Trial Outcomes & Findings for Game Plan for PrEP (NCT NCT04973267)

NCT ID: NCT04973267

Last Updated: 2024-08-28

Results Overview

Number of participants who reported missing 4+ consecutive days of PrEP doses

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 73 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-08-28

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	37	36
Overall Study COMPLETED	37	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Game Plan for PrEP

Baseline characteristics by cohort

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.	Total n=73 Participants Total of all reporting groups
Age, Continuous	33.4 years STANDARD_DEVIATION 7.4 • n=5 Participants	37.4 years STANDARD_DEVIATION 10 • n=7 Participants	35.4 years STANDARD_DEVIATION 9.0 • 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	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Years on PrEP	2.7 years STANDARD_DEVIATION 2.2 • n=5 Participants	2.5 years STANDARD_DEVIATION 2.2 • n=7 Participants	2.6 years STANDARD_DEVIATION 2.1 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants who reported missing 4+ consecutive days of PrEP doses

Outcome measures

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.
Pre-exposure Prophylaxis (PrEP) Lapse Days	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Past 6 months

Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period

Outcome measures

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.
Persistence With Pre-exposure Prophylaxis (PrEP)	5 Participants	7 Participants

PRIMARY outcome

Timeframe: Month 1, Month 3, and Month 6

The total number of days in which participants reported drinking alcohol in the past 30 days

Outcome measures

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.
Number of Alcohol Drinking Days Month 1	9.98 days Standard Error 1.29	11.38 days Standard Error 1.49
Number of Alcohol Drinking Days Month 3	9.12 days Standard Error 1.20	7.49 days Standard Error 1.03
Number of Alcohol Drinking Days Month 6	7.21 days Standard Error 0.97	9.25 days Standard Error 1.28

PRIMARY outcome

Timeframe: Month 1, Month 3, and Month 6

The average number of standard alcoholic drinks consumed when participants reported drinking over the past 30 days

Outcome measures

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.
Average Number of Drinks Consumed Per Drinking Day Month 1	3.89 standard drinks Standard Error 0.36	4.02 standard drinks Standard Error 0.37
Average Number of Drinks Consumed Per Drinking Day Month 3	4.37 standard drinks Standard Error 0.37	4.60 standard drinks Standard Error 0.37
Average Number of Drinks Consumed Per Drinking Day Month 6	3.94 standard drinks Standard Error 0.37	4.49 standard drinks Standard Error 0.40

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.
Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) Month 1	2.70 bring drinking days Standard Error 0.54	3.84 bring drinking days Standard Error 0.70
Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) Month 3	2.70 bring drinking days Standard Error 0.55	2.58 bring drinking days Standard Error 0.50
Number of Heavy Drinking Days (5+ Drinks on a Single Occasion) Month 6	2.82 bring drinking days Standard Error 0.57	3.65 bring drinking days Standard Error 0.71

SECONDARY outcome

Timeframe: Month 3 and Month 6

The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL

Outcome measures

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.
Phosphatidylethanol Level Month 3	95.57 ng/mL Standard Error 8.03	77.61 ng/mL Standard Error 8.59
Phosphatidylethanol Level Month 6	72.47 ng/mL Standard Error 8.79	93.58 ng/mL Standard Error 9.49

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention n=37 Participants 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.	Control n=36 Participants 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.
Tenofovir Diphosphate Adherence Month 3	0.68 predicted probability Standard Error 0.09	0.83 predicted probability Standard Error 0.07
Tenofovir Diphosphate Adherence Month 6	0.76 predicted probability Standard Error 0.08	0.74 predicted probability Standard Error 0.08

SECONDARY outcome

Timeframe: 6 Months

Population: No data were collected

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tyler Wray, PhD

Brown University - SPH

Phone: 4018636659

Email: tyler_wray@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place