Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women
Phase: NA
Conditions: Alcohol; Harmful Use, Binge Drinking, Risk Behavior, HIV Infection
Sponsor: Johns Hopkins University

 
 
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Computerized Brief Alcohol Intervention in 
HIV infected and At Risk Women Attending 
an Urban STD Clinic, Phase 2: The 
Randomized Controlled Trial 
 
 
 
 
 
 
 
 
NCT01125371 
 
 
 
 
 
 
 
 
July 8, 2015 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Date: _________07/08/2015  
Principal Investigator: Geetanjali Chander, MD MPH_____ 
Application Number: _NA_00068856__________ 
 
 
 
JHM IRB - eForm A 
 
 
 
 
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1. 
Abstract 
The major risk factor for HIV acquisition among women is high-risk heterosexual sex, including 
unprotected vaginal and anal sex, and sex with a high-risk partner. Hazardous alcohol use has been 
associated with high risk sexual behaviors and prevalent gonorrhea among women attending an urban STI 
clinic, both of which increase a woman’s vulnerability to HIV acquisition and transmission.  This 
application proposes a randomized controlled trial (RCT) of a culturally tailored computer-directed brief 
alcohol intervention (CBI) enhanced with cell-phone booster calls using interactive voice response 
technology (IVR) and text messaging among HIV-infected and at-risk women attending an urban STI 
Clinic.  Hazardous drinking women (N=450) presenting to the clinic will be randomized to one of three 
arms: 1) usual clinical care/attention control, 2) clinic-based, CBI, or 3) clinic-based, CBI + 3 booster calls 
using IVR supplemented with text messages. The CBI, an evidence-based method for behavior change uses 
principles of motivational interviewing, to counsel on: 1) alcohol use and 2) associated HIV/STI risk 
behaviors.  Primary outcomes, measured at 3, 6, and 12 month intervals, include alcohol-related risk 
behaviors (number of binge drinking episodes, drinking days/week, and drinks per drinking day), sexual 
risk behaviors (number of partners, episodes of unprotected vaginal/anal sex, episodes of sex while high), 
and occurrence of HIV/STI biomarkers.  We hypothesize that a computer-delivered intervention will 
reduce alcohol use and high risk sexual behaviors among women attending an urban STD clinic. Prior to 
implementing the RCT, the CBI and IVR software and text messages have been revised to 1) include the 
association between hazardous alcohol use and risky sexual behaviors, and 2) ensure their relevance and 
acceptability using quantitative/qualitative feedback from a sample of women attending a Baltimore City 
STI clinic.  The proposed research focuses on a particularly vulnerable population of urban HIV at-risk and 
HIV-infected women seeking treatment in a public STI clinic and examines novel BI intervention delivery 
strategies specifically tailored to be culturally/socially relevant to this population. If the intervention(s) 
prove to be effective, study findings will offer “real life” specialty care clinics a screening and intervention 
package that is practical, low cost, and easy to implement. 

 
 
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2. 
Objectives (include all primary and secondary objectives) 
This application proposes a randomized controlled trial (RCT) of computer-delivered BI and 
telephone booster calls using IVR or text messaging for hazardous or binge drinking (>3 
drinks/occasion) HIV-infected and HIV-at risk women (N=450) seeking care for either HIV or 
STIs in an urban STI Clinic.  Study groups reflect three levels of intervention: 1) usual 
care/attention control, 2) clinic-based, computer-delivered, BI + text message boosters, and 3) 
clinic-based, computer-delivered, BI + 3 booster calls using IVR. Outcomes will be assessed at 
baseline, 3, 6, and 12 month intervals and will include alcohol-related risk behaviors (number of 
binge drinking episodes, drinking days/week, and drinks/occasion), sexual risk behaviors (multiple 
partners, episodes of unprotected vaginal/anal sex, alcohol before/during sex), and occurrence of 
HIV and other STIs. 
 
Aim 1:  To determine the effectiveness of computer-delivered BI (CBI), enhanced with IVR and 
booster text messages in decreasing alcohol risk behaviors among hazardous/binge drinking 
women attending an urban STI Clinic. 
 
Hypothesis 1a: Women receiving BI + IVR/text will have fewer binge drinking episodes and lower 
alcohol consumption (number of standard drinks/week, number of drinking days/week) compared to 
usual care. 
Hypothesis 1b: Women receiving BI will have fewer binge drinking episodes and lower alcohol 
consumption (number of standard drinks/week, number of drinking days/week) compared to usual 
care. 
Hypothesis 1c: Women receiving BI + IVR will have fewer binge drinking episodes and lower 
alcohol consumption (number of standard drinks/week, number of drinking days/week) compared to 
BI only. 
 
Aim 2: To determine the effectiveness of computer-delivered BI enhanced with IVR and text 
messaging boosters in decreasing sexual risk behaviors among hazardous/binge drinking women 
attending an urban STI Clinic. 
 
 
Hypothesis 2a: Women receiving CBI + IVR/text will report fewer 1) sexual partners,2) episodes 
of unprotected vaginal or anal intercourse, 3) episodes of sex while high compared to control. 
Hypothesis 2b: Women receiving CBI only will report fewer 1) sexual partners,2) episodes of 
unprotected vaginal or anal intercourse, 3) episodes of sex while high compared to control. 
Hypothesis 2c: Women receiving BI + IVR/text report fewer 1) sexual partners,2) episodes of 
unprotected vaginal or anal intercourse, 3) episodes of sex while high compared to those receiving 
CBI only. 
 
Aim 3: To observe the impact of computer-delivered BI enhanced with IVR and text messaging 
boosters on incidence rates of HIV and STI biomarkers and HIV among hazardous/binge drinking 
women attending an urban STI Clinic. 
 
 
Hypothesis 3a: Women receiving CBI + IVR/text will have lower rates of incident 
gonorrhea, Chlamydia or HIV compared to control. 
 
Hypothesis 3b: Women receiving CBI only will have lower rates of incident gonorrhea, 
Chlamydia or HIV compared to control. 
 
Hypothesis 3c: Women receiving BI + IVR/text will have lower rates of incident gonorrhea, 
Chlamydia, or HIV compared to those receiving CBI only. 
 

 
 
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3. Background  
3.a  HIV among African American Women 
African American (AA) women comprise only 12% of the US female population, and yet account for 
66% of new HIV infections1. Of the 126,964 women living with HIV/AIDS, 64% are black, 19% are white,  The 
rate of AIDS diagnosis for black women (45.5/100,000 women) is approximately 23 times the rate for white 
women2   In fact, HIV/AIDS related conditions are now the leading cause of death from AA women aged 25-341.  
High risk heterosexual sex is the major risk factor for HIV acquisition among AA women, including unprotected 
vaginal and anal sex, and sex with a high-risk partner. Faced with these staggering statistics, new, culturally 
competent, HIV prevention interventions are critical to improve the health and well-being of AA women. 
3.b HIV among women in Maryland 
In Maryland, HIV/AIDS cases attributable to heterosexual transmission have been increasing 
steadily since 1994, surpassing infections attributable to injection drug use in 20023. In 2003, 36% of 
incident HIV cases were reported among women, 68.5% of which were attributable to heterosexual 
exposure.3  AA women account for 85% of prevalent HIV cases among women in Maryland4. In 2006 there 
were 1022 newly diagnosed cases of HIV in Baltimore City, 87% among AA, and 37% among women3. 
Historically, the vast majority of Maryland residents with HIV infection have first been diagnosed at the 
Baltimore City Health Department’s (BCHD) STI Clinics. Baltimore’s two public STI clinics represent the 
highest volume sites for confidential HIV testing in the state of Maryland with 13,500 tests performed 
annually.  HIV incidence is very high among those accepting testing, and is estimated at 1.5% per year.5 
Baltimore also ranks among the top US cities in STI morbidity; approximately 50% of STI clinic patients 
have a treatable STI at first clinic presentation6.  Baltimore City STI clinic patients are at high risk for HIV 
in a region of high HIV prevalence; therefore, this medical setting is a critical site for HIV prevention.  
3.c STIs and HIV risk among Women 
STIs disproportionately affect AA women.  In 2006, the Neisseria gonorrhea rate among AA 
women was 14 times higher than that among white women (618.1and 44.4 per 100,000 population, 
respectively).   The rate of Chlamydia trachomatis among AA women was more than seven times higher 
than the rate among white women.7  STIs can adversely affect a woman’s health since they are often 
asymptomatic and difficult to diagnose.  The health complications from STIs in women are frequent and a 
significant cause of reproductive health morbidity, including pelvic inflammatory disease, and infertility.8, 9  
Furthermore, genital lesions serve as an entry point for HIV, resulting in an increased vulnerability to 
acquisition and transmission of HIV infection.  The presence of certain STIs can increase the risk of 
acquiring HIV infection from 2 fold to 5 fold10, 11. Women attending an STI clinic are at particular risk for 
acquisition and transmission of HIV.   
3.d Alcohol Use Is Linked to HIV, Sex and Drug Risk Behaviors among Women  
The prevalence of HIV infection among alcoholics is higher than that in the general population.12, 13  
Studies report over 40% prevalence of alcohol problems among HIV-infected individuals.14, 15 These 
findings underscore the importance of understanding the impact of alcohol use on unsafe sexual behaviors 
in HIV-infected and HIV at-risk individuals particularly since sexual transmission of HIV is, in principle, 
preventable.  Among HIV-infected and HIV at-risk women, those who are hazardous drinkers are more 
likely to have: (1) multiple or casual sex partners;16-21 (2) unprotected sexual intercourse22-24; (3) 
intravenous drug use (IDU) sex partners or sex trading partners for money or drugs.25, 26 Importantly, as the 
amount or frequency of alcohol increases, so does the likelihood of risky sexual behavior.27-31  In global 
studies of general population women, alcohol use is linked to increased likelihood of having multiple sex 
partners as well as unprotected sex.32, 33  Event level studies, assessing the association between alcohol use 
during sex and condom use,  have been contradictory, although it appears more that some inconsistency 
stems from recall bias on the part of inconsistent condom users34 and/or omission of partner  substance 
abuse.35  Such findings underscore the importance of using careful timeline follow back methods as well as 
assessing the partner intoxication status at the time of sex. Alcohol use is also associated with increased 
rates of HIV drug risk behaviors.  Concurrent alcohol and IDU or sharing injection equipment is 
common.36  Stein and colleagues 37-39 studying IDU in a needle exchange program found that individuals 

 
 
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with a history of hazardous alcohol use were over two times more likely to share needles, after controlling 
for demographic and behavioral factors associated with needle sharing.  Using event specific analysis, 
needle sharing days were directly linked with alcohol use days.  Alcohol use independently increases the 
risk of engaging in unsafe sexual behaviors and in drug use. 
3.e. Alcohol Use Is Linked to STIs/HIV among Women  
Alcohol use is associated with Chlamydia, and gonorrhea, even when behavioral risk factors are 
controlled.40-42  Alcohol may alter biological susceptibility to HIV or STIs.  Clinical and experimental 
studies have demonstrated that excessive alcohol consumption can result in impairment of the immune 
system, and can impact several immune functions including immune tolerance and host defense against 
opportunistic infections.43 In a representative household survey of US adults, hazardous alcohol use, 
independent of high risk sexual activities, was the most important variable marking STI history and 
predicting future STIs.44  Alcohol use is also associated with a reported history of STIs among community-
recruited AA adults 45.  In a large household survey, the likelihood of having an STI in the past year was 
related to the frequency of alcohol use during the past month. Among young women aged 18 to 25, 
2.1 percent of those who did not drink alcohol in the past month had a past year STI compared with 
4.2 percent of those who were binge drinkers (>4 drinks per occasion in the past 30 days), and 7.3 percent 
of heavy alcohol drinkers (>4 drinks on the same occasion on each of 5 or more days in the past 30 day). 
Importantly, alcohol consumption appears to directly increase the risk of HIV infection. A large scale study 
of more than 8,000 women in Rakai, Uganda found that consuming alcohol before sexual intercourse 
increased the risk of acquiring HIV by 40% for women. The study also found that if both partners 
consumed alcohol, the risk increased by 81% for women.46 Whether mediated by biologic or behavioral 
variables, alcohol abuse can enhance risk of HIV acquisition. 
 
