Personalized Feedback to Reduce HIV+ Hazardous Drinking in Primary Care
Phase: NA
Conditions: Alcohol Consumption
Sponsor: University of Houston

Brief Personalized Feedback Intervention for Hazardous Drinking in an HIV Clinic 
NCT ID not yet assigned 
04/17/19 

 
 
Study Protocol 
 
1.0 
Objectives 
The goal of this research is to demonstrate the efficacy of an ambulatory 
evidence- and computer-based Personalized Feedback Intervention (PFI) among 
hard-to reach HIV+ hazardous alcohol users in primary care. 
Hypothesis 1: The PFI group will show reduced drinking behavior and alcohol-
related risky sexual behavior at 3 month follow-up. Hypothesis 2: Effects on 
alcohol related risky sexual behavior will be mediated by reduction in drinking. 
Hypothesis 3: Changes in alcohol use attitudes, normative perceptions, self-
efficacy for alcohol abstinence, intentions to use, alcohol outcome expectancies, 
and protective behavior strategies will mediate intervention effects on drinking 
behavior. 
2.0 
Background 
Rates of hazardous alcohol use among HIV+ individuals is approximately two 
times of that found in the general population. Hazardous alcohol use contributes 
to problems with HIV medication adherence, risky sexual behavior, psychological 
problems as well as rapid disease progression, medication toxicities, organ failure, 
and poor viremic control and may lead to increased risk of transmission and 
premature death. If PFI can be successfully transported to the HIV+ populations 
via primary care and be effective in reducing hazardous alcohol use among HIV+ 
hazardous alcohol users, then PFI will be shown to be effective in a setting where 
such hard-to-reach HIV+ hazardous alcohol users are most likely to be engaged. 
3.0 
Inclusion and Exclusion Criteria 
Inclusion Criteria: HIV positive serostatus as confirmed by medical records, after 
providing consent and completing the HIPAA authorization; AUDIT scores for 
the last 30 days for women: >=7 and for men: >= 8; between the ages of 18 and 
50 years of age; reading level on the WRAT 4 above 5th grade and proficient in 
English, although English does not have to be the first language; not currently in 
an alcohol treatment program.  
Exclusion Criteria: Unwillingness to participate; inability (e.g. mental capacity) to 
provide informed consent and/or HIPAA authorization; current suicidality; 
psychotic symptoms; currently pregnant; currently receiving treatment to reduce 
alcohol use; not currently HIV+; AUDIT scores less than 7 for women and 8 for 
men; under the age of 18 or over the age of 50; reading level below 5th grade; lack 
of proficiency in English. 
Justification: The inclusion of HIV+ individuals with AUDIT scores greater than 
or equal to 7 for women and greater than or equal to 8 for men represents the 
target population of the present study. Pregnant individuals and those under the 
age of 18 and over the age of 50 are excluded because we are interested in 
reduction of sexual risk-taking behavior and because psychosocial adjustment 
scores may be influenced by pregnancy and age. Reading level and language 

 
 
proficiency are inclusion criteria to facilitate understanding of study materials and 
measures. Psychotic symptoms and current suicidality are an exclusion criterion 
to ensure that participants are of sound mind to participate willingly. Current 
treatment in an alcohol program is an exclusion criteria because this may present 
a confound with intervention outcomes. 
Determination: We will employ a one-step screening process. Upon providing 
consent and completing the HIPAA authorization, participants will be asked 
questions regarding: their gender, HIV status as confirmed via medical records, if 
they are between 18 and 50, and whether or not they are pregnant (women). 
Additionally, they will be directed to complete the AUDIT and asked to disclose 
whether they are currently in an alcohol treatment program. Furthermore, 
participants will be assessed for current suicidality and current psychosis. We will 
also assess their reading level using the Word Reading component of the WRAT-
4,. Participants must meet the following criteria in order to be eligible to take the 
baseline and the intervention: they must be HIV+, be between 18 and 50 years 
old, not pregnant (for women), not have any current psychiatric diagnosis that 
would preclude them from participating in our study, able to read at a 5th grade 
level per the Word Reading component of the WRAT-4, report scores of at least 
seven for women and eight for men on the AUDIT, not currently suicidal, and not 
currently in alcohol treatment. Eligible participants will be given the option to 
either complete the baseline/intervention activities at that time, or to schedule to 
take it at another time. Participants who do not meet eligibility criteria will be 
thanked for their time, and dismissed.  If a patient endorses current suicidality, a 
protocol to further assess the level of suicidality is in place.  
During baseline, participants will complete a series of questionnaires on a tablet 
or laptop computer. Upon completion of the survey, participants will randomly 
receive either the PFI or attention control feedback. A follow-up assessment will 
be conducted three months after the baseline/intervention, and will include all 
measures from the initial baseline. The estimated amount of time it will take to 
complete each component of the study are as follows: the screening session: 30 
minutes; baseline/intervention: 60 minutes (including 20-30 minutes for the 
intervention); and follow-up session: 30-40 minutes.  
None of the following populations will be recruited: 
 
