Alcohol Health Education Among College Drinkers

• Sponsor: Abby Braitman (Other)
• Overall Status: Completed
• CT.gov ID: NCT03433794
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 537
• Arms: 3
• Actual Duration (Months): 19.4

Study Details

Study Description

Brief Summary

Alcohol use among college students is both widespread and problematic. There are many negative consequences associated with frequent alcohol use, ranging from mild (e.g., hangovers, missed classes) to severe (e.g., assault, even death). Online interventions targeting alcohol use among college students reduce alcohol consumption and associated problems. These interventions are popular among colleges because they are relatively inexpensive and easily disseminated. However, online interventions are not as efficacious as face-to-face interventions, such as brief motivational interviews. The proposed project employs emailed boosters in a randomized, controlled trial in an effort to improve the efficacy an existing, popular, free online intervention, while at the same time maintaining low cost and easy dissemination.

Adding boosters after interventions is a common technique to improve the efficacy of the original intervention. Boosters have been used successfully for alcohol use interventions among those seeking injury treatment in emergency medical settings. However, prior research has not supported booster efficacy for college student alcohol interventions. The current project develops and evaluates the effectiveness of boosters for a widely-used college student alcohol intervention. Specifically, the present project improves boosters by providing easy access via email; providing succinct, personalized feedback; and providing reminders of protective behavioral strategies. To test the effectiveness of adding boosters, participants randomized to alcohol-intervention-plus-boosters receive emails 2 weeks after the intervention with tailored feedback based upon their reported alcohol consumption. Participants are assessed up to nine months. The current research addresses the following specific aims:

Aim 1: Improve the efficacy of an easily-disseminated computerized intervention by adding personalized follow-up boosters, where efficacy is evidenced by reduced drinking and negative alcohol-related consequences (i.e., stronger effect sizes in the booster group immediately after receiving the booster).

Aim 2: Extend the duration of the reduction in drinking and associated problems through the use of these personalized follow-up boosters (i.e., significant differences between the booster and control groups at later timepoints).

Aim 3: Examine protective behavioral strategies highlighted by the booster as mediating behavioral mechanisms of change.

Condition or Disease	Intervention/Treatment	Phase
College Student Drinking	Behavioral: Alcohol 101 Plus (TM); Behavioral: Booster; Behavioral: Lilly for Better Health	Phase 1

Detailed Description

Alcohol use within the college student population is both widespread and problematic. There are many negative consequences associated with frequent alcohol use, ranging from mild (e.g., hangovers, missed classes) to severe (e.g., assault, even death). College student alcohol use is a significant problem, and reducing consumption and associated problems is a priority among researchers, educators, and mental health professionals who work with this population.

Online interventions targeting alcohol use among college students reduce alcohol consumption and associated problems. These interventions are popular among colleges because they are relatively inexpensive and easily disseminated. However, online interventions are not as efficacious as face-to-face interventions, such as brief motivational interviews. The current project employs emailed boosters in a randomized, controlled trial in an effort to improve the efficacy an existing, popular, free online intervention, Alcohol 101 Plus (TM), while at the same time maintaining low cost and easy dissemination.

Adding boosters after interventions is a common technique to improve the efficacy of the original intervention. Boosters have improved the efficacy or effect duration for interventions targeting smoking cessation, mammograms, dating violence, caregiver skills, binge eating, and many other behaviors. Boosters have been used successfully for alcohol use interventions among those seeking injury treatment in emergency medical settings. Despite these successes, prior research has not supported booster efficacy for college student alcohol interventions. The current project develops and evaluates the effectiveness of boosters for a widely-used college student alcohol intervention by improving on the design of boosters. Specifically, the present project improves boosters by providing easy access via email to minimize burden; providing succinct, personalized feedback; and providing reminders of protective behavioral strategies. To test the effectiveness of adding boosters, participants randomized to the alcohol-intervention-plus-boosters condition receive emails 2 weeks after the intervention with tailored feedback based upon their reported alcohol consumption. Participants are initially assessed biweekly, then every three months up to nine months. The current research addresses the following specific aims:

Aim 1: Improve the efficacy of an easily-disseminated computerized intervention by adding personalized follow-up boosters, where efficacy is evidenced by reduced drinking and negative alcohol-related consequences (i.e., stronger effect sizes in the booster group immediately after receiving the booster).

Aim 2: Extend the duration of the reduction in drinking and associated problems through the use of these personalized follow-up boosters (i.e., significant differences between the booster and control groups at later timepoints after the significant differences between the intervention-only and control groups erode).

Aim 3: Examine protective behavioral strategies highlighted by the booster as mediating behavioral mechanisms of change.

3A: Determine if increased exposure to protective strategies through an emailed booster results in increased use of these strategies.

3B: Determine if those who increase their use of protective behavioral strategies decrease their alcohol consumption and related problems they experience.

3C: Assess the combination of these two effects (i.e., the indirect effect). The proposed study will be a critical first step to adapt existing online interventions. The findings from this study will be used to identify implications for modifying the protocol or booster.

Study Design

• Study Type: Interventional
• Actual Enrollment: 537 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: The intervention is an online program, not an individual, so masking is not necessary. Similarly, the same online survey is deployed in all follow-up assessments regardless of condition, and data are not collected by individuals, so making is not necessary.
• Primary Purpose: Treatment
• Official Title: Alcohol Health Education
• Actual Study Start Date: Jan 29, 2013
• Actual Primary Completion Date: Sep 10, 2014
• Actual Study Completion Date: Sep 10, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.	Behavioral: Lilly for Better Health; This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.
Active Comparator: Intervention Only Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. Their email 2 weeks later contained only a reminder to participate in follow-up surveys.	Behavioral: Alcohol 101 Plus (TM); It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.
Experimental: Intervention-plus-Booster Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies.	Behavioral: Alcohol 101 Plus (TM); It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.; Behavioral: Booster; Personalized feedback was emailed to participants. Content included sex-specific descriptive normative information (i.e., drinks per week typically consumed by males and females at the same institution), as well as reminders of harm reduction strategies (i.e., techniques the participant reported using in their last survey, versus techniques not used).; Other Names: Personalized Normative Feedback

Outcome Measures

Primary Outcome Measures

1. Alcohol Consumption [Past 2 weeks, reported at Baseline assessment (pre-intervention)]

   Participant self-reported number of standard drinks consumed by participant over the past 2 weeks

Secondary Outcome Measures

1. Alcohol-related Consequences [Past 2 weeks, reported at Baseline assessment (pre-intervention)]

   Participant self-report on the Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, & Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Current college students at the sponsor institution at the time of enrollment

• Between the ages of 18 and 24

• Consumed at least standard drink of alcohol in the past 2 weeks

Exclusion Criteria:

• Under age of 18

• Over age of 24

• Not a college student

• Did not drink alcohol in the past 2 weeks

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abby Braitman
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Abby L Braitman, Ph.D., Old Dominion University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abby Braitman, Research Assistant Professor, Old Dominion University
• ClinicalTrials.gov Identifier: NCT03433794
• Other Study ID Numbers: 12-194; F32AA021310
• First Posted: Feb 15, 2018
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcohol Drinking in College

Study Results

Participant Flow

Pre-assignment Detail	Participants read study description and eligibility criteria, and signed up to attend a baseline session. Upon joining the study and completing an informed consent document, they were randomly assigned to arm/group of the study. After completing the online survey, 26 individuals were identified as ineligible and not enrolled.

Arm/Group Title	Control	Intervention Only	Intervention-plus-Booster
Arm/Group Description	The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies. Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
Period Title: Baseline
STARTED	183	173	181
COMPLETED	183	173	181
NOT COMPLETED	0	0	0
Period Title: Baseline
STARTED	183	173	181
COMPLETED	117	112	109
NOT COMPLETED	66	61	72
Period Title: Baseline
STARTED	183	173	181
COMPLETED	98	95	91
NOT COMPLETED	85	78	90
Period Title: Baseline
STARTED	183	173	181
COMPLETED	94	85	80
NOT COMPLETED	89	88	101
Period Title: Baseline
STARTED	183	173	181
COMPLETED	69	73	71
NOT COMPLETED	114	100	110
Period Title: Baseline
STARTED	183	173	181
COMPLETED	65	58	50
NOT COMPLETED	118	115	131
Period Title: Baseline
STARTED	183	173	181
COMPLETED	49	52	39
NOT COMPLETED	134	121	142

Baseline Characteristics

Arm/Group Title	Control	Intervention Only	Intervention-plus-Booster	Total
Arm/Group Description	The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies. Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.	Total of all reporting groups
Overall Participants	183	173	181	537
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.792 (1.779)	19.792 (1.726)	19.370 (1.476)	19.650 (1.674)
Sex: Female, Male (Count of Participants)
Female	122 66.7%	116 67.1%	124 68.5%	362 67.4%
Male	61 33.3%	57 32.9%	57 31.5%	175 32.6%
Race/Ethnicity, Customized (Count of Participants)
Caucasian or White	82 44.8%	92 53.2%	88 48.6%	262 48.8%
African-American or Black	74 40.4%	59 34.1%	68 37.6%	201 37.4%
Asian or Pacific Islander	11 6%	8 4.6%	6 3.3%	25 4.7%
Native American	1 0.5%	0 0%	3 1.7%	4 0.7%
Other	10 5.5%	10 5.8%	14 7.7%	34 6.3%
Hispanic	24 13.1%	18 10.4%	13 7.2%	55 10.2%
non-Hispanic	158 86.3%	154 89%	167 92.3%	479 89.2%
Region of Enrollment (participants) [Number]
United States	183 100%	173 100%	181 100%	537 100%

Outcome Measures

1. Primary Outcome

Title	Alcohol Consumption
Description	Participant self-reported number of standard drinks consumed by participant over the past 2 weeks
Time Frame	Past 2 weeks, reported at Baseline assessment (pre-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention Only	Intervention-plus-Booster
Arm/Group Description	The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies. Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
Measure Participants	183	173	181
Mean (Standard Deviation) [drinks]	16.929 (14.826)	17.988 (16.870)	18.039 (16.382)

2. Secondary Outcome

Title	Alcohol-related Consequences
Description	Participant self-report on the Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, & Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes).
Time Frame	Past 2 weeks, reported at Baseline assessment (pre-intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention Only	Intervention-plus-Booster
Arm/Group Description	The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.	Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies. Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
Measure Participants	183	173	181
Mean (Standard Deviation) [problems]	6.656 (5.566)	7.156 (6.066)	7.011 (6.367)

Adverse Events

Arm/Group Title	Control		Intervention Only		Intervention-plus-Booster
Arm/Group Description	The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.		Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.		Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies. Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
All Cause Mortality
	Control		Intervention Only		Intervention-plus-Booster
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/183 (0%)		0/173 (0%)		0/181 (0%)
Serious Adverse Events
	Control		Intervention Only		Intervention-plus-Booster
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/183 (0%)		0/173 (0%)		0/181 (0%)
Other (Not Including Serious) Adverse Events
	Control		Intervention Only		Intervention-plus-Booster
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/183 (0%)		0/173 (0%)		0/181 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.