Among HIV-infected women alcohol use is prevalent and has been associated with increased STI. 
Among a sample of predominantly AA HIV infected women, 52% had a positive score on the CAGE 
questionnaire.  Among these women, a +CAGE was associated with 1) trichomonas vaginalis and 2) 
having sex only while drinking alcohol or having sex with their partner when they both had been 
drinking.47 In addition, alcohol use has recently been shown to be associated with HIV-1-RNA vaginal 
shedding among women on antiretroviral therapy.  Among an urban sample of HIV infected women, 
moderate to hazardous levels of alcohol use were associated with vaginal shedding of HIV-RNA (>50 
copies/ml) after adjustment for HIV viral load, immunosuppression and antiretroviral adherence.48 These 
two studies suggest that hazardous alcohol use in an important target for intervention among HIV infected 
women. 
3.f. Alcohol Use Is a Barrier to HIV Prevention Interventions and Treatment Adherence 
Alcohol use is a barrier to HIV prevention interventions.  In the NIMH National Multisite HIV 
Prevention Trial of 3,104 participants from 37 clinics in 7 regional sites, alcohol problems were a 
significant predictor of relapsed and unprotected patterns of sexual behavior among participants in the 
intervention condition over 1 year.  The authors concluded that, “HIV preventive intervention efforts 
should include a focus on alcohol abuse”.49  Patients who are HIV+ and drink at hazardous levels have 
lower rates of antiretroviral therapy use and worsening virologic and immunologic status.50 
3.g. Treatment for Hazardous Alcohol Use Can Reduce HIV Risk Behaviors 
Treatment of hazardous alcohol use, however, can be effective in reducing sexual and drug risk 
behaviors and HIV transmission.  Among alcoholic patients, HIV risk behavior decreased when treatment 
was provided for alcohol abuse51, 52.  Stein and colleagues performed motivational interviewing as a brief 
intervention to reduce alcohol intake among needle exchange participants. They found an average reduction 
in drinking days from 12 at baseline to 8.3 at six months.53 Importantly, a subsequent analysis demonstrated 
a reduction in HIV risk by decreased injection equipment sharing in the brief intervention group.54Thus, 
alcohol treatment can be considered primary HIV prevention.  
3.h Alcohol Use among Women 
Women are important targets for alcohol interventions.   Women are more sensitive to alcohol 
impairment than men.  Controlling for body weight, women achieve higher blood alcohol levels than men 
after drinking equivalent amounts. 55 Although women are less likely than men to develop alcohol abuse or 

 
 
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dependence, they are over represented among harmful/hazardous drinkers.56   The threshold for harmful 
alcohol effects is strikingly low in women, with more than one drink per day placing women at risk for 
negative health consequences.57  Women make up one-third of the estimated 14 million Americans who 
abuse or are dependent upon alcohol.  While men drink alcohol in larger amounts than women do, alcohol-
dependent women often experience greater physical impairment, sooner, once they begin to drink 
heavily.58, 59  Women alcoholics develop alcohol-related liver disease, heart disease, and brain disorders 
earlier in their drinking careers than men.  Heavy/ hazardous alcohol use is less likely to be detected in 
women receiving health services.60  Women may be less likely to seek and or engage in alcohol treatment 
services,61 making nontraditional care settings particularly important for reaching this population.  
Furthermore, women who abuse alcohol are less likely to be identified60, and over the lifetime, less likely 
to enter treatment compared to men .62  
3.i. Brief Alcohol Interventions for Women 
Most alcohol-related health consequences are experienced not by alcohol-dependent persons but by 
the much larger group of hazardous drinkers whose problems are at an early or milder stage.  This has led 
to increased efforts to identify and intervene with these at-risk drinkers earlier in their drinking careers 
before symptoms and problems advance.  Brief advice on setting safe drinking limits can have significant 
and sustained impact on drinking levels in this at-risk population. These brief interventions (BI) begin with 
a focused assessment of alcohol and drug use and related problems. Next in a brief, interaction, the 
interventionist 1) provides personalized feedback based on assessment findings (e.g., elevated liver 
function test results or other medical problems, absenteeism or lateness at work, marital distress) 2) 
discusses pros/cons of drinking and 3) offers specific drinking reduction strategies, such as goal setting for 
"sensible" drinking..   
A recent Cochrane Review of the BI literature has confirmed its overall effectiveness in reducing 
alcohol intake63 and long-term consequences of hazardous alcohol use, especially in men.  Booster phone 
calls reinforcing intervention content have also been shown to improve efficacy of BI; however, the key 
implication noted in this review was that more evaluative research on women and minorities was needed.   
Manwell and colleagues64 presented long-term results of a randomized clinical trial of BI for hazardous 
drinking women of childbearing age (i.e., averaged more than 11 drinks/week; reported heavy drinking 
[more than 4 drinks/occasion] during the preceding month; or reported 2 or more symptoms on the CAGE).   
Out of almost 6,000 women screened in 17 primary care clinics, 12% met the definition of problem 
drinking.  The intervention consisted of two physician-delivered sessions.. Overall, there were significant 
reductions in average weekly drinking and binge drinking in the intervention group compared to the control 
group.  Specifically, a 47% reduction in mean drinks/week (14.1 to 7.5) occurred within 6 months of the 
intervention and was sustained over 48-month follow-up.65  Similarly, binge drinking in the last month 
decreased from 93% to 68% of the sample and there was a corresponding reduction in the number of binge 
drinking episodes from 5.1 to 3.0 per month.  More recently, BI produced reductions in hazardous alcohol 
use among postpartum women.  In intent-to-treat analyses, women in the BI group, compared with controls, 
reported significantly greater reductions from baseline to 6 months in number of standard drinks consumed 
(14.2-drink reduction versus 5.1), number of drinking days (3.4-day reduction versus 1.2), and number of 
heavy drinking days** (1.8-day reduction versus 0.5;).66  These studies confirm the significant number of 
women of childbearing age who are experiencing problem drinking and the effectiveness of a brief 
physician-based intervention to produce long-term, sustainable reductions in drinking. They also reflect 
that while brief and effective, these interventions do require clinical and staff resources that may lead to 
difficulty in translation to “real-world” clinical settings.   
3.j. Computer-Directed Interventions 
One alternative approach to counselor- or health practitioner-delivered interventions is computer-directed 
BI.  Computer-directed BIs offer tremendous advantages in reducing the multiple barriers that to-date have 
impeded translation of brief interventions from research studies to clinical practice, even though such 
approaches cannot replicate the human elements of traditional interventions. Specifically, they offer 
tremendous advantages in terms of:  Reach (computer-based interventions (CBIs) can be economically and 

 
 
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quickly implemented with large groups of patients); Replicability (CBIs offer perfect replication so that 
fidelity monitoring is no longer necessary); Anonymity (our team and others have shown patients are more 
willing to disclose sensitive information to a computer67) Flexibility (range of strategies can be 
“programmed” and matched to patient characteristics with empirically-derived decision rules); 
Functionality (software can be modified quickly and easily (as proposed in the current grant application); 
Cost and Time (single touch screen laptop can intervene with thousands of patients annually with little time 
and effort from busy medical staff); and Rigor (replicability is at the core of CBIs).    
3.k. The Motivation Enhancement System (MES) 
Drs. Svikis (Consultant) and Ondersma have developed a specific computer-directed screening and 
intervention program that targets substance use in individuals identified through medical settings.  The 
intervention component of MES is based primarily on Motivational Interviewing principles68, which are 
themselves derived from a range of conceptual models, including Decisional Balance theory;69 ;Self-
Perception theory;70 and Self-Regulation theory.71  The core components of the BI/MES that assist clients 
in reducing/abstaining from alcohol are to: 1) create dissonance between the client identified costs and 
benefits of drinking and 2) develop client generated methods to address drinking triggers therefore building 
self-efficacy to change behavior. The goal of the MES is to facilitate self-change and/or treatment 
engagement via a single intervention session. It consists of screening, assessment and intervention modules 
which are presented using a Tablet PC (a laptop computer with an integrated touch screen).  
 
The screening component requires 10 minutes to complete and identifies patients at risk for 
hazardous drinking using a visually attractive screen that provides only the most pertinent information.  No 
keyboarding is required; all answers are provided by choosing responses from a list or by touching a visual 
analogue scale.  A mobile three-dimensional cartoon character (Peedy the Parrot) is capable of over 50 
specific animated actions and does the “talking” for the entire program.  Peedy the Parrot reads each item 
for the participant, acts as narrator and guide throughout the process, and provides occasional comic relief. 
Participants listen to Peedy via headphones to ensure privacy.  The MES is thus completely private and 
requires no computer or reading literacy; and in studies to-date, participants have consistently given it near-
perfect ratings for ease of use. For those who screen positive for alcohol/drug risk, the assessment 
component requires 20-30 minutes to complete and obtains detailed information about smoking, drinking 
and drug use (recent and lifetime) and problems associated with use. It also obtains baseline estimates of a 
patient’s level of interest and motivation to change substance use as well as the extent to which the person 
feels he/she can make a change.         
 
Research to-date with MES has targeted primarily post-partum women. The intervention 
component, presented as a 20-minute “Patient Health Check-Up”., consists of three components:  (a) 
feedback regarding substance use, the negative consequences of substance use reported by the participant, 
and the participant’s self-reported readiness to change; (b) elicitation of the pros and cons of substance use 
and related change, in which the participant chooses from a list of options the positive and negative aspects 
of the substance use for them; and (c) a summary and query regarding the participant’s interest in change, 
followed by optional goal-setting regarding their substance use (and provision of a menu of change options/ 
strategies). Throughout the intervention Peedy (the animated parrot narrator) “reflects” back the 
participant’s answers and helps to establish a constructive atmosphere in which the participant can consider 
the possibility of behavior change.   
 
Based on human factors research and experiences from earlier NIDA-funded software development, 
the MES software was designed to meet five primary requirements.  First, flexibility was paramount in 
order to minimize the time and cost of future modifications.  Second, the MES had to have a “clean” 
appearance, with minimal distractions, a small number of total colors, and an expressive narrator/guide.  
Third, the MES had to be easy to use for persons at any level of reading or computer literacy; this meant 
that all instructions, questions, answers, and interactions had to be presented aurally as well as visually.  
Fourth, the MES had to replicate the key elements of a traditional brief intervention as much as possible.  
Fifth and finally, the MES had to be brief in order to fit easily within the health care setting. 
 
