥5 drinks) or reduced 
drinking relative to baseline. The results of the ITM assessments of drinking will also provide data that 
the interventionists can present to participants to reinforce positive changes in drinking and address 
potential difficulties in changing drinking. Once each week, the ITM system will ask participants the 
number of missed doses of ART in the prior week. Based on participant response, a text will be sent that 
either (a) reinforces/congratulates the participant for not missing any doses or (b) for those missing any 
doses, states the importance of taking every dose of ART regardless of whether drinking alcohol that 
day. In addition, two times each week, the system will send a message randomly selected from a bank of 
affirming messages and quotes on health, well-being, and sexual/gay identity. These positive messages 
have been cited as important to include during focus groups with former trial participants. Once each 
week, a tip for reducing drinking will be sent.  
For those assigned to EI, ITM will continue beyond 30 days but change in intensity. Daily 
assessments of drinking will be replaced by weekly assessments of number of days drinking alcohol, 
number of drinks consumed, heavy drinking, and ART adherence. The system will reinforce positive 
changes in drinking and ART adherence. Positive affirming messages run twice a week throughout EI, 
and tips for changing drinking run once a week. 
 
Follow-up Assessments 
All participants in the main trial, regardless of treatment condition, will be assessed on a variety of 
interview, self-report, and biochemical measures at 6 and 12 months after the baseline interview. 
Interviewers conducting follow-ups will be different from those conducting the baseline session when 
feasible and will not be informed of subjects' treatment condition assignment. To ensure that the 
accuracy of self-reports is not affected by intoxication, alcohol breathanalysis will be conducted at all 
assessments. Subjects with a BrAC >.02 g/dl (an alcohol level that may affect assessment) will not be 
assessed and their follow-up appointment will be re-scheduled for the following day or at the next 
available time. All subjects will provide serum samples at each follow-up. 
In order to maximize study participant retention, we will offer follow-up 6- and 12-month visits by 
phone for any participant who, in the course of the 12-months of study participation, moves to a location 
that makes it impossible to travel to Fenway Health or JMHMC for in-person visits.  These phone visits 
will include a subset of assessments as well as referrals for mental health or substance abuse services.  In 
addition, for those participants in EI, they will be given counseling by phone at the 6-month visit rather 
than by videoconference.  We will then mail the full compensation check to an address specified by the 
participant. Participants will be compensated $100 for the baseline interview, $50 for the 6-month 
interview, and $60 for the 12-month interview, for a total of $210 in the form of checks or gift cards. 
Those found ineligible at baseline will be compensated $50 for their time given the eligibility is 
confirmed within the first half of the baseline interview.  Participants will also receive a Charlie Ticket 
in the amount of the cost of a round-trip T ride at each study visit that they attend in person.  
Using procedures and assessments already approved, collateral informants will be interviewed to 
corroborate self-reports of drinking. All participants will complete two collateral letter forms at the 
intake session with the option to opt out completely or to only provide one collateral informant. If a visit 
is not scheduled after a minimum of three attempts using the participant’s preferred mode of contact, or 
if a visit is not scheduled by the remaining two weeks of their visit window, collateral letters will be 
either mailed or emailed to informants depending on the contact information provided by the participant. 
These letters inform the collateral that the subject is participating in this study and that he has given the 
study personnel permission to call them should there be a loss of contact with the participant. These 
letters also note that the participant has given us permission to ask them questions regarding the 
participant’s drinking. If a follow-up visit is not scheduled after a minimum of three attempts using the 
participant’s preferred mode of contact, or if a visit is not scheduled by the remaining two weeks of their 

 
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visit window, collaterals will be contacted in order to ask them questions regarding the participant’s 
drinking. Participants will be instructed to provide names of individuals who see them often enough to 
know about their alcohol use and their current contact information. These individuals do not have to 
know about participants’ HIV status, and that information will not be provided to them.  Participants 
will be informed that collateral informants will be told that they are participating in a study being 
conducted at Fenway Health or Florida International University, and so they should choose people with 
whom they are comfortable sharing that information. 
 
