Hazardous Alcohol Use
Conditions
Keywords
PrEP, Alcohol, Substance use, Depression
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAlcohol-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.
Sponsors
University Health Network, Toronto
Maple Leaf Research
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
Participants will be randomly assigned to either the intervention condition or treatment as usual (TAU) based on a 2:1 intervention:TAU ratio.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must be: * aged 18 years or older, * be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC), * be a man who identifies as gay, bisexual, and/or a man who has sex with other men, * have been prescribed PrEP for at least 3 months, and * meet the criteria for hazardous drinking, (i.e., based on a score of ≥4 on the Alcohol Use Disorders Identification Test-Consumption measures (AUDIT-C)).
Exclusion criteria
* Participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption: Phosphatidylethanol (PEth) | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
| Intervention Feasibility: Intervention Uptake | At study baseline | 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. |
| Intervention Feasibility: Intervention Completion | At study baseline | 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. |
| Intervention Acceptability | At 6-months post-baseline | 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 |
| Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
| Alcohol Consumption: Drinks Consumed in a Typical Week | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
| Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence: Past Month Visual Analog Scale (VAS) | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
| PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
| Retention in PrEP Care: PrEP Appointment Attendance | Six-month follow-up period | Missed PrEP appointments across the six-month follow-up period will be identified through clinic chart extraction. |
| Condomless Sex | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
| Sexually Transmitted Infection (STI) Incidence | Six-month follow-up period | Incident sexually transmitted infections (STIs) during the 6-month follow-up period will be identified through clinic chart extraction. |
| PrEP Adherence: 7-day ACTG-based Measure | Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| Treatment as Usual Treatment as usual (TAU) participants will not receive the intervention. | 41 |
| Total | 122 |
Baseline characteristics
| Characteristic | Alcohol-focused Brief Intervention | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 8.7 | 33.3 years STANDARD_DEVIATION 9.3 | 33.6 years STANDARD_DEVIATION 8.9 |
| AUDIT-C hazardous drinking | 81 Participants | 41 Participants | 122 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 6 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 30 Participants | 81 Participants |
| Region of Enrollment Canada | 81 participants | 41 participants | 122 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 81 Participants | 41 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 41 |
| other Total, other adverse events | 0 / 81 | 0 / 41 |
| serious Total, serious adverse events | 0 / 81 | 0 / 41 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | Baseline | 81 Participants |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | 3-months | 63 Participants |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | 6-months | 68 Participants |
| Treatment as Usual | Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | Baseline | 41 Participants |
| Treatment as Usual | Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | 3-months | 38 Participants |
| Treatment as Usual | Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) | 6-months | 35 Participants |
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.
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Population: Missing values were imputed by controlled multiple imputations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alcohol-focused Brief Intervention | Alcohol Consumption: Drinks Consumed in a Typical Week | Baseline | 8.3 Drinks/week | Standard Deviation 6.2 |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Drinks Consumed in a Typical Week | 3-months | 8.9 Drinks/week | Standard Deviation 7.4 |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Drinks Consumed in a Typical Week | 6-months | 9.3 Drinks/week | Standard Deviation 8.5 |
| Treatment as Usual | Alcohol Consumption: Drinks Consumed in a Typical Week | Baseline | 9.7 Drinks/week | Standard Deviation 9 |
| Treatment as Usual | Alcohol Consumption: Drinks Consumed in a Typical Week | 3-months | 9.1 Drinks/week | Standard Deviation 8 |
| Treatment as Usual | Alcohol Consumption: Drinks Consumed in a Typical Week | 6-months | 9.2 Drinks/week | Standard Deviation 7.9 |
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.
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Population: Missing values were imputed by controlled multiple imputations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alcohol-focused Brief Intervention | Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | Baseline | 7.9 Maximum drinks | Standard Deviation 4 |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | 3-months | 7.8 Maximum drinks | Standard Deviation 4.7 |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | 6-months | 7.4 Maximum drinks | Standard Deviation 3.9 |
| Treatment as Usual | Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | Baseline | 8.2 Maximum drinks | Standard Deviation 3.7 |
| Treatment as Usual | Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | 3-months | 7.3 Maximum drinks | Standard Deviation 3.4 |
| Treatment as Usual | Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months | 6-months | 7.7 Maximum drinks | Standard Deviation 3.2 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | Alcohol Consumption: Phosphatidylethanol (PEth) | 3-months | 37 Participants |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Phosphatidylethanol (PEth) | Baseline | 41 Participants |
| Alcohol-focused Brief Intervention | Alcohol Consumption: Phosphatidylethanol (PEth) | 6-months | 50 Participants |
| Treatment as Usual | Alcohol Consumption: Phosphatidylethanol (PEth) | 6-months | 27 Participants |
| Treatment as Usual | Alcohol Consumption: Phosphatidylethanol (PEth) | Baseline | 23 Participants |
| Treatment as Usual | Alcohol Consumption: Phosphatidylethanol (PEth) | 3-months | 18 Participants |
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
Time frame: At 6-months post-baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alcohol-focused Brief Intervention | Intervention Acceptability | 1. Overall, I was very satisfied with the Personalized Drinking Feedback Report. | 5.72 units on a scale | Standard Deviation 1.02 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 2. Using the personalized Drinking Feedback Report was very frustrating. | 2.58 units on a scale | Standard Deviation 1.5 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 3. I would recommend the Personalized Drinking Feedback Report to my friends. | 5.27 units on a scale | Standard Deviation 1.22 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 4. The Personalized Drinking Feedback Report was easy to use. | 5.76 units on a scale | Standard Deviation 0.98 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 5. The Personalized Drinking Feedback Report provided me accurate information. | 5.60 units on a scale | Standard Deviation 0.92 |
| Alcohol-focused Brief Intervention | 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 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 7. The Personalized Drinking Feedback Report was appealing to me. | 3.47 units on a scale | Standard Deviation 0.89 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 8. I liked the Personalized Drinking Feedback Report. | 3.69 units on a scale | Standard Deviation 0.74 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 9. I welcomed the Personalized Drinking Feedback Report. | 3.74 units on a scale | Standard Deviation 0.81 |
| Alcohol-focused Brief Intervention | Intervention Acceptability | 10. The Personalized Drinking Feedback Report met my approval. | 3.85 units on a scale | Standard Deviation 0.63 |
| Alcohol-focused Brief Intervention | 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 |
| Alcohol-focused Brief Intervention | 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 |
| Alcohol-focused Brief Intervention | 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
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.
