Trial Outcomes & Findings for Reducing Stigma Among Healthcare Providers to Improve Mental Health Services (NCT NCT02793271)

Results Overview

Health Provider Outcome: 12-item scale of willingness to interact with persons with mental illness, minimum = 12, maximum = 72, higher score is worse outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

Baseline (Pre-Training)

Results posted on

2026-07-22

Participant Flow

Health facilities were randomized across arms. Health workers from the randomized health facilities were recruited in each arms. They were followed-up until 16 months post-training. Any health workers who were accessed at 16 months post-training are defined as "completed". Follow-up time period: Pre-training \| Post-training \| 4 months post training \| 16 months post-training

Unit of analysis: Health facilities

Participant milestones

Participant milestones
Measure	PRIME The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Overall Study STARTED	45 17	43 17
Overall Study COMPLETED	33 14	33 15
Overall Study NOT COMPLETED	12 3	10 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Stigma Among Healthcare Providers to Improve Mental Health Services

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRIME n=17 Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=17 Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.	Total n=34 Health Facilities Total of all reporting groups
Sex: Female, Male Female	5 Participants n=9 Participants	8 Participants n=27 Participants	13 Participants n=267 Participants
Age, Customized 21-29 years	14 Participants n=9 Participants	12 Participants n=27 Participants	26 Participants n=267 Participants
Age, Customized 30-39 years	12 Participants n=9 Participants	17 Participants n=27 Participants	29 Participants n=267 Participants
Age, Customized 40-49 years	15 Participants n=9 Participants	8 Participants n=27 Participants	23 Participants n=267 Participants
Age, Customized 50-56 years	4 Participants n=9 Participants	6 Participants n=27 Participants	10 Participants n=267 Participants
Sex: Female, Male Male	40 Participants n=9 Participants	35 Participants n=27 Participants	75 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Asian	45 Participants n=9 Participants	43 Participants n=27 Participants	88 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=9 Participants	43 Participants n=27 Participants	88 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race/Ethnicity, Customized Brahman/Chhetri (upper Hindu castes)	36 Participants n=9 Participants	31 Participants n=27 Participants	67 Participants n=267 Participants
Race/Ethnicity, Customized Other (eg, Dalit lower Hindu castes, Janajati)	9 Participants n=9 Participants	12 Participants n=27 Participants	21 Participants n=267 Participants
Region of Enrollment Nepal	45 Participants n=9 Participants	43 Participants n=27 Participants	88 Participants n=267 Participants

PRIMARY outcome

Timeframe: Baseline (Pre-Training)

Health Provider Outcome: 12-item scale of willingness to interact with persons with mental illness, minimum = 12, maximum = 72, higher score is worse outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=17 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=17 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Social Distance Scale (SDS) - Baseline	33.8 Scores on a scale Standard Deviation 12.1	36.5 Scores on a scale Standard Deviation 12.5

PRIMARY outcome

Timeframe: 4 months Post-Training

Population: 5 from PRIME and 5 from PRIME+RESHAPE dropped out between baseline and midline (i.e 4-months post-training)

Health Provider Outcome: 12-item scale of willingness to interact with persons with mental illness, minimum = 12, maximum = 72, higher score is worse outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=16 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=16 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Social Distance Scale (SDS) - 4 Months Post-training	31.3 Scores on a scale Standard Deviation 14.1	25.9 Scores on a scale Standard Deviation 12.0

PRIMARY outcome

Timeframe: 16 months post-training

Population: 12 PCP/3 health facility from PRIME and 10 PCP/2 health facility from RESHAPE dropped out between baseline to 16 months-post training follow-up

Health Provider Outcome: 12-item scale of willingness to interact with persons with mental illness, minimum = 12, maximum = 72, higher score is worse outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=14 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=15 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Social Distance Scale (SDS) - 16 Months Post-training	31.4 Score on a scale Standard Deviation 14.6	25.9 Score on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: Baseline

Health worker outcome: Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=17 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=17 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Mental Health Gap Action Programme - Knowledge Test - Baseline	65 Score on a scale Standard Deviation 11.4	63.9 Score on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: 4 months post-training

Population: 5 PCP/1 health facility from PRIME and 5 PCP/1 health facility from RESHAPE dropped out between baseline to 4 months-post training follow-up

Health worker outcome: Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=16 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=16 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Mental Health Gap Action Programme - Knowledge Test - 4 Months Post-training	78.3 Score on a scale Standard Deviation 8.93	83.7 Score on a scale Standard Deviation 7.18

SECONDