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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34AA027195 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Game Plan for PrEP | Experimental | 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. |
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| Lifestyle Habits Videos | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Game Plan for PrEP | Behavioral | See arm description. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-exposure Prophylaxis (PrEP) Lapse Days | Number of participants who reported missing 4+ consecutive days of PrEP doses | 6 months |
| Persistence With Pre-exposure Prophylaxis (PrEP) | Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period | Past 6 months |
| Number of Alcohol Drinking Days | The total number of days in which participants reported drinking alcohol in the past 30 days | Month 1, Month 3, and Month 6 |
| 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 | Month 1, Month 3, and Month 6 |
| 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 | Month 1, Month 3, and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphatidylethanol Level | The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL | Month 3 and Month 6 |
| Tenofovir Diphosphate Adherence |
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Inclusion Criteria:
Exclusion Criteria:
Eligible participants will be assigned male sex at birth and report current male gender.
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| Name | Affiliation | Role |
|---|---|---|
| Tyler Wray, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Pre-exposure Prophylaxis (PrEP) Lapse Days | Number of participants who reported missing 4+ consecutive days of PrEP doses | Posted | Count of Participants | Participants | 6 months |
|
9 months
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tyler Wray, PhD | Brown University - SPH | 4018636659 | tyler_wray@brown.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2021 | Jun 24, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2021 | Jan 31, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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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.
| Attention-Matched Control Lifestyle Habits Videos |
| Behavioral |
Web-based videos providing information on sleep hygiene and proper diet. |
|
The predicted probability of tenofovir diphosphate adherence (>= 4 doses/week) detected in dried blood spot samples collected at 3- and 6-months
| Month 3 and Month 6 |
| Any Sexually-transmitted Infection (STI) Diagnosis | 6 Months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Years on PrEP | Mean | Standard Deviation | years |
|
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.
|
|
| Primary | Persistence With Pre-exposure Prophylaxis (PrEP) | Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period | Posted | Count of Participants | Participants | Past 6 months |
|
|
|
| Primary | Number of Alcohol Drinking Days | The total number of days in which participants reported drinking alcohol in the past 30 days | Posted | Mean | Standard Error | days | Month 1, Month 3, and Month 6 |
|
|
|
| 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 | Posted | Mean | Standard Error | standard drinks | Month 1, Month 3, and Month 6 |
|
|
|
| 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 | Posted | Mean | Standard Error | bring drinking days | Month 1, Month 3, and Month 6 |
|
|
|
| Secondary | Phosphatidylethanol Level | The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL | Posted | Mean | Standard Error | ng/mL | Month 3 and Month 6 |
|
|
|
| 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 | Posted | Mean | Standard Error | predicted probability | Month 3 and Month 6 |
|
|
|
| Secondary | Any Sexually-transmitted Infection (STI) Diagnosis | No data were collected | Posted | 6 Months |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | 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. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Month 6 |
|
| Month 6 |
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| Month 6 |
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