Alcohol; Harmful Use, Human Immunodeficiency Virus Exposure
Conditions
Keywords
PrEP, Alcohol Use, HIV, STIs, LGBTQ
Brief summary
This small pilot randomized controlled trial will test whether a brief, web-based intervention inspired by the principles of motivational interviewing helps high-risk men who take pre-exposure prophylaxis (PrEP) moderate their alcohol use, and improve key outcomes of PrEP care, including adherence, persistence, and STI rates. Men with a history of lapses in PrEP adherence will be randomly assigned to either (1) use the web-based intervention, called Game Plan for PrEP, or (2) watch video clips encouraging healthy lifestyles (e.g., sleep hygiene, balanced diet; attention-matched control). Participants will complete STI testing and submit dried blood spot (DBS) samples to facilitate analyses of alcohol use and PrEP adherence biomarkers at baseline, 3-months, and 6-months during the study period. Participants will also complete online surveys at baseline, 1-month, 3-months, and 6-months during the study period.
Detailed description
This small, pilot randomized controlled trial will explore preliminary evidence for the efficacy of Game Plan for PrEP, a brief, web-based intervention inspired by brief motivational interventions. The study will test whether Game Plan for PrEP is efficacious in reducing heavy drinking and sexually-transmitted infection (STI) incidence, and improving PrEP adherence/persistence, among heavy drinking men who have sex with men who are on PrEP, but who report a recent history of missing 3 or more consecutive doses in the past month. In this study, we will randomize 50 gay and bisexual men to receive either (1) Game Plan for PrEP (GP4PrEP) or (2) an attention-matched control at the same PrEP care/monitoring visit that they reported meeting eligibility criteria. We will use self-report measures of alcohol use collected at 1-, 3-, and 6-months and changes in a biomarker of alcohol use collected at baseline, 3-, and 6-months to explore whether Game Plan for PrEP reduces binge drinking compared with control. We will also use data from a biomarker of PrEP adherence to explore whether Game Plan for PrEP improves PrEP adherence versus control.
Interventions
BEHAVIORALGame Plan for PrEP
See arm description.
BEHAVIORALAttention-Matched Control Lifestyle Habits Videos
Web-based videos providing information on sleep hygiene and proper diet.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators will be blinded to study condition. Staff collecting dried blood spot samples will also be blinded to condition. Participants will be encouraged to complete online surveys using an automated email system, so outcomes assessors will not be present.
Intervention model description
Participants will be randomly assigned 1:1 to one of two conditions: (1) Game Plan for PrEP and (2) an attention-matched control consisting of videos encouraging healthy lifestyle habits.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current male gender * 18+ years old * Fluent in English * Heavy alcohol use in the past month (\>5 drinks on a single occasion or \>14 drinks in a week) * Currently prescribed and actively taking PrEP * Report missing \> 3 PrEP doses in a row at least once in the past 3 months.
Exclusion criteria
* Reporting a history or risk of complicated alcohol withdrawal * Reporting currently receiving medications or counseling for an alcohol or drug use disorder * Injection drug use in the past year * Positive screen for drug-related disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) | Month 1, Month 3, and Month 6 | The total number of days on which participants reported drinking 5+ drinks in a single day over the past 30 days |
| Persistence With Pre-exposure Prophylaxis (PrEP) | Past 6 months | Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period |
| Number of Alcohol Drinking Days | Month 1, Month 3, and Month 6 | The total number of days in which participants reported drinking alcohol in the past 30 days |
| Average Number of Drinks Consumed Per Drinking Day | Month 1, Month 3, and Month 6 | The average number of standard alcoholic drinks consumed when participants reported drinking over the past 30 days |
| Pre-exposure Prophylaxis (PrEP) Lapse Days | 6 months | Number of participants who reported missing 4+ consecutive days of PrEP doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phosphatidylethanol Level | Month 3 and Month 6 | The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL |
| Tenofovir Diphosphate Adherence | Month 3 and Month 6 | The predicted probability of tenofovir diphosphate adherence (\>= 4 doses/week) detected in dried blood spot samples collected at 3- and 6-months |
| Any Sexually-transmitted Infection (STI) Diagnosis | 6 Months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants will be asked to use Game Plan for PrEP for however long they wish. Game Plan for PrEP is a web-based intervention that provides users with feedback about how much their risk for HIV is reduced on PrEP, their risk for bacterial STIs, and helps them make a plan to take their medication regularly and reduce their risk for STIs. Game Plan for PrEP also providers users with feedback about their alcohol use compared to others in their age group and encourages them to make a plan to reduce it. | 37 |
| Control Participants in this condition will view several videos that encourage them to adopt sleep hygiene and healthy diet behaviors. The videos were selected to last as long as the average time users engage with Game Plan for PrEP in its initial modules.
