Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
Phase: NA
Conditions: HIV/AIDS, Alcohol Abuse
Sponsor: University of California, San Francisco

 
 
 
Masibambisane:  
Couple-Based Motivational Interviewing with Mobile Breathalyzers to Reduce Alcohol Use in 
South Africa 
 
 
 
 
Funded by: National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 
Bethesda, MD 
 
NCT 05756790 
 
Version: 4.0 
 
Date: May 8, 2023 
 
 

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TABLE OF CONTENTS 
1. 
Introduction 
2. 
Study Objectives and Design 
 
 
2.1  
Intervention Feasibility 
 
 
2.2  
Aim 1 
 
 
2.3  
Aim 2 
2.4  
Aim 3 
2.5       Study Design 
3. 
Study Population 
3.1 
Couple Eligibility  
3.2  
Recruitment Process 
3.3  
Participant Retention 
3.4  
Participant Withdrawal 
4. 
Intervention Description 
5. 
Study Procedures 
5.1  
Procedures for FGDs with couples 
5.2       Procedures for FGDs with key stakeholders 
5.3       General procedures  
5.4       Training  
5.5       Supervision 
5.6  
Fidelity monitoring of intervention 
5.7       Recruitment and retention 
5.8       Randomization process 
5.9       Control condition 
5.10 
Procedures for mobile breathalyzers 
5.11 
Survey assessments 
5.12 
Medical record extraction 
5.13 
Blood samples 
5.14 
Exit interviews 
6.  
Safety Monitoring and Adverse Event Reporting 
 
 
6.1  
Safety Monitoring 
6.2  
Adverse Events 
6.3  
Data Safety and Monitoring Board 
7. 
Statistical Considerations 
7.1  
Analysis of FGDs to refine the intervention 
7.2  
Feasibility and acceptability data analysis 
7.3  
Hypotheses and methods for preliminary/exploratory analyses 
7.4  
Power analyses 
8. 
Human Subjects Considerations 
 
 
8.1  
Ethical Review 
 
 
8.2  
Informed Consent 
8.3   
Risks 
8.4  
Benefits 
8.5  
Confidentiality 
8.6       Incentives 

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8.7       Study Discontinuation 
9. 
Administration 
9.1  
Compliance 
9.1.1 Training, Quality Assurance (QA) and Supervision 
9.1.2 Assessment Training 
9.1.3 Assessment Quality Assurance 
9.1.4 Data Entry and Management 
9.2 Study Monitoring 
9.2.1 Data Monitoring Procedures 
9.2.2 Data-Related Risk Reporting and Action Plan 
9.2.3 Safety Monitoring Procedures 
9.3 Study Records 
9.4 Use of Information and Publications 
10. 
References 
 
 

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Study Investigators  
Amy Conroy, PhD 
Principal Investigator 
Center for AIDS Prevention Studies 
University of California, San Francisco 
 
Alastair van Heerden, PhD 
Site Principal Investigator 
Human and Social Development Programme  
Human Sciences Research Council 
 
Tyrel Starks, PhD 
Co-Investigator 
Department of Psychology 
Hunter College, City University of New York 
 
Torsten Neilands, PhD 
Co-Investigator 
Center for AIDS Prevention Studies  
University of California, San Francisco 
 
Judith Hahn, PhD 
Co-Investigator 
Center for AIDS Prevention Studies 
University of California, San Francisco 
 
 
 
 

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SCHEMA 
Design: 
Formative qualitative phase followed by pilot randomized controlled trial 
 
Population: Heterosexual couples with at least one heavy alcohol drinker on antiretroviral 
therapy 
 
Study size: 
40 key stakeholders and 90 couples/180 individuals (220 people total) 
 
Study duration: 36 months 
 
Aim 1: To develop a couple-based Motivational Interviewing intervention with mobile 
breathalyzer technology to deliver real-time feedback on blood alcohol content (BAC) levels. We 
will target heavy alcohol users with HIV and enroll their primary partner.  
 
Aim 2: To develop and pilot test the study procedures for a future randomized controlled trial 
(RCT) of the couple-based intervention. We will develop and pilot test: a) training procedures; b) 
randomization procedures; c) the pilot study procedures; and d) data collection instruments.  
 
Aim 3: To determine the feasibility and acceptability (F&A) of couple-based MI as a standalone 
intervention and when combined with mobile breathalyzers with couples to provide real-time 
feedback and support.  
 
Study Site: Vulindlela/Sweetwaters community, KwaZulu-Natal, South Africa 
 
 
 

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1.0 
INTRODUCTION 
In sub-Saharan Africa (SSA), alcohol use is described as “adding fuel to the fire” for people 
living with HIV (PLWH)[1], threatening the success of HIV treatment programs and progress 
towards UNAIDS goals.[2-5] Our research in SSA suggests that primary partners are key to the 
success of alcohol interventions given their critical role in helping drinkers reduce alcohol use 
and the couple dynamics that intersect with alcohol use.[6-9] Harnessing this powerful form of 
social support is critical in a setting where clinical services for alcohol misuse are inadequate and 
can be costly for patients. One approach that has been effective at reducing alcohol use among 
PLWH is motivational interviewing (MI) that incorporates mobile technology for real-time 
feedback.[10-17] MI is a collaborative, goal-oriented style of communication with particular 
attention to the language of change. It is designed to strengthen personal motivation for and 
commitment to a specific goal by eliciting and exploring the person’s own reasons for change 
within an atmosphere of acceptance and compassion. 
In this study, we propose to develop and test a couple-based MI intervention with mobile 
breathalyzer technology to provide dyadic support around drinking for HIV-affected couples in 
KwaZulu-Natal, South Africa.  
Few couple-based MI approaches have been developed for alcohol use, particularly in the 
African context. In the US, there is evidence that couple-based MI is feasible, acceptable, 
scalable, and efficacious at reducing substance use.[9, 18-20] In studies with individuals, daily 
monitoring of drinking levels, when paired with MI, has a greater effect on drinking than MI 
alone[15-17] and we hypothesize that monitoring may have additional benefits with couples. 
Although primary partners are generally aware of a drinker’s alcohol use, they have inaccurate 
knowledge of drinking amounts and frequency, in part, because drinking often occurs in gender-
segregated spaces in SSA. Accurate knowledge of drinking levels in real-time is critical to 
trigger couple communication, and timely and tailored social support. Mobile breathalyzers have 
been shown to be a feasible and acceptable strategy for self-monitoring alcohol use in studies 
with individuals[21-23] and new products have been developed for dyads that share blood 
alcohol content (BAC) levels with support partners via a mobile app. Our scientific premise is 
that mobile breathalyzers to provide real-time feedback and support can be synergistic with a 
couple-based MI approach that fosters couple communication and problem-solving skills to 
effectively engage with the breathalyzers and work together to reduce alcohol use. We 
hypothesize that this combination will have a greater effect on drinking reductions than couple-
based MI alone.  
 
 

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2.0 Study objectives and Design 
2.1 Intervention Feasibility 
Preliminary data to support proposed intervention: Couple-based MI interventions for substance 
use have demonstrated feasibility, acceptability and preliminary efficacy. Co-I Starks developed a 
couple-based MI intervention with US male couples called We Test to enhance the effectiveness 
of couples HIV testing and counselling (CHTC) by including structured components to address 
substance use and couple communication skills. The RCT findings showed that completion of a 
substance use module led to immediate decreases in drug use, and when combined with training 
in couple communication, resulted in reductions in drug use at 3- and 6-month follow-up.[19] Co-
I Starks also developed a three-session MI-based intervention with US male couples to reduce HIV 
risk and drug use (Couples Health Project).[19, 20] A pre-pilot RCT of the intervention prototype 
with 20 couples showed that: 1) 19 out of 20 couples completed all three MI sessions; 2) retention 
was high at 1-month (95%) and 3-month (93%) follow-up; 3) and couples found the intervention 
highly acceptable. In the pilot RCT that followed, the intervention significantly reduced drug use 
at the 3-month follow-up among participants with high levels of baseline drug use.[20] We 
acknowledge that US male couples and those in South Africa may differ (e.g., higher rates of IPV 
and heavy drinking in South Africa), which our adaptation plan will take into account.   
 
Our team’s research in KZN suggests that a technology-based intervention will be feasible. In 
South Africa, smartphone penetration rates are high (82%) and of all provinces, KZN has the 
second highest number of 4G/LTE subscribers.[24] Mobile phones have been successfully 
incorporated into interventions in South Africa and elsewhere in the region.[25-27] Multiple 
studies at the proposed site have demonstrated the feasibility of digital interventions in HIV care. 
Site PI van Heerden demonstrated the feasibility of using an mHealth system to improve linkage-
to-care after home-based testing[28] and a conversational agent (chatbot) to provide counselling 
for HIV self-testing.[29] These studies rely on high smartphone penetration rates and a strong 
mobile network. Pilot data from 2016 with PLWH in KZN (n=101) found that 96% of participants 
reported using a cell phone.[28] The research area is serviced by a strong network of mobile phone 
towers and in speed tests conducted at 14 sites spanning a distance of 60 km, we achieved an 
average download speed of 22.6 Mbps (3.5– 54.5 Mbps) and upload speed of 6.2 Mbps (0.05–14.2 
Mbps). Although network conditions vary, speed tests show that we will have ample bandwidth to 
use the mobile breathalyzer technology for this study. 
2.2. Aim 1 
In the first phase (months 1-12), we will adapt our team’s interventions to address alcohol use in 
South African couples living with HIV and incorporate the mobile breathalyzers. 
2.3. Aim 2 
As part of the first phase, we will develop the intervention manual, training procedures, 
randomization procedures, implementation procedures, and data collection instruments for the 
pilot RCT.  
 