Measures 
Assessment focuses on six domains: (a) screening and background measures; (b) measures of 
alcohol use and problems, other substance use, and motivation to change; (c) measures of risky sexual 
behavior and ART adherence; (d) clinical assays and biomarker assessment; (e) measures of 
neurocognitive function; and (f) measures of treatment utilization. To reduce subject burden and 
potential assessment reactivity effects, assessments have been reduced to only those measures that are 
essential to study purposes. The interviews at baseline, 6 months, and 12 months should not exceed 120 
minutes.  
We will primarily use measures that have already been approved as part of this protocol.  A 
description of each of the measures is provided below.  We are not including copies of the measures that 
have been previously reviewed. Any additional measures will be submitted for approval prior to their 
implementation.  Table 1 shows the schedule of assessments, indicating when each measure will be 
administered. 
Table 1. Schedule of Main Study Assessments  
Assessment: 
Screening Baseline - 
Session 1 
6-Month 
Follow-up 
12-Month 
Follow-up 
Measure 
 
 
 
 
Chart Review 
X 
 
 
 
Initial Screening  
X 
 
 
 
Medical Record Review 
 
X 
X 
X 
Alcohol Consequences Scale 
 
X 
 
 
Alcohol Contemplation Ladder 
 
X 
X 
X 
Alcohol-ART Interaction Beliefs and 
Behaviors 
 
X 
X 
X 
Alcohol and Drug Use History 
 
X 
 
 
Alcohol Withdrawal (SAWS/CIWA) 
 
X 
 
 
Antiretrovial Therapy (ART) 
Adherence 
 
X 
X 
X 
Childhood Sexual Abuse 
 
X 
 
 
Conflict Tactics Scale (CTS) 
 
X 
 
X 
Demographics 
 
X 
 
 
Depressive Symptoms (CES-D 10) 
 
X 
X 
X 
Drinking Motives 
 
X 
X 
X 
HIV History 
 
X 
X 
X 
HIV Stigma 
 
X 
X 
X 
Important People Assessment (IPA) 
 
X 
X 
X 
Internet and Communications Use 
(Use of Technology) 
 
X 
 
 
LGBIS Internalized Homonegativity 
Subscale 
 
X 
 
 
MINI 7.0 (DSM-V) 
 
X 
 
 

 
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Multiple Discrimination Scale 
 
X 
 
X 
Neurocognitive Assessment 
 
X 
X 
X 
Quantity-Frequency Survey 
(Computer Assisted Self-Interview, 
CASI via Qualtrics) 
 
X 
X 
X 
ReACH Website Access 
 
 
X 
X 
Serum collection 
 
X 
X 
X 
Short Inventory of Problems (SIP) 
 
X 
X 
X 
Smoking History Questionnaire 
 
X 
 
 
Smoking Status Questionnaire 
 
 
X 
X 
Timeline Followback Interview 
 
X 
X 
X 
Treatment Services Review 
 
X 
X 
X 
UCLA Loneliness Scale 
 
X 
X 
X 
Urine Drug Screen 
 
X 
X 
X 
Vital Signs & BrAC 
 
X 
X 
X 
Payment: 
 
$100 
$50 
$60 
 
Screening and Background Measures  
Participants approached during HIV care visits or calling in to the study will complete a brief screen 
assessing primary inclusion criteria, namely that they are male, are receiving HIV care at Fenway Health 
or other health care facilities in the greater Boston or Miami area , meet drinking criteria, had oral or 
anal sex with a man in the past 12 months and/or identify as a gay or bisexual man, have no current or 
past 3 month opportunistic infection(s), and, if receiving ART, have been on a stable regimen for at least 
3 months. When a participant completes informed consent at the baseline interview, he will be asked to 
provide permission for staff to access his medical record in the clinic to confirm eligibility and to obtain 
key HIV treatment information, including, but not limited to, duration of illness, CD4 nadir, medication 
history, and whether he has had any other illnesses such as sexually transmitted diseases.  If a participant 
receives dental care at Fenway Health, he will be asked to provide permission for staff to view his future 
dental appointments in order to able to schedule study follow-ups that are potentially more conveniently-
timed for when he is already scheduled for appointments at this location.   
We will obtain complete demographic information on each participant who is eligible and will also 
assess depressive symptoms using the Center for Epidemiologic Studies – Depression scale [CES-D;2]. 
Depressive symptoms, which can sometimes result from excessive alcohol consumption, have been 
associated with poor ART adherence and are therefore important to assess as a covariate. The Treatment 
Services Review will assess use of major medical care outside of the health care facility where the 
participant normally receives care. Internet and Communication Use (use of technology) will be asked in 
order to learn what means of communication may be most effective in administering interventions in 
this population and whether there are potential barriers to the text messaging program.  We will also ask 
participants how often they accessed the ReACH project website for information on alcohol use and 
HIV in the past 6 months. Experienced discrimination due to HIV status, race/ethnicity, and sexual 
orientation will be assessed with the Multiple Discrimination Scale 3. Internalized homonegativity will 
be measured using a 5-item subscale from the Lesbian, Gay, and Bisexual Identity Subscale (Mohr & 
Fassinger, 2000). 
 
