The Less is More Study

Study Overview
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Brief Summary
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In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.

Official Title
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Novel Extensions of Alcohol Contingency Management in People Living With HIV

Conditions
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Alcohol Use

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: mHealth
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Frequent alcohol use in the past 30 days based on responses on the Timeline Followback (TLFB; Sobell and Sobell, 2003) HIV positive Fluency in English Willingness to attempt alcohol abstinence for at least 30 days and then to attempt alcohol use on fewer days than at baseline after that Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study Exclusion Criteria: Psychiatric conditions that would interfere with participation in the study Current alcohol withdrawal as indicated by a score of 8 or higher on the Clinical Institute Withdrawal Scale (CIWA; Sullivan et al., 1989) or lifetime history of medically assisted detoxification Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment. After participants blow their first positive BrAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BrAC, they will be excluded from this study and offered referrals for alcohol treatment. Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors Psychosis or other severe psychiatric disability Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Contingent Condition<br>Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, encouragement to reduce drinking but payment not based on drinking. | Behavioral: Counseling<br>* Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.<br>|
| Experimental: mHealth and CM<br>Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings. Participants will also interact with a mobile health application to facilitate drinking reduction. | Behavioral: Counseling<br>* Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning<br>Behavioral: mHealth<br>* Participants will engage with an application designed to gamify drinking reduction.<br>|
| Experimental: CM<br>Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings | Behavioral: Counseling<br>* Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days abstinent via smartphone breathalyzer readings | Within-subject comparison between percent abstinent days based on smartphone breathalyzer readings during the 30-Day Phase 1 Contingency Management induction compared to the 30-day baseline period based on self-report on the timeline followback | Baseline to 30 Days | 
| Predict percent days abstinent via smartphone breathalyzer readings based on risk factors. | All participants will attempt to reduce alcohol consumption. Only those who are able to will continue to the second phase of the intervention. We will seek to identify which factors are predictive of abstinence. | Baseline to 30 Days | 
| Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption. | Participants will engage in a Contingency Management program aimed at reducing alcohol consumption. A novel CM delivery system will be used intended to gamify the process. | 30 Days to 60 Days | 
| Drinking reduction through Contingency Management will predict non-drinking outcomes | Participants who are able to successfully reduce their alcohol consumption may see other health benefits including reduced HIV viral load. | Baseline to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days abstinent via wrist biosensor readings | Among responders during the Phase 1 Contingency Management induction period, comparison among Phase 2 study conditions regarding percent abstinent days based on wrist biosensor readings. Percent days abstinent at baseline based on self-report and based on smartphone breathalyzer readings during Phase 1 will be included in this model. | Baseline to 60 Days |