2.4 Aim 3 
In the second phase (months 13-36), we will recruit 90 couples who will be randomized to a 
control arm, couple-based MI arm, and couple-based MI plus mobile breathalyzers arm. Couples 
will be assessed at baseline, , 2, and 6-months post intervention initiation and a subsample of 15 

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couples will complete exit interviews. In months 31-36, we will analyze the F&A data, discuss 
the findings as a team, and identify modifications to the intervention in preparation for a future 
trial.  
2.5 Study design 
For Aim 1, we will adapt a couple-based MI framework and interventions developed by co-I Starks 
(We Test and the Couples Health Project) to address alcohol use in heavy alcohol users and their 
primary partners and incorporate the mobile breathalyzer component. We will follow the ADAPT-
ITT framework by conducting focus group discussions (FGDs) with around 40 key stakeholders 
to gain feedback on the intervention and then refining the intervention. For Aim 2, we will develop 
training procedures, study procedures, and data collection instruments that will be pilot tested 
during the RCT. For Aim 3, we will conduct a three-arm RCT with 30 couples randomized to the 
following arms (90 couples total): 1) an enhanced usual care control condition; 2) couple-based 
MI; and 3) couple-based MI with mobile breathalyzers for real-time feedback. For arm 2 and 3, 
couples will receive 3 MI sessions over a 60-day period with an experienced counselor to help 
strengthen communication and problem-solving skills around alcohol use. For Arm 3, couples will 
use the mobile breathalyzers and app for 60 days and receive the same MI sessions, which will 
also incorporate feedback on BAC levels (prior 30 days) and teach couples how to effectively 
engage with the breathalyzers. This design will allow us to assess the effectiveness of couple-based 
MI alone and the added synergistic effect of the mobile breathalyzers on alcohol use and HIV 
outcomes (e.g., adherence to antiretroviral therapy (ART), viral suppression). Our F&A outcomes 
will include enrollment and retention rates, satisfaction with both intervention arms, MI session 
attendance rates, and follow-up survey completion rates. We will also conduct qualitative 
interviews with a subset of 15 couples to contextualize F&A data and refine the intervention and 
procedures for a future full-scale efficacy trial. 
3.0 Study Population 
3.1. Couple Eligibility 
Inclusion criteria: 
(1) In a primary relationship for at least six months 
(2) Aged 18-49 
(3) Have at least one partner (the “index patient”) with a positive AUDIT-C screen (score of 4 
for men and 3 for women; prior 3 months) and on ART for at least six months (a time when 
alcohol use is found to rebound) who has disclosed their HIV status to their partner in the study 
(4) Both partners separately agree to participate in the study for the couple to be enrolled. 
 
Exclusion criteria: 
We will exclude participants with an AUDIT-C score greater than 12, indicating risk of severe 
alcohol use disorder. Participants with severe drinking issues may not benefit from a brief 
counseling-based intervention and may need more intensive treatment that our study can provide.  
 
Considering the intervention has a technology component and there may be a difference in 
acceptability between younger/older participants, we will impose an upper age limit of 49 (an 
age in which smartphone ownership and internet connectivity drops off in South Africa). We will 
not exclude those without phones or with incompatible phones to avoid widening the digital 
divide and excluding those who could really benefit from the intervention. We have budgeted for 

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phones to be provided. Our intervention may not be appropriate for couples experiencing severe 
IPV. We will exclude those who fear for their safety by participating in the study and/or report 
severe IPV in the past 3 months using the WHO measure for South Africa, which assesses 
physical, sexual, and emotional violence, and determines whether it is mild, moderate, or severe. 
The WHO measure for IPV contains 8 questions that assess perpetration and victimization of 4 
types of severe violence including physical (kicking, punching, hitting, beating, scalding, 
burning), threats using weapons such as a gun or a knife, and restraint (i.e. holding down) in the 
past three months. The WHO questions on IPV will be administered to both members of the 
couple. Couples-based interventions in South Africa have successfully employed this 
approach. We believe this approach balances sample generalizability with safety. If couples 
report any IPV (mild, moderate, or severe) during screening or over the study, we will follow an 
established protocol to assess safety, provide emotional support, and provide intervention and/or 
linkage to psychological and/or medical services. If either person in the couple declines to 
participate, the couple as a whole will be ineligible.  
  
Dr. Conroy’s prior work with couples in this community in KZN showed that less than 1% of 
female partners reported any alcohol use, with the primary drinker almost always being the male 
partner. As such, we will not exclude dual-drinking couples since these couples could really 
benefit from the intervention. However, should we enroll couples with two heavy alcohol 
drinkers, our couple-based MI approach is designed to be flexible to handle cases where both 
partners are heavy drinkers, and will consider change behavior in both partners. The software for 
the breathalyzer is not optimized for both partners being “testers” and “accountability partners.” 
Therefore, in couples with two qualified drinkers, whichever one is screened first will be 
considered the “index patient” and get the breathalyzer. In couples with two heavy drinkers on 
ART, both partners will have blood draws for viral load and/or alcohol use at follow-up visits. 
3.2. Recruitment Process 
Aim 1: For the two FGDs with couples (3-4 couples per group), we will recruit couples using 
procedures from our prior studies with couples in South Africa and Malawi. A team of recruiters 
will approach index patients at HIV clinics while waiting to attend appointments. We will 
announce the study during the daily health information talks in the waiting rooms and interested 
patients can approach the recruiters. If the patient is interested and eligible, we will provide them 
with a study information card to give their primary partner and will set up a phone appointment 
to screen the partner. If both partners are interested and eligible, the couple will be invited for a 
secondary screening to verify that the partnership is legitimate (e.g., confirming partner names, 
relationship length, etc.). To ensure we capture primary partnerships, both partners will be asked, 
“Of all your romantic partners, who are you the closest with?” Screenings will be interviewer-
administered using tablet devices. If the couple remains eligible, both partners will provide 
written informed consent and be invited to participate. Partners will be consented separately to 
ensure a lack of coercion. Couples who are ineligible will be informed that they are ineligible but 
will not be given a specific reason why (i.e. which eligibility criteria they did not meet). 
Recruiters may deflect questions about eligibility by saying, "the computer program determines 
eligibility but does not provide a specific reason." Similarly, couples who are ineligible because 
one or the other does not want to participate will not be informed that this is the reason for 
ineligibility to avoid disclosing each partner's decision to provide consent.  
 

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Couples may also be identified from previous or current studies who have consented to be 
contacted for other research studies, and through our community partners and associated HIV 
testing/care services. 
For the three FGDs with stakeholders (6-8 per group), which will consist of HIV care providers 
(nurses, clinic volunteers, clinicians), community representatives and religious leaders who 
interact with couples who drink, and alcohol vendors (e.g., shebeen owners, local brewers), we 
will recruit them using our professional networks in this region of KZN.  
 
Aims 2 and 3: We will recruit couples using a combination of community-based and clinic-based 
recruitment approaches. Index patients who are heavy drinkers on ART for at least 6 months will 
be targeted first, followed by their primary partner. We will recruit around 120 couples to 
achieve the desired sample size of 90 couples (180 individuals). This assumes we will lose 
around 25-30% after randomization based on other studies at this site.  
We will use a combination of active and passive recruitment strategies to enroll the sample.  
Community-based recruitment: Index patients will be identified through community-based 
organizations or through locations in the community where drinkers can be found. Recruiters 
will use procedures established at HSRC to identify and recruit participants using a community 
mobilization approach. Individuals and couples will be targeted by a team of recruiters, who will 
approach potential participants in public areas in the community, such as alcohol venues (e.g., 
shebeens, bottle shops), markets, sports grounds, taxi ranks, HIV clinics, and community events. 
Recruiters will target couples together if possible, although our other studies have shown that 
couples are not often together in public. Potential participants will also be recruited passively 
(i.e., through fliers in the community). These fliers describe the study and invite interested 
individuals to contact the project staff by calling or sending a free “call me” SMS to the 
telephone number listed. Recruiters will return these messages as soon as possible and no later 
than the next working day.  
Clinic-based recruitment: We will also actively recruit index patients at HIV clinics during 
morning health talks when patients are attending appointments. Recruiters will screen index 
patients in the waiting rooms immediately following the talks or distribute fliers/information 
cards so interested patients can later contact the study team if interested. We will also passively 
recruit index patients using fliers placed at the clinics. Clinic-based outreach teams and care 
providers will also help to identify HIV patients who are heavy alcohol drinkers and on ART for 
at least six months and refer patients to the HSRC recruiters. 
Recruitment from other studies: There are other studies at the HSRC site that may be able to 
refer participants to the study team, for example, if they were ineligible for another study but 
may be interested in participating in research.   
In either approach, recruiters will ask potential participants if they would like to hear about the 
study and explain the nature of the study using standard recruitment scripts.  
If the index patient is interested and eligible, we will provide them with a study information card 
to give their primary partner and will set up a phone appointment to screen the partner. If both 
partners are interested and eligible, the couple will be invited for a secondary screening to verify 
that the partnership is legitimate (e.g., confirming partner names, relationship length, how the 

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couple met) and assess the risk for violence by participation in the study. To ensure we capture 
primary partnerships, both partners will be asked, “Do you have a primary partner, meaning a 
person who you are committed to above anybody else and with whom you have had sexual 
relations?” Screenings will be interviewer-administered using tablet devices either in-person or 
via phone. If the couple remains eligible and is a legitimate couple, both partners will provide 
written informed consent and be invited to participate. Partners will be consented separately to 
ensure a lack of coercion.  
3.3. Participant Retention 
 
Aim 1 requires only a single interaction with participants. The intervention period for Aim 2 and 
3 will last 60 days with assessments at baseline, 2-months and 6-months post intervention 
initiation. Upon enrollment, we will obtain contact information (e.g., two cell phone numbers, 
directions to households, and contact information for up to three other individuals) to facilitate 
tracking. For the pilot study in Aim 3, participants will also be provided with phones allowing us 
the capability to reach them via SMS or calls as an alternative to their main phone number. 
Participants will be contacted regularly (e.g., twice a month) to update contact information and 
check on location. Prior to the assessment visits, reminder calls and SMS messages will be made 
to both partners one week before the appointment and again 1-2 days prior. For participants who 
miss appointments, we will limit the number of phone call attempts to 3-4 to respect privacy and 
the right to refuse. There may be special circumstances when outreach workers will be 
dispatched to participants’ homes (with their prior consent) such as when calls do not go through.  
 
We anticipate that we will lose a very small percentage of couples due to break-ups, deaths, and 
migration (<5% in another study at the site called Uthando Lwethu), which we have accounted 
for in recruitment and analysis plans. One assessment will be conducted with each partner 
separately following the break-up to understand when the couple broke up, whether study 
participation contributed to the break-up, and if not, other reasons for why the couple broke-up.  
The breakup assessment will also allow us to identify any negative effects of participation on 
couples. If the study contributed to the break-up or the break up was a negative experience, we 
will follow the adverse event logging process. We will continue to follow each partner 
individually and administer study assessments given that our study outcomes (e.g., alcohol use) 
are at the individual level. This will allow us to explore whether participation in the intervention, 
despite the break-up, still had an effect on their alcohol use. However, couples who break-up 
before participation in the intervention will exit the study.  
3.4. Participant Withdrawal 
Couples or individuals are free to leave the study at any time. If a participant notifies a staff 
member of their desire to withdraw from the study the staff member will ask if the couple or 
individual would like to share the reason they are withdrawing from the study. If the couple 
shares this information, the staff member will include that in their file and store their file in the 
“withdrawn participants” section of the filing cabinet. The project coordinator or project director 
must be notified of the situation.  

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4.0 Intervention Description 
The two intervention arms consist of standalone MI (arm 2) and MI Plus (arm 3), which consists 
of MI sessions in arm 2 plus use of the mobile breathalyzer and app for two months. Both 
intervention arms are conducted with the couple as a unit.  
MI Plus will consist of: 1) manualized MI sessions with couples and a counselor; 2) handheld 
breathalyzer with accompanying mobile app to deliver real-time feedback on drinkers’ BAC 
levels to both partners. BAC data collected will be also used to provide personalized feedback 
based on summarized displays (e.g., calendar) of BAC levels in the MI sessions.  
MI Sessions: We will aim for around 3 in-person sessions over a 60-day period with each session 
lasting 60-75 minutes – consistent with the format used in the Couples Health Project. We will 
administer MI sessions that are structured and manualized, as a roadmap for moving through 
content. MI is a collaborative process between a counselor and client, aimed at exploring and 
resolving ambivalence towards changing a behavior. Our approach will center around four MI 
processes (engagement, focusing, evoking, and planning)[30] and a fifth process around 
relationship quality based on co-I Starks’ MI framework for couples[19, 20]. Starks recently 
published a paper using qualitative data from a couple-based MI intervention that supports the 
necessity of including relationship quality as a fifth MI process when working with couples.[31] 
An exploration of dyadic strengths is necessary to support couples with divergent views in the 
resolution of interpersonal ambivalence and the development of shared goal. Starks developed 
structured activities for exploring couples’ shared goals and a lexicon of counselor skills that are 
effective in responding to dyadic ambivalence and achieving accommodation.[20]  
Outline of MI Sessions: The first session will occur within two weeks after baseline and the two 
subsequent sessions will be delivered at 30 and 60 days after couples have used the breathalyzer 
app. In the first session, the counselor will establish rapport and draw out the couples’ 
communication strengths and weaknesses. The counselor will review baseline alcohol levels 
using this as a starting point to evoke change talk. The session ends with the creation of a goal to 
reduce alcohol use. Session 2 will review the BAC data (or self-reported alcohol use if in the 
non-breathalyzer arm) from the past 30 days using a calendar approach, a check-in on goals set 
in Session 1, and a review of communication successes and challenges. The session ends with 
the creation of a behavioral goal for the next session. Session 3 begins with a review of BAC 
data (or self-reported alcohol use if in the non-breathalyzer arm) from the past 30 days using a 
calendar approach, a check-in on goals set in Session 2, and ends with a discussion of long-term 
goals and related planning. If both partners are heavy drinkers, then couples will develop goals in 
each session for both partners. 
Mobile Breathalyzer for Couples: We will use BACtrack View, which consists of a handheld 
commercial-grade breathalyzer and mobile app. To avoid disruptions in cellular service by 
having to manually purchase data, we will automatically replenish participants’ data when 
running low. To reach those who could greatly benefit from the intervention and to avoid 

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widening the digital divide, we will provide phones to participants who do not have compatible 
smartphones. 
5.0 Study Procedures 
5.1 Procedures for FGDs with couples: We will conduct two FGDs with 3-4 couples (6-
8 individuals) each. We will recruit couples using procedures from our prior studies with couples 
in South Africa and Malawi. A team of recruiters will approach index patients at HIV clinics 
while waiting to attend appointments. We will announce the study during the daily health 
information talks in the waiting rooms and interested patients can approach the recruiters. If the 
patient is interested and eligible, we will provide them with a study information card to give their 
primary partner and will set up a phone appointment to screen the partner. If both partners are 
interested and eligible, the couple will be invited for a secondary screening to verify that the 
partnership is legitimate (e.g., confirming partner names, relationship length, etc.). To ensure we 
capture primary partnerships, both partners will be asked, “Do you have a primary partner, 
meaning a person who you are committed to above anybody else and with whom you have had 
sexual relations?” Screenings will be interviewer-administered using tablet devices. If the couple 
remains eligible, both partners will provide written informed consent and be invited to 
participate. Partners will be consented separately to ensure a lack of coercion. 
5.2 Procedures for FGDs with key stakeholders: We will conduct three FGDs with 6-
8 stakeholders each. Key stakeholders will consist of HIV care providers (nurses, clinic 
volunteers, clinicians), community representatives and religious leaders who interact with 
couples who drink, and alcohol vendors (e.g., shebeen owners, local brewers). Stakeholders will 
be recruited using our professional networks in this region of KZN. 
5.3 General procedures for the FGDs: FGDs will be conducted in private rooms at community 
halls or at the HSRC Sweetwaters office. Dr. Conroy will train research assistants on the study 
objectives, interview guide, and FGD methods using a decade’s worth of training materials from 
studies in SSA. Research assistants will conduct the FGDs in isiZulu or English using a 
structured guide. FGDs will elucidate ways to make the intervention more feasible and 
acceptable to the target population and to obtain feedback on the curriculum. We will ask: What 
are your overall impressions of this program? What aspects of the program will people 
like/dislike the most? What types of couples and drinkers will be most/least likely to participate? 
How can we improve the program to increase participation among couples? If this service was 
offered today, would you recommend it to couples? To assess how to implement the intervention 
in the future, FGDs with stakeholders will elicit feedback on strategies to increase uptake of the 
breathalyzers by local agencies. FGDs will be audio-recorded, transcribed, and translated to 
English. 
5.4 Training. Given the skills required to deliver MI, we will hire certified HIV testing 
counselors with 2+ years of counselling and/or facilitation and community experience. 
Facilitators and the HSRC research manager will attend a multi-day didactic training workshop 
(in-person, at HSRC) with Dr. Starks, following a curriculum based on workshops at the 
Motivational Interviewing Network of Trainers and Dr. Starks’ prior research on couples MI. 
The next few weeks will consist of role-plays, practice, coaching and feedback, including mock 
sessions with peers and pilot couples which will be recorded for Dr. Starks. A follow-up training 
session will be held to cover more advanced MI skills with Dr Starks. This will be held online 

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(Zoom) several weeks after the initial training and facilitators have had time to practice. To 
minimize intervention drift, facilitators will be required to conduct two additional mock 
counseling sessions per month in English, which will be video-recorded and used in monthly 
booster sessions with Dr. Starks (remotely on Zoom). The project manager at HSRC will also be 
trained by Dr. Starks on coaching techniques to help oversee the training and role playing in 
Zulu and provide feedback as needed.  
Before being cleared to interact with participants, facilitators will be required to demonstrate 
competency through three mock sessions in English.  
 
We will also train a pair of interviewers to recruit couples and conduct assessment visits. Drs. 
Conroy and van Heerden will lead additional training with staff, covering topics on couples 
counseling, the mobile breathalyzer technology, how to handle ethical issues with couples, health 
education around alcohol use and HIV, the intervention manuals and procedures, and 
professional conduct.  
5.5 Supervision. Supervision of facilitators will occur as follows. Following each session, 
facilitators will listen to the audio-recording in Zulu and complete a self-assessment, identifying 
areas they did well, struggled with, or faced challenges with couples. The HSRC research 
manager or their peer facilitator will also listen to audio-recordings and complete an assessment 
form. Study investigators will meet with the research manager to discuss the self-assessments, 
and supervisor/peer assessments to assess competency and identify areas for further coaching. If 
budget allows, we will translate and transcribe a random set of MI sessions into English for Dr. 
Starks to provider further training.  
 
