Trial Outcomes & Findings for PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP) (NCT NCT05097430)
NCT ID: NCT05097430
Last Updated: 2025-02-10
Results Overview
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.
COMPLETED
NA
122 participants
At study baseline
2025-02-10
Participant Flow
Participant milestones
| Measure |
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.
|
Treatment as Usual
Treatment as usual (TAU) participants will not receive the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
41
|
|
Overall Study
COMPLETED
|
80
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)
Baseline characteristics by cohort
| Measure |
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
81 participants
n=5 Participants
|
41 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
AUDIT-C hazardous drinking
|
81 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At study baselinePopulation: 128 were eligible; 122 took part in the study.
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.
Outcome measures
| Measure |
Treatment as Usual
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=128 Participants
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.
|
|---|---|---|
|
Intervention Feasibility: Intervention Uptake
|
—
|
122 Participants
|
PRIMARY outcome
Timeframe: At study baselinePopulation: All 81 participants assigned to the intervention condition completed the intervention module.
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.
Outcome measures
| Measure |
Treatment as Usual
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Intervention Feasibility: Intervention Completion
|
—
|
81 Participants
|
PRIMARY outcome
Timeframe: At 6-months post-baselinePopulation: 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.
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
Outcome measures
| Measure |
Treatment as Usual
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=78 Participants
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.
