Trial Outcomes & Findings for An Adaptive Intervention for Depression Among Latinos Living With HIV (NCT NCT03668379)
NCT ID: NCT03668379
Last Updated: 2024-10-21
Results Overview
This is one composite measure. Feasibility of the adaptive treatment strategy (ATS) will be measured to assess whether the ATS is appropriate for further testing, relevant and sustainable. Feasibility of the ATS will be reported as a composite score of the following measures taken at the end of the second-stage treatment: 1. Total number of participants screened, eligible and enrolled; 2. At least 80% of all BAT \& CBT sessions completed; 3. 80% retention of participants across all "outcome groups".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
4 months
Results posted on
2024-10-21
Participant Flow
Participant milestones
| Measure |
Behavioral Activation Therapy
During the initial stage treatment, the active comparator arm is the behavioral activation (BAT) program intervention. BAT is informed by behavioral theory and has been shown to be a highly efficacious treatment for depression. A total of five, 1-hour sessions will be delivered every two weeks. During Session 1, the focus will be on providing an introduction to BAT, as well as building "confianza" (mutual trust) between the patient and provider. Sessions 2 \& 3 will review the initial session, introduce "high" value activities and barriers to BAT protocols. Sessions 4 \& 5 will review progress, challenges \& maintenance strategies.
If participants responded to the intervention, they will continue with stage 1 treatment. This means that they will stay the course with the current assignment, which means finishing three more sessions, which makes the overall total of eight sessions.
|
Behavioral Activation Therapy & mHealth
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
If participants responded to the intervention, they will continue with stage 1 treatment. This means that they will stay the course with the current assignment, which means finishing three more sessions, which makes the overall total of eight sessions.
|
Behavioral Activation Therapy Augment With mHealth
This arm included participants who did not respond to BAT in stage 1.
In stage 1, a trained graduate student provided five weekly BAT sessions. Session 1, the focus was on providing an introduction to BAT, as well as building "confianza" (mutual trust) between the patient and provider. Sessions 2 \& 3 reviewed the initial session, introduce "high" value activities and barriers to BAT protocols. Sessions 4 \& 5 reviewed progress, challenges \& maintenance strategies.
"Non-responders" to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention in the second stage.
|
Behavioral Activation Therapy Switch to Cognitive Behavioral Therapy & mHealth
This arm included participants who did not respond to BAT in stage 1.
In stage 1, a trained graduate student provided five weekly BAT sessions. Session 1, the focus was on providing an introduction to BAT, as well as building "confianza" (mutual trust) between the patient and provider. Sessions 2 \& 3 reviewed the initial session, introduce "high" value activities and barriers to BAT protocols. Sessions 4 \& 5 reviewed progress, challenges \& maintenance strategies.
"Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
|
Behavioral Activation Therapy & mHealth Switch to Cognitive Behavioral Therapy & mHealth
This arm included participants who did not respond to BAT \& mHealth.
In stage 1, a trained graduate student provided five weekly BAT sessions.
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
"Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
|
Behavioral Activation Therapy & mHealth Augment With Behavioral Activation Therapy & mHealth
This arm included participants who did not respond to BAT and BAT \& mHealth.
In stage 1, a trained graduate student provided five weekly BAT sessions.
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
"Non-responders" to the BAT \& mHealth intervention may be re-randomized to receive an additional "dose" of BAT \& mHealth in the form of an additional session of BAT.
|
|---|---|---|---|---|---|---|
|
Stage 1 Intervention (Months 1-2)
STARTED
|
5
|
5
|
0
|
0
|
0
|
0
|
|
Stage 1 Intervention (Months 1-2)
COMPLETED
|
4
|
3
|
0
|
0
|
0
|
0
|
|
Stage 1 Intervention (Months 1-2)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Stage 2 Intervention (Months 3-4)
STARTED
|
4
|
3
|
0
|
0
|
0
|
0
|
|
Stage 2 Intervention (Months 3-4)
COMPLETED
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Stage 2 Intervention (Months 3-4)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Adaptive Intervention for Depression Among Latinos Living With HIV
Baseline characteristics by cohort
| Measure |
Behavioral Activation Therapy
n=5 Participants
During the initial stage treatment, the active comparator arm is the behavioral activation (BAT) program intervention. BAT is informed by behavioral theory and has been shown to be a highly efficacious treatment for depression. A total of eight, 1-hour sessions will be delivered every two weeks.
Augment w/mHealth: "Non-responders" to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
|
Behavioral Activation Therapy & mHealth
n=5 Participants
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
Augment w/BAT \& mHealth: "Non-responders" to the BAT \& mHealth intervention may be re-randomized to receive an additional "dose" of BAT \& mHealth in the form of an additional session of BAT.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
48.4 Years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
47 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Patient Health Questionnaire-9
|
10.2 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 4.21 • n=7 Participants
|
11.9 units on a scale
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
The Index of HIV Care Engagement-- or index of
|
4.24 units on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
4.15 units on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
4.20 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: In this study, all participants assigned to their 1st stage treatment either responded and entered the maintenance arm or did not complete the intervention. Thus, we had no non-responders and no re-randomized participants who would have either augmented or changed their 1st stage treatment. Results reflect this result and zero cells in the other arms.
This is one composite measure. Feasibility of the adaptive treatment strategy (ATS) will be measured to assess whether the ATS is appropriate for further testing, relevant and sustainable. Feasibility of the ATS will be reported as a composite score of the following measures taken at the end of the second-stage treatment: 1. Total number of participants screened, eligible and enrolled; 2. At least 80% of all BAT \& CBT sessions completed; 3. 80% retention of participants across all "outcome groups".