Adults unable to consent and/or HIPAA authorization 
 
Individuals who are not yet adults (infants, children, teenagers) 
 
Pregnant women 
 
Prisoners 
 
Students for whom you have direct access to/influence on grades 
 
4.0 
Vulnerable Populations 
N/A  
 

 
 
5.0 
Number of Subjects 
 
LOCAL: 
Expected maximum number of participants to be enrolled and complete baseline 
appointment: 150 
150 participants will allow for statistical analyses to determine group differences 
between participants randomized to the control (n=75) and treatment (n=75) 
conditions. 
 
6.0 
Recruitment Methods 
 
LOCAL: 
Participants will be recruited via referral from the staff and via flyers at each of 
the study sites. Please see the attached documents for specific scripts/language 
used in recruitment. 
7.0 
Study Timelines 
The screening assessment will last approximately 30 minutes. 
The baseline/intervention appointment will last approximately 1 hour and thirty 
minutes. 
The 3-month follow-up appointment will last approximately 30-40 minutes. 
 
The anticipated duration to enroll study participants is three years. 
The estimated date to complete the study is December 2020. 
 
8.0 
Study Endpoints 
The primary study endpoint will be the completion of the 3-month follow-up 
session by each of the total number of subjects to be enrolled in the study. The 
secondary study endpoint will be the completion of data analyses.  
9.0 
Procedures Involved 
At Thomas Street Clinic and Legacy Community Health, potential participants 
will be referred to an on-site research assistant, who will screen them for study 
eligibility criteria. Screening procedures are expected to take 30 minutes. Upon 
providing consent and HIPAA authorization, participants will complete screening 
procedure. Additionally, relevant information from the participant's medical 
records will be obtained. Access to participants' medical records will be requested 
from the participant in order to assess, history of sexually transmitted infection, 

 
 