Time frame: At study baseline
Population: All 81 participants assigned to the intervention condition completed the intervention module.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol-focused Brief Intervention | Intervention Feasibility: Intervention Completion | 81 Participants |
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.
Time frame: At study baseline
Population: 128 were eligible; 122 took part in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alcohol-focused Brief Intervention | Intervention Feasibility: Intervention Uptake | 122 Participants |
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.
Time frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Population: Missing values were imputed by controlled multiple imputations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | Condomless Sex | Baseline | 78 Participants |
| Alcohol-focused Brief Intervention | Condomless Sex | 3-months | 70 Participants |
| Alcohol-focused Brief Intervention | Condomless Sex | 6-months | 71 Participants |
| Treatment as Usual | Condomless Sex | Baseline | 38 Participants |
| Treatment as Usual | Condomless Sex | 3-months | 37 Participants |
| Treatment as Usual | Condomless Sex | 6-months | 33 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | PrEP Adherence: 7-day ACTG-based Measure | Baseline | 23 Participants |
| Alcohol-focused Brief Intervention | PrEP Adherence: 7-day ACTG-based Measure | 3-months | 15 Participants |
| Alcohol-focused Brief Intervention | PrEP Adherence: 7-day ACTG-based Measure | 6-months | 27 Participants |
| Treatment as Usual | PrEP Adherence: 7-day ACTG-based Measure | Baseline | 12 Participants |
| Treatment as Usual | PrEP Adherence: 7-day ACTG-based Measure | 3-months | 18 Participants |
| Treatment as Usual | PrEP Adherence: 7-day ACTG-based Measure | 6-months | 15 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | PrEP Adherence: Past Month Visual Analog Scale (VAS) | Baseline | 6 Participants |
| Alcohol-focused Brief Intervention | PrEP Adherence: Past Month Visual Analog Scale (VAS) | 3-months | 2 Participants |
| Alcohol-focused Brief Intervention | PrEP Adherence: Past Month Visual Analog Scale (VAS) | 6-months | 6 Participants |
| Treatment as Usual | PrEP Adherence: Past Month Visual Analog Scale (VAS) | Baseline | 1 Participants |
| Treatment as Usual | PrEP Adherence: Past Month Visual Analog Scale (VAS) | 3-months | 6 Participants |
| Treatment as Usual | PrEP Adherence: Past Month Visual Analog Scale (VAS) | 6-months | 3 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | Baseline | 21 Participants |
| Alcohol-focused Brief Intervention | PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | 3-months | 19 Participants |
| Alcohol-focused Brief Intervention | PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | 6-months | 25 Participants |
| Treatment as Usual | PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | Baseline | 15 Participants |
| Treatment as Usual | PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | 3-months | 14 Participants |
| Treatment as Usual | PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations | 6-months | 18 Participants |
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.
Time frame: Six-month follow-up period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | Retention in PrEP Care: PrEP Appointment Attendance | Baseline | 6 Participants |
| Alcohol-focused Brief Intervention | Retention in PrEP Care: PrEP Appointment Attendance | 3-months | 1 Participants |
| Alcohol-focused Brief Intervention | Retention in PrEP Care: PrEP Appointment Attendance | 6-months | 2 Participants |
| Treatment as Usual | Retention in PrEP Care: PrEP Appointment Attendance | Baseline | 3 Participants |
| Treatment as Usual | Retention in PrEP Care: PrEP Appointment Attendance | 3-months | 1 Participants |
| Treatment as Usual | Retention in PrEP Care: PrEP Appointment Attendance | 6-months | 2 Participants |
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.
Time frame: Six-month follow-up period
Population: Having any STI in the last 3 months was identified through clinic chart extraction.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alcohol-focused Brief Intervention | Sexually Transmitted Infection (STI) Incidence | Baseline | 23 Participants |
| Alcohol-focused Brief Intervention | Sexually Transmitted Infection (STI) Incidence | 3-months | 12 Participants |
| Alcohol-focused Brief Intervention | Sexually Transmitted Infection (STI) Incidence | 6-months | 15 Participants |
| Treatment as Usual | Sexually Transmitted Infection (STI) Incidence | Baseline | 5 Participants |
| Treatment as Usual | Sexually Transmitted Infection (STI) Incidence | 3-months | 3 Participants |
| Treatment as Usual | Sexually Transmitted Infection (STI) Incidence | 6-months | 6 Participants |