Dr. Starks will provide monthly supervision to staff on intervention delivery. Dr. Conroy will 
meet quarterly with van Heerden to provide strategic direction and support. PI Conroy will take 
primary responsibility for the design, implementation and analysis of the qualitative data, 
working with the other co-Investigators. 
5.6 Fidelity monitoring of intervention. After each session, facilitators will complete a checklist 
to ensure each section of the intervention was covered. Intervention sessions will be audio-
recorded. The HSRC manager will listen to audio files of sessions and also complete a checklist 
for the sessions. Self-assessment forms described above will contain rating for key MI 
components (e.g., collaboration, respect, etc.). A separate space on the checklist and self-
assessment forms will be provided for written comments. Completed forms will be discussed in 
regular Zoom calls with the team to discuss areas where further guidance is needed and to help 
problem-solve challenges.  
5.7 Recruitment and retention. We will recruit and randomize around 120 couples to meet our 
target sample size of 90 couples, assuming that we will lose around 25-30% of couples after 
randomization. We anticipate that we will lose a very small percentage of couples due to break-
ups, deaths, and migration (<5% in Uthando Lwethu), which we have accounted for in 
recruitment and analysis plans.  
5.8 Randomization process. After informed consent and the baseline assessment, couples will be 
randomized to either the control arm, the couple-based MI arm, or the couple-based MI with 

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mobile breathalyzers arm (MI Plus). We will use randomly permuted block sizes (e.g., 3, 6, and 
9) generated using a computerized and secure process. The UCSF project coordinator and the 
HSRC data manager will use the table that the statistician created to print documents that assign 
participants to one of the three arms. These documents will be placed in sealed envelopes and 
maintained by the HSRC data manager. HSRC interviewers will take a small subset of envelopes 
into the field with them. At the end of the baseline survey, the index patient will be given the 
envelope that contains the random assignment. Couples will receive an appointment card with a 
date for their next study visit following randomization.  
5.9 Control condition. Participants will receive the Usual Care (UC) defined by the South 
African national 2019 ART Clinical Guidelines (updated in March 2020). The harms of alcohol 
use are briefly discussed during the morning health talks in the waiting rooms of HIV clinics. 
HIV clients are advised that alcohol intake should be reduced to <2 standard drinkers/day for 
men and <1 for women for 5 out of 7 days per week. After randomization, couples in the control 
arm will receive brief alcohol counseling modeled off WHO guidelines and Dr. Conroy’s 
intervention in Malawi, which uses participants’ baseline AUDIT scores for messaging around 
alcohol reduction and lasts 5-10 minutes. In selecting the control, we chose to balance our ethical 
obligation to provide basic health information on alcohol use (minimal in this setting), while 
maximizing the generalizability of our findings to inform a future RCT, which will employ a UC 
control group. Clinical trial experts recommend the UC condition over other designs such as a 
time-and-attention control (TAC) when the long-term goal is to inform implementation science 
and scale-up. Our long-term goal will be to test the effectiveness of a scalable alcohol 
intervention. Moreover, because TAC designs have an active but different intervention, there is 
the risk of positively-biased intervention results because the comparison arm can distract 
participants from making reductions in alcohol use they would have otherwise made. 
5.10 Procedures for mobile breathalyzers with couples in MI Plus arm. Drinkers will be provided 
with handheld breathalyzers and both partners will receive access to the breathalyzer results. 
Drinkers will receive SMS requests to take a breathalyzer test twice per day (e.g., in the morning 
at 11 am and in the evening at 8 pm). After the drinker completes each breathalyzer test, the 
partner receives a notification that the drinker completed a test and can view the test results. 
Partners will receive a unique login username and password linked to their study ID. Dr. Conroy 
and the research manager(s) will facilitate a 1-2 hour training for couples how to use the 
breathalyzers/phones (e.g., charging, Wi-Fi, Bluetooth), complete breathalyzer tests, app 
functionality, trouble-shooting issues, and technical support. Couples will be instructed to use the 
breathalyzers for a 60-day period. Assessments at 60 days will allow us to assess the effects on 
alcohol use immediately following the 60-day intervention period.  
A technology navigator will monitor daily compliance and check-in with participants to assist 
with login credentials, lost or damaged devices, cellular connectivity, difficulties using the 
phones or breathalyzers, and intentional non-use of the breathalyzers—with close monitoring 
during the first week. Navigators will monitor for safety issues and IPV (interpersonal violence) 
during routine check-ins and will provide assistance should a safety/IPV issue arise. 
 
5.11 Survey assessments. Assessment visits will be held in community-based locations such as 
youth centers or in our team’s mobile caravans used in other couples’ studies. To minimize loss-

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to-follow-up, we will administer follow-up surveys over the phone in the case that a participant 
moves out of the area or is unavailable for an extended period of time. For the pilot study, 
surveys will be administered at baseline and 2-months (after receiving all MI sessions and/or 
using the breathalyzers for 60 days), and 6-months post-intervention initiation. Measures 
collected will be the same across visits with the exception of time-invariant variables such as 
demographics (collected at baseline only). All measures will be pre-tested, tailored for South 
Africa, and translated to isiZulu and back-translated to English. See Appendix with full survey 
instrument. Survey assessments will be interviewer-administered on tablet devices using 
REDCap mobile, last around 90 minutes, and uploaded to a secure web-based storage system. 
Partners will be assessed separately, but simultaneously, in private interview rooms.  
 
 
Domain 
Measure (alphas noted are from prior studies with couples) 
Primary 
outcomes  
(future trial) 
Alcohol use 
Number of drinking days in past 21, assessed using the three-week timeline 
follow-back method (TLFB) confirmed with the PEth biomarker.[32] AUDIT-C 
positive (score of ≥4 for men and ≥4 for women) and/or PEth positive (≥35 
ng/ml).[33, 34]  
Secondary 
outcomes  
(future trial) 
Viral 
suppression 
and ART 
adherence 
Viral suppression will be defined as less than 1000 copies/mL for DBS viral load. 
ART adherence will be captured using the bean method for low-literacy 
populations[35], by placing beans in a bowl for the number missed pills in the 
past 30 days. We will dichotomize adherence using a 95% cutoff, based on data 
showing that patients who miss ≥5% of doses have worse virologic 
outcomes.[36]  
Couple 
communication 
Constructive, avoidant, and demand-withdraw communication (communication 
patterns questionnaire; α=0.69-0.72).[37] 
IPV 
Physical, sexual, and emotional violence (WHO domestic violence measure; 
validated among PLWH; α=0.75-0.83).[38, 39]  
Relationship 
dynamics 
Trust (dyadic trust scale; α=0.82).[40] Intimacy (emotional intimacy subscale of 
Sternberg love scale; α=0.90).[41] Unity (inclusion of self-in-other measure).[42] 
Relationship satisfaction (couple satisfaction index, single item).[43] Sexual 
satisfaction (couple sexual satisfaction scale; α=0.89).[44]  
Mediating 
variables  
(future trial)  
Shared illness 
appraisal 
Single item that asks: “When you think about problems related to your [or your 
partner’s] alcohol use, to what extent do you view this as “our problem” [shared 
by you and your partner equally] or mainly your [your partner’s] own 
problem?”.[45] 
Communal 
coping 
Dyadic coping inventory, modified for alcohol use.[46, 47] Partners are asked 
how often they, as a couple, engage in activities to deal with alcohol (e.g., “We 
try to cope with alcohol issues together and search for solutions”).  
Alcohol social 
support  
Alcohol-specific partner support (to be adapted from the Social Provision 
Scale).[48]  
Covariates 
(future trial) 
Socio-
demographics 
Gender, age, marital status, relationship length, religion, living children, 
education level, household asset index.[49] 
5.12 Medical record extraction. For participants living with HIV, we will access their medical 
record information including recent HIV results. We will obtain this information from electronic 
HIV registries (e.g., Tier.Net) or online databases (e.g., National Health Laboratory System), or 

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by requesting clinical files from patients’ HIV clinic. Participants will be asked to bring their 
clinic cards to study visits, which contain identifiers that can be used to look up HIV test results.   
5.13 Blood samples. At screening, we will obtain consent to confirm HIV status for all 
participants who report being positive using a point-of-care test. We will have results in 10-15 
minutes. We will base eligibility on the result of this test. We will only test potential participants 
who report living with HIV. We will not return test results. At the two-month follow-up visit, we 
will collect blood samples via finger pricks for testing using DBS cards. Participants who are 
heavy drinkers will be tested for PEth. Participants who are heavy drinkers and living with 
HIV will have their viral load tested. PEth is 95% sensitive and 73% specific for detecting 
heavy drinking in the past 21 days and is highly correlated with number of drinking days among 
PLWH in SSA. PEth samples will be processed at the United States Drug Testing Laboratories 
using liquid chromatography tandem mass spectrometry. PEth samples on DBS cards will be 
stored at the HSRC research center until they can be batch transported to the US laboratory. PEth 
results will be reported as positive/negative and in ng/ml. Viral load DBS samples will be 
processed at the Universal Pathology Laboratory (UPL) in South Africa or an HPTN Network 
Laboratory certified laboratory facility. Viral load DBS samples will be processed using the 
Aptima HIV-1 Quant Dx Assay (DBS supplement) with a lower limit of detection of 30 
copies/ml. In line with standard clinical practice in South Africa, less than 1000 copies/ml will 
be the threshold for viral suppression.  
 
5.14 Exit interviews 
 
Sampling: To contextualize the feasibility and acceptability data, we will conduct 60-90 minute 
exit interviews with 15 couples at the 2-month follow-up. Around five couples will be recruited 
from each arm, purposively sampled by participation level. For Arm 2, participation will be 
categorized as: low=attended one MI session, medium=attended two sessions, and high=attended 
all three sessions. For Arm 3, we will aim to enroll couples with varying test completion rates, 
categorized as low=completed less than 70% of breathalyzer tests, medium=completed 70-85% 
of tests, and high=completed>85% of tests. We will also try to interview couples in which both 
partners were heavy alcohol users to further understand how the intervention impacts dual 
drinkers.  
 
Interview questions: We will elicit information on intervention preferences and satisfaction with 
domains of the intervention (e.g., frequency of breathalyzer tests and MI sessions, length, 
content, format of MI sessions). To explore dyadic mechanisms of change, we will elicit 
information on whether and how the breathalyzers and MI sessions enhanced communication, 
communal coping, and support. We will also elicit information on technology issues (e.g., user 
app experience, network connectivity, load shedding and power outages, battery life, trouble 
with logins) and contextual issues (e.g., literacy, alcohol stigma). Given the central question of 
whether the mobile breathalyzer technology can be used with couples to trigger support, we will 
assess how knowledge of BAC levels impacts the relationship (e.g., increases in couple conflict, 
changes in communication), how both partners interpret and respond to BAC levels, and the 
types of partner support provided and when.  
 

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Procedures: Given the gender-power dynamics in this setting, the PI Conroy’s prior qualitative 
research, and the potential bias (e.g., women not feeling comfortable voicing their opinions in 
front of male partners) and increased risk for violence that could result from interviewing 
partners together, we will interview both partners separately, but simultaneously. Interviews will 
be audio-recorded, transcribed word-for-word, and translated from isiZulu to English, and 
imported into Dedoose for analysis.  
 
