Trial Outcomes & Findings for Text Message Intervention for Alcohol Use and Sexual Violence in College Students (NCT NCT05065918)

NCT ID: NCT05065918

Last Updated: 2024-10-17

Results Overview

as measured using a 30-day timeline follow-back (TLFB)

Recruitment status

COMPLETED

Study phase

Target enrollment

183 participants

Primary outcome timeframe

3 month follow up

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Control - Alcohol Use Reduction Content Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Overall Study STARTED	92	91
Overall Study COMPLETED	91	89
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Text Message Intervention for Alcohol Use and Sexual Violence in College Students

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control - Alcohol Use Reduction Content n=92 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=91 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.	Total n=183 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants	91 Participants n=7 Participants	183 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	20 years STANDARD_DEVIATION 1.07 • n=5 Participants	21 years STANDARD_DEVIATION 1.47 • n=7 Participants	20 years STANDARD_DEVIATION 1.30 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	69 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	83 Participants n=7 Participants	170 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	10 Participants n=7 Participants	20 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants	73 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants	91 participants n=7 Participants	183 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 month follow up

as measured using a 30-day timeline follow-back (TLFB)

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=92 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=91 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Number of Drinking Days Per Month	6.45 drinking days in the past 30 days Standard Deviation 4.50	5.91 drinking days in the past 30 days Standard Deviation 4.97

PRIMARY outcome

Timeframe: 6 month follow up

as measured using a 30-day timeline follow-back (TLFB)

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=91 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=89 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Number of Drinking Days Per Month	5.98 drinking days in the past 30 days Standard Deviation 3.84	6.00 drinking days in the past 30 days Standard Deviation 3.85

PRIMARY outcome

Timeframe: 3 month follow up

as measured using a 30-day timeline follow-back (TLFB)

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=92 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=91 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Number of Binge Drinking Days Per Month	6.45 binge drinking days in the past 30 days Standard Deviation 4.50	5.91 binge drinking days in the past 30 days Standard Deviation 4.97

PRIMARY outcome

Timeframe: 6 month follow up

as measured using a 30-day timeline follow-back (TLFB)

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=91 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=89 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Number of Binge Drinking Days Per Month	2.03 binge drinking days in the past 30 days Standard Deviation 2.55	1.71 binge drinking days in the past 30 days Standard Deviation 2.51

PRIMARY outcome

Timeframe: 3 month follow up

Use of sexual violence harm reduction strategies assessed with an 11 item scale used by the American College Health Association's National College Health Survey of Protective Behavioral Strategies. Participants report on how often when drinking/socializing in the past 3 months they used each of the specific behaviors on a 5-point Likert scale ranging from (1 = never, 5 = always; theoretical range 11-55) with higher scores indicating higher frequency use of harm reduction strategies.

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=92 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=91 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Use of Sexual Violence Harm Reduction Strategies	36.72 score on a scale Standard Deviation 6.38	37.26 score on a scale Standard Deviation 6.19

PRIMARY outcome

Timeframe: 6 month follow up

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=91 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=89 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Use of Sexual Violence Harm Reduction Strategies	37.26 score on a scale Standard Deviation 6.19	36.20 score on a scale Standard Deviation 6.33

SECONDARY outcome

Timeframe: 3 month follow up

Alcohol and sexual consent scale. A series of questions were asked to measure recognition of what constitutes sexual violence and attitudes related to the role of alcohol in risk for sexual violence. 12 item scale, using a 5-point Likert scale ranging from ("strongly disagree" to "strongly agree"; theoretical range of 12-60), with a higher mean score indicating greater knowledge and recognition.

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=92 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=91 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Knowledge of Sexual Violence and Alcohol Risk	37.35 score on a scale Standard Deviation 3.95	36.72 score on a scale Standard Deviation 3.72

SECONDARY outcome

Timeframe: 6 month follow up

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=91 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=89 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Knowledge of Sexual Violence and Alcohol Risk	37.11 score on a scale Standard Deviation 3.58	36.70 score on a scale Standard Deviation 5.51

SECONDARY outcome

Timeframe: 3 month follow up

Perceived behavioral control subscale of the Sexual Consent Scale-Revised. Participants reported how efficacious they feel at obtaining consent for sexual activity of a 5-point Likert scale. 11 item scale ("strongly disagree" to "strongly agree"; theoretical range of 11-55). Higher scores indicate greater self-efficacy.

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=92 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=91 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Self-efficacy to Obtain Sexual Consent.	42.78 score on a scale Standard Deviation 7.03	40.92 score on a scale Standard Deviation 7.74

SECONDARY outcome

Timeframe: 6 month follow up

Outcome measures

Outcome measures
Measure	Control - Alcohol Use Reduction Content n=91 Participants Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).	Intervention - Sexual Violence and Alcohol Use Harm Reduction Content n=88 Participants sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Self-efficacy to Obtain Sexual Consent.	42.42 score on a scale Standard Deviation 7.29	40.53 score on a scale Standard Deviation 7.42

Adverse Events

Control - Alcohol Use Reduction Content

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention - Sexual Violence and Alcohol Use Harm Reduction Content

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

Jocelyn Anderson

The University of Arkansas for Medical Sciences

Phone: 501-686-7712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place