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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| Maple Leaf Research | OTHER |
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The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment.
Although HIV pre-exposure prophylaxis (PrEP) is an effective tool that can help prevent the acquisition of HIV, its degree of effectiveness has been shown to be linked to a number of key behaviors, including treatment adherence, attendance in follow-up care, and the concurrent use of condoms. Hazardous alcohol consumption has the potential to contribute to suboptimal PrEP adherence, poor retention in PrEP care, and condomless sex/sexually transmitted infections (STIs); and its impact on these PrEP-related behaviors may also become exacerbated in the presence of concurrent issues such as substance use and depression, thus reflecting a potential syndemic effect. The present investigation entails a pilot randomized controlled trial in which 120 hazardous drinking, PrEP-prescribed men who have sex with men (MSM) will be randomly assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual. Participants assigned to the former condition for whom substance use- and/or depression-related concerns are identified will additionally be provided with links to relevant supportive resources. Feasibility and acceptability of the intervention will be examined. Furthermore, biomarker testing and self-report electronic surveys at baseline, 3-months, and 6-months will be employed to assess the preliminary impact of the intervention on alcohol use, PrEP adherence, retention in PrEP care, and the engagement in condomless sex/STI acquisition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol-focused brief intervention | Experimental | Intervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption. |
|
| Treatment as usual | No Intervention | Treatment as usual (TAU) participants will not receive the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol-focused brief intervention | Behavioral | The primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility: Intervention Uptake | Intervention uptake will be employed as an indicator of intervention feasibility. Intervention uptake will entail the proportion of eligible, hazardous drinking, PrEP-prescribed MSM who express a willingness to take part in the intervention trial. | At study baseline |
| Intervention Feasibility: Intervention Completion | Intervention completion will be employed as an indicator of intervention feasibility. This outcome will entail the proportion of participants assigned to the intervention condition who complete the intervention module. | At study baseline |
| Intervention Acceptability | Intervention acceptability will be assessed using a 13-item self-report measure that is comprised of two published scales (references shown below) and three items created by the investigators. Bauermeister JA, Pingel ES, Jadwin-Cakmak L, et al. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav 2015 Oct;19(10):1860-74. NDA-NIH. NIMH Data Archive (NDA). 2020. Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention Measure. https://nda.nih.gov/data\_structure.html?short\_name=aimiamfim01 | At 6-months post-baseline |
| Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | Self-report-based Alcohol Use Disorders Identification Test (AUDIT) scores will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, World Health Organization. Dept. of Mental Health and Substance Dependence. The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care. 2nd ed. Geneva: World Health Organization; 2001. A cut-off based on AUDIT-C (i.e., AUDIT-consumption) criteria categorizes the presence (i.e., AUDIT-C scores ≥4) or absence (i.e., AUDIT-C scores <4) of hazardous drinking. Minimum and maximum scores of the AUDIT-C are 0 and 12, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence: 7-day ACTG-based Measure | Self-reported adherence to PrEP will be assessed using a 7-day, PrEP-focused, ACTG-based adherence measure (the reference for the original, antiretroviral therapy (ART)-focused ACTG measure is shown below). 7-day adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Chesney MA. Ickovics JR. Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: Tthe AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committe of the Adult AIDS Clinical Trials Group (AACTG) AIDS Care. 2000;12:255-266. |
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Inclusion Criteria: Participants must be:
Exclusion Criteria:
The study only includes men who have sex with men. This criterion is based on the fact that in Canada and the United States, men who have sex with men (MSM) remain the risk group most affected by HIV, comprising roughly two-thirds of all new infections.
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| Name | Affiliation | Role |
|---|---|---|
| Paul A. Shuper, PhD | Senior Scientist and Section Head | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maple Leaf Medical Clinic | Toronto | Ontario | M5G 1K2 | Canada | ||
| Toronto General Hospital |
Due to the sensitive nature of the data, there is no plan to make IPD available to other researchers. Data will only be accessible to designated research personnel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol-focused Brief Intervention | Intervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption. Alcohol-focused brief intervention: The primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns. |
| FG001 | Treatment as Usual | Treatment as usual (TAU) participants will not receive the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol-focused Brief Intervention | Intervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption. Alcohol-focused brief intervention: The primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Feasibility: Intervention Uptake | Intervention uptake will be employed as an indicator of intervention feasibility. Intervention uptake will entail the proportion of eligible, hazardous drinking, PrEP-prescribed MSM who express a willingness to take part in the intervention trial. | 128 were eligible; 122 took part in the study. | Posted | Count of Participants | Participants | At study baseline |
|
Data for each participant was collected over 6 month study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcohol-focused Brief Intervention | Intervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption. Alcohol-focused brief intervention: The primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns. |
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This was a pilot trial and was therefore not statistically powered to test the effect of the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Shuper | Centre for Addiction and Mental Health (CAMH) | 416-535-8501 | 34097 | paul.shuper@camh.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2020 | Jan 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Participants will be randomly assigned to either the intervention condition or treatment as usual (TAU) based on a 2:1 intervention:TAU ratio.