Analysis: We will use our successful analysis approach developed for dyadic qualitative data. 
This consists of coding one couple at a time by assigning new and a priori codes to both 
partners’ transcripts. We will write an analytic memo for each couple that summarizes key 
factors involved, key themes or constructs, and within-couple consistencies and discrepancies. 
We will code the next set of couple transcripts and write an analytic memo for that couple and 
repeat this process until all transcripts are coded and 15 couple memos are written. We will 
construct data matrices to compare and contrast codes and themes between couples. An 
investigator meeting will be held to review the emergent patterns/themes, in conjunction with the 
quantitative findings, and to identify any final modifications to the intervention. 
6.0 Safety monitoring and adverse event reporting 
6.1. Safety monitoring 
Safety-related risks could consist of: 1) loss of confidentiality; 2) loss of privacy; 3) couple 
tension, conflict and/or violence, and coercion; 4) discomfort or distress as a result of the 
personal and sensitive nature of the interviews or intervention sessions on alcohol, relationship 
dynamics, and violence; and 5) risks associated with finger pricks to collect blood samples for 
viral load and alcohol biomarkers (Phsphatidylethanol, or "PEth”).  
 
Any incidents involving subject safety will be reported to both institutional IRBs (Human 
Sciences Research Council and The University of California, San Francisco by the PI within 10 
working days. The following information will be included in any report: 1) all serious adverse 
events associated with study procedures and/or 2) any events or problems involving the conduct 
of the study or patient participation, including problems with the recruitment or consent 
processes. The US PI will also provide a description of any problems or issues observed in the 
course of the study to each IRB on an annual basis. 
 
Safety monitoring procedures. All safety-related risks will be monitored routinely at the time 
of assessment or intervention sessions. Procedures are in place to protect the confidentiality of 
information from one’s partner and to monitor any confidential information. Interviewers and 
intervention staff will be trained to increase their sensitivity and present a caring and non-
threatening manner regarding topics such as sexuality, HIV, and relationship issues. At any sign 
of discomfort or distress, or by request, interviews will be stopped. Confidentiality will be 
assured to participants at the time of consent, and they will be assured their answers or responses 
cannot be used against them for any reason, or for denial of any medical treatment. Standardized 
procedures will be documented and reviewed with staff regarding the possibility of tension, 
conflict or violence between partners. Procedures will be in place to monitor and respond to any 
instances reported by the participants of any type of negative relationship event, and proper 
action will be taken, including staff intervention and/or provision of referral for services 
depending on the level of the event (e.g., relationship conflict, an episode of domestic violence, 

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etc.). If a participant is referred to outside services, they will be provided with a formal referral 
letter.  
 
Safety-related risk reporting and action plan. Interviewers and intervention staff at HSRC 
will report any breach of confidentiality incurred by the participants to the UCSF project 
coordinator, who will then inform the site PI and the US PI. Any participant in need of treatment 
due to distress, relationship conflict, or alcohol issues will be referred for appropriate services 
following staff completing the study protocol pertaining to these situations. As indicated above, 
in the event that a participant is referred to outside services, they will be provided with a formal 
referral letter.  The US PI will ultimately be responsible for informing the IRBs and the DSMB 
through the IRB adverse event reporting procedure, and the Project Office through immediate 
email of any life-threatening incident, and through annual reports of other incidents. In the event 
of any adverse or life-threatening events occurring at an unacceptable level, the US PI will take 
appropriate action to halt the study, release a participant from the study, or modify the study 
procedures to reduce or eliminate the identified risk. 
6.2. Adverse events 
Any adverse events following participation will be tracked via referral and clinician follow-up. 
We will adapt the standard HSRC adverse event form adverse event form to document the 
incident, actions taken, supervisor notes, and follow-up steps. This form, supplemented by any 
additional staff notes will be provided to the appropriate agencies, including the University of 
California, San Francisco and HSRC Research Ethics Committees and the funding agency (NIH, 
USA). Any resulting recommendations from the IRB will be communicated to NIH. The site PI 
will be responsible for monitoring and reporting of any adverse events to the US PI, and will 
involve the DSMB as described below.  
6.3. Data Safety and Monitoring Board 
The level of risk from this behavioral intervention trial is minimal. We have developed the 
following plan to monitor the trial and to deal with data and safety monitoring. A Data and 
Monitoring Safety Board (DSMB) consisting of HIV behavioral and international research 
experts will be assembled. 
 
The DSMB will meet using a video-conference platform such as Zoom. The DSMB will approve 
the overall protocol, assessments, and consent forms. All reports of adverse events (AE) will be 
reported to them, as well as to the IRBs (UCSF and HSRC). Severe adverse events (SAE) will 
trigger an immediate meeting of the DSMB. Additional meetings will be arranged as needed, 
following any emergent AE issues. The DSMB will review all accrued data to assess whether the 
study aims were met and to ensure that the benefits of the intervention outweigh any harm.  
7.0 STATISTICAL CONSIDERATIONS 
7.1 Analysis of FGDs to refine the intervention. Using a template analysis approach [50], we will 
develop a pre-determined template based on elements of the intervention to retain or refine, and 
new elements to add to address the needs of the target population. Study investigators will 
generate a draft of the template with thematic codes for relevant domains of the intervention, and 
will independently code the FGD transcripts. The investigative team will then discuss the 
emerging themes, identify areas for further adaptation, and refine the intervention manual. 
Depending on the extent of the changes, we may hold a meeting with HSRC’s CAB to review 

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the FGD findings and identify intervention content and procedures that need to be added, 
removed, or refined.  
7.2 Feasibility and acceptability data analysis. Our primary objective is to evaluate F&A of the 
intervention and study procedures. The primary analyses will include descriptive statistics of 
F&A indicators, comparing each statistic (e.g., percent retained) to the threshold listed in Table 
4. Above-threshold findings will suggest a reasonable level of F&A while below-threshold 
findings would suggest that remedial modifications to study procedures and/or design would be 
required prior to moving forward with a full-scale trial. We will stratify the statistics by gender 
to consider sex as a biological variable. 
 
 

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Table 4. F&A 
Domain 
Measure 
Threshold 
Arm(s) 
Recruitment 
Number of couples enrolled per 
week 
Average 5 per week/20 per 
month 
All 
Enrollment  
Proportion of eligible couples 
who enroll and complete baseline 
assessment 
80% of eligible couples will 
complete enrollment 
All 
Randomization 
Proportion of enrolled couples 
who complete randomization 
process 
90% of enrolled couples will 
complete randomization 
All 
Participation 
Proportion of couples who attend 
66% and 100% of MI sessions 
100% of couples will attend 
66% (2 out of 3) of sessions; 
75% of couples will attend all 3 
sessions 
2, 3 
Engagement with 
mobile breathalyzer 
technology 
Proportion of breathalyzer tests 
taken after prompted; number of 
partner SMS messages sent and 
received on BAC results; number 
of drinker SMS reminders to take 
breathalyzer tests sent and 
received; average length of time 
to take breathalyzer tests after 
prompted; average number of app 
logins per week to access BAC 
data (for both partners); average 
user session length; number of 
lost/stolen phones and 
breathalyzers 
70% completion rate 
3 
Retention 
Retention rates; reasons for 
dropouts 
85% retention at 2-month 
follow-up 
All 
Process outcomes 
Length of MI sessions in minutes 
≤90 minutes per session[9] 
2, 3 
Intervention fidelity 
Expert ratings of quality of 
intervention using audio-recorded 
intervention sessions (checklists) 
>80% inter-rater reliability 
2, 3 
Assessment 
procedures 
Length of surveys; proportion of 
couples who complete baseline, 1, 
2, and 6-month surveys 
90 minutes; 75% of all couples 
will complete all assessments 
All 

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Acceptability 
Proportion of couples satisfied 
with the intervention. Couples 
will decide their satisfaction 
together since this is a dyadic 
intervention.  
75% of couples reporting being 
satisfied or very satisfied 
All 
 
 

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7.3 Hypotheses and methods for preliminary/exploratory analyses. Although the purpose of this 
study is to determine F&A rather than to conduct formal hypothesis tests, we will evaluate 
exploratory hypotheses as part this assessment process. For example, we expect that: H1) 
participants in the couples MI-only group (arm 2) will report a greater reduction in the number of 
drinking days (confirmed with PEth) than participants in the control group (arm 1); H2) 
participants in the couples MI with mobile breathalyzers group (arm 3) will report a greater 
reduction in the number of drinking days than participants in the couples MI-only group (arm 2). 
Secondarily, we also anticipate that intervention participants will report a higher odds of 
adherence to ART and viral suppression than those in the control arm. We also anticipate the 
intervention participants will report higher (indicating more positive) scores on communication 
and relationship dynamics and less intimate partner violence than those in the control arm. 
Reflecting the exploratory nature of these analyses, alpha will be set at .05 for all inferential 
analyses.  
7.4 Power analyses. Formal tests of health outcomes or attempts to obtain valid estimates of 
effect sizes are not statistically justified for the proposed study. Pilot studies, by design, cannot 
definitively test hypotheses due to their smaller sample sizes and the frequent design adjustments 
necessary to maximize recruitment, retention and quality assessment of outcomes. Effect size 
estimates are not sufficiently reliable given the breadth of the confidence intervals. However, to 
supply additional information, we conducted several power analyses using NCSS PASS. In sum, 
our study is powered to detect small to medium distances to confidence limits for descriptive 
statistics and medium to large longitudinal analysis effects, though, as noted above, formal 
hypothesis testing will not be the focus of this F&A study.  
8.0 Human Subjects Considerations 
8.1 Ethical Review 
The study protocol, informed consent forms, and other requested documents — and any 
subsequent modifications — will be reviewed by the Human Sciences Research Council 
Research Ethics Committee in South Africa, and the Institutional Review Board at the University 
of California, San Francisco. Subsequent to initial review and approval, the responsible 
IRBs/ECs will review the study at least annually.   
 