and HIV/AIDS disease severity (e.g., T cell count and viral load). Those who 
meet initial eligibility will be invited to participate in a baseline assessment and 
intervention. Before the screening assessment begins, each participant will be 
provided informed consent and complete a HIPAA authorization form. The 
screening assessment is expected to take approximately 30 minutes to complete, 
and the baseline procedure is expected to take approximately 30 minutes to 
complete. Following the baseline assessment, eligible participants will be 
randomized between an intervention group and a control group. In the same 
appointment as the baseline assessment, participants in the intervention group will 
receive a computerized personalized feedback intervention lasting approximately 
20-30 minutes, while the control group will receive an attention control 
information session that will be comparable in focus on health-related behaviors 
(e.g., nutrition, exercise). We will use behaviors in the attention control feedback 
that are not associated with study outcomes. Attention control feedback will have 
text and graphs that are similar in appearance and length (i.e., approximately 20-
30 minutes) to intervention feedback. The appointment will conclude with a post-
treatment assessment lasting approximately 5 minutes. The total time to complete 
the baseline assessment, intervention/attentional-control, and posttreatment 
assessment will be approximately one hour and thirty minutes. Each participant 
will also be asked to complete a 3-month follow-up assessments that will last 
approximately 20-30 minutes. The primary analysis strategy for evaluating 
hypotheses will consist of multi-level regression analyses, (Hierarchical Linear 
Modeling (HLM) or mixed-effects modeling). With respect to evaluating main 
effects of experimental conditions on drinking, each participant will provide 
baseline, post-intervention, and the 3-month follow-up data. Repeated measures 
data define a two level data structure with repeated responses within-individuals 
as level-1 and individuals at level-2. The study evaluates an intervention condition 
against a comparison condition, with changes in perceived norms as a mediator. 
Specific hypotheses will be tested using specific contrast vectors, using a 
generalized linear hypothesis framework. Distributional assumptions will be 
considered and we will incorporate negative binomial or zero-altered count 
models as needed.  
Tasks to be performed: 
Each participant will complete a screening process, a baseline assessment, a 
computerized intervention/attentional control, a post-treatment assessment, and a 
3-month follow-up assessment. The screening process will cover certain 
inclusion/exclusion criteria and record the participant's contact information. The 
screening process will last 30 minutes. Participants who are eligible will be 
invited to a baseline appointment, which they may either complete at that time, or 
schedule on another day that is more convenient. The baseline assessment will 
last approximately 1 hour and thirty minutes (20-30 minutes for assessment) and 
including a diagnostic interview and questionnaire measures of demographic 
information, health status, alcohol treatment history, alcohol use outcomes and 
modifiers (norms, attitudes, self-efficacy, intentions, expectancies, behavior 
strategies, motives), sexual behavior, depression/anxiety symptoms, HIV-related 
symptoms, and HIV-related outcomes (e.g. CD4 count, quality of life). Following 

 
 
the baseline assessment, participants who are eligible will be randomized to either 
an intervention group or a control group. In the same appointment as the baseline 
assessment, participants in the intervention group will receive a computerized 
personalized feedback intervention (PFI) lasting approximately 20-30 minutes 
(included in the 1 hour and thirty minutes baseline session), and the control group 
will receive an attention control information session that will be comparable in 
focus on health-related behaviors (e.g., nutrition, exercise), also lasting 20-30 
minutes (also included in the 1 hour and thirty minutes baseline session).  PFI 
highlights discrepancies between one's own drinking and typical drinking; 
reframes use in terms of personal, social, financial, and health consequences; and, 
offers strategies for reducing alcohol use. The content and process of the PFIs will 
be based on our previously efficacious interventions reducing problematic 
drinking behavior among other populations (Carey et al., 2007; Cunningham et 
al., 2010) and increasing non-alcohol-related health-protective behavior (e.g. 
condom use; medication adherence) among HIV+ individuals (Abamecha, 
Godesso, & Girma, 2013; Janepanish, Dancy, & Park, 2011; Saal & Kagee, 2012; 
Westmaas et al., 2012). PFI highlights discrepancies between one's own drinking 
and typical drinking; reframes use in terms of personal, social, financial, and 
health consequences; and, offers strategies for reducing alcohol use. The feedback 
is non-confrontational in tone, seeks to increase motivation to reduce drinking and 
is based on the information provided during the baseline assessment. The PFI 
condition will take 20-30 minutes to complete. Each component of the feedback 
will be presented on its own screen. Time on each feedback component section 
will be tracked as one measure of feedback participation. Feedback will be 
programmed using Qualtrics and will be hooked into the baseline's data entry 
module, thereby allowing data to be imported directly from the survey into the 
feedback. Attention control information will be comparable in focus on health-
related behaviors (e.g., nutrition, exercise). We will use behaviors in the attention 
control feedback that are not associated with study outcomes. Attention control 
feedback will have text and graphs that are similar in appearance and length (i.e., 
20-30 minutes) to intervention feedback. The initial appointment will conclude 
with a post-treatment assessment lasting approximately 5 minutes that will assess 
1) the degree to which the participant has processed the PFI; and 2) the 
participant's current readiness to change alcohol use.  
Each participant will also be asked to complete a 3-month follow-up assessment 
that will last approximately 20-30 minutes and will assess the study outcomes or 
mediators from the baseline assessment. Based on the feedback provided in the 
intervention, it is expected that the treatment group will modify their drinking 
behavior to be more closely aligned with typical drinking patterns, and that the 
reduction in alcohol use-related problems will result in less risky sexual behaviors 
associated with alcohol use and increased HIV medication adherence. 
 