Measures of Alcohol Use and Problems, Other Substance Use, and Motivation to Change 
We will gather information about age of onset of alcohol use, period of heaviest drinking, most 
drinks consumed on a single day, and number of lifetime drug classes used. Current and past alcohol and 
substance use disorders (as well as screening for mania and psychosis) will be assessed at baseline using 
the MINI 7.0.1 4. Urine Drug Screen. In addition to providing a breath sample for alcohol concentration 
analysis at each in-person assessment, participants also will provide a urine sample for testing for recent 

 
Page 10 of 21 
drug use: PCP, ecstasy, barbiturates, methadone, oxycodone, benzodiazepines, methamphetamine, THC, 
opiates, and cocaine. Alcohol withdrawal symptoms will be assessed using the Clinical Institute 
Withdrawal Assessment for Alcohol, revised 1.  
Timeline Followback (TLFB). The TLFB interview 5 will be used to assess past 30 day alcohol use. 
The TLFB interview is a valid and reliable calendar-assisted structured interview which provides a way 
to cue memory so that accurate recall is enhanced 6-8. It will provide data on the percentage of drinking 
days, drinks consumed per week, and the percentage of heavy drinking days. The TLFB also 
will be used to provide a valid assessment of drug use behavior 9. The Short Inventory of Problems [SIP; 
10] will be used to assess the extent to which subjects have experienced problems related to their alcohol 
use in the 3 months prior to each interview. The SIP assesses 15 negative consequences of alcohol use 
and has good psychometric properties 10,11. Cigarette smoking will be assessed at baseline including 
whether participants consider themselves “smokers”, age of initiation, current smoking rate, and number 
of years of regular smoking, quitting attempts and corresponding methods. At follow-ups, the 
questionnaire will query current smoking rate and whether any quit attempts have been made since the 
last follow-up. Perceptions of alcohol related consequences and motivation to change alcohol use will be 
assessed using the 28 item validated Alcohol Consequences Scale (12) and the Alcohol Contemplation 
Ladder which consists of one item where participants indicate the statement which best reflects their 
motivation to make changes in their alcohol use (13). The inclusion of these two scales at will allow us 
to better understand the motivations for change in the sample. 
The short form of the Conflict Tactics Scale (14). We have previously received approval to 
administer the Conflict Tactics Scale (CTS) Short Form to assess intimate partner violence (IPV) but, in 
the new segment of this project, we had not sought approval to continue using it. We are asking for this 
approval now. We have modified the response options to be consistent with other studies of IPV with 
HIV-positive gay and bisexual men, which have often used a combination of response-choices that track 
past year and past 5 year experiences (15).  
The CTS contains some questions about physical violence and sexual coercion. Consistent with 
our procedures, participants reporting significant injury victimization in a relationship (items 5, 11, 15, 
or 17) will be offered referrals to local and national domestic violence abuse shelters and resources, such 
as the Massachusetts domestic violence hotline and the national domestic violence hotline. Those who 
have current concerns for their safety (e.g., since many men may no longer be in the relationship in 
which the violence occurred) will be given the opportunity to talk with a doctoral level clinician (Kahler, 
Pantalone, Monti, or Mayer) on the study if they choose to do so. Responses to questions on the CTS 
would not require reporting to authorities given that they do not reflect intent to harm or imminent risk 
or reflect child or elder abuse. 
HIV History: Participants will be asked 6 self-report items about their HIV medication history, 
including when they first tested HIV-positive, their recent viral load test, when they began taking ART 
medications and number of doses at their Baseline visit, and 5 self-report items at 6-month and 12-
month follow up. These data are important to understand the impact of the intervention on ART 
adherence, which is a key outcome of our study. Antiretroviral Therapy (ART) Adherence: We are 
including a 3-item measure of ART adherence (16), which is a secondary outcome of the study; 
therefore, the inclusion of this variable is critical for our study.  HIV Stigma: This 12-item scale assesses 
the internalization of negative messages about one’s HIV status, and has been associated with substance 
use, sexual risk, and suboptimal adherence in samples of HIV-positive adults (17,18).  The addition of 
this scale will enable us to better understand the ways in which stigma impacts key outcomes of the 
intervention. 
UCLA Loneliness Scale: This 20-item self-report measure will be administered to assess perceptions 
of loneliness and isolation (19) 12 (12) to will enable us to better understand the social factors 
contributing to alcohol use, which a key outcome of the study. Important People Assessment (IPA): 
Social networks have a strong impact on substance use behaviors; therefore, we are including a 7-item 