3.l. Summary and Significance of MES to the Proposed RCT  

 
 
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For the current application, the potential significance of MES is clear.  First, MES is a proactive, 
low-cost intervention that can reach a large number of primary care patients.  Second, it requires only a 
single session and can be delivered in conjunction with a primary care appointment.  Third, it is perfectly 
replicable with no need for staff training and fidelity monitoring and issues of resistance are no longer 
relevant.  Fourth, since the initial investment has already been made in the development of MES software, 
modification and revision to target specific patient groups can occur with minimal time and effort. Fifth, 
similar populations to the one we are studying have found this technology simple and easy to use.  
 
3.m. IVR and its use among hazardous drinking individuals 
Using behavioral counseling through IVR to augment computer-delivered BI is innovative, has the 
potential to improve outcomes, and allows for widespread implementation of behavioral interventions 
among vulnerable and underserved populations that do not have routine access to primary care providers 
for disease management. Furthermore, IVRIVR is a telephone based technology that uses touch tone 
phones to allow the user to interact with a computer using the keypad or voice response system. IVR has 
gained increased attention in the implementation of behavioral interventions because of its ease of use, 
accessibility, efficiency and immediacy. Recent studies on its effectiveness for a variety of chronic health 
problems, including obesity, pre-diabetes, and smoking cessation are promising. 72-75 In addition, IVR has 
generally been found to be as reliable in obtaining clinical information as structured clinical interviews.76 
Reports of alcohol consumption using IVR have been found to highly correlate with blood alcohol 
concentration and reports from a cohabitating partner.77 Generally, for the management of alcohol use 
disorders, IVR has been used as a means of daily self-report of drinking and has been found to be 
associated with overall decreases in alcohol consumption.78 Recently, IVR was tested in an HIV setting 
where 31 hazardous drinking HIV infected individuals received a brief alcohol intervention followed by 
automated daily telephone self-monitoring and feedback (graphical display of drinking) at 30 days.  The 
authors found the intervention to be feasible among this population, and an overall reduction in alcohol use 
although due to the nature of the study there was no control group.79 While this study did not use IVR for 
personalized counseling/tailored counseling, it did demonstrate the feasibility of using IVR among 
hazardous drinking HIV+ persons. 
3.n. Text messaging and its use among hazardous drinking individuals 
The use of text messaging has risen dramatically in the past five years, with ¾ of the US adults using text 
messaging with a median of 10 texts per day (Pew Internet. http://www.pewinternet.org/Reports/2011/Cell-
Phone-Texting-2011.aspx) 
Using short messaging services (SMS) technology, text messages can be sent to participants to reinforce 
content from behavioral interventions. To date, text messaging has been used to support smoking cessation, 
weight loss, medication adherence, and diabetes management (Fledjsoe 2009). In a recent pilot study, 
Weitzel et al investigated the use of tailored text messages to reduce alcohol related consequences among 
college students. Among 40 participants, those randomized to the text messaging group reported 
significantly fewer drinks per drinking day during the study period. These results demonstrate preliminary 
feasibility of delivering alcohol related interventions via text messages and the rationale for further testing 
text messaging counseling among hazardous drinking individuals.  
3.0 STI Clinics as a venue for intervention 
Brief HIV/STI prevention counseling delivered at the Baltimore and other STI clinics has been 
effective in reducing HIV risk behaviors and STIs;80, 81 however there is a need to integrate sex and 
substance abuse risk reduction programs since these two behaviors are so frequently associated.82-84 Data 
from our clinic (in studies C.2.1) and others suggest that these patients have high rates of hazardous alcohol 
use and that this is associated with sexual risk behaviors and STIs.85, 86  Thus, testing the effectiveness of a 
combined alcohol and sexual risk reduction intervention is more feasible in a setting where rates of 
behaviors are high and where STIs can feasibly be diagnosed.  As STIs are irrefutable biomarkers of high 
risk sexual behavior or linkage to a high risk sexual network an STI diagnosis can validate self-reported 
behavioral change and is a surrogate marker of behavioral risk reduction 87.  Importantly, the feasibility and 

 
 
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acceptability of integrating substance abuse services into primary care at an STI clinic and sustaining such 
services has been demonstrated.88  
 
Summary 
This proposed research has high scientific and public health significance.  First, the study population will 
be predominantly African-American women, a group at exceptionally high risk for HIV.  Second, it 
examines the effectiveness of empirically validated, brief alcohol interventions delivered using highly 
novel and innovative technology.  Third, it tailors the intervention to enhance the cultural and social 
relevance of the content to more effectively engage this vulnerable population of urban women. Fourth, it 
implements the intervention in a STI clinic, a potentially important venue for delivering such care given the 
overrepresentation of alcohol and sexual risk behaviors in this setting.  Finally, computer-directed BI and 
telephone counseling through IVR/text messaging offer a low-cost, efficient means of intervention delivery 
with high potential for widespread dissemination.   
 
3.p. Preliminary Studies 
Representative Research Findings Relevant to the Proposed Research.  The following paragraphs 
highlight some of the research contributions of various members of our research team and demonstrate our 
group’s history of collaboration and expertise and ability to successfully complete the proposed research 
 
3.p.1.Gender, binge drinking, high risk sex, and sexually transmitted infections (Hutton, McCaul, 
Erbelding) We examined the association between binge drinking and risky sexual behaviors/STIs among 
patients attending the STI Clinics of the Baltimore City Health Department (BCHD). A total of 671 STI 
clinic patients were tested for STIs, and 
queried about recent alcohol/drug use and 
risky sexual behaviors using audio 
computer-assisted-self-interview. The 
association between binge drinking and 
sexual behaviors/STIs was analyzed using 
logistic regression adjusting for age, 
employment, and drug use. Binge drinking 
was reported by 30% of women and 42% 
of men. 21% reported having sex while 
drinking. Gender differences were found in 
rates of receptive anal sex which increased 
linearly with increased alcohol use among 
women but did not differ among men (see 
Figure 1). Within gender analyses showed that women binge drinkers engaged in anal sex at more than 
twice the rate of women who drank alcohol without binges (33.3% vs. 15.9%; p < 0.05) and 3 times the rate 
of women who abstained from alcohol (11.1%; p < 0.05). Having multiple sex partners was more than 
twice as common among women binge drinkers than women abstainers (40.5% vs. 16.8%; p < 0.05). 
Gonorrhea was nearly 5 times higher among women binge drinkers compared to women abstainers (10.6% 
vs. 2.2%; p < 0.05). The association between binge drinking and sexual behaviors/gonorrhea remained after 
controlling for drug use. Among men, rates of risky sexual behaviors/STIs were high, but did not differ by 
alcohol use. Rates of binge drinking among STI clinic patients were high. Among women, binge drinking 
was uniquely associated with risky sexual behaviors and an STI diagnosis. These findings support the need 
to routinely screen for binge drinking as part of clinical care in STI clinics. Women binge drinkers, in 
particular, may benefit from interventions that jointly address binge drinking and risky sexual behaviors. 
Developing gender-specific interventions could improve overall health outcomes in this population.98  
ACASI vs. Face-to-Face Interview: Assessing Response Bias  
Another substudy in the same BCHD STI clinic population (N=669) demonstrated the feasibility of using 
an ACASI-formatted survey, and its superiority to face to face interviews (FFI) as a data collection tool for 

 
 
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sensitive sexual risk behaviors (61). All participants initially underwent ACASI, and subsequently a FFI. A 
series of questions on illicit drug use and sexual risk behaviors were asked. In comparing responses to 
similar questions between the two interview modes (FFI compared to using the ACASI), participants 
reported 1) sensitive sexual behaviors such as same sex contact, receptive rectal sexual exposure, orogenital 
contact, and 2) a greater number of sex partners in the last month more frequently with the ACASI.  The 
study demonstrated that patient reporting of sensitive sexual risk behaviors (same sex contact, exchange of 
drugs/money for sex, number of sexual partners in the month) in FFI was highly susceptible to social 
desirability bias. We concluded that the ACASI might be a more reliable assessment method for reporting 
of sexual behaviors than face-on interviews with the STI clinician and that use of the ACASI within this 
setting was feasible.99 This study, which was conducted on the same population that will be recruited for 
this proposal highlights the importance of including ACASI to minimize the extent of response bias among 
the participants. 
 
3.p.2 Alcohol use remains prevalent among women attending an urban STI clinic and is associated 
with risky sex (Chander, Hutton, Finklestein, McCaul, Erbelding). We recently (July 2008) conducted 
a pilot study among 200 women attending the BCHD STI Clinic to determine the prevalence of alcohol 
use.  Participants were recruited from the waiting area and through flyers handed out by patient registration 
staff.  Alcohol use was queried through the AUDIT-C.  In this sample 88% of women were AA, 27% had 
less than a high school education, 34% graduated from high school, and the remaining 40% had some 
college or greater. Among this sample, the overall prevalence of any alcohol use was 57%; 25% reported 
binge drinking (≥ 4 drinks per occasion) and 29% met NIAAA criteria for hazardous drinking (> 7 drinks 
per week or ≥ 4 drinks per occasion).  52% of women had a score of 3 or greater on the AUDIT-C, 
reflecting hazardous alcohol use. Overall, 38% of women had risky sex, defined as either 1) a diagnosis of 
a sexually transmitted infection at the time of the survey or 2) reporting unprotected anal or vaginal 
intercourse while high. Binge drinking (Adjusted OR: 2.04 [95% CI:0.99-4.26], hazardous use (AOR: 2.10 
[1.01-4.35]) and a positive AUDIT-C (AOR:2.54 (1.28-5.03) were all associated with high risk sexual 
behaviors even after adjusting for age, race, education, and illicit drug use. These findings affirm that binge 
drinking and hazardous alcohol use continue to be problems in the STI clinic setting.  Further, the study 
confirms the team’s ability to recruit patients from the STI clinic lobby areas while waiting to see their 
practitioners. 
 
3.p.3 Cell phone use is more common than internet use among women attending an urban STI Clinic.  
In the same pilot study discussed above, women 
were asked about their cell phone and internet 
use.  Of those surveyed, 93% used cell phones 
(Table 1). Neither alcohol nor drug use were 
associated with cell phone use.  In contrast to 
the high percentage of cell phone use, only 48% 
of women used the internet once per week or 
greater.  Not surprisingly, some college or 
graduate school (AOR: 5.13 (2.22-11.85)) and a 
high school degree (AOR: 2.71 (2.25-6.39) 
were associated with an increased odds of 
internet use compared to those with less than a 
high school education, while older age was 
associated with decreased internet use. Women 
were also asked if they would be interested in 
receiving health advice over the telephone 
(either cell phone or text messaging). Sixty nine 
percent of women stated they would be 
interested. These data demonstrate that cell 
Table 1:Cell Phone and Internet Use Among 200 
Women Attending an Urban STI Clinic 
Internet usage 
Total Sample  
(N=200) 
Hazardous 
drinkers (N= 
109) 
Never 
39 (20%) 
27 (25%) 
Once per month 
32 (16%) 
18 (17%) 
Less than once per 
week 
32 (16%) 
17 (16%) 
1-6 days per week 
32 (16%) 
17 (16%) 
Daily 
61 (31%) 
27 (25%) 
Cellular telephone 
usage 
 
 
Yes  
185 (92.5%) 
97 (89%) 
No 
15 (7.5%) 
12 (11%) 
Sends or Receives 
Text Messages 
 
 
Yes  
156 (78%) 
78 (72%) 
No 
44 (22%) 
31 (28%) 

 
 
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phones use is widespread within this population and suggests that interventions via cell phone may be more 
accessible to urban women with low levels of internet use. Moreover, the majority of women surveyed 
stated that they would be interested in receiving health advice delivered by a cell-phone. 
3.p.4 Randomized Trial of Brief Alcohol Interventions Among HIV-Infected Women (McCaul, 
Chander, & Hutton). In this RCT (R01 AA14500),  hazardous/binge drinking HIV infected women 
receiving care in the Johns Hopkins HIV clinic were randomized to a therapist delivered brief alcohol 
intervention versus usual care.  All participants undergo an ACASI interview at 0, 3, 6, & 12 months and 
those randomized to the intervention received a brief alcohol intervention + 2 booster phone calls . 
Outcome measures included: alcohol/drug use, engagement in substance abuse treatment services, HIV-risk 
behaviors, HIV disease markers and medication adherence, and psychiatric symptoms.  Early testing of our 
BI curriculum revealed the participants’ observation that their heavy drinking was often a “trigger” for 
having sex that was not typical (e.g. rougher sex, casual sex, or unprotected sex). This underscored the 
importance of targeting the combination of sex and alcohol use in future risk reduction applications.  
 