|
|---|---|---|
|
Intervention Acceptability
2. Using the personalized Drinking Feedback Report was very frustrating.
|
—
|
2.58 units on a scale
Standard Deviation 1.50
|
|
Intervention Acceptability
1. Overall, I was very satisfied with the Personalized Drinking Feedback Report.
|
—
|
5.72 units on a scale
Standard Deviation 1.02
|
|
Intervention Acceptability
3. I would recommend the Personalized Drinking Feedback Report to my friends.
|
—
|
5.27 units on a scale
Standard Deviation 1.22
|
|
Intervention Acceptability
4. The Personalized Drinking Feedback Report was easy to use.
|
—
|
5.76 units on a scale
Standard Deviation 0.98
|
|
Intervention Acceptability
5. The Personalized Drinking Feedback Report provided me accurate information.
|
—
|
5.60 units on a scale
Standard Deviation 0.92
|
|
Intervention Acceptability
6. How likely to continue using the Personalized Drinking Feedback Report if it were available?
|
—
|
4.78 units on a scale
Standard Deviation 1.54
|
|
Intervention Acceptability
7. The Personalized Drinking Feedback Report was appealing to me.
|
—
|
3.47 units on a scale
Standard Deviation 0.89
|
|
Intervention Acceptability
8. I liked the Personalized Drinking Feedback Report.
|
—
|
3.69 units on a scale
Standard Deviation 0.74
|
|
Intervention Acceptability
9. I welcomed the Personalized Drinking Feedback Report.
|
—
|
3.74 units on a scale
Standard Deviation 0.81
|
|
Intervention Acceptability
10. The Personalized Drinking Feedback Report met my approval.
|
—
|
3.85 units on a scale
Standard Deviation 0.63
|
|
Intervention Acceptability
11. I benefited from the information provided by the Personalized Drinking Feedback Report.
|
—
|
3.54 units on a scale
Standard Deviation 0.72
|
|
Intervention Acceptability
12. I found the information provided by the Personalized Drinking Feedback Report to be useful.
|
—
|
3.65 units on a scale
Standard Deviation 0.75
|
|
Intervention Acceptability
13. I reduced my drinking as a result of going through the Personalized Drinking Feedback Report.
|
—
|
2.65 units on a scale
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)
Baseline
|
41 Participants
|
81 Participants
|
|
Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)
3-months
|
38 Participants
|
63 Participants
|
|
Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)
6-months
|
35 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: Missing values were imputed by controlled multiple imputations.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Alcohol Consumption: Drinks Consumed in a Typical Week
Baseline
|
9.7 Drinks/week
Standard Deviation 9.0
|
8.3 Drinks/week
Standard Deviation 6.2
|
|
Alcohol Consumption: Drinks Consumed in a Typical Week
3-months
|
9.1 Drinks/week
Standard Deviation 8.0
|
8.9 Drinks/week
Standard Deviation 7.4
|
|
Alcohol Consumption: Drinks Consumed in a Typical Week
6-months
|
9.2 Drinks/week
Standard Deviation 7.9
|
9.3 Drinks/week
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: Missing values were imputed by controlled multiple imputations.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months
3-months
|
7.3 Maximum drinks
Standard Deviation 3.4
|
7.8 Maximum drinks
Standard Deviation 4.7
|
|
Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months
Baseline
|
8.2 Maximum drinks
Standard Deviation 3.7
|
7.9 Maximum drinks
Standard Deviation 4.0
|
|
Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months
6-months
|
7.7 Maximum drinks
Standard Deviation 3.2
|
7.4 Maximum drinks
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Alcohol Consumption: Phosphatidylethanol (PEth)
Baseline
|
23 Participants
|
41 Participants
|
|
Alcohol Consumption: Phosphatidylethanol (PEth)
3-months
|
18 Participants
|
37 Participants
|
|
Alcohol Consumption: Phosphatidylethanol (PEth)
6-months
|
27 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: Missing any PrEP dose during the past 7 days was classified as being non-adherent. Missing values were imputed by controlled multiple imputations.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
PrEP Adherence: 7-day ACTG-based Measure
Baseline
|
12 Participants
|
23 Participants
|
|
PrEP Adherence: 7-day ACTG-based Measure
3-months
|
18 Participants
|
15 Participants
|
|
PrEP Adherence: 7-day ACTG-based Measure
6-months
|
15 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: Participants who indicated \<60% PrEP adherence during the past month were classified as sub-optimally adherent. Missing values were imputed by controlled multiple imputations.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
PrEP Adherence: Past Month Visual Analog Scale (VAS)
6-months
|
3 Participants
|
6 Participants
|
|
PrEP Adherence: Past Month Visual Analog Scale (VAS)
Baseline
|
1 Participants
|
6 Participants
|
|
PrEP Adherence: Past Month Visual Analog Scale (VAS)
3-months
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: Tenofovir values were dichotomized to identify any nonadherence (\< 1250 fmol/punch). Missing values were imputed by controlled multiple imputations.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations
Baseline
|
15 Participants
|
21 Participants
|
|
PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations
3-months
|
14 Participants
|
19 Participants
|
|
PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations
6-months
|
18 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Six-month follow-up periodMissed PrEP appointments across the six-month follow-up period will be identified through clinic chart extraction.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Retention in PrEP Care: PrEP Appointment Attendance
Baseline
|
3 Participants
|
6 Participants
|
|
Retention in PrEP Care: PrEP Appointment Attendance
3-months
|
1 Participants
|
1 Participants
|
|
Retention in PrEP Care: PrEP Appointment Attendance
6-months
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)Population: Missing values were imputed by controlled multiple imputations.
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.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Condomless Sex
Baseline
|
38 Participants
|
78 Participants
|
|
Condomless Sex
3-months
|
37 Participants
|
70 Participants
|
|
Condomless Sex
6-months
|
33 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Six-month follow-up periodPopulation: Having any STI in the last 3 months was identified through clinic chart extraction.
Incident sexually transmitted infections (STIs) during the 6-month follow-up period will be identified through clinic chart extraction.
Outcome measures
| Measure |
Treatment as Usual
n=41 Participants
Treatment as usual (TAU) participants will not receive the intervention.
|
Alcohol-focused Brief Intervention
n=81 Participants
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.
|
|---|---|---|
|
Sexually Transmitted Infection (STI) Incidence
Baseline
|
5 Participants
|
23 Participants
|
|
Sexually Transmitted Infection (STI) Incidence
3-months
|
3 Participants
|
12 Participants
|
|
Sexually Transmitted Infection (STI) Incidence
6-months
|
6 Participants
|
15 Participants
|
Adverse Events
Alcohol-focused Brief Intervention
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paul Shuper
Centre for Addiction and Mental Health (CAMH)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place