 
Page 11 of 21 
IPA which has been widely used in studies addressing alcohol and other substance use behaviors (20). 13 
(13) The inclusion of this measure will allow us to better understand participant’s social network 
characteristics of participants and whether they change over time as a function of the intervention. 
Childhood Sexual Abuse (CSA) (21): Numerous studies document a high prevalence of childhood 
sexual abuse (CSA) among HIV-positive gay and bisexual men, and has been associated with HIV risk 
and substance use behaviors (22, 23).  We will administer an 8 item measure of CSA to better 
understand whether the intervention has a different impact on participants who have experienced CSA 
compared to those who have not 
Collateral Reports. Collateral informants will be interviewed regarding the participant’s drinking. 
These interviews will be confidential, and no information regarding the participant will be provided to 
the collateral. Collaterals will estimate the number of drinking days in the past month, the average 
number of drinks consumed per drinking day, and the number of heavy drinking days.  They will 
indicate their level of confidence in their knowledge of the participant’s drinking and only reports for 
which the collateral was at least “fairly confident” will be considered. The use of collaterals may 
increase honesty in reporting by participants and provides an index of the validity of self-reported 
drinking.  
Measures of ART Adherence and Sexual Behavior 
 
Timeline Followback (TLFB). The TLFB administered will be used to assess medication adherence 
and sexual risk behaviors as we have been doing in our current study.  Due to the cognitive demands of 
completing a TLFB with alcohol, drug, sex, and adherence behavior, we will only go back 30 days from 
the interview for these measures. The TLFB has been shown to be a valid measure of adherence 14,15 and 
facilitates examination of alcohol-adherence associations on a daily basis 16-18. Participants will review 
each of the 30 days on the calendar, indicating the number of doses prescribed and taken each day. The 
dependent variable will be the percent of days with missed ART doses. 
 
The TLFB interview for sex risk behaviors has previously been shown to be feasible, reliable, and 
valid 19, even in a high-risk population (psychiatric outpatients) 20. In order to better assess sexual risk 
reduction strategies, this assessment asks whether their HIV-negative partners are on PrEP, in addition 
to whether participants engaged in other deliberate risk reduction strategies (i.e., strategic positioning, 
having oral instead of anal sex).  This interview assesses each occasion of sexual activity over the past 
30 days, with detailed information on the type of partner (long-term, dating, casual, or anonymous); HIV 
status of partner (positive, negative, or unknown); type of sexual activity (anal, insertive or receptive); 
condom use; and whether the participant was under the influence of alcohol and/or other substances. 
Three variables will be derived from this measure: occasions of unprotected anal intercourse (UAI), and 
occasions of UAI with a partner of negative or unknown status. The latter variable captures occasions of 
sex that carry the highest risk of HIV transmission 21. 
 
Computer-Assisted Self Interviewing (CASI).  We will use a brief CASI to provide a secondary 
assessment of alcohol, sex, and ART adherence that may reduce under-reporting of behaviors due to 
social desirability. The CASI queries behavior over the prior 6 months. The Sexual Risk Assessment 
queries the number and gender of partners with whom the participant reported having sex and the 
number of times the participant had unprotected insertive or receptive anal sex or vaginal sex with a 
partner of HIV-negative or unknown HIV status.  The CASI also assess alcohol and drug use using a 
quantity-frequency interview, and adherence using a recent questionnaire that has recently been 
validated in a large sample of MSM by collaborators at Brown 22. 
Cross-behavioral measures. We will assess alcohol-ART interactive toxicity beliefs with a scale by 
Kalichman et al. that predicts non-adherence on drinking days 23. We will assess motives for drinking 
24,25, including our newly validated scale for sexual drinking motives 26.  
Standard Clinical Assays and Research Biomarker Assessment 
We will collect serum samples from all participants. Some clinical assays will be run in real time and 
will include immunologic profiling (CD4/CD8 enumeration) and complete blood count while others 