Measures: 
Screener: Contact information (e.g. phone number; email address); age; date of 
birth; gender; HIV status; dosage of anti-HIV drugs; other medications' dosage; 

 
 
pregnancy status; whether expect to re-locate within the next 3 months (for 
follow-up purposes); Alcohol Use Disorders Identification Test (AUDIT; e.g. 
Have you or someone else been injured as a result of your drinking?); treatment 
history to reduce alcohol use (2 items: current and past);; Wide Range Assessment 
Test (WRAT), 3rd Edition-Word Reading subtest (Stone et al., 1995). Initial and 
Follow-up appointments: Demographics (e.g. age, sex, education); Graded 
Chronic Pain Scale (e.g., In the past six months, how intense was your worst pain, 
rated on a 0 to 10 scale where 0 is “no pain” and 10 is “pain as bad as could be”?); 
Hurricane Harvey Experience (e.g., Did your home get flooded?); HIV/AIDS 
Stigma Scale (e.g. I feel guilty because I have HIV/AIDS); HIV medical history 
(e.g. date of transmission, method of transmission, CD4+ count); ACTG 
Adherence Questionnaire (e.g. Number of HIV medication doses missed within 
the last 2 weeks?); WHO HIV Quality of Life (e.g. How would you rate your 
quality of life?); Medical History and Present Medical Condition Questionnaire 
(e.g. asthma, high blood pressure, COPD); the psychosis portion of the Mini 
International Neuropsychioatric Interview 6.0.0 (MINI 6.0.0); Drinking Motives 
Questionnaire (DMQ); Protective Behavior Strategies (PBS); Alcohol Outcome 
Expectancies (CEOA); Drink Refusal Self Efficacy Questionnaire-Revised 
(DRSEQ-R); Alcohol Use Attitudes; Suicide Behaviors Assessment (SBA); 
Drinker Inventory of Consequences (DRINC); Inventory of Depression and 
Anxiety Symptoms (IDAS) (only the General Depression, Social Anxiety, and 
Panic subscales: 33 items); AUDIT; Timeline Follow-Back (TLFB; for all 
substances); 11 items); Daily Drinking Questionnaire (e.g. On average, during the 
last month, how often have you consumed alcohol?); Quantity/Frequency/Peak 
Alcohol Use Index (e.g. Think of the occasion you drank the most this past 
month. How much did you drink?); Short Inventory of Problems (SIP2R; I have 
been unhappy because of my drinking); Sex-related Alcohol Expectancies Scale 
(e.g. After a few drinks I have sex with people with whom I wouldn't have sex if I 
were sober.); Sexual Experiences Inventories (e.g. Have you ever had anal sexual 
intercourse?); Risky Sexual Behavior and Alcohol-Related Risky Sexual Behavior 
(e.g. You said you had anal sex __ times in the past 3 months. Of the __ times, 
how many times did you consume alcohol before or during the sexual 
encounter?); Drinking Norms Rating Form (e.g. Consider a typical week during 
the last month. How much alcohol, on average (measured in number of drinks), 
does a typical male/female about your age drink on each day of a typical week?); 
Intentions to Drink (e.g. On average, during the next month, how often do you 
intend to consume alcohol?); Readiness to Change Questionnaire (e.g. [Likert 
response to:] My drinking is a problem sometimes.); Participant Locator Form 
(PLF; e.g. contact info for relatives could get in touch with the participant if s/he 
moves between baseline and 3 month follow-up); Participant Contact Form (PCF; 
e.g. contact information); Behavior and Symptom Identification Scale (BASIS-24; 
During the past week, how much difficulty did you have ... managing your day-
to-day life?); . 
10.0 Setting 