Each site Investigator will make safety and progress reports to the IRBs/ECs at least annually, 
and within three months after study termination or completion. These reports will include the 
total number of participants enrolled in the study, the number of participants who completed the 
study, all changes in the research activity, all SAEs, and all unanticipated problems involving 
risks to human subjects or others.   
 
The results of all DSMB reviews of the study also will be provided to the IRBs/ECs.   
8.2 Informed Consent 
Consent for participation in pilot RCT. Couples will arrive together for their appointments which 
will begin with the informed consent process. Partners will be consented individually in a private 
interview room by a gender-matched interviewer in the local language. The consent process will 
cover topics on the purpose of the study, potential risks and benefits, how confidentiality will be 

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ensured, voluntary participation, the funding agency and study investigators, and contact 
information for the study PIs. The study’s consent form will be read and explained to them by 
the interviewer. A detailed description of the study procedures will be included. The consent 
form will include the information that they have the right to refuse or withdraw from 
participation at any time. The consent form will provide detailed descriptions of the expectations 
of being a participant in either of the study groups, along with the accompanying potential risks 
and benefits of each. Information will be presented on randomization, following procedures used 
to describe randomization in our prior studies in the region. A paper version of the information 
sheet will be offered to participants with the goals of the research, the study procedures, and the 
names and contact info for the principal investigators will also be provided, and a contact 
number for the local PI. The consent process will also ask respondents if they agree to be 
contacted to participate in additional study activities beyond what is required for the proposed 
study and whether it is acceptable to track them at their homes if phone calls do not go through.   
 
Consent for biomarker collection. The main consent form will include consent for obtaining 
biomarker specimens, detailing the appropriate risks, procedures involved, and any benefits. 
Respondents will be informed of the risks/benefits and that the results of the HIV and alcohol 
biomarker (PEth) tests will not be made available to them. 
 
Consent for qualitative data collection. For the qualitative phases (FGDs for Aim 1 and exit 
interviews for Aim 3), we will use separate consent forms. For the FGDs, the process will inform 
respondents that others in the group will learn of their HIV status (although all group members 
will be HIV+) and confidentiality cannot be assured so they must choose carefully the 
information that is shared with other group members. 
 
Electronic signatures for consent will be obtained for all participants; for those who cannot write 
their names, they will place an “X,” their thumbprint, or their mark on the consent form. The 
interviewer and an impartial witness, who the participants knows and trusts, will also sign the 
consent form. All consent forms will be translated into isiZulu (the predominant local language) 
and then back translated by a separate individual in order to ensure proper translation. Given the 
high levels of illiteracy in this context, study staff will read the written version of the consent 
form and test for an understanding at the end with a series of simple questions (e.g., “can you tell 
me what will happen if you agree to participate in the study?”). Respondents will be offered a 
copy of the consent form in isiZulu (or in English, if preferred). All consent forms will be 
approved by the IRBs of both UCSF and HSRC in South Africa.  
8.3 Risks 
This study is considered minimal risk. However, participation requires at least one partner to be 
HIV+ and thus respondents may be identifiable to others in the community by their participation 
in the study. The risks associated with knowledge of a respondent’s HIV+ status in the 
community include social stigma (e.g., rejection, isolation) and discrimination (e.g., loss of 
employment or status in the community). The potential risks of the study can be grouped into 
five categories: 1) loss of confidentiality; 2) loss of privacy; 3) couple tension, conflict and/or 
violence, and coercion; 4) discomfort or distress as a result of the personal and sensitive nature 
of the interviews or intervention sessions on alcohol, relationship dynamics, and violence; 5) 

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risks associated with finger pricks to collect blood samples for viral load and alcohol biomarkers 
(PEth); and 6) risk of COVID-19 infection.  
The intervention may not be appropriate for couples experiencing severe current IPV. We will 
exclude couples in which one or both members report concerns about their safety or report 
experiencing or perpetrating severe IPV in the prior 3 months. IPV measures will be adapted 
WHO measure for South Africa, which assesses physical, sexual, and emotional violence, and 
determines whether it is mild, moderate or severe. This approach was chosen to minimize 
exacerbation of potentially volatile situations while participating in a relationship-focused 
intervention. Given that we are not excluding couples based on ever experiencing severe IPV, 
and including those couples reporting any mild- to moderate IPV, we believe that this balances 
sample generalizability with participant safety. 
Loss of confidentiality. The loss of confidentiality may lead to disclosure of HIV infection and 
alcohol use disorder. Stigma associated with disclosure may include social harms such as 
discrimination (e.g., lost of employment or status in the community), physical harm (e.g., acts of 
violence being committed against people who have HIV), and psychological harm such as 
embarrassment (e.g., being questioned by family members about alcohol use). To protect 
participants’ confidentiality the following steps will be taken: 1) all staff will receive training at 
the initiation of the study and ongoing supervision to ensure their understanding of any and all 
confidentiality-protecting procedures; 2) participants’ names will not be associated with any 
research instruments; 3) only research identification numbers will be used on data; 4) any tracing 
or other contact information, including signed consent forms will be stored separately from the 
data; 5) all records will be stored in locked file cabinets in study offices at HRSC; 6) the files 
linking research identification numbers and names will be stored in a separate locked file 
cabinet, and a computer file only accessible by the Research Manager, PI and Co-Is; 7) all 
computers/tablets/phones on which any data are stored will be password protected. 
As this is a study involving couples, additional measures are needed to protect each participant’s 
confidentiality from their partner. From our prior work, we have developed procedures to 
minimize risk. For the study assessment interviews, all participants will be interviewed by a 
gender-matched interviewer who will conduct the interview in a private room. Couples will 
arrive together but be consented and interviewed separately. Prior to their separation, study staff 
will inform them that they may contact the staff member who interviewed them, but they will not 
be permitted to have contact with the interviewer who administered the survey to their partner. 
This procedure will enhance the participants’ confidence that the information they disclose will 
be kept confidential and not disclosed to their partner. Each study staff member will only interact 
with one participant, and the interviewers will be instructed not to compare answers between 
them regarding a couple’s answers. 
The consent form will include specific language regarding the confidentiality of the partner’s 
study data: “Please be aware that you will not be told any information that your partner says in 
his or her interview. This includes any information your partner might say about his or her 
health, even if we think you do not know this information. Likewise, no information you say in 
your interview will be told to your partner, even if we think your partner might not know this 
information.” Interviewers will be trained to ensure that participants understand this condition 
during the informed consent process, including information about the confidentiality of their own 

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and their partner’s data. As mentioned above, systematically providing this information will 
eliminate partner’s surmising that it is being provided due to information disclosed during the 
interview. It is possible that partners might ask each other about their responses to certain 
questions or issues discussed. Interviewers will be trained to discuss with participants ways of 
coping with this situation. 
Loss of privacy. We will screen and interview couples in private locations and will take 
additional measures to protect respondents’ HIV+ status. Although most activities will take place 
in the HIV clinics or other central community-based location, it will be important that 
interviewers maintain respondents’ privacy if visiting the communities of respondents. To 
protect individuals’ privacy, we will utilize language such as “Healthy Living” rather than 
referring to HIV or alcohol use when discussing the study. 
There is the potential for additional privacy risks related to use of the breathalyzers in public, 
which could be stigmatizing if others in the community learn about their association with an HIV 
and alcohol study. When training participants on how to use the technologies for the study, we 
will counsel participants on how to best respond to questions from others on the breathalyzers 
and strategies to maximize privacy (e.g., finding a private space at drinking establishments to 
record BAC levels). During the consent process, we will explain these risks to participants to 
ensure they feel comfortable using the breathalyzers in the public space and participating in the 
study. We will provide a pouch to cover the breathalyzer and a phone cover to disguise the phone 
brand so these devices are not identifiable to the community and linked to the study.  
During the FGDs which also utilize a group format, we will take additional measures to protect 
privacy. We will discuss the risks to confidentiality due to participating in FGDs in the informed 
consent processes. We will emphasize the fact that comments made during FGD sessions are to 
be kept confidential. However, it is possible that participants may repeat comments made or 
heard during FGDs in a different context in the future. They may also disclose the identity of 
other participants in the group. We will ask participants to not to talk specifically about 
themselves, but more generally about people they know who are like them or live in their 
communities. Although personal information and experiences may be discussed, the FGDs will 
primarily serve to obtain opinions on the proposed health intervention. The FGDs will be 
conducted in English/isiZulu by trained qualitative researchers with extensive experience in 
ensuring the safe conduct of group discussions. As with the interviews and survey, respondents 
will have the right at any time to decide not to participate or answer questions. 
Couple tension, conflict, and/or violence, and coercion. It will be communicated in the consent 
form that while study staff members will not reveal participant information to their partner, it is 
possible that their partners might ask them about their responses to certain questions or issues 
they discussed. Interviewers will be trained to discuss with participants’ ways of coping with this 
situation if the participant expresses concern or distress about this matter during consent, the 
administration of the survey, or after it is completed. 
Although we have not had problems in the past in South Africa with participants reporting 
coercion, staff members will be trained to be sensitive to the possibility that one member of the 
couple was pressured or coerced by the other partner to participate in the study. Questions may 
be posed such as “Did you come here freely?” or “Will something bad happen to you if you say 