 
Page 12 of 21 
including virologic assays (serologic HBV/HCV status, HIV-1 PVL and if required HBV, HCV viral 
loads) and a full liver profile (liver enzymes, bilirubin) will be processed and frozen before sent to labs 
for analysis. When possible and within the appropriate timeframe, all clinical values will be taken from 
patients’ electronic medical records for patients who receive care at Fenway Health. For those who 
receive care at other health care facilities in the greater Boston or Miami area, we will ask their 
permission to request those values from their providers. Clinical lab values obtained through this study 
will be added to participants’ medical records if they receive care at Fenway Health. For those receiving 
care at other health care facilities in the greater Boston area, we will request their permission to notify 
their providers of abnormal lab values. We also will use the samples to obtain serum biomarkers of 
inflammation (21-plex cytokine/chemokine assay); oxidative stress (4-HNE/LPO, 8-OHdG, AGE, 
carbonyl); insulin resistance and metabolic dysfunction; neurodegeneration (BDNF, ICAM, VCAM, 
GDNF, NGF, HGF, bFGF); and ceramide levels/profiles (see Virology Core for further details), as well 
as recent alcohol use (phosphotidyl ethanol). The non-clinical assays will be used only for research 
purposes and not entered into participants’ medical records. 
Measures of Neurocognitive Functioning 
We will conduct a brief battery of neurocognitive tests that are likely to be sensitive to the effects of 
heavy alcohol consumption and HIV. The neurocognitive test results from baseline will be used for 
feedback for those in MI as we have been doing in our current study and has been done in other trials. 
The battery takes a total of 20 minutes to complete and includes the WTAR 27,28, Trails A and B 29, Digit 
Symbol 30, Hopkins Verbal Learning test 31-33, and the Controlled Oral Word Association Test 34-36. All 
of these measures are well-established neurocognitive measures that have each been widely used in 
numerous studies of HIV 37-41 and alcohol 42-55 effects on brain functioning.  
Measures of Treatment Utilization 
Concurrent Treatment. Use of other treatments for alcohol or other substance use will be assessed 
including use of pharmacotherapy for excessive drinking (type and duration), number of sessions of 
counseling received for drinking or substance use, and the number of Alcoholics Anonymous or 
Narcotics Anonymous meetings attended. Those seeking alcohol or other substance use treatment 
beyond that offered in the study will be retained following the intent to treat principle.   
 
Safety Monitoring 
 
In an effort to meet the NIH policy for Data and Safety Monitoring, we have created a system for 
oversight of the project.  Oversight of internal monitoring of the participants’ safety will be conducted 
by the PI, Dr. Christopher Kahler. Drs. Monti (Brown), Mayer (Fenway Health), Pantalone (Fenway 
Health), and Míguez (Florida International University (FIU), Miami) also will participate in the 
development and administration of the plan.  Investigators on this application have extensive experience 
with clinical trials for excessive drinking and clinical and observational studies with HIV-infected 
patients.   
Entities Conducting Monitoring: 
 
The Institutional Review Boards (IRBs) at Brown University, Fenway Health, FIU, Jackson 
Memorial Hospital Medical Center, and the University of Miami will review this protocol and all 
procedures and will provide oversight.  Monitoring will be done by the Principal Investigator, Dr. 
Christopher Kahler, the Brown University IRB, and the respective site IRBs.  Drs. Monti, Mayer, 
Pantalone, and Míguez (Co-I’s) will also participate in the administration of the monitoring plan.  
What is Monitored? 
 
Monitoring is done of all procedures to ensure that they conform to the approved protocol; of 
unforeseen circumstances that might arise and affect safety; of all reports of serious adverse events as 
defined in 38 CFR 46 and the FDA 312.32 (death, life-threatening experience, new or prolonged 
hospitalization, persistent or significant disability/incapacity); of other significant adverse events 

 
Page 13 of 21 
(adverse events that lead to drop out by participant or termination by the investigator); of unexpected 
adverse events resulting from the study; and of expected adverse events.  
 