3.p.5 Development and Pilot Testing of Computer-Delivered Screening and Brief Intervention 
Software (Ondersma, Chase, Svikis, & Schuster, 2005). This three-study series was conducted to 
determine the acceptability and preliminary efficacy of a computer-based brief motivational intervention 
(the Motivation Enhancement System, or MES).100, 101 In Study 1, quantitative and qualitative feedback 
from 30 post-partum women and 17 women in treatment for drug use were used to modify the software. In 
Study 2, 50 urban post-partum women who reported drug use in the month prior to pregnancy completed 
the intervention and provided repeated within-session ratings of state motivation. In Study 3, a total of 30 
women were randomly assigned to intervention or control conditions with 1-month follow up. Overall, 
women rated the MES as highly acceptable and easy to use and reported significant increases in state 
motivation at post-intervention and at one-month follow-up (d = .49). These preliminary results were 
encouraging and suggested that further work in this area was warranted.   
3.9.6Randomized Clinical Trial of Screening and Brief Intervention Software With Post-Partum 
Women (Ondersma, Svikis, & Schuster, 2007).  This randomized trial built upon the successful 
development work cited above, and was based on the principle that implementation of brief interventions 
with this population could be greatly facilitated by computer-based interventions.102 Participants were 107 
post-partum women recruited from an urban obstetric hospital primarily serving a low-income population. 
Women were randomized into assessment only vs. assessment plus brief intervention conditions; 76 (71%) 
returned for follow-up evaluation, with the intervention being a 20-minute, single-session computer-based 
brief motivational session (based on Motivational Interviewing methods) combined with two non-tailored 
mailings. At four-month follow-up, the frequency of illicit drug use other than marijuana increased slightly 
for the control group, but declined among intervention group participants (p < .05, between-groups Mann-
Whitney U; d = .50); the magnitude of intervention effects on changes in marijuana use frequency was 
similar, but did not reach statistical significance. Point-prevalence analysis at follow-up did not show 
significant group differences in drug use. However, trends under a range of assumptions regarding 
participants lost to follow-up all favored the intervention group, with most effect sizes in the moderate 
range (OR’s 1.4 to 4.7). Alcohol use was not the primary outcome of this study. However, among this 
sample, there was also significantly less alcohol use at a level of weekly or greater among the intervention 
group (7%) versus the control group (29%).  Adjusting for baseline alcohol use, in logistic regression, the 
control group had a significantly lower odds of consuming alcohol less than weekly (compared to weekly 
or greater) than the intervention group (OR: 0.162).  These results supported the efficacy of this high-reach, 
replicable brief intervention and demonstrate the research team’s ability to conduct RCTs using MES in 
medical settings.  Since a “standard care, no treatment” control group was not included, effect sizes may 
be conservative as research suggests the assessment only condition may have served as an intervention, 
leading to greater reductions in substance than expected with routine practice.     
 
3.p.7 Interactive Voice Response Technology (Finkelstein) Dr. Finkelstein has significant experience in 
development and systematic evaluation of patient-centered information technology, including IVR. IVR is 

 
 
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a telephone based technology that uses touch tone phones to allow the user to interact with a computer 
using the keypad or voice response system. One study with high relevance to this proposal carried out 
usability testing of two automated home-based systems designed to monitor patients' health status and 
improve self-care. 103 TLC-DietAid, an IVR system that uses computer telephony to carry out totally 
automated telephone conversations with patient users, monitors dietary behavior of dyslipidemia 
(cholesterolemia) patients in their homes and provides them with nutrition information, advice, and 
behavioral counseling, principally to lower saturated fat in their diets and thus lower low-density 
lipoprotein cholesterol (LDL-C) in their sera. During weekly conversations, TLC-DietAid speaks to 
patients over the telephone using computer-controlled digitized human speech. The patients, in turn, 
communicate with TLC-DietAid using the touch-tone keypad of their telephones. In usual practice, patients 
call TLC-DietAid once a week, however, for this evaluation study they used it every day for 2 weeks. 
Conversations typically last between 5 and 10 min, depending on the number or complexity of the topics 
addressed and the user's responses. After each conversation, TLC stores the information recorded by 
patients in a database, for use in tailoring future conversations. The systems were evaluated in two separate 
qualitative studies.104 The qualitative analysis 
uncovered "medium-specific" and "content-specific" issues that addressed either the process of the 
interaction or its content. The results demonstrated that patient-users tended to evaluate each system on the 
basis of how it fit into everyday life and corresponded to personal preferences. The methodology also 
allowed the system designers to understand users' concerns and the context of adoption in order to design 
changes to address such concerns. This study demonstrates Dr. Finkelstein’s ability to design and 
implement an IVR system, and his use of qualitative methods to modify the system. An important finding 
from this work was that users evaluated the system on its compatibility with their lives. Because cell phone 
use is prevalent in our proposed sample (93% surveyed used cell phones), this mode of intervention 
delivery may be particularly acceptable and may be more accessible to individuals who may not regularly 
access the health care system..  
 
3.p.8 Results from the Development Phase of this R01 Proposal 
Development and Pilot Testing of Computer-Delivered Screening and Brief Intervention Software in 
the Baltimore City STI Clinic  
In the development phase of this study we performed 20 in-depth interviews with women attending the 
BCHD STD clinic who reported binge drinking or having sex while under the influence of alcohol. The 
goal of these interviews was to obtain information from women about their alcohol use, alcohol 
expectancies, and alcohol use within their community to tailor the computerized intervention to women 
attending the BCHD STD clinic. Thematic saturation was reached. Drs. Chander and Hutton performed 
these in-depth interviews and the data have been independently coded and analyzed and used to 
tailor/modify the existing computerized BI to ensure its relevance to the STD clinic population 
Initial software modifications were made by programmers at VCU, tested by investigators, followed by 
additional modifications and then piloted among women attending the BCHD STD clinic. Results from our 
first 10 pilot participants demonstrated that the intervention is twenty minutes in length. Peedy the parrot, 
the motivational interviewer/interventionist is well-liked by participants and the intervention is well 
accepted. Three participants felt that Peedy the parrot’s voice was either too slow, or difficult to 
understand, and software modifications were made to address this. 
 
The attention control, which consists of content related to dental health, has been developed and is twenty 
minutes in length to match the length of the CBI. 
 
 
In addition to performing the in-depth interviews, and subsequently modifying the computerized brief 
intervention, we also developed and pilot tested the audio computer administered self interview (ACASI) to 
be used for screening, baseline and follow-up assessments. This has been piloted among 10 women who 

 
 
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have responded favorably to the ACASI. The women have filled out confidential questionnaires on survey 
content and there have been no complaints of questions being too personal.  The baseline length of time 
varies between 07 and 30 minutes based on participants’ familiarity with computers (see table 4).  
 
Table 3: Evaluation of ACASI by Pilot Participants 
Median Time to Complete Baseline 
Assessment 
10 minutes, range 7-30 minutes 
Like working with the computer 
1/10 did not like using the computer 
Ease of computer use 
10/10 said using the computer was easy 
Comfort with questions 
1/10 participants was uncomfortable 
answering questions about anxiety/mood 
Confusing questions 
0/10 said any questions were confusing 
Irritating questions 
0/10 said that any of the questions were 
irritating 
Questions too personal 
0/10 said questions too personal 
 
 
 
3. Summary  
Hazardous/binge alcohol use is prevalent among women attending Baltimore City STI clinics and 
associated with particularly high risk behaviors: unprotected sex, multiple sex partners, and anal 
intercourse.  The MES system, based on the principles of motivational interviewing, offers an innovative, 
and replicable means of delivering brief alcohol/STI interventions among the vulnerable population of 
HIV-infected and HIV-at risk women.  Enhancement of this intervention with cell-phone based telephone 
counseling using IVR and text messaging has the potential to reach individuals who may not routinely 
engage regular health care.  The investigative team brings a depth and diversity of experience that will 
allow them to tailor the MES, IVR and text messaging intervention delivery systems and content to the 
target study population of urban women.  
 
4.Study Procedures 
All procedures are for research purposes only. 
4.a. Study design,  
4.a.1. Overview of Study Design: 
We propose a randomized controlled trial (RCT) of computer-delivered BI and telephone booster calls 
using interactive voice technology and text messaging for hazardous/binge drinking women seeking care 
for  sexually transmitted infections in the Baltimore City Health Department STI Clinic (BCHD STI) 
(N=450).  The arms of the RCT will reflect three levels of intervention: 1) usual care/attention control, 2) 
clinic-based, computer-delivered, brief alcohol intervention, and 3) clinic-based, computer-delivered, brief 
alcohol intervention + 3 booster calls using IVR supplemented with counseling text messages. The primary 
outcomes will be measured at baseline, 3, 6, and 12 month intervals and will include alcohol-related risk 
behaviors (number of binge drinking episodes, drinking days/week, and drinks per occasion), sexual risk 
behaviors (number of partners, and number of unprotected vaginal and/or anal sex occasions, sex while 
high), and occurrence of STI biomarkers.  See Study Design Overview Below 
 
 

 
 
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4.a.2. Study Setting and Participants 
This study will take place at the BCHD STI Clinic. The Eastern District STI clinic of the BHCD 
processes over 12,000 Clinic patient visits per year (Table 5).   
The majority of patients who use the BCHD STI 
Clinics seek episodic treatment primarily for 
gonorrhea, syphilis, HIV, and chlamydial infections 
but also for other STIs such as trichomonas, non-
gonococcal urethritis, herpes simplex virus infections, 
and human papilloma virus (HPV) infections.  The 
Eastern STI Clinic is easily accessible to public 
transportation services, and is located in high 
prevalence areas for STIs and HIV infection.  The 
clinic is staffed by 6-8 nurse practitioners and 
physician assistants trained in STI diagnosis and 
treatment, contraceptive care and counseling, HIV 
risk assessment, and pre-and post-test HIV 
counseling.  The clinics operate Monday through 
Friday, 8:30 a.m. to 5:00 p.m.  Individuals attend the 
clinic on a “walk-in, first-come, first served” basis 
and are assigned an appointment time for that day as 
they register. Clinicians are trained to provide HIV 
prevention counseling to all patients within their 
clinical encounter so that care is delivered according 
to an integrated HIV/STI treatment and prevention 
model. Our study focuses on women seeking STI 
services within this setting.  Characteristics of the 
population are described in the Table. Forty seven percent of visits are made by women and 5% are HIV 
infected. 
 
