Trial Outcomes & Findings for Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing (NCT NCT01977092)
NCT ID: NCT01977092
Last Updated: 2018-07-17
Results Overview
Measured by dichotomous measure of whether or not any time spent incarcerated in past 6 months.56 follow-up interviews were conducted in jails, when allowed and the participant was comfortable, but we did not conduct interviews in prison. See participant flow for number of participants in prison.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
330 participants
Primary outcome timeframe
Baseline, 6 months, and 12 months
Results posted on
2018-07-17
Participant Flow
The recruitment of 330 study participants followed a two-step process: first we recruited the house, and then we recruited residents that moved in to those houses. The approximately 50 SLHs participating in the study were located in the Los Angeles area and all were members of the Sober Living Network.
To avoid mixing individuals who received the intervention with individuals who did not within the same house, we randomized at the house level. Once a house was randomized to a study condition, all of the individuals recruited from that house received the same intervention.
Participant milestones
| Measure |
Motivational Interviewing Case Management
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Motivational interviewing case management
|
Resource Referrals
Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.
Resource referrals
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
181
|
|
Overall Study
COMPLETED
|
118
|
151
|
|
Overall Study
NOT COMPLETED
|
31
|
30
|
Reasons for withdrawal
| Measure |
Motivational Interviewing Case Management
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Motivational interviewing case management
|
Resource Referrals
Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.
Resource referrals
|
|---|---|---|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
23
|
14
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
In prison
|
3
|
11
|
Baseline Characteristics
Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing
Baseline characteristics by cohort
| Measure |
Motivational Interviewing Case Management
n=149 Participants
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Motivational interviewing case management
|
Control - Resource Referrals
n=181 Participants
Respondents will receive sober living house services as usual along with a list of resources that can be used to address a variety of problems.
control - Resource referrals
|
Total
n=330 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
|
147 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
263 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
149 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Legal status
Probation(including drug court)
|
129 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Legal status
Parole
|
20 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.
Measured by dichotomous measure of whether or not any time spent incarcerated in past 6 months.56 follow-up interviews were conducted in jails, when allowed and the participant was comfortable, but we did not conduct interviews in prison. See participant flow for number of participants in prison.
Outcome measures
| Measure |
Motivational Interviewing Case Management
n=149 Participants
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Motivational interviewing case management
|
Control/Resource Referrals
n=181 Participants
Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.
Resource referrals
|
|---|---|---|
|
Change in Criminal Justice Outcomes
Baseline · Not incarcerated in past 6 months
|
66 Participants
|
70 Participants
|
|
Change in Criminal Justice Outcomes
Baseline · Incarcerated in past 6 months
|
83 Participants
|
111 Participants
|
|
Change in Criminal Justice Outcomes
6 months · Not incarcerated in past 6 months
|
94 Participants
|
108 Participants
|
|
Change in Criminal Justice Outcomes
6 months · Incarcerated in past 6 months
|
14 Participants
|
37 Participants
|
|
Change in Criminal Justice Outcomes
12 months · Not incarcerated in past 6 months
|
94 Participants
|
105 Participants
|
|
Change in Criminal Justice Outcomes
12 months · Incarcerated in past 6 months
|
24 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews.
Measured by whether or not the participant reports complete abstinence from all substance use for last 6 months on Timeline Followback (TLFB).
Outcome measures
| Measure |
Motivational Interviewing Case Management
n=149 Participants
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Motivational interviewing case management
|
Control/Resource Referrals
n=181 Participants
Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.
Resource referrals
|
|---|---|---|
|
Change in Alcohol and Drug Use (Timeline Follow Back)
Baseline · Not abstinent
|
100 Participants
|
126 Participants
|
|
Change in Alcohol and Drug Use (Timeline Follow Back)
Baseline · Abstinent
|
49 Participants
|
55 Participants
|
|
Change in Alcohol and Drug Use (Timeline Follow Back)
6 months · Not abstinent
|
55 Participants
|
82 Participants
|
|
Change in Alcohol and Drug Use (Timeline Follow Back)
6 months · Abstinent
|
53 Participants
|
63 Participants
|
|
Change in Alcohol and Drug Use (Timeline Follow Back)
12 months · Not abstinent
|
62 Participants
|
80 Participants
|
|
Change in Alcohol and Drug Use (Timeline Follow Back)
12 months · Abstinent
|
56 Participants
|
71 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, and 12 monthsPopulation: 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.
Measured by whether or not the participant was worried about HIV in past 6 months.
Outcome measures
| Measure |
Motivational Interviewing Case Management
n=149 Participants
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Motivational interviewing case management
|
Control/Resource Referrals
n=181 Participants
Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.
Resource referrals
|
|---|---|---|
|
Change in Worries About HIV in Past 6 Months.
Baseline · Didn't have HIV worry
|
25 Participants
|
48 Participants
|
|
Change in Worries About HIV in Past 6 Months.
Baseline · Had HIV worry
|
124 Participants
|
133 Participants
|
|
Change in Worries About HIV in Past 6 Months.
6 months · Didn't have HIV worry
|
41 Participants
|
82 Participants
|
|
Change in Worries About HIV in Past 6 Months.
6 months · Had HIV worry
|
67 Participants
|
63 Participants
|
|
Change in Worries About HIV in Past 6 Months.
12 months · Didn't have HIV worry
|
73 Participants
|
98 Participants
|
|
Change in Worries About HIV in Past 6 Months.
12 months · Had HIV worry
|
45 Participants
|
53 Participants
|
Adverse Events
Motivational Interviewing Case Management
Serious events: 12 serious events
Other events: 0 other events
Deaths: 3 deaths
Resource Referrals
Serious events: 30 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Motivational Interviewing Case Management
n=149 participants at risk
MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months).
Motivational interviewing case management
|
Resource Referrals
n=181 participants at risk
Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems.
Resource referrals
|
|---|---|---|
|
Psychiatric disorders
Depressive symptoms
|
0.67%
1/149 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
1.7%
3/181 • Number of events 6 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Psychiatric disorders
Suicidal symptoms
|
2.0%
3/149 • Number of events 3 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
8.3%
15/181 • Number of events 27 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
General disorders
Staph infection
|
2.0%
3/149 • Number of events 3 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.00%
0/181 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
General disorders
Contusions and lacerations
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
1.1%
2/181 • Number of events 4 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Cardiac disorders
Cardiac arrhythmia, unspecified
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
1.1%
2/181 • Number of events 2 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
General disorders
Alcohol withdrawal
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.55%
1/181 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Unspecified asthma with (acute) exacerbation
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.55%
1/181 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
General disorders
Fracture
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.55%
1/181 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
1.1%
2/181 • Number of events 2 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Nervous system disorders
Seizure disorder
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.55%
1/181 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.55%
1/181 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
General disorders
Unconsciousness NOS
|
1.3%
2/149 • Number of events 2 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.55%
1/181 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage, unspecified
|
0.00%
0/149 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.55%
1/181 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Acute embolism and thrombosis of unspecified deep veins of lower extremity
|
0.67%
1/149 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.00%
0/181 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Infarction of spleen
|
0.67%
1/149 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.00%
0/181 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
Endocrine disorders
Biliary acute pancreatitis
|
0.67%
1/149 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.00%
0/181 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
|
General disorders
Contusions
|
0.67%
1/149 • Number of events 1 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
|
0.00%
0/181 • Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place