Monitoring is done of all study inclusion and exclusion criteria. During this clinical trial, we will 
notify officials, as mandated by law, if a participant reports intentions to harm him/herself or others, or 
reports child abuse or abuse of an elder.  The PI (Dr. Kahler) is a licensed clinical psychologist, who will 
be available on call in case of any psychological adverse events. In the event a participant were to report 
a need or interest in treatment for alcohol/substance dependence, psychiatric disorder, or distress, an 
appropriate referral to resources will be provided based on an extensive list of referral resources 
maintained at each study site. 
Frequency of Monitoring: 
 
 
All adverse events will be continuously monitored by the PI.  Participants will be given contact 
information so that they can inform us of events that occur in between study visits.  Dr. Kahler will 
conduct daily oversight of participant safety.  He will videoconference weekly with staff to review 
participant progress and their experiences with the experimental procedures, including adverse events.  
Any adverse events that are observed and/or reported will be immediately reported to Dr. Kahler.  The 
Investigators will be available to meet outside of the weekly meetings, if necessary, due to concerns 
regarding a particular participant or any problems that may arise for participants.  If necessary, they will 
make appropriate recommendations for changes in protocol.  
 
 
The Brown University and collaborating IRBs conduct the monitoring at the continuing reviews 
as scheduled, whenever modification requests are considered, and upon receiving reports of serious 
adverse events from the PI or anyone else.  NIAAA monitors the study upon receipt of annual progress 
reports and whenever other information is received.   
Reporting Plan: 
 
Any serious adverse events that are observed and/or reported will be immediately reported to Dr. 
Kahler.  Unexpected serious adverse events are reported to Brown University, the site IRBs, and to NIH 
by telephone and by written report within 48 hours of our receipt of information regarding the event.  
All other adverse events related to the study will be reported at the continuing review.  All serious 
adverse events related to the study will be reported annually in the Progress Report sent to the NIAAA 
Project Officer.    
Any actions taken by the IRB, other than acceptance of the adverse event report, will be reported 
to NIAAA along with any changes or amendments to the protocol requested by the IRB in response to 
these reports.  Proposed changes or amendments to the protocol in general must be requested first in 
writing to the Brown and site IRBs, which will then grant or deny permission to make the requested 
change or amendment in protocol. NIAAA will subsequently be informed of any substantive changes or 
amendments in approved protocol.   
 
Data Quality Assurance and Confidentiality 
(a) Procedures to ensure the validity and integrity of the data.  Several procedures currently in practice in 
our laboratory will also be utilized for this study to guarantee the validity, integrity, accuracy, and 
completeness of the data.  It will be made clear to all participants that all information obtained during 
assessments is confidential.   
(b) Procedures to guarantee the accuracy and completeness of the data during data collection, 
transmission, and analysis.  First, the Data Coordinator will review each file within 2 weeks of data 
collection for completeness, accuracy, and validity of responses.  All scanned data will be verified by 
the Data Coordinator using a computerized verification program. Data files are accessible only to project 
personnel and are password protected.  The Data Coordinator will review the distributions of all raw 
data to ensure that data are within range and to check missing data with the hard copy of the data. The 
project database (including uploaded data files from the computer (CASI), text messaging database and 

 
Page 14 of 21 
scanner machine) is password protected and accessible only to the project’s Data Coordinator, staff 
members on the project, and members of the Biostatistics Core.   
(c) Procedures to maintain confidentiality. Study staff will maintain strict confidentiality regarding all 
aspects of a subject’s participation in this study. Any individual information gathered in the course of 
the study will not be discussed with anyone who is not directly involved with this study. For each stage 
of the research, participant names and contact information will be maintained in a 
recruitment/enrollment database during the course of the study.  Once individuals enroll in the study, 
names will be linked to participant ID number in this database, which will be kept in a restricted access 
folder on a secure server.  This file will be assigned a code name unrelated to the name of the study.  
Signed consent forms will be kept in a locked file cabinet, separate from any other project data.  Once 
data collection is completed, the corresponding recruitment/enrollment database will be deleted as it is 
unnecessary to maintain the link between participant identity and study data.  All information collected 
as part of this study will be accessible only to research staff who have completed mandatory training in 
the protection of human subjects.   
 
Potential Risks to Participants 
Potential risks in the study are considered low and include: (1) potential discomfort related to 
completing questionnaires about sensitive information such as sexual behavior and alcohol/drug 
problems, (2) potential discomfort during blood draws for viral load, CD4, and liver function tests, (3) 
potential breach of confidentiality and/or privacy; (4) symptoms of alcohol withdrawal. 
 