4.a.3. Recruitment 
We plan to screen 1800 women receiving care at the BCHD STD Clinic over 30 months with the goal 
of recruiting approximately 15 women per month. Study participants will be identified by four 
mechanisms.  
1) Women registering in the BCHD STI clinic will be given a standard form with the following question: 
“Have often in the last year have you had more than three drinks of alcohol on one occasion?” This 
form has already been integrated into the routine registration procedures at the Druid Hill STD Clinic, 
and will be added to the procedures at Eastern STD Clinic. This form will be reviewed by the study 
research assistant, and for those women who have had more than three alcoholic drinks on one occasion 
in the past year, a sticker will be placed on the form asking the provider to discuss referral to the study 
with the patient. This form will be included in the registration packet given to clinicians irrespective of 
the patient’s drinking status.   
2) Flyers will be posted in the clinic waiting room.  
3) Participants will be recruited by provider referral. In addition to screening for alcohol use at 
registration, providers in the STD clinic ask all patients the following two questions as part of routine 
clinical care. These questions are integrated into the electronic medical record/standard history and 
physical form used at all patient encounters: 1) “In the last month: have you had sex when you were 
intoxicated on alcohol? 2) “In the last one month: Have you had more than 3 drinks on one occasion?” 
If a woman answers yes to either of these questions, providers may refer her for screening. 
Table 5: Demographic Characteristics BCHD 
STI Clinic: Eastern District  
Characteristic 
BCHD STI Clinic:  
 (n=12,768 visits) 
Gender 
     Male 
     Female 
 
6744 (52.8) 
6024 (47.2) 
Race/Ethnicity 
     African 
American 
     White 
     Hispanic 
     Other 
 
10776  (84.4)  
796 (6.2) 
1002 (7.8) 
194 (1.4) 
Age 
 
     <15 
11 (.1) 
     15-19 
1136 (8.9) 
     20-24 
3307 (25.9) 
     25-29 
2629 (20.6) 
     30-34 
1464(11.4) 
     35-39 
1096(8.5) 
     40-44 
1279(10) 
     45+ 
1848(14.4) 

 
 
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4) Waiting room recruitments: a table will be set up in the waiting room of the STD clinics where a 
research assistant will be seated with flyers advertising the study. The research assistant will follow a 
standard script that asks if a participant would like to screened for a study examining a computer delivered 
intervention to focusing on healthier behaviors (see attached script in supplemental study documents). In 
the waiting room, there will be no mention of alcohol or sexual risk behaviors. If a woman is willing to 
undergo screening, she will be taken to a private room, where more information can be given about the 
study, as well as screening and consent.  In the event that a table is not available, a research assistant will 
be seated in the waiting room with recruitment flyers and any discussion of the study will only include 
information detailed on the attached script. 
4.a.4.Informed Consent 
Women who present for study screening will undergo informed consent in a private office in the BCHD 
STD Clinic. Consent will be obtained during usual clinic hours and 15 minutes will be allotted for 
obtaining consent. The consent forms will specify that the purpose of the study is to test the effectiveness of 
a computer-delivered brief intervention (with or without follow-up phone calls) among women with 
hazardous alcohol use.  They will be informed that they will be randomly assigned to 1 of 3 study 
conditions (usual care, computer-directed brief alcohol intervention, or computer-directed brief alcohol 
intervention + booster phone calls) and that they may choose to leave the study at any time without 
compromising their health care at the BCHD. They will also be informed that if they consent to the study, 
they will participate in 4 research interviews including baseline, 3, 6 and 12 months. Risks and benefits of 
the study will be clearly explained as will alternate therapies. Participants will also be informed that that the 
study will have a confidentiality certificate administered by the National Institute of Alcohol Abuse and 
Alcoholism. After the consent form is reviewed, the participant will be asked questions regarding the 
consent form reflecting key study procedures, including randomization, for example, 1) what is the purpose 
of the study? 2) What are the study risks? 3) How will study group be determined? 4) What will be done to 
protect her confidentiality. The participant must answer all of these questions correctly to ensure adequate 
understanding of the consent form. If questions are not answered correctly, the research assistant will 
review the study procedures until the participant demonstrates understanding. 
We will not be enrolling women who do not speak English. Because the intervention has an audio 
component, we will not be enrolling individuals who are hearing impaired.   
 
4.a.5 Screening and Eligibility: 
Women will be screened for the study in a private office in the BCHD STD Clinic. We anticipate screening 
1800 women, with 25% meeting study eligibility. The screening will be comprised of the following 
questions to determine study eligibility.  
 
1) Age 
2) Patient of the BCHD STD Clinic 
3) Quick Drinking Screen (a measure of daily quantity and weekly frequency of alcohol use) 
4) Sex while under the influence of alcohol in the past 3 months 
5) Sexually active with men 
6) Pregnant 
7) Able to speak and read English 
8) Currently enrolled in alcohol treatment 
9) Own a cell phone 
10) Uses text messaging 
11) Not moving out of the area in the next 12 months. 
 
 
Inclusion Critieria 

 
 
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Age >=18 and 
 
 
 
 
 
 
 
 
Patient of BCHD STD Clinic and 
Sexually active with men in the last 90 days and any 1 of the following three criteria:  
 
 
 
 
 
Average of 8 or more drinks per week or  
 
 
 
 
Two heavy drinking episodes (4 drinks/occasion) in past  3 mos/90 days   or    
Sex while under the influence of alcohol in last 3 months/90 days on two or more occasions 
 
Exclusion Criteria 
Actively Psychotic or severe mental health symptoms 
Unable to speak or read English 
Pregnant 
No cell phone 
Does not text message and not interested in starting 
Currently enrolled in alcohol treatment 
 
 
Women who are ineligible for the study will receive $5.00 for their time. Women who are eligible for the 
study will participate in the baseline assessment described below in section 4.a.8. 
 
4.a.6. Randomization 
After women undergo their baseline assessment they will be randomized to one of three study arms: 1) 
Computerized Brief Intervention (CBI) + Cell phone counseling/text messages 2) CBI only 3) Attention 
Control/Usual Care. Randomization will be stratified by current illicit drug use.  
4.a.7. Study Arms 
Attention Control/Usual Care 
An attention control arm has been created for this study to ensure that intervention effects are not a result of 
the increased attention one receives from participating in behavioral interventions. For participants 
randomized to the attention control arm the RA will record their group assignment and bring Peedy the 
Parrot onto the screen.  They will then participate in computer-delivered informational intervention on oral 
health. Specifically, individuals will watch a series of videos on the importance of brushing and flossing 
teeth. In addition, they will receive educational information on gingivitis, gum disease, links between gum 
disease and overall health. Finally they will receive instruction on how to properly brush and floss teeth.  
The rationale for including dental information in the attention control arm is that poor oral hygiene has 
been identified as a major public health problem in Baltimore City.  
 
Participants in all three arms will receive a “Healthy Woman” pamphlet that includes local resources 
including a comprehensive list of federally qualified health centers in Baltimore City and local resources 
for free dental care, psychiatric care, primary medical care, substance abuse treatment programs (including 
tobacco), AA and NA meetings, and domestic violence. This will be submitted to the IRB once it is 
complete. 
 
Computerized Brief Intervention 
Women randomized to either the CDI + IVR/text or CBI only will receive the computer-delivered brief 
intervention targeting alcohol use and risky sexual behaviors. Participants will interact with the computer 
via Peedy, a three dimensional animated character. Peedy the Parrot has been found in previous research to 
be well-understood and well-liked. The 20-minute intervention will be delivered as an ACASI, with 
participants listening to Peedy using headphones. The computerized intervention will focus on 1) providing 
feedback on the participants alcohol use and HIV risk behaviors, 2) emphasizing personal responsibility for 
change, 3) providing clear advice to change risky behaviors, 4) providing a menu of options for change, 5) 
using empathy as a counseling style, and 6) enhancing self-efficacy. The MES is heavily based on 

 
 
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Motivational Interviewing principles.68 It thus includes traditional motivationally-oriented intervention 
components: feedback, pros and cons, and optional goal-setting. The MES tailors more thoroughly on 
present willingness to change. Thus, the above components are primarily presented to participants who are 
unwilling to initiate a change attempt. Those who are willing move directly into optional goal-setting, 
which includes a menu of change options as well as elements normally found in a “change plan worksheet” 
(specification of goals, problem-solving regarding how to address possible obstacles, etc.). It also provides 
expanded options for additional information, for addressing self-efficacy with participants whose 
willingness is high but confidence is low; and for assistance with relapse prevention—all presented only for 
participants who indicate interest in this information. The current MES also includes the ability to utilize 
the participant’s first name, following data from Dijsktra108 indicating that just this simple addition results 
in additional perceptions of personal relevance, with consequent increases in efficacy. Finally, women will 
be given a brief handout summarizing ways to avoid, cope and escape risky moods and situations 
associated with alcohol use (uploaded as supplemental document).  
 
For the present study, these components have been tailored to the target women served by BCHD 
STI Clinic based on in-depth interviews done with women attending the clinic, and on feedback on the 
intervention after the MES was revised to reflect content from in-depth interviews. For example, the 
benefits of continuing to use alcohol (e.g., social network of alcohol using friends, helps person cope with 
stress, alcohol expectancies, avoidance of withdrawal) will also be discussed in conjunction with the 
benefits of reducing or stopping use (e.g., improved physical and psychological health, reductions in family 
conflicts and problems, reductions in high risk sexual and drug related behaviors).  Opportunities to look at 
what life will be like five years in the future if the person continues to use alcohol as compared to making a 
choice to cut down or stop using alcohol are provided.  Finally, participants have the chance to set goals to 
reduce or stop using alcohol either on their own or with assistance from AA, or another substance abuse 
program of their choice.  The CBI script that was programmed into the MES software is attached as an 
appendix to this proposal. 
 
CBI + Booster phone calls using Interactive Voice Response Technology (IVR) and text messaging 
This enhanced CBI arm, will use the MES-delivered brief intervention described above and be 
followed by three booster phone calls using IVR.  The booster calls will occur 2, 4, and 6 weeks after 
intervention delivery. Participants randomized to this arm, will be informed that they will receive these 
calls. They will be asked if there are specific days of the week they would prefer to be called and if specific 
times of the day. The booster calls will reinforce the intervention content, query participants regarding 
drinking behaviors and goals, and build self-efficacy. The IVR used for this study has been developed by 
Dr. Finkelstein (Co-I).  This computer-based telecommunications system uses computer telephony to carry 
out automated telephone conversations with patient users.  The system is programmed with branching logic 
that responds to the respondents answer to a particular question. The system speaks to patients over the 
telephone using computer-controlled digitized human speech.  Individuals randomized to this arm of the 
trial will be given, instructions, and the schedule for their receiving calls from study staff.   
IVR Procedures: When a woman is called through the IVR system, the woman is asked to enter the 
last 4 digits of her social security number to verify her identity. Once her identity is confirmed, she will 
then undergo the counseling session. 
 
Intervention content for booster phone calls: Content of the calls is based on content from the CBI. 
Women will be asked if they met their goals for safer alcohol use and safer sex, and based on their 
response, they will be branched into different counseling algorithms. The duration of the call is 5 minutes.  
The content of the call which has been programmed into the IVR is attached to this application as an 
appendix. 
Text message boosters 
 
Text messages will be delivered over 6 weeks. Participants randomized to this arm will be informed that 
they will be receiving these text messages. Text messages will be sent in the morning and evening and on 
weekends. The content of the texts is theory based. Individuals will receive three text messages per week 

 
 
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after receiving the intervention. Text messages are attached to this proposal in the supplemental study 
documents. 
 