Attention-Matched Control Lifestyle Habits Videos: Web-based videos providing information on sleep hygiene and proper diet. | 36 |
| Total | 73 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 7.4 | 37.4 years STANDARD_DEVIATION 10 | 35.4 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 27 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 37 Participants | 36 Participants | 73 Participants |
| Years on PrEP | 2.7 years STANDARD_DEVIATION 2.2 | 2.5 years STANDARD_DEVIATION 2.2 | 2.6 years STANDARD_DEVIATION 2.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 36 |
| other Total, other adverse events | 0 / 37 | 0 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 36 |
Outcome results
Primary
Average Number of Drinks Consumed Per Drinking Day
The average number of standard alcoholic drinks consumed when participants reported drinking over the past 30 days
Time frame: Month 1, Month 3, and Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Average Number of Drinks Consumed Per Drinking Day | Month 1 | 3.89 standard drinks | Standard Error 0.36 |
| Intervention | Average Number of Drinks Consumed Per Drinking Day | Month 3 | 4.37 standard drinks | Standard Error 0.37 |
| Intervention | Average Number of Drinks Consumed Per Drinking Day | Month 6 | 3.94 standard drinks | Standard Error 0.37 |
| Control | Average Number of Drinks Consumed Per Drinking Day | Month 1 | 4.02 standard drinks | Standard Error 0.37 |
| Control | Average Number of Drinks Consumed Per Drinking Day | Month 3 | 4.60 standard drinks | Standard Error 0.37 |
| Control | Average Number of Drinks Consumed Per Drinking Day | Month 6 | 4.49 standard drinks | Standard Error 0.4 |
Primary
Number of Alcohol Drinking Days
The total number of days in which participants reported drinking alcohol in the past 30 days
Time frame: Month 1, Month 3, and Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Alcohol Drinking Days | Month 6 | 7.21 days | Standard Error 0.97 |
| Intervention | Number of Alcohol Drinking Days | Month 1 | 9.98 days | Standard Error 1.29 |
| Intervention | Number of Alcohol Drinking Days | Month 3 | 9.12 days | Standard Error 1.2 |
| Control | Number of Alcohol Drinking Days | Month 6 | 9.25 days | Standard Error 1.28 |
| Control | Number of Alcohol Drinking Days | Month 1 | 11.38 days | Standard Error 1.49 |
| Control | Number of Alcohol Drinking Days | Month 3 | 7.49 days | Standard Error 1.03 |
Primary
Number of Heavy Drinking Days (5+ Drinks on a Single Occasion)
The total number of days on which participants reported drinking 5+ drinks in a single day over the past 30 days
Time frame: Month 1, Month 3, and Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) | Month 1 | 2.70 bring drinking days | Standard Error 0.54 |
| Intervention | Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) | Month 3 | 2.70 bring drinking days | Standard Error 0.55 |
| Intervention | Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) | Month 6 | 2.82 bring drinking days | Standard Error 0.57 |
| Control | Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) | Month 1 | 3.84 bring drinking days | Standard Error 0.7 |
| Control | Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) | Month 3 | 2.58 bring drinking days | Standard Error 0.5 |
| Control | Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) | Month 6 | 3.65 bring drinking days | Standard Error 0.71 |
Primary
Persistence With Pre-exposure Prophylaxis (PrEP)
Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period
Time frame: Past 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Persistence With Pre-exposure Prophylaxis (PrEP) | 5 Participants |
| Control | Persistence With Pre-exposure Prophylaxis (PrEP) | 7 Participants |
Primary
Pre-exposure Prophylaxis (PrEP) Lapse Days
Number of participants who reported missing 4+ consecutive days of PrEP doses
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Pre-exposure Prophylaxis (PrEP) Lapse Days | 3 Participants |
| Control | Pre-exposure Prophylaxis (PrEP) Lapse Days | 3 Participants |
Secondary
Any Sexually-transmitted Infection (STI) Diagnosis
Time frame: 6 Months
Population: No data were collected
Secondary
Phosphatidylethanol Level
The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL
Time frame: Month 3 and Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Phosphatidylethanol Level | Month 3 | 95.57 ng/mL | Standard Error 8.03 |
| Intervention | Phosphatidylethanol Level | Month 6 | 72.47 ng/mL | Standard Error 8.79 |
| Control | Phosphatidylethanol Level | Month 3 | 77.61 ng/mL | Standard Error 8.59 |
| Control | Phosphatidylethanol Level | Month 6 | 93.58 ng/mL | Standard Error 9.49 |
Secondary
Tenofovir Diphosphate Adherence
The predicted probability of tenofovir diphosphate adherence (\>= 4 doses/week) detected in dried blood spot samples collected at 3- and 6-months
Time frame: Month 3 and Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Tenofovir Diphosphate Adherence | Month 6 | 0.76 predicted probability | Standard Error 0.08 |
| Intervention | Tenofovir Diphosphate Adherence | Month 3 | 0.68 predicted probability | Standard Error 0.09 |
| Control | Tenofovir Diphosphate Adherence | Month 3 | 0.83 predicted probability | Standard Error 0.07 |
| Control | Tenofovir Diphosphate Adherence | Month 6 | 0.74 predicted probability | Standard Error 0.08 |