Protection against Risks 
 
Potential risks of the study are considered low. For the possibility of subjective discomfort from 
answering questions, any distress will be minimized by assurance that participants can refuse to answer 
any question that they do not feel comfortable addressing and may withdraw at any time without 
penalty. Interviewers are skilled in talking about sensitive information with subjects, and subjects may 
decide to end an interview at any time. In the unlikely event that a participant experiences considerable 
distress we will make a referral (if needed) for clinical assessment and/or counseling provided onsite. 
Subjects will be asked to provide urine and blood samples for testing. Potential discomfort during the 
blood draw and urine collection will be explained during informed consent. Subjects can choose to 
withdraw from the study without penalty.   
 
Confidentiality is maintained as follows.  Data files recorded with a participant identification 
number will be stored at their respective clinics; Fenway Health in Boston and JMHMC in Miami. 
These files are accessed only by project staff, who will be either Fenway Health, JMHMC, or Brown 
University employees. All project staff are knowledgeable about confidentiality and human subjects 
protection.  Follow-up contact forms that require identifying information are stored separately from data 
files and are accessed only by those staff conducting follow-up interviews. Information about 
participants that is needed for intervention delivery will be collected by staff at Fenway Health or 
JMHMC and uploaded without identifying information to a secure Brown folder.  Brown staff 
conducting videoconferences with participants will do so in room that is private from other Brown staff.  
The videoconference software used is HIPAA compliant.  During follow-up telephone calls to the 
participants' homes, no information is provided to others in the household.  All blood samples are 
identified by subject ID number only before being sent to the Virology Core for testing.  Data files 
contain no identifying information, including date of birth and town of residence.  Data are transmitted 
to the Data Core at the Center for Statistical Sciences in encrypted format. 
 
 
All text messages sent from subjects to our phone number will be catalogued and encrypted, 
stored per Brown University security standards. Once received the responses from each participants will 
be separated from the cell phone number and identified only by ID number. All participants will be 
advised to set up password protection on their cell phones and to erase messages after responding to 

 
Page 15 of 21 
minimize the chance of loss of private information. We state explicitly in the consent that we will not be 
able to respond in real-time to any concern a participant has that is outside the expected responses that is 
sent to our phone number, nor any text message outside the scope of the question we ask.  
 
 
Breach of confidentiality is highly unlikely because all information will be identified with a 
numeric code only and stored in a locked file cabinet. An enrollment database linking names and study 
identification numbers will be kept in a secure folder separate from other subject data sources and will 
be used to facilitate the collection of follow-up data. Only grant staff will have access to this database. 
All staff are or will be fully trained in relevant ethical principles and procedures, including 
confidentiality. All assessment and treatment procedures will be closely supervised by the PI. All 
audiotapes will be erased upon completion of data analysis.  
 
Some subjects may experience mild to moderate symptoms of alcohol withdrawal such as 
insomnia, psychomotor agitation, or hand tremor if they choose to stop or substantially reduce drinking; 
however, more significant withdrawal symptoms will be unlikely given our exclusion criteria. 
Specifically, we will exclude individuals who show clinically significant alcohol withdrawal at baseline 
after abstaining from alcohol for 24 hours. Given our exclusion criteria, any alcohol withdrawal 
symptoms are likely to be mild to moderate in intensity and transient.  
 
During this clinical trial, we will notify officials, as mandated by law, if a participant reports 
intentions to harm him/herself or others, or reports child abuse or abuse of an elder. If a participant 
reports current suicidal ideation when completing the MINI, the participant will be evaluated by Dr. 
Pantalone (or another licensed clinical professional) at Fenway Health or a licensed clinical professional 
at JMHMC before being ruled out of the study. 
 
Our rigorous screening procedures will help to ensure that consenting volunteers are recruited 
who do not report significant psychiatric disturbance. However, in the event a participant were to report 
a need or interest in treatment for substance dependence, psychiatric disorder, or distress, an appropriate 
referral to resources will be provided. We have included a description of the plan for data and safety 
monitoring of the research and adverse event reporting to ensure the safety of participants.  
 