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This is not a double-blind study. Participants in the intervention arm will be aware that they are receiving the intervention but the investigators will not know as the randomization will take place within the software program.
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| Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| Alcohol Consumption: Drinks Consumed in a Typical Week | A single self-report question will ask "How many drinks containing alcohol do you have on a typical week when you are drinking?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | A single self-report question will ask "What is the greatest number of drinks you've had on one day in the last 3 months?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| Alcohol Consumption: Phosphatidylethanol (PEth) | PEth levels will be measured from dried blood spot (DBS) samples using liquid chromatography-tandem mass spectrometry to identify hazardous drinking. PEth will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| PrEP Adherence: Past Month Visual Analog Scale (VAS) | A self-report-based, PrEP-focused visual analog scale (VAS) will be used to assess PrEP adherence over the past month (the reference for the original, antiretroviral therapy (ART)-focused VAS is shown below). Past month adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Amico KR. Fisher WA. Cornman DH, et al. Visual analog scale of ART adherence: Association with 3-day self-report and adherence barriers. J Acquir Immune Defic Syndr. 2006;42:455-459. | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | Dried blood spots will be assessed for Tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate concentrations using validated liquid chromatography tandem mass spectrometry. Concentrations will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| Retention in PrEP Care: PrEP Appointment Attendance | Missed PrEP appointments across the six-month follow-up period will be identified through clinic chart extraction. | Six-month follow-up period |
| Condomless Sex | The engagement in condomless anal sex will be assessed using a self-report measure based on an MSM-focused sexual behavior assessment that has been employed in previous trials (see reference below). Condomless sex will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. The Explore Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet 2004;364:41-50. | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
| Sexually Transmitted Infection (STI) Incidence | Incident sexually transmitted infections (STIs) during the 6-month follow-up period will be identified through clinic chart extraction. | Six-month follow-up period |
| Toronto |
| Ontario |
| M5G 2C4 |
| Canada |
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
| BG001 | Treatment as Usual | Treatment as usual (TAU) participants will not receive the intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| AUDIT-C hazardous drinking | Count of Participants | Participants |
|
|
|
| Primary | Intervention Feasibility: Intervention Completion | Intervention completion will be employed as an indicator of intervention feasibility. This outcome will entail the proportion of participants assigned to the intervention condition who complete the intervention module. | All 81 participants assigned to the intervention condition completed the intervention module. | Posted | Count of Participants | Participants | At study baseline |
|
|
|
| Primary | Intervention Acceptability | Intervention acceptability will be assessed using a 13-item self-report measure that is comprised of two published scales (references shown below) and three items created by the investigators. Bauermeister JA, Pingel ES, Jadwin-Cakmak L, et al. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav 2015 Oct;19(10):1860-74. NDA-NIH. NIMH Data Archive (NDA). 2020. Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention Measure. https://nda.nih.gov/data\_structure.html?short\_name=aimiamfim01 | Scales on Items 1-6: 1=Strongly Disagree, 2=Disagree, 3=Somewhat Disagree, 4=Neither Agree or Disagree, 5=Somewhat Agree, 6=Agree, 7=Completely Agree. Scales on Items 7-10: 1=Completely Disagree, 2=Disagree, 3=Neither Agree or Disagree, 4=Agree, 5=Completely Agree. Scales on Items 11-13: 1=Completely Disagree, 2=Disagree, 3=Neither Agree or Disagree, 4=Agree, 5=Completely Agree. | Posted | Mean | Standard Deviation | units on a scale | At 6-months post-baseline |
|
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|
| Primary | Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | Self-report-based Alcohol Use Disorders Identification Test (AUDIT) scores will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, World Health Organization. Dept. of Mental Health and Substance Dependence. The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care. 2nd ed. Geneva: World Health Organization; 2001. A cut-off based on AUDIT-C (i.e., AUDIT-consumption) criteria categorizes the presence (i.e., AUDIT-C scores ≥4) or absence (i.e., AUDIT-C scores <4) of hazardous drinking. Minimum and maximum scores of the AUDIT-C are 0 and 12, respectively. | Overall changes in alcohol consumption were evaluated using AUDIT-C hazardous drinking criteria (i.e., AUDIT-C score ≥ 4). Missing values were imputed by controlled multiple imputations. | Posted | Count of Participants | Participants | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
|
|
|
| Primary | Alcohol Consumption: Drinks Consumed in a Typical Week | A single self-report question will ask "How many drinks containing alcohol do you have on a typical week when you are drinking?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | Missing values were imputed by controlled multiple imputations. | Posted | Mean | Standard Deviation | Drinks/week | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
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|
|
| Primary | Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | A single self-report question will ask "What is the greatest number of drinks you've had on one day in the last 3 months?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | Missing values were imputed by controlled multiple imputations. | Posted | Mean | Standard Deviation | Maximum drinks | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