4.a.8. Research Assessments 
Consented subjects will participate in a baseline assessment prior to randomization, and at 3 month, 6-
months and 12 months follow-up. All research interviews and questionnaire administrations will be 
conducted by the Research Assistants who are blind to study condition and ACASI. The Research 
Assistants will be trained and receive day-to-day supervision on the assessment instruments by Dr. 
Hutton.Assessment instruments will characterize subjects using data obtained by self-report questionnaires, 
interviews, and objective physical measures.  We have included this breadth of measurement strategies to 
increase the accuracy and scope of our findings.  Subjects are breathalyzed before the interview to ensure 
that they are sober at the time of the research assessment.  Also, should a subject appear impaired either 
from other drug use or illness, the research interview will be rescheduled.  Subjects will receive bus tokens 
or cab fare to facilitate their transportation to and from their appointments. 
 
Assessment instruments were selected to balance the need for study data across several outcome domains 
with the length and duration of the data collection.  Since assessment alone can modify behavior, it is 
important to reduce the length/intensity of the assessment battery.   
 
The following assessments will be performed. The baseline and follow-up assessments are uploaded as 
supplemental study documents to this proposal. 
 
Table 6:STUDY ASSESSMENTS Baseline 
Follow-up Visits 
3 
Mos 
6 
Mos 
12 
Mos 
Informed Consent 
X  
  
  
  
Demographics 
X 
 
 
 
General Health (Dental Questions) 
X 
X 
X 
X 
Health and Lab Assessments 
  
  
  
  
Pregnancy 
X 
X  
X 
X 
Contraception (Medical Record 
Abstraction) 
 X 
 
  
X  
Urine Gonorrhea and Urine 
Chlamydia 
X  
X 
X 
X 
History of STI (Medical Record 
Abstraction 
 X 
 
 
X 
Rapid HIV Test (per BCHD STD 
Clinic procedure) 
X 
 
X 
X 
Alcohol and Drug Assessments 
  
  
  
  
Breath Alcohol 
X 
X 
X 
X 
Alcohol Use Disorders Identification 
Test 
 X 
X 
X 
X 
Time Line Follow Back* 
X 
X 
X 
X 
Quick Drinking Screen 
X 
X 
X 
X 
Readiness Ruler 
X 
X 
X 
X 
Alcohol Expectancy 
X 
X 
X 
X 
Alcohol Treatment Entry 
X 
X 
X 
X 
Urine Drug Screen 
X 
X 
X 
X 
Heavy Smoking Index 
X 
X 
  
X 
MINI Alc 
X 
  
  
  
Psychiatric 
  
  
  
  
Patient Health Questionnaire 
(depression) 
X  
X 
X 
X 

 
 
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GAD-7 (anxiety) 
X 
X 
X  
X 
Primary Care PTSD 
X 
X 
X  
X 
Patient Health Questionnaire for 
Panic 
X 
 X 
X 
X 
Sexual Risk Assessment 
  
  
  
  
Time Line Follow-Back 
X 
X 
X 
X 
NIDA Risk Behavior Assessment 
(Modified) 
X 
 
 
X 
HIV Assessment (HIV+ 
individuals only) 
 
  
  
  
ART Adherence VAS 
X 
X 
X 
X 
ART Persistence 
X 
X 
X 
X 
CD4 count/HIV-RNA (Medical 
Record Abstraction) 
X 
 
X 
X 
HAART Regimen (Medical Record 
Abstraction) 
X 
X 
  
X 
 
* The Time Line Follow Back Interview may be audiotaped for fidelity checks. 
 
a) Demographics and Sexual History: Participants will be asked a range of demographic questions 
including their age, race-ethnicity, highest grade in school, marital status, employment, income, housing 
status, age of sexual debut, prior history of STI, sexual orientation, pregnancy history 
 
b) Alcohol/Drug Use/Sexual Behaviors: The Time-line Follow-back will be used to obtain a detailed recent 
history of alcohol and drug use and sexual risk behaviors. Using structured interview prompts, the TLFB 
quantifies alcohol, and drug use and sexual activity on each day during the last thirty days. TLFB yields 
detailed quantity/frequency data including type of alcohol consumed, number of drinking days, mean 
number of drinks/drinking day, and number of binge drinking days, type of drug use, quantity and 
frequency of use and number of drug using days. Sexual risk behaviors that will be queried will include the 
number of sexual encounters in the 30days, types of sexual encounters (main or casual or exchange), type 
of intercourse (anal, oral, vaginal), condom use, sex while high, and drug and alcohol use by partner at time 
of sex.  
 
c) Alcohol/sex expectancies will be measured using a modified version of the Revised Alcohol Expectancy 
Questionnaire122, 123. Items are rated on a scale of 1 (disagree strongly) to 6 (agree strongly). An example 
includes “I enjoy having sex more if I've had some alcohol” 
 
d)Psychological distress:  will be assessed based on the Patient Health Questionnaire (PHQ) for depression, 
panic, and anxiety (GAD-7) 
 
e) Readiness to Change will be assessed using readiness rulers.  
 
f) Alcohol Treatment Entry: Admission to off-site alcoholism treatment programs and engagement in 
Alcoholics Anonymous or Narcotics Anonymous will be assessed during the follow-up interviews 
 
g)  Breath Alcohol Concentration (BAC) will be obtained using an Alcosensor IV.  
 
h) Urine Pregnancy Testing: Urine pregnancy testing will occur at baseline, 3, 6, and 12 months. Urine 
pregnancy testing is performed on-site by the laboratory staff at the BCHD Eastern STD Clinic. 
 
i) Urine toxicology specimens.  The following drug classes will be included: opiates (methadone, 
buprenorphine, morphine, dilaudid, codeine, demerol); sedatives/ tranquilizers (barbiturates and 

 
 
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benzodiazepines); stimulants (amphetamine and cocaine); and marijuana.  Urine specimens will be 
collected at screening and each follow-up visit. 
 
j) Gonorrhea and Chlamydia: Urine STI testing will occur at baseline and 3, 6, and 12 months after intake, 
and at all voluntary (unscheduled) clinic visits.  We will record whether STI infection occurs at each of 
these visits, as well as reason for presentation at voluntary visits. Urine specimens will be obtained and 
tested for urine gonorrhea and Chlamydia using the Gen Probe. The Gen-Probe APTIMA Combo 2 (Gen-
Probe, San Diego, CA) assay detects both C. trachomatis and N. gonorrhea. The test is highly sensitive and 
specific for the detection of both organisms and is comparable to a cervical swab collected by a clinician. 
Urine STI testing is performed by the laboratory at the BCHD Druid STD Clinic.  
 
k) Rapid HIV testing will per performed using the OraQuick Advance Rapid HIV1/2 antibody test. 
Participants will be offered this test at baseline, 3, 6 and at 12 month follow-up. This testing is offered 
routinely in the BCHD STI Clinic to all individuals presenting for an STI exam. Women agreeable to HIV 
testing will be referred to the HIV testing and counseling services in the BCHD STD clinic. Testing will 
not be done by our study staff. Permission to obtain results of rapid HIV testing performed by the STI 
clinic staff will occur at the time of study consent. 
 
l). HIV medication adherence: Among persons with HIV, this will be assessed using an ART Adherence 
Visual analog scale and an ART Persistence Questionnaire. 
 
m) Medical record abstraction: At the time of consent we will obtain permission to access participant’s 
BCHD medical record. We will review the medical record at baseline and at their twelve month follow-up 
to determine past STIs, contraception use, and pregnancy. For those who are HIV infected, we will access 
the medical record to collect CD4, HIV-RNA and use of antiretrovirals. 
 
O) Phosphatidylethanol (PEth):148 At the 12 month visit, we will collect blood spot for the measurement of PEth, a 
direct ethanol metabolite that is detectable in the blood for more than 2 weeks after sustained ethanol intake. This will 
be collected on a sub-sample of women enrolled in the trial to validate self-reported alcohol consumption. 
Participation will be voluntary and we will obtain separate consent for this.  PEth has been shown to be a sensitive 
and specific marker for recent alcohol consumption. We anticipate collecting this biomarker on approximately 60 
women. Collection occurs via finger-stick using Lancet. Participants providing a blood sample for PEth will receive 
$5.00 in remuneration. 
 
While the majority of follow-up assessments at 3, 6, and 12 months will occur in person, if a participant 
requests that a follow-up assessment be completed over the telephone, via SKYPE, or through the US mail, 
we will allow for this on a case-by-case basis. We will ensure that any assessment over SKYP or the 
telephone is performed in a private office, in the 1830 E. Monument Street Bldg, 8th floor. 
 
4.a.12. Follow-Up Procedures 
We have previously been successful in obtaining consent and research participation from individuals 
attending the BCHD STI Clinic. In our previous study, a subset of individuals was invited to undergo a 
SCID interview.  Of those consenting for study and who completed initial interview (N=671), 233 agreed 
to SCID  interview and 201 (86%) returned to complete it. In other studies (see Appendix 3) taking place in 
the BCHD STI clinics, recruitment has generally exceeded projected numbers and retention has ranged 
from 71-95% . In our trial of BI among HIV-infected AA women, follow-up rates to date have exceeded 
93%. Based on our prior research experience, and our extensive follow-up procedures detailed below, we 
expect to achieve research follow-up rates exceeding 75% at 12 months.   
 
Follow-up assessments will be scheduled at the time of enrollment and confirmed prior to, and at 
each follow-up assessment visit. To optimize follow-up rates at all assessment time points (3, 6, & 12 
months) we will follow a standard protocol.  At the time of enrollment, a participant tracking form will be 
filled out, which includes the participants primary contact information (address, telephone number), 

 
 
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secondary and tertiary addresses, and two to three alternate contacts. Names, addresses, telephone numbers 
and releases of information for all three collateral informants will be obtained and entered into the data 
system at enrollment.  Whenever possible, these contact persons are varied in their type of involvement 
with the participant; that is, a contact person may be a family member, a social worker, a parole or 
probation officer, or a close personal friend.   
Reminder cards will be mailed two weeks prior to the scheduled appointment, and telephone calls 
(made cell phones and alternate contact numbers) will be made one week, and 24 hours prior to the 
scheduled assessment. In addition, text messages will be sent to remind women of their upcoming 
appointments 24 to 48 hours prior to their scheduled visit, and if a participant agrees, we will email 
appointment reminders. To keep the study “fresh” in the minds of the participants, birthday cards and 
holiday cards will be mailed. Reminder cards and birthday cards will be submitted to the IRB once their 
design is complete.  
In addition to our standard protocol for participant tracking and follow-up, we will also be hiring a 
disease intervention specialist (DIS). DIS are currently used by the BCHD STI clinic to track individuals 
with positive STI tests who fail to return for follow-up. Using established BCHD STI clinic procedures for 
tracking and follow-up, the DIS will locate individuals who fail to attend their scheduled follow-up 
assessments and participants who have positive STI tests at a study assessment and are unable to be reached 
by telephone. The DIS will first call the individual and if unable to leave a message, will call alternate 
contacts. If unsuccessful, she will conduct a field visit to the home. If no success, she will conduct field 
visits to alternate contact addresses. If unsuccessful, she will call again at a different time of day, and if no 
return call after 48 hours, a second field visit will occur.  If still unsuccessful, the DIS will send a registered 
letter to the participant at the addresses listed at the time of enrollment. If the DIS is able to establish 
contact during the field visit, the DIS will schedule the next study follow-up. 
 