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no?” Should the staff member have this suspicion, s/he will be trained to immediately terminate 
the survey or session and provide the participant with appropriate referrals and the study 
incentive. Any data collected will be destroyed. The staff member will also be trained to offer the 
participant the opportunity to remain in the interview room for the appropriate amount of time 
that it would have taken to complete the survey or interview so that the study partner would not 
be alerted to the fact that the interview was terminated. If necessary, back-up staff members who 
are clinicians can be contacted to assess the appropriate immediate steps, should intervention be 
needed. Should evidence of coercion/violence arise in the intervention sessions, assessment 
visits, or exit interviews, the counselor will provide the appropriate clinical intervention 
regarding participation of the couple, including assessing the level of safety and whether 
immediate medical/psychological attention is needed, and/or provide community referrals. 
Depending on the situation, procedures as described above will be followed in terms of 
determining next appropriate steps. 
Interviewers and other intervention staff will also be trained in the identification of, and proper 
response to, issues of coercion or abuse, and will be familiar with how to facilitate referrals for 
intimate partner violence assistance (either for the violent partner or the victimized partner). For 
example, staff will assess the degree of threat, whether the participant’s life is currently at risk, 
or whether the crisis is not of an imminent nature. Depending on the degree of threat, the 
participant could be referred immediately to a district crisis center, or, in lesser threat situations, 
could be provided with referrals for community-based services. 
As stated in the inclusion criteria, couples will be excluded if they report a history of severe 
intimate partner violence in the past three months or feel their safety would be at risk. We do not 
wish to exclude a lifetime experience of violence from our sample, as that would potentially 
exclude participants who could benefit the most from the alcohol intervention. By screening out 
recent episodes (past three months) of severe intimate partner violence and/or women who feel 
their safety could be jeopardized by participation, we aim to have a sample that balances 
potential benefit with relatively low risk from a couples-based intervention. Incident risk for IPV 
will be assessed at all follow-up visits and intervention sessions. If IPV is reported during these 
visits, we will follow an established protocol to document the situation, assess safety for the 
partner(s), provide emotional support, and appropriate intervention and/or linkage to 
psychological and/or medical services.  
We will also use a combination of actively and passive monitoring for violence during the 
intervention sessions and while the couples are independently using the breathalyzer devices. For 
active monitoring, a designated technology navigator will routinely check in with participants 
(separately with each partner) to ensure compliance and to troubleshoot any technical issues with 
using the breathalyzers/phones and will discretely monitor for violence. For passive monitoring, 
the technology navigator or another staff member at HSRC will be paired to participants and will 
be available to be contacted via phone should a safety issue arise during the study period. If a 
violence or safety concern is reported, the staff member will follow an established protocol to 
assess the degree of threat, whether the participant’s life is currently at risk, or whether the crisis 
is not of an imminent nature. Depending on the degree of threat, the participant could be referred 

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immediately to a district crisis center, or, in lesser threat situations, could be provided with 
referrals for community-based services. 
Should a participant specifically request an IPV referral during a study visit, the staff member 
will immediately terminate the interview, provide the participant with the study reimbursement, 
offer to let the participant remain in the interview room for the approximate time of completion, 
and the assessment protocol for determining participant safety will be triggered. In addition, our 
resource list given to all participants will include intimate partner violence programs, clinicians, 
and support groups specializing in relationship abuse and violence. 
Discomfort/distress. There could be some discomfort with the sensitive nature of the interviews 
on topics including alcohol use and couple conflict. Interviewers and study staff will be trained 
to minimize distress/discomfort to respondents, to recognize any signs of distress, and to make 
appropriate referrals to community-based services, if necessary. Our research team has a 
significant amount of experience conducting behavioral surveys and interviews within the field 
of HIV prevention and treatment, and with couples, including in the proposed setting. It has been 
our experience that it is rare for a participant to find the interview upsetting. We have 
infrequently encountered episodes of mild embarrassment or awkwardness, which quickly 
dissipate. Experienced lay counselors will be available on the study staff for consultations or 
referrals, should a respondent exhibit severe symptoms of mental distress. All couples’ 
counseling sessions will be conducted by lay counselors, but who have received significant 
training pertaining to couples, so any distress during an intervention session will be able to be 
processed and dealt with appropriately. All staff will be trained in the proper referral procedures, 
and will be provided with ongoing supervision of such issues by the Research Manager. Through 
our work in this community, we have compiled a list of community-based resources, including 
mental health counseling, general health services, domestic violence, and substance use. This list 
of referrals will be continually updated, and systematically provided to every individual at every 
visit, which will reduce the likelihood that any one couple or individual would be identified as 
needing a particular service. Informed consent documents will inform research participants of 
potential discomfort around certain interview topics and the option to refuse to answer or skip 
any questions on the surveys that they are uncomfortable answering. 
Blood draw injury. Viral load and PEth tests require participants to provide a blood sample 
through finger pricks. The physical risks associated with finger pricks are low, but could include 
pain and rarely, bruising and/or infection. All study staff will be crossed trained in how to collect 
DBS samples and in good clinical practice (GCP). GCP protocols will be followed for the 
handling and storage of DBS samples. Research assistants will report any complications 
resulting from the blood collection to the field study coordinator, who will make an immediate 
report to the local and UCSF PIs. The PIs will take responsibility for reporting serious adverse 
events to the IRBs.    
Procedures for handling alcohol dependency. This is a pilot study of a behavioral intervention to 
reduce customary levels of alcohol consumption. Study staff will be clear in instructing 
participants not to drink alcohol in excess of their customary amounts such that study 
participation does not incur any increased risk above that of their customary alcohol 
consumption. Control arm participants will receive brief advice on alcohol use as part of the 
enhanced care control condition. However, our screening and follow-up visits may uncover 

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possible alcohol dependence, using an AUDIT-C score of greater than 8. Our electronic data 
collection instruments will flag these participants in real-time and alert the interviewer to take 
action. In this case, we will provide simple advice to help participants cut down slowly on their 
alcohol use and avoid the negative effects of alcohol withdrawal. For example, participants will 
be advised: “If you are a heavy drinker, we advise you to gradually reduce your alcohol 
consumption. We advise that you do not stop drinking suddenly because you may feel alcohol 
withdrawal symptoms that may seriously affect your health.” We will continue with study 
activities but will have procedures in place to refer patients to several private alcohol and 
substance use referral centers/services in the local area (SANCA, LifeLine, and SADAG). At any 
point in the study, participants who request or ask about services to help them with their alcohol 
dependency will be referred to such services. If significant alcohol problems are encountered 
during the couples’ MI sessions or other intervention activities, study participants will be 
encouraged to discuss these problems with their health care providers and will be referred to 
alcohol and substance use services in the community. 
 
Procedures for handling severe depression and suicidality: If a participant shows signs of severe 
depression (e.g., score ≥20 on the PHQ-9 scale) or suicidality (e.g., indication on PHQ item 9) 
during the study assessments or intervention sessions, study staff will follow an established 
protocol to assess risk and make the appropriate referrals and linkages into services. In the case 
of suicidality, staff will be trained on how to conduct a suicide risk assessment including how to 
differentiate between potential suicidal ideation and non-suicidal ideation. In the case of suicidal 
ideation, staff will assess past and current suicidal episodes and screen for other risk and 
protective factors to determine the appropriate safety plan. Referrals and linkage into services 
will be made in consultation with the broader HSRC clinical and community outreach teams 
using internal procedures for handling cases of distress and poor mental health.  
 
COVID-19 safety management plan: To protect study participants, their families and research 
staff from the risk and spread of COVID-19, the study will adhere to all Kwa-Zulu Natal 
Department of Health directives aimed at mitigating the spread of COVID-19. We will inform 
research participants of requirements to undergo COVID-19 screening and reporting of screening 
results to the local public health authorities whenever the results may point at a possible infection 
with the disease, for their benefit. We will also provide participants and staff with 3 ply face 
masks, avail hand washing stations at the study sites, and provide hand sanitizers. We will pre-
screen participants before physical contact, check temperature and observe social distancing 
requirement of 1.5 meters during face-to-face interaction with participants. We will inform the 
participants of the measures that we will be taking during any form of face-to-face contact. We 
will also have daily mandatory screening for staff who are making contact with participants, and 
only those without any COVID-19 symptoms will be allowed to make contact with participants. 
The staff will also disinfect furniture and sanitize their hands after every contact with a 
participant. Finally, we will select a large conference room with good ventilation (open windows 
and fans) to further reduce risk of transmission for COVID-19.  
 
8.3.1. Minimizing risks 
 
We will handle risks associated with couples research by following similar procedures from our 
team’s prior work with couples in southern Africa. Any risks to respondents that stem from 

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participation in the intervention, assessment visits, exit interviews, or focus group discussions 
will be minimized by: 1) training of staff in the ethical conduct of research; 2) training of staff in 
issues specifically pertaining to couples in this setting (i.e., potential for couple 
tension/conflict/violence, or coercion); and 3) close monitoring of any adverse events with 
appropriate IRB reporting; and 4) referrals to professional or community agencies providing 
mental health (including alcohol use disorders) or other appropriate services, when necessary. 
Refresher trainings on ethical procedures will be held as needed and ongoing adherence to all 
ethical practices will be closely monitored by the Research Manager and site PI. 
 
During the screening process, we will have established procedures in place for ensuring that 
HIV+ individuals have verbally disclosed their HIV status to their primary partners in order to 
minimize risk associated with unintended disclosure (e.g., distress, conflict or arguments, break-
ups, violence). If we cannot establish that disclosure has occurred, the screening process will be 
terminated due to ineligibility. We will consider HIV status disclosure to have occurred from the 
patient to their partner only if verified by the partner. If both partners are HIV-positive, both 
partners will be required to have disclosed to the other. Should the situation arise where we 
identify that HIV+ individuals have not disclosed their HIV status to their partner, we will have 
resources available (e.g., study HIV counselors) and referral pathways in place. Screening will 
be an interactive process and study staff will pause and check for understanding of all eligibility 
criteria.  
 
As this is a study involving couples, additional measures are needed to protect each participant’s 
confidentiality from their partner. From our prior work, we have developed procedures to 
minimize risk. For the ongoing assessment interviews, all participants will be interviewed by a 
gender-matched interviewer who will conduct the interview in a private room. Couples will 
arrive together but be consented and interviewed separately. Prior to their separation, study staff 
will inform them that they may contact the staff member who interviewed them, but they will not 
be permitted to have contact with the interviewer who administered the survey to their partner. 
This procedure will enhance the participants’ confidence that the information they disclose will 
be kept confidential and not disclosed to their partner. Each study staff member will only interact 
with one participant, and the interviewers will be instructed not to compare answers between 
partners unless required for the study (e.g., confirming the couple is eligible). 
 