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|
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| Primary | Alcohol Consumption: Phosphatidylethanol (PEth) | PEth levels will be measured from dried blood spot (DBS) samples using liquid chromatography-tandem mass spectrometry to identify hazardous drinking. PEth will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | PEth levels were dichotomized in accordance with hazardous drinking cut-offs (i.e., PEth ≥ 35 ng/ml). Missing values were imputed by controlled multiple imputations. | Posted | Count of Participants | Participants | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
|
|
|
| Secondary | PrEP Adherence: 7-day ACTG-based Measure | Self-reported adherence to PrEP will be assessed using a 7-day, PrEP-focused, ACTG-based adherence measure (the reference for the original, antiretroviral therapy (ART)-focused ACTG measure is shown below). 7-day adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Chesney MA. Ickovics JR. Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: Tthe AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committe of the Adult AIDS Clinical Trials Group (AACTG) AIDS Care. 2000;12:255-266. | Missing any PrEP dose during the past 7 days was classified as being non-adherent. Missing values were imputed by controlled multiple imputations. | Posted | Count of Participants | Participants | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
|
|
|
| Secondary | PrEP Adherence: Past Month Visual Analog Scale (VAS) | A self-report-based, PrEP-focused visual analog scale (VAS) will be used to assess PrEP adherence over the past month (the reference for the original, antiretroviral therapy (ART)-focused VAS is shown below). Past month adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Amico KR. Fisher WA. Cornman DH, et al. Visual analog scale of ART adherence: Association with 3-day self-report and adherence barriers. J Acquir Immune Defic Syndr. 2006;42:455-459. | Participants who indicated <60% PrEP adherence during the past month were classified as sub-optimally adherent. Missing values were imputed by controlled multiple imputations. | Posted | Count of Participants | Participants | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
|
|
|
| Secondary | PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | Dried blood spots will be assessed for Tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate concentrations using validated liquid chromatography tandem mass spectrometry. Concentrations will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. | Tenofovir values were dichotomized to identify any nonadherence (< 1250 fmol/punch). Missing values were imputed by controlled multiple imputations. | Posted | Count of Participants | Participants | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
|
|
|
| Secondary | Retention in PrEP Care: PrEP Appointment Attendance | Missed PrEP appointments across the six-month follow-up period will be identified through clinic chart extraction. | Posted | Count of Participants | Participants | Six-month follow-up period |
|
|
|
| Secondary | Condomless Sex | The engagement in condomless anal sex will be assessed using a self-report measure based on an MSM-focused sexual behavior assessment that has been employed in previous trials (see reference below). Condomless sex will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. The Explore Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet 2004;364:41-50. | Missing values were imputed by controlled multiple imputations. | Posted | Count of Participants | Participants | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) |
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| Secondary | Sexually Transmitted Infection (STI) Incidence | Incident sexually transmitted infections (STIs) during the 6-month follow-up period will be identified through clinic chart extraction. | Having any STI in the last 3 months was identified through clinic chart extraction. | Posted | Count of Participants | Participants | Six-month follow-up period |
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| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Treatment as Usual | Treatment as usual (TAU) participants will not receive the intervention. | 0 | 41 | 0 | 41 | 0 | 41 |
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| 4. The Personalized Drinking Feedback Report was easy to use. |
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| 5. The Personalized Drinking Feedback Report provided me accurate information. |
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| 6. How likely to continue using the Personalized Drinking Feedback Report if it were available? |
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| 7. The Personalized Drinking Feedback Report was appealing to me. |
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| 8. I liked the Personalized Drinking Feedback Report. |
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| 9. I welcomed the Personalized Drinking Feedback Report. |
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| 10. The Personalized Drinking Feedback Report met my approval. |
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| 11. I benefited from the information provided by the Personalized Drinking Feedback Report. |
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| 12. I found the information provided by the Personalized Drinking Feedback Report to be useful. |
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| 13. I reduced my drinking as a result of going through the Personalized Drinking Feedback Report. |
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| 6-months |
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| 6-months |
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| 6-months |
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| 6-months |
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| 6-months |
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| 6-months |
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| 6-months |
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| 6-months |
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| 6-months |
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| 6-months |
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