 
4b.Study duration and number of study visits required of research participants. 
The study duration is 12 months, with study visits occurring at baseline, 3 months, 6 months and 12 
months. 
4c.Blinding 
Because this is a behavioral intervention that involves counseling, participants will not be blinded to their 
study condition; however, research assistants performing the Time Line Follow Back Interview will be 
blinded to the participant’s assigned study condition, as will the Principle Investigator and Co-
Investigators. The Study coordinator will be aware of group assignment, but will not be assessing patient 
outcomes.  
 
4d. Justification of why participants will not receive routine care. 
All participants in the study will receive routine care offered by the BCHD STD Clinic. No current therapy 
will be stopped.  
 
4e.Justification for inclusion of a placebo or non-treatment group. 
This study does include an attention control group which will receive all of the usual care provided by the 
STD clinic, along with computer delivered information of the importance of regular dental care. This usual 
care group/attention control is included because it is essential to understand the efficacy of the computer 
delivered brief alcohol intervention alone, compared to usual care. Because not all women will have access 
to cell phones or text messaging, or they may not choose to engage in cell phone based counseling, it is 
important to establish whether a single computer delivered brief alcohol intervention decreases alcohol use 
and high risk sexual behaviors. In addition, the attention control condition is needed to determine the 
effects of our assessment on participant’s drinking behaviors. 
 
4f.Definition of treatment failure or participant removal criteria. 

 
 
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Participants will only be removed from the study if they become pregnant. The rationale is as follows:  
pregnant women should be referred for more extensive counseling on alcohol use to prevent alcohol 
exposure to the fetus and Fetal Alcohol Spectrum Disorders. 
 
4g.Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
If the study ends prematurely, all enrolled participants will still receive routine care offered by the BCHD 
STD Clinic. Women interested in receiving counseling for alcohol use will be referred to local treatment 
programs and Baltimore City Community Psychiatry. 
 
5.Inclusion/Exclusion Criteria 
Inclusion Critieria 
Age >=18 and 
 
 
 
 
 
 
 
 
Patient of BCHD STD Clinic and 
Sexually active with men in the last 90 days and any 1 of the following three criteria:  
 
 
 
 
 
Average of 8 or more drinks per week or  
 
 
 
 
Two heavy drinking episodes (4 drinks/occasion) in past  3 mos/90 days   or    
Sex while under the influence of alcohol in last 3 months/90 days (on at least two occasions) 
 
Exclusion Criteria 
Actively Psychotic or servere mental health symptoms 
Unable to speak or read English 
Pregnant 
No cell phone 
Does not text message and not interested in starting 
Currently enrolled in alcohol treatment 
6.Drugs/ Substances/ Devices 
a. NA 
 
 
 

 
 
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5. Study Statistics 
a. Primary outcome variable. 
1.Binge drinking episodes  
2.Drinks per drinking day  
3. Drinking days in the past week 
b. Secondary outcome variables. 
1. Unprotected vaginal or anal sex 
2. Number of sexual partners 
3. Episodes of unprotected sex while high 
4. Incident STI 
c. Statistical plan including sample size justification and interim data analysis. 
Power Estimates for Sample Size Determination and Statistical Analysis  
 
Our primary alcohol-related outcome is a  reduction in hazardous drinking among HIV at-
risk AA women across twelve months. We have defined hazardous drinking as >7 drinks per 
week or >3 drinks per occasion (also defined as binge drinking). Our data from the BCHD STI 
clinic indicate that 29% of women drink at hazardous levels. These women are the target 
population for our research. 
Power estimates were derived using existing ACASI data from an earlier study in the STI 
clinic (Prelim Studies C.2.1 & C.2.3) and a recent pilot study in the same clinic during July 
2008.  Expected intervention effect sizes for alcohol-related outcomes were estimated from 
published studies of computerized BI with urban post-partum women ,126 and from brief alcohol 
interventions among women of child-bearing age.127  Ondersma and colleagues randomized 107 
postpartum women with illicit drug use to computerized BI or control. Their trial was designed 
to determine preliminary efficacy of a one-time computer-delivered BI on drug use.  The 
intervention was found to have a moderate effect size with odds ratios from 1.4 to 4.7. Manwell 
and colleagues128  presented long-term results of a randomized clinical trial of BI for problem 
drinking women of childbearing age (i.e., averaged more than 11 drinks/week; reported heavy 
drinking [more than 4 drinks during a single drinking episode] during the preceding month; or 
reported 2 or more symptoms on the CAGE).   Out of almost 6,000 women screened in 17 
primary care clinics, 12% met the definition of problem drinking.  Overall, there were 
significant reductions in average weekly drinking and binge drinking in the intervention group 
compared to the control group.  Specifically, there was a 47% reduction in mean drinks per 
week (14.1 to 7.5) that occurred within 6 months of the BI and was sustained over the 48-month 
follow-up period. 129 Similarly, binge drinking in the last month decreased from 93% to 68% of 
the sample and there was a corresponding reduction in the number of binge drinking episodes 
from 5.1 to 3.0 per month.   
Expected intervention effect sizes for sexual risk behavior outcomes were estimated from 
published studies of sexual risk reduction among individuals in alcohol treatment, and among 
individuals attending at STI clinic. Avins and colleagues examined sexual risk behaviors before 
and after alcohol treatment among 112 sexual active individuals. 130 In this study, the proportion 
of individuals using condoms consistently increased from 22% before treatment to 35% after 
alcohol treatment. Project Respect, a three arm randomized trial, tested behavioral counseling 
(enhanced counseling vs. brief counseling vs. didactic messages only) to reduce STI and risky 
sexual behaviors.  In this study, both counseling arms demonstrated a decreased incidence of 
STI compared to control group that received didactic messages. Specifically, 149 participants 
(10.4%) in the didactic messages arm had new STDs compared with 103 (7.2%) in the enhanced 
counseling arm (RR, 0.69; 95% CI, 0.54-0.88) and 107 (7.3%) in the brief counseling arm (RR, 
0.71; 95% CI, 0.58-0.89). Through the 12-month visit, 211 participants (14.6%) in the didactic 

 
 
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messages arm had developed new STDs, compared with 165 (11.5%) in the enhanced 
counseling arm (RR, 0.78; 95% CI, 0.64-0.94) and 173 (12.0%) in the brief counseling arm (RR, 
0.81; 95% CI, 0.67-0.98). The 2 interactive counseling interventions had very similar cumulative 
incidence of STD through the 6- and 12-month visits.131  
 
Primary Outcomes 
AIM 1:  To determine the effectiveness of computer-delivered BI and IVR/text in decreasing 
alcohol risk behaviors among hazardous/binge drinking African/American women attending an 
urban STI Clinic. 
 
Hypothesis 1a: Women receiving BI + IVR/text will have fewer binge drinking episodes and lower 
alcohol consumption (number of standard drinks/week, number of drinking days/week) compared to 
usual care. 
 
Hypothesis 1b: Women receiving BI will have fewer binge drinking episodes and lower alcohol 
consumption (number of standard drinks/week, number of drinking days/week) compared to usual 
care. 
 
Hypothesis 1c: Women receiving BI + IVR will have fewer binge drinking episodes and lower 
alcohol consumption (number of standard drinks/week, number of drinking days/week) compared to 
BI only. 
 
Power Analysis. For these outcomes, power calculations for a given sample size were derived on the 
basis of maximum effect size to be detected over time between the three study arms assuming a repeated 
measures analysis (baseline and three follow-up periods) and a balanced design.  The calculation was 
performed for varying sample sizes, three levels of ES (0.2-, 0.4, and 0.5)132 or effect size133 three levels of 
rho or within-person correlation between measurements, and an alpha level of 0.0167 (0.05 experiment-
wise error rate Bonferroni type adjustment134 for three pair-wise hypothesis comparisons at 6 months with 
earlier and later treatment effects tested at an unadjusted alpha of 0.05)).  Table 7 shows the resulting 
power calculations for 150 and 100 participants per study arm under these options. 
 
Table 7. Power estimates^a for projected study arm sample sizes for count 
outcomes  
Sample size per 
arm 
rho 
Effect size (ES) 
N=150 (450 
total) 
 
0.3  
0.4  
0.5  
 
0.3 
.85 
.97 
.99 
 
0.4 
.78 
.98 
.99 
 
0.5 
.72 
.95 
.99 
 
 
 
 
 
N=100(300 total) 
 
 
 
 
 
0.3 
.64 
.91 
.99 
 
0.4 
.56 
.86 
.98 
 
0.5 
.50 
.80 
.96 
^a Experiment-wise alpha = 0.05 
 
 
Thus for the primary outcomes, the sample sizes of 150and 100 (with 30% potential loss-to-
follow up), under consideration provide adequate power for medium effect sizes regardless of 
the assumed within-person correlation between measurements. For these outcomes we assume 

 
 
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an effect size of 0.35 (between small and medium). As a generalized concept, ES represents the 
mean difference between two groups normalized by a pooled group standard deviation,  
 
Seconday Outcomes: Sexual risk outcomes Aims 2 & 3 
AIM 2: To determine the effectiveness of computer-delivered BI and IVR/text in decreasing sexual 
risk behaviors among hazardous/binge drinking African/American women attending an urban STI 
Clinic.  
 
Hypothesis 2a: Women receiving BI + IVR will report fewer 1) sexual partners,2) episodes of 
unprotected vaginal or anal intercourse, 3) episodes of sex while high compared to those receiving 
usual care. 
 
Hypothesis 2b: Women receiving BI only will report fewer 1) sexual partners,2) episodes of 
unprotected vaginal or anal intercourse, 3) episodes of sex while high compared to those receiving 
usual care. 
 
Hypothesis 2c: Women receiving BI + IVR report fewer 1) sexual partners,2) episodes of 
unprotected vaginal or anal intercourse, 3) episodes of sex while high compared to those receiving 
BI only. 
 
 
Power Analysis. The power calculations for episodes of unprotected vaginal or anal intercourse with 
a given sample size and episodes of sex after or while drinking alcohol were derived using the effect 
size approach in Table 6.  Estimates of the mean number of such episodes for the usual care group 
at baseline and standard deviation are 2.03 and 2.06, respectively.  For a medium effect size, this 
would translate to being able to detect a difference of 1 episode. The number of sexual partners was 
considered as a proportion of participants having only one partner versus more than one partner. 
The power calculations for this proportional outcome for a repeated measures analysis were derived 
using equations in Diggle et al.135  The calculations were performed with parameters similar to 
those for the primary outcomes, using a range of proportion differences from the usual care group 
estimate.  Table 8 shows examples of the power calculations for this outcome. 
 
Table8. Power estimates^a for projected study arm sample sizes for proportion outcomes  
Sample size per arm 
rho 
Change in proportion having sex after 
or while drinking alcohol/week 
(decrease from 20.5%) 
Change in proportion of 1 (vs > 1) 
sexual partner/week (increase from 
59.5%) 
 
 
6% 
8% 
10% 
10% 
15% 
20% 
N=150 (450 total) 
 
 
 
 
 
 
 
 
0.2 
.51 
.79 
.95 
.77 
.98 
.99 
 
0.5 
.34 
.59 
.81 
.56 
.91 
.99 
 
0.8 
.25 
.45 
.68 
.43 
.81 
.97 
 
 
 
 
 
 
 
 
 
Aim 3: To observe the impact of computer-delivered BI enhanced with IVR and text messaging 
boosters on incidence rates of HIV and STI biomarkers and HIV among hazardous/binge 
drinking women attending an urban STI Clinic. 
 
