Human Immunodeficiency Virus ExposureNCT04973267
Game Plan for PrEP
A study testing Game Plan for PrEP in people with Human Immunodeficiency Virus Exposure and Alcohol; Harmful Use, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus Exposure, Alcohol; Harmful Use
- What is being tested?
- Game Plan for PrEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Game Plan for PrEP: A Pilot Trial of a Web-based Intervention to Help High-risk Men on PrEP Adhere to Their Medication, Reduce Alcohol Use, and Encourage Safe Sex
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.
Read the 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.
- Being tested
- Game Plan for PrEP, Attention-Matched Control Lifestyle Habits Videos
- Keywords
- PrEP, Alcohol Use, HIV, STIs, LGBTQ
- Medical subject headings
- Alcohol Drinking, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Plan for PrEPBehavioural
See arm description.
Attention-Matched Control Lifestyle Habits VideosBehavioural
Web-based videos providing information on sleep hygiene and proper diet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Game Plan for PrEP |
| 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. Receives: Behavioral: Attention-Matched Control Lifestyle Habits Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-exposure Prophylaxis (PrEP) Lapse Days
Number of participants who reported missing 4+ consecutive days of PrEP doses
Measured: 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
Measured: Past 6 months
Number of Alcohol Drinking Days
The total number of days in which participants reported drinking alcohol in the past 30 days
Measured: 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
Measured: 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
Measured: Month 1, Month 3, and Month 6
Secondary outcomes (3)
Phosphatidylethanol Level
The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL
Measured: Month 3 and Month 6
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
Measured: Month 3 and Month 6
Any Sexually-transmitted Infection (STI) Diagnosis
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jul 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Tyler Wray, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973267
- Sponsor's protocol ID
- 2105002999
- Other IDs
- 5R34AA027195
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2021
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game Plan for PrEP: A Pilot Trial of a Web-based Intervention to Help High-risk Men on PrEP Adhere to Their Medication, Reduce Alcohol Use, and Encourage Safe Sex
- ClinicalTrials.gov ID
- NCT04973267
- Acronym / sponsor ID
- 2105002999
- Keywords
- PrEP, Alcohol Use, HIV, STIs, LGBTQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Game Plan for PrEP | Experimental | Behavioral: Game Plan for PrEPParticipants 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. |
| Lifestyle Habits Videos | Sham comparator | Behavioral: Attention-Matched Control Lifestyle Habits VideosParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Plan for PrEPSee arm description. | Behavioural | Game Plan for PrEP |
| Attention-Matched Control Lifestyle Habits VideosWeb-based videos providing information on sleep hygiene and proper diet. | Behavioural | Lifestyle Habits Videos |
Primary outcome
Pre-exposure Prophylaxis (PrEP) Lapse Days
Time frame: 6 months
Number of participants who reported missing 4+ consecutive days of PrEP doses
Persistence With Pre-exposure Prophylaxis (PrEP)
Time frame: 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
Time frame: 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
Time frame: Month 1, Month 3, and Month 6
The average number of standard alcoholic drinks consumed when participants reported drinking over the past 30 days
Number of Heavy Drinking Days (5+ Drinks on a Single Occasion)
Time frame: 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
3 secondary outcomes
Phosphatidylethanol Level
Time frame: Month 3 and Month 6
Tenofovir Diphosphate Adherence
Time frame: Month 3 and Month 6
Any Sexually-transmitted Infection (STI) Diagnosis
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler Wray, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Plan for PrEP in people with Human Immunodeficiency Virus Exposure and Alcohol; Harmful Use, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-exposure Prophylaxis (PrEP) Lapse Days (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.