 
 
The research study will be conducted at Thomas Street Health Center and Legacy 
Community Health.  
Screening sessions will be conducted when a participant calls or goes up to a research 
assistant at either the Thomas Street Health Center or Legacy Community Health 
expressing interest in the study. Screening sessions will last approximately 30 
minutes. All other assessments will take place via computerized questionnaires and a 
diagnostic interview conducted in person at the study location in a room that has been 
reserved for study use. The setting will likely be familiar to participants and will 
mitigate discomfort. Data will be entered using computer-delivered surveys 
programmed using Qualtrics.  
Unless otherwise noted, behaviors will be reported over the past three months to 
prevent overlap in assessment time points and to enhance recall. Given that all 
measures are subject to error and limitations, multiple measures will be included for 
each core construct to ensure our ability to effectively evaluate each aim. The 
assessments will begin with a series of practice questions such that participants can 
become familiar with responding to different question types (e.g., Likert items, open 
response questions). Participants who are notified of their eligibility at the end of the 
screening assessment will immediately be routed to the baseline survey, if they are 
able to complete baseline procedures at that time.  
Confidentiality will be maintained by conducting assessments in a private office and 
by having participants complete computerized surveys on a password-protected 
laptop, with information stored according to the participant's study number. All 
participant information will be de-identified, and the consent form and reimbursement 
form will not record the participant's study number. Questionnaires completed via 
Qualtrics will also be coded with an arbitrary study number. This online system is 
password protected, such that only personnel affiliated with the study are able to 
access the data. The diagnostic interview will be audiotaped to allow for the PI to 
cross-check diagnoses with the principal investigator. Audio recordings will be 
deleted once they have been reviewed by the PI. Importantly, these audio recordings 
will only be coded with an arbitrary study number and not identifying information 
(e.g., name, date of birth). If during the baseline assessment a participant provides 
responses that suggest suicide risk, referral will be made to the psychiatric clinic at 
the Thomas Street Health Clinic and Legacy Community Health. Additionally, the 
Principle Investigator (PI), a clinical psychologist, will be informed immediately if a 
patient is a suicide risk and the PI will work closely with staff at Thomas Street 
Health Clinic or Legacy Community Health to respond to the issue. 
11.0 Risks to Subjects 
Risk for emotional distress while completing questionnaires and diagnostic 
interview may occur and will likely be minimal and temporary. Referrals for 
psychiatric care will be made if deemed appropriate. 
12.0 Potential Benefits to Subjects 

 
 
 
Participants who are randomized to the computerized personalized feedback intervention 
may benefit from receiving feedback about how their alcohol use and alcohol-related 
risky sexual behavior compare to age-based normative behavior, which may serve as a 
motivator to reduce risk-related behavior by utilizing protective behavior strategies 
presented by the intervention. Participants who are randomized to the computerized 
attentional control may benefit from the health-related information presented to them 
(e.g. nutrition, exercise). 
 
 
13.0 Withdrawal of Subjects 
Participants will be withdrawn for not arriving to study appointments. 
14.0 Costs/Payments to Subjects 
Participants will be provided $50 for the baseline assessment, and $40 for the 3-
month follow-up.   
 
15.0 Confidentiality 
 
Consent forms with identifying information (names, address) will be filed separately 
from the actual study data, under lock and key. A password protected computer file will 
contain information linking participant names to their assigned numbers. Only the 
researchers will have access to this information. Questionnaire packets, when applicable, 
will also be stored under lock and key. All data will have personal identifiers removed 
and the data will be aggregated through qualitative analyses. 
 
16.0 Provisions to Protect the Privacy Interests of Subjects 
Private rooms will be used for all assessments. 
17.0 Informed Consent Process 
Eligible participants will be offered informed consent by an on-site research 
assistant at Thomas Street Clinic and Legacy Community Health, who will be 
trained to go through eligibility criteria and the consent form with participants. 
Additionally, participants will complete a HIPAA authorization form. For those 
who are eligible to participate in the study, the baseline appointments will begin 
with the research personnel describing the study to each participant via the 
consent form, which will be provided to the participant. The research 
assistant/interviewer will explain the study purpose, procedures, risks, benefits, 
and voluntary basis of participation to each participant. 
18.0 Process to Document Consent in Writing 

 
 
The study will be following “SOP: Written Documentation of Consent (HRP-
091).”   
 