Hypothesis 3a: Women receiving CBI + IVR/text will have lower rates of incident gonorrhea, 
Chlamydia or HIV compared to control. 
 
Hypothesis 3b: Women receiving CBI only will have lower rates of incident gonorrhea, 
Chlamydia or HIV compared to control. 
 
Hypothesis 3c: Women receiving BI + IVR/text will have lower rates of incident gonorrhea, 
Chlamydia, or HIV compared to those receiving CBI only. 

 
 
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3.The proportion of having at least one STI biomarker versus none was employed in deriving the 
power calculations as in Aim 3.  The calculations were performed with parameters similar to those 
for the primary outcomes, using a range of proportion differences from the usual care group 
estimate.  For the outcome of the proportion of participants having at least one STI biomarker 
versus none (estimated at 19.2% for the usual care group at baseline), the power for 150, at sample 
sizes under consideration, is reasonable (close to 80%) for a 50% decrease in the proportion, that 
is, about 9%. 
 
 Statistical Analysis. The principal statistical analyses for the three primary outcomes will proceed 
in two phases for each outcome separately: a cross-sectional evaluation of the study arms at baseline 
and full longitudinal evaluations of study effectiveness.  The baseline comparisons of the 
participants in the study arms will be performed on demographic characteristics and outcome 
measurements. The analyses will include chi-square tests, and parametric and non-parametric 
analysis of variance appropriate to the characteristic or outcome being compared, and will evaluate 
the baseline comparability of the participants in the study arms.  Study effectiveness will be 
evaluated through longitudinal analyses of marginal treatment differences performed with general 
linear model formulations using the generalized estimating equations technique135 and parameters 
based on the underlying distribution of the outcome (e.g., Normal or Poisson or negative binomial).  
All dependent variables (number of binge drinking episodes, number of drinks per week, number of 
drinking days per week, number of sexual partners, number of episodes of sex while high, episodes 
of unprotected sex) will be analyzed as individual models with treatment group as the primary 
independent variable. All models will include baseline illicit drug use, age, HIV status, and 
psychiatric symptoms to adjust for potential imbalances in strata co-factors. Interaction terms will 
be created (including, but not limited to, prior STI, psychiatric symptoms, time) to test if specific 
covariates modify intervention effects and any interaction at a significance of p ≤ 0.1 will be further 
tested. 
 
All available information from participants will be included in the analyses regardless of 
participation level.  Diagnostics will be employed to evaluate the appropriateness of model 
assumptions and covariance structure, with alternate strategies (e.g., transformations, non-linear 
models, non-parametric methods, alternate covariance structure) used if necessary. Individual 
contrasts will be employed to examine pair-wise differences between groups and between the 
baseline and follow-up measurement periods. Tests will be conducted at a two-sided alpha = 0.05 
level of significance, pair-wise comparisons between the study groups will be conducted with an 
experiment-wise alpha = 0.05, and estimates will be provided with 95% confidence intervals. All 
efficacy outcome measures will be analyzed under the intent-to-treat principle, and the sample 
analyzed will include all subjects who are randomized regardless of whether they actually received 
the study treatment to which they were assigned or completed the study. Non-compliance will not 
be a large factor as the intervention is given at a short period of time (a single time point for the 
brief intervention and over 6 weeks for those with the IVR). However, it is probable that some 
individuals will drop out of the trial. In this case it is possible that there could be a selection bias. 136 
To address this potential bias, we will use inverse probability of dropout weights (this is analogous 
to the inverse probability of censoring weights that have been used in observational studies. 136-142  
Briefly, a subject specific weight that corresponds to the inverse probability that the individual 
remains in the trial up to time t (the scheduled visits at 3, 6, 9 and 12 months). These weights are 
then applied to the generalized linear model with GEE that was previously used for the intent-to-
treat analysis.136, 143   The weights act such that each individual not only represents themselves but 
also for those with similar characteristics but have removed themselves from the study.136.  Thus 
individuals who are over-represented as they are the most likely to remain within the trial are down 
weighted, whereas those who have a higher tendency to withdraw from the study are up-weighted. 

 
 
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Essentially a pseudopopulation (based on the original study population) is constructed in which the 
selection bias is removed.136 . The weights are constructed by applying a pooled logistic model 
assessing the probability of dropout by time using baseline and time-varying covariates to construct 
the model.137, 138   An important assumption (not unique to these methods) is that there are no 
unmeasured confounders that are missing from these models. To assess the impact of possible 
unmeasured confounders, sensitivity analyses for marginal structural models will be applied. 144, 145. 
Analyses will be performed primarily using SAS v9.1 (SAS Institute, Inc. Cary NC).  
 
 
d. Early stopping rules. 
We do not plan to conduct interim analyses of the dependent measures.   
6. Risks 
 
There are two primary risks to this study: breach of confidentiality and psychological distress. 
Participants will be asked to provide sensitive information related to alcohol and drug use, and high 
risk sexual behaviors. Every effort will be made to ensure confidentiality, including the use of 
ACASI, and a federal certificate of confidentiality. Psychological/emotional distress may occur 
during assessment interviews or during the brief intervention as issues related to drugs, alcohol, 
and sexual risk behaviors may be emotionally difficult.  
 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
1) Confidentiality: Participants will be asked to provide sensitive information related to alcohol 
and drug use, and high risk sexual behaviors. We will obtain a federal Certificate of 
Confidentiality to protect the participant against the release of private/sensitive information.  In 
addition, all participants will be assigned unique study identification numbers. A master file 
linking study identification numbers to participant names/contact information will be kept in a 
password protected file that only the investigators and project manager will have access to. In 
addition, all paper files and data will be kept in a locked filing cabinet.  
Confidentiality of Cell Phone Counseling and Text Messaging: Individuals will be counseled 
via their cell phone using IVR technology and text messages. In the event that a cell phone is 
misplaced or borrowed by another individual there is the risk of breaching confidentiality. To 
avoid this, prior to the delivery of cell phone counseling, women will be required to enter the 
last 4 digits of their social security number. In addition, IVR counseling calls originate from a 
secure Johns Hopkins Server, maintained by Dr. Finkelstein’s research group. Thus no calls will 
be linked to the STD clinic. Similarly, for text messaging, no personal identifiers will be linked 
to text messages. Because text messages originate from a secure Johns Hopkins server, text 
messages will not be linked to the STD clinic. 
 
 All study outcomes will be reported as aggregate data.  In addition, all investigators and members 
of the research team will have completed Johns Hopkins University on-line modules on Human 
Subjects Research and HIPAA. HIV testing and counseling are performed routinely within the 
BCHD STI Clinic. All women who undergo HIV testing and counseling will be informed that the 
result of their test is confidential but that there will be mandatory reporting of new cases to the State 
of MD. We expect breach of confidentiality to be a rare or infrequent event. 
2) A second risk to this study is psychological distress. A participant may become uncomfortable while 
answering sensitive questions related to drug and alcohol use, sexual risk behaviors, mood, anxiety 
or during the brief intervention.  If a woman experiences significant distress during the interview, 
the research assessment will be stopped, and Dr. Heidi Hutton, a PhD in Clinical Psychology, or 
Dr. Geetanjali Chander a general internist, will evaluate the participant, and assess if she is at risk 
for harming herself or others.  If necessary, they will either personally escort her or if need be 

 
 
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engage emergency escort to the Johns Hopkins University Emergency Department which is less 
than one-quarter mile from the STI clinic. We expect this risk to be occur infrequently. 
 
b. Steps taken to minimize the risks. 
To minimize risks associated with breach of confidentiality, each participant will be assigned a 
unique study ID. A master file linking study identification numbers to participant names/contact 
information will be kept in a password protected file that only the investigators and project manager 
will have access to. In addition, all paper files and data will be kept in a locked filing cabinet. All 
study outcomes will be reported as aggregate data.  All IVR and text message counseling will 
originate from a secure Johns Hopkins Server, and thus will not be linked to the STD clinic. In 
addition, all investigators and members of the research team will have completed Johns Hopkins 
University on-line modules on Human Subjects Research and HIPAA. HIV testing and counseling 
are performed routinely within the BCHD STI Clinic. 
 
c. Plan for reporting unanticipated problems or study deviations. 
Study deviations and unanticipated problems will be reported to the Johns Hopkins IRB by the 
Principal Investigator. 
 
An adverse event (AE) is any untoward medical occurrence in a subject, not necessarily having a 
causal relationship with the study. A serious adverse event (SAE) is any untoward medical 
occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or 
prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, 
or e) is a congenital anomaly/birth defect. 
AE's may be graded as: Mild (no limitation of usual activities), Moderate (some limitation) or 
Severe (inability to carry out usual activities). The relationship of the AE to the study procedures is 
classified as: Not related, Unlikely, Possible, Probable, or Definite. The principal investigator will 
be responsible for distinguishing between an AE and SAE. SAE will be reported by telephone to the 
Johns Hopkins Medical Institute (JHMI) IRB, NIAAA project officers, and the Baltimore City 
Health Department (BCHD) within 48 hours of a SAE. The same classification and procedures will 
be applied to any SAE or AE occurring during the 12-month participant follow-up period. 
 
Annual reports will be submitted by the principal investigator to the NIAAA project officer, the 
IRB, and BCHD summarizing all adverse events and how they were addressed by the study team. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
We will obtain information on drug use, an illegal behavior that may place subjects at legal risk 
if confidentiality is breached.  We have obtained a certificate of confidentiality from the NIH 
National Institute on Alcohol Abuse and Alcoholism to reduce this risk. 
 
e. Financial risks to the participants. 
There is no cost to participants of study participation.  All study procedures are paid for by the 
research grant. 
 
 
 
7. Benefits 
Participants in the study may have the opportunity to receive counseling for hazardous alcohol use. 
Both the assessments and the interventions will result in an increased awareness of health behaviors. 
Benefits to others include increased knowledge of the effectiveness of brief alcohol intervention 
among high-risk women. In addition, if effective, computer-directed brief intervention may be 
adopted for more widespread use in STI clinics. 

 
 
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Ultimately if computer-directed brief alcohol/sexual risk reduction intervention or telephone 
counseling via IVR is found to be effective in reducing hazardous alcohol use and/or risky 
behaviors and improving health outcomes, this technology can be transferred to STI clinic settings 
for widespread implementation. Furthermore, if the intervention(s) prove to be effective study 
findings will offer “real life” specialty care clinics a screening and intervention package that is 
practical and would require no additional staff time and resources for implementation 
 
 
 
8. Payment and Remuneration 
Randomized participants will receive $30 for participation in the baseline assessment In addition, 
all participants, regardless of group assignment, will be paid for follow-up assessments at 3-mos 
($35); 6-mos ($40) and 12-mos ($50) with a $20 bonus for completing all three assessments.  
These procedures have yielded high rates of participation in other RCTs with substance abusing 
populations.  Also, subjects will receive bus tokens to facilitate their transportation to and from the 
interviews. Individuals who complete the 15 minute screening but do not qualify for the 
intervention will receive $5 for their time. Individuals who receive and respond to booster calls 
will be reimbursed for their cell phone minutes at $5 per call. They will also receive an additional 
$5 to cover the expense of text messages. 
 
9. Costs 
There are no costs of the study procedures to participants.  
 
 
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