Outcome measures
| Measure |
Behavioral Activation Therapy Maintenance
n=5 Participants
During the initial stage treatment, the active comparator arm is the behavioral activation (BAT) program intervention. BAT is informed by behavioral theory and has been shown to be a highly efficacious treatment for depression. A total of eight, 1-hour sessions will be delivered every two weeks. D Augment w/mHealth: "Non-responders" to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
|
Behavioral Activation Therapy & mHealth Maintenance
n=5 Participants
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
Augment w/BAT \& mHealth: "Non-responders" to the BAT \& mHealth intervention may be re-randomized to receive an additional "dose" of BAT \& mHealth in the form of an additional session of BAT.
|
|---|---|---|
|
Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)
Completion Percentage
|
4 Participants
|
3 Participants
|
|
Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)
Retention Percentage
|
0 Participants
|
0 Participants
|
|
Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)
Enrolled
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThis is one composite measure. Acceptability of the adaptive treatment strategy will be measured to determine the tolerability or appropriateness of the SMART intervention from the perspective of both participants and clinicians.Acceptability of the ATS will be reported as a composite score of the following measures taken at the end of the second-stage treatment: 1. Greater than 90% adherence to the BAT \& CBT session schedule; 2. Responsiveness to text-messages: a) \>80% of all two-way messages replied back to study line during the set of blocked hours; b) \>90% of participants reporting direct benefit from one-way text messages; 3. Acceptability responses coded from post-intervention exit interview transcripts; 4. Limited number of barriers to participation reported by participants in exit interviews; 5. Responses to a brief survey (to be developed) assessing clinic staff acceptability of the intervention.
Outcome measures
| Measure |
Behavioral Activation Therapy Maintenance
n=5 Participants
During the initial stage treatment, the active comparator arm is the behavioral activation (BAT) program intervention. BAT is informed by behavioral theory and has been shown to be a highly efficacious treatment for depression. A total of eight, 1-hour sessions will be delivered every two weeks. D Augment w/mHealth: "Non-responders" to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
|
Behavioral Activation Therapy & mHealth Maintenance
n=5 Participants
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
Augment w/BAT \& mHealth: "Non-responders" to the BAT \& mHealth intervention may be re-randomized to receive an additional "dose" of BAT \& mHealth in the form of an additional session of BAT.
|
|---|---|---|
|
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)
90% Adherence
|
3 Participants
|
1 Participants
|
|
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)
Two-Way Text-Message Response
|
0 Participants
|
0 Participants
|
|
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)
One-Way Text-Message Response
|
0 Participants
|
0 Participants
|
|
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)
Acceptability Responses
|
0 Participants
|
0 Participants
|
|
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)
Barriers
|
0 Participants
|
0 Participants
|
|
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)
Responses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The disruptions of COVID-19 prevented us from collecting data 12-month survey data and thus, we have entered "0" into the cells as instructed.
Self-reported adherence will be measured using the the visual analog scale (VAS), a 10-cm line on which participants indicate the percentage of doses (intervals of 10 percentage points indicated from 0% to 100%) of all HIV medications taken in the past 30 days (Amico et al., 2006). Higher percentage indicates greater adherence to HIV medications. This measure will be used for descriptive purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: We could not abstract viral load data from 1 participant.
Viral load measures the amount of HIV virus in the blood. Viral load data abstracted from patient medical records will act as a descriptive measure of HIV-related clinical outcomes. A detectable viral load is a measurement of the amount of HIV in the blood, and an indication that HIV is replicating in the body. Undetectable viral load means that there is not enough of the virus to be detected.
Outcome measures
| Measure |
Behavioral Activation Therapy Maintenance
n=4 Participants
During the initial stage treatment, the active comparator arm is the behavioral activation (BAT) program intervention. BAT is informed by behavioral theory and has been shown to be a highly efficacious treatment for depression. A total of eight, 1-hour sessions will be delivered every two weeks. D Augment w/mHealth: "Non-responders" to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
|
Behavioral Activation Therapy & mHealth Maintenance
n=5 Participants
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
Maintenance: "Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.
Switch to CBT \& mHealth: "Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.
Augment w/BAT \& mHealth: "Non-responders" to the BAT \& mHealth intervention may be re-randomized to receive an additional "dose" of BAT \& mHealth in the form of an additional session of BAT.
|
|---|---|---|
|
Viral Load
Detectable viral load
|
1 participants
|
1 participants
|
|
Viral Load
Undetectable viral load
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The disruptions of COVID-19 prevented us from collecting data 12-month survey data and thus, we have entered "0" into the cells as instructed.
Patient Health Questionnaire-9 is a self-report measure of depression with a range from 0-27, with higher score indicating greater severity of depression symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: The disruptions of COVID-19 prevented us from collecting data 12-month survey data and thus, we have entered "0" into the cells as instructed.
Engagement in care will be measured utilizing the multidimensional index of engagement in HIV care, a 10-item unit-dimensional patient-centered scale that assesses provider, clinic, and patient-level characteristics associated with being engaged in HIV care. This measure will be used for descriptive purposes. Mean scores are the sum of all 10 items divided by 10 with a range of 1-5, and higher scores indicate better engagement in care.
Outcome measures
Outcome data not reported
Adverse Events
Behavioral Activation Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Activation Therapy & mHealth
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
John Sauceda, PhD, Associate Professor
University of California, San Francisco
Phone: 415-502-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place