In sum, the proposed 3-year project is a pilot study for a couple-based motivational interviewing 
intervention aimed towards reducing heavy alcohol use and improving adherence to ART among 
HIV-positive alcohol users. We will collect data using surveys, focus group discussions, exit 
interviews, biomarkers, tracking logs, mobile app data, and intervention forms to address the 
specific aims. The assessments and interventions pose no more than minimal risk to participants, 
and we have taken steps to minimize risk. The data and safety monitoring plan identifies the PI 
(Dr. Conroy) as the primary individual responsible for monitoring the risks to human subjects 
with regards to data and safety related issues. We will use available mental health professionals 
and medical procedures to address any psychological or physical risks that may arise. Serious 
adverse events will be reported promptly to the UCSF and HSRC Research Ethics Committee, 
the DSMB, and project officer of the funding source.  

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8.4 Benefits 
8.4.1. Overall benefits to participants 
There are no direct benefits to the study participants. However, they may gain motivation and 
skills to reduce alcohol use and engage in communication better with their partner around 
alcohol use. Some participants might find it therapeutic to discuss alcohol and issues in their 
relationships, as we found in our formative research with this population. The larger public 
health community could benefit if the intervention is found to be feasible and acceptable, and 
later shown through a full-scale trial to be efficacious at reducing alcohol use and improving 
HIV treatment outcomes, and potentially, reducing the burden of HIV and heavy alcohol use in 
the community. While there are some risks to participating in the study, based on prior 
experience, we feel that the likelihood of participants experiencing negative events due to 
participation is low. The risk to individual participants is small, and the potential to provide 
information that could benefit the target population outweighs the risk. 
8.5 Confidentiality 
See section on risks for discussion of confidentiality and steps taken to protect it and 
consequences if violated. 
8.6 Incentives 
Participants will be reimbursed based on the time, inconvenience and expense model of 
reimbursement in research. Each person screened will be given R40 for completing the screener. 
Each participant will be given R100 for participation in study assessment visits and R100 for exit 
interviews. We propose R50 as a token of appreciation for participants attending each 
intervention session. Participants selected for focus group discussions will be reimbursed with 
R210 per session. Participants in the MI plus breathalyzer arm will be reimbursed R5 for each 
breathalyzer test completed, for a maximum of R10 per day or R300 per month. Reimbursements 
proposed are for participant time and inconvenience. No participant incurred expenses are 
anticipated – sessions will be scheduled in community venues and all study related consumables 
will be provided by the study team. At the end of the study, all participants in all arms of the 
study who completed their participation, will be entered into a lottery to win a second-hand 
iPhone. We will use this method to distribute the iPhones used in the study. 
8.7 Study Discontinuation 
This study may be discontinued at any time by the Protocol Chairs, government or regulatory 
authorities, and/or site IRBs/ECs. 
 
9. ADMINISTRATION 
9.1 Compliance 
 
9.1.1. Training, Quality Assurance (QA) and Supervision  
The investigative team has experience in staffing, training, and supervising clinical research 
studies, including behavioral intervention trials. Our proposed QA protocol is based upon 
experience in other studies at University of California, San Francisco, University of California- 
San Francisco, and in sub-Saharan Africa. The QA protocols will be led by the PI and Dr. 
Conroy, given their additional experience with clinical trials.  
 

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9.1.2. Assessment training 
Assessment interviewers will be selected based on a minimum of one-year experience with HIV-
research quantitative standardized interviews. We have developed a detailed training manual for 
the training and ongoing supervision of assessment staff which will provide specific information 
on study policies and procedures. Initial training, led by the Dr. van Heerden and Dr. Conroy, 
will occur in an intensive workshop in which the following are covered: 1) general interviewing 
skills; 2) specific training relevant to this study, particularly with regard to conducting research 
with couples; 3) extensive training in research ethics; and 4) observed practice and certification 
as interviewers. The training will include specific modules regarding domestic violence, 
especially as pertains to any report of partner violence by a participant, and the proper response 
to a disclosure.  
 
9.1.3. Assessment Quality Assurance  
Given the structured format of the assessments there is less concern with interviewers veering 
from the protocol than in other interviewing situations. However, we recognize the importance of 
internal validity of assessment procedures and have developed the following procedures: (1) A 
supervisor (Project Director or Lead Interviewer) will sit in on random interviews to ensure 
standardization of administration; (2) a standardized evaluation form will be used, based on the 
specifics of the assessment; and (3) the PD will oversee the QA of assessments and provides 
feedback and supervision as appropriate.  
 
9.1.4 Data Entry and Management  
The mobile application displays questions on the screen and then gives interviewers the ability to 
enter responses directly into the mobile phone or tablet. Once complete, the research instrument 
(i.e. survey, baseline interview) is temporarily stored in a non-readable encrypted file on the 
device/tablet. When in an area with network coverage, completed forms are uploaded and 
removed from the handset approximately every 60 seconds. If no network signal is present, the 
data is stored on the phone until such time that phone detects a network signal. Checks will be 
placed to ensure correct information has been entered. Information from the research instruments 
will be uploaded to a secured server. The UCSF Research Manager will monitor incoming data 
on a daily basis and generate data queries for unusual or unexpected entries and communicate 
with the HSRC team to resolve queries.  
 
9.2 Study monitoring 
9.2.1. Data monitoring procedures.  
Recruitment goals will be carefully monitored by the Project Director, and the PI. We will also 
monitor the presence of any missing data and loss to follow-up. Co-I, Neilands, will serve as the 
study’s biostatistician and will provide ongoing monitoring of the study progress. We will also 
provide this information to the DSMB on a consistent basis.  
 
9.2.2. Data-related risk reporting and action plan.  
We will closely track incoming numbers of participants via ongoing recruitment activities, and 
weekly and monthly reports will be compiled by the study staff. We will utilize similar 
procedures to monitor any missing data or missed follow-up assessments. Recruitment and 
missing data reports will be monitored weekly by the Project Director, statistician, Co-Is, and PI. 
All data will be protected on firewall-protected servers at University of California San Francisco 
and HSRC. Any identification of recruitment rates or follow-up rates that represent threats to our 

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ability to sufficiently answer the research questions will be met with action by the PI to intervene 
to remedy the shortcomings. Should a situation arise of insufficient power or early detection of 
research questions the investigators will discuss halting the study, when and if needed, and 
would report such action to the IRBs at the University of California, San Francisco and HSRC, 
the DSMB, and project officer. Completion rates of intervention activities will be monitored in 
parallel fashion. 
 
9.2.3. Safety monitoring procedures.  
All safety-related risks will be monitored routinely at the time of assessment or intervention 
sessions. Procedures are in place to protect the confidentiality of information from one’s partner 
and to monitor any confidential information. Interviewers and intervention staff will be trained to 
increase their sensitivity and present a caring and non-threatening manner regarding topics such 
as sexuality, HIV, and relationship issues. At any sign of discomfort or distress, or by request, 
interviews will be stopped. Confidentiality will be assured to participants at the time of consent, 
and will be assured their answers or responses cannot be used against them for any reason, or for 
denial of any medical treatment. Detailed protocols will be in place regarding the possibility of 
tension, conflict or violence between partners. Protocols will be in place to monitor and respond 
to any instances reported by the participants of any type of negative relationship event, and 
proper action will be taken, including staff intervention and/or provision of referral for services 
depending on the level of the event (e.g., relationship conflict, an episode of domestic violence, 
etc.) 
 
9.3 Study Records 
 
Consent forms will be stored separately from questionnaire data and data collection forms, and 
will not be linkable to study data (surveys and follow-up visits). Special permission will be 
obtained for audio files to be digitally recorded of the couples’ counselling sessions, but this 
material will only be used for quality control procedures. All individuals will be given a 
confidential study identification number and all data will be labelled only with this identification 
number. There will only be one master list linking participants’ names and study identification 
numbers. We will keep this list separate from all other materials in a locked file in a locked 
office at the HSRC study site. We will keep a back-up file of this list on a password protected 
computer file, and select HSRC study staff (site PI, Project Director, and Interviewers) will have 
access. Access will be necessary by HSRC staff for tracking purposes.  Digital audio files from 
the couples’ counselling sessions (again for QA purposes only) will be kept in a password 
protected, encrypted computer file.  
 
All data – electronic and paper – will be kept for a period of up to 5 years. The data will be 
stored through REDCap and Dropbox, and destroyed after 5 years.  
 
9.4 Use of information and publications.  
 
We plan to focus our dissemination efforts in the following contexts: 
 
1. 
Scientific community: We plan to communicate our results to other researchers through 
published papers in peer-reviewed journals and through scientific presentations given at national 
and/or international conferences. 

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2. 
HIV care providers (clinicians, nurses, counselors, and other providers): It is possible 
that our intervention may be of interest to HIV care providers who work with couples and/or 
HIV-positive individuals as a potential strategy to reduce alcohol consumption and improve 
treatment engagement and clinical outcomes. We will aim to disseminate salient findings to HIV 
care providers as they become available. Our prior research made use of monthly HIV grand 
rounds in the hospitals as a forum for dissemination and encouraging feedback on the findings, 
and we will explore other forums such as regular staff meetings with providers, and national 
conferences in South Africa which are widely attended by HIV care providers.   
 
3. 
Community members: We will aim to communicate the findings to the study participants 
and communities represented by the study participants. The findings could be disseminated 
during the daily health information talks given in the waiting rooms at the HIV clinics or at other 
large meetings for people living with HIV such as support groups. We will also communicate the 
findings to key stakeholders in the communities (e.g., religious leaders, tribal leaders, etc.). We 
have successfully completed this type of outreach in our prior studies in this setting (e.g., 
community forums). The information disseminated will be available in English and in the local 
language of isiZulu, in either written or verbal form. To facilitate access to our work, we will 
make study materials available online and in print format. Any published results will not identify 
any participants. 

 
35 
 
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36 
 
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