19.0 Data Management 
 
Data will be collected using self-report questionnaires and clinical diagnostic interviews. 
All measures will be completed confidentially, using a secure encrypted web server, will 
be identified with a unique patient identification number generated for research purposes 
only. Consent forms with identifying information (names and study code) will be filed 
separately from the actual study data, under lock and key. A password protected 
computer file will contain information linking participant names to their assigned 
numbers. Only the researchers will have access to this information. Questionnaire 
packets, when applicable, will also be stored under lock and key in a filing cabinet. All 
data will have personal identifiers removed and the data will be aggregated through 
qualitative analyses. All paper copies of study data will be stored in locked filing cabinets 
in Dr. Carla Sharp's laboratory located in the Texas Institute for Measurement, 
Evaluation and Statistics (TIMES) on the 4th floor of the Health and Biomedical 
Sciences building. All digital study data that is collected via Qualtrics will be stored 
using encryption and password protection on the TIMES server, which is compliant with 
HIPAA and allows for the separation of participant identifying information and 
participant study data. Audio recordings and interview data will also be stored on the 
encrypted and password-protected University of Houston server maintained by TIMES. 
All study data will be stored for a minimum of 3 years following the conclusion of the 
study, which will occur when all data analysis is finished. 
 
20.0 Sharing of Results with Subjects 
Study results will not be shared with participants. 
21.0 Resources  
Drs. Sharp and Zvolensky have extensive experience recruiting among HIV+ 
adults. Dr. Neighbors has extensive experience with the design and testing of 
personalized feedback interventions. 
22.0 Additional Approvals 
N/A 
 
23.0 HIPAA 
We will be obtaining and using individually identifiable health information 
associated with a HIPAA-covered component or entity in the course of the 
research. Access to this information is necessary to confirm participants’ HIV 
status, as well as to determine T-4 cell count and viral load.  
 

 
 
This protected health information (PHI) will be filed separately from the actual 
study data, under lock and key. A password protected computer file will contain 
information linking participant names to their PHI. Only the researchers will have 
access to this information. All data will have personal identifiers removed and the 
data will be aggregated through qualitative analyses 3 years following the 
conclusion of the study. All PHI will be stored in locked filing cabinets in Dr. 
Carla Sharp's laboratory located in the Texas Institute for Measurement, 
Evaluation and Statistics (TIMES) on the 4th floor of the Health and Biomedical 
Sciences building. All PHI will be stored for a minimum of 3 years following the 
conclusion of the study, which will occur when all data analysis is finished. PHI 
information will not be reused or disclosed to any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of protected health information for which 
an authorization or opportunity to agree or object is not required by 45 CFR 
164.512. 
Given that the purpose of this study is to reduce alcohol-related harms among 
those who are HIV+, it is necessary to ensure that we are targeting the correct 
population.  Therefore, this research cannot be practicably conducted without 
access to use of this PHI. 
PHI will not be accessed prior to subject authorization.  
 
24.0 Statistical Analysis Plan 
The primary analysis strategy for evaluating hypotheses will consist of multi-level 
regression analyses, (Hierarchical Linear Modeling (HLM) or mixed-effects 
modeling). With respect to evaluating main effects of experimental conditions on 
drinking, each participant will provide baseline, post-intervention, and the 3-
month follow-up data. Repeated measures data define a two level data structure 
with repeated responses within-individuals as level-1 and individuals at level-2. 
The study evaluates an intervention condition against a comparison condition, 
with changes in perceived norms as a mediator. Specific hypotheses will be tested 
using specific contrast vectors, using a generalized linear hypothesis framework. 
Distributional assumptions will be considered and we will incorporate negative 
binomial or zero-altered count models as needed.