Potential Benefits of the Proposed Research to the Subjects and Others 
As part of their participation in the study, participants will receive a brief intervention which could 
lead to reduced hazardous drinking. Furthermore, subjects will be participating in a study that may 
provide knowledge to guide the future treatment of HIV-infected patients who drink heavily. Given that 
the risks to subjects are considered to be minimal, the risk-benefit ratio is deemed favorable. 
In addition, this study has the potential to contribute valuable information about the potential for 
brief alcohol interventions to reduce drinking in patients in HIV primary care and about the effects of 
reducing drinking on a range of important HIV-related biomedical and behavioral outcomes. Developing 
effective interventions that address alcohol use in HIV patients can make a major public health impact 
by reducing the morbidity, mortality, and transmission risk associated with heavy alcohol use. Given the 
substantial health risks associated with heavy drinking in HIV patients and the relatively minor risks to 
subjects, the importance of the potential knowledge to be gained relative to the subject risk is favorable.  
Alternative treatments. Participants will be randomized to receive a brief alcohol intervention in 
addition to their standard HIV care. Alternative alcohol treatments are available in the Boston and 
Miami areas, including specialized addictions treatment services housed within Fenway Health and 
JMHMC. Individuals desiring additional treatment for alcohol problems will be given appropriate 
referrals.  
 
Informed Consent 
 
All participants will be fully informed of the purposes and procedures of the study. Research 
interviewers will describe the screening and the study to potential participants, including that if they are 
eligible and then agree to participate, they will be re-contacted over the following twelve months, that 

 
Page 16 of 21 
they are paid for completing the follow-up interviews, that the information they provide is kept 
confidential, and that they may withdraw at any time without penalty. If an individual wishes to 
participate, he will be asked to sign an informed consent form prior to completing the baseline 
assessment. Participants are provided with a copy of the consent forms, and the originals are kept in 
locked files at Fenway Health and JMHMC. 
 
 

 
Page 17 of 21 
Statistical Analysis Plan 
 
For primary outcomes—(a) drinks per week and (b) number of heavy drinking at 6- and 12-
months follow-ups—we fit marginalized zero-inflated negative binomial (MZI-NB) models to test the 
main and interactive effects of each of the three factors in the study design: 
𝑙𝑜𝑔{𝐸(𝑌)} = 𝛽0 + 𝛽1𝐴+ 𝛽2𝐵+ 𝛽3𝐶+ 𝛽12𝐴𝐵+ 𝛽23𝐵𝐶+ 𝛽13𝐴𝐶+ 𝛽123𝐴𝐵𝐶+ 𝛾𝑋.  (Eq1) 
with a similar logit model describing the excess zeros as in the traditional zero-inflation model. The 
terms 𝐴, 𝐵, and 𝐶 in Eq1 are dummy variables for BI vs. MI, no ITM vs. ITM, and no EI vs. EI; and 
coded orthogonally so they can be evaluated concurrently with the three 2-way interactions and one 3-
way interaction among these factors. The model parameters 𝛽1, 𝛽2 and 𝛽3 capture the main effects, and 
𝛽13, . . . , 𝛽123  capture the two- and three-way interaction effects. The models are adjusted for baseline 
covariates 𝑋, including the baseline value of the dependent variable, recruitment site, and indicators for 
interventionists. Following intention-to-treat principles, we conduct regression analyses on all 
participants who were randomized to an intervention condition regardless of the number of sessions of 
intervention they completed.  
 
Secondary outcomes for this study are: (1) the number of days engaging in condomless sex with 
a non-steady partner in the past 30 days at 6 and 12 months, (2) percentage of the past 30 days taking all 
prescribed ART doses at 6 and 12 months, and (3) HIV viral suppression (i.e., <20 copies/ml) at 12 
months. Due to limited variation in condomless sex and ART adherence outcomes, we dichotomize 
these, respectively, as: (a) 0 day vs > 1 day of condomless sex with non-steady partner and (b) > 95% 
ART adherent [i.e., perfect or near-perfect adherence] vs < 95% ART adherence. For secondary 
outcomes, logistic regression models, similar to the model above but replacing the left-hand side of Eq1 
by ℎ{𝐸(𝑌)} with ℎ(. ) being the logit link function, were used to test the main and interactive effects of 
the three study factors.  
 
Missing data. We conducted our primary analyses using complete data. We also used re-ran 
analyses with imputed data as a sensitivity analysis. Imputation of missing data was carried out using the 
chained-equation method (R MICE package) assuming that data were missing at random. We 
maintained the longitudinal structure of the data and built imputation models that imputed missing 
values at 6 months only using baseline data and observed 6-month data, and imputed the missing values 
at the 12 months using baseline and imputed 6-month data and observed 12-month data. Imputations 
were iterated until the distribution of imputed values stabilized. Five complete datasets were created and 
used for regression analyses. The results were then pooled using Rubin’s method56,57. 
 

 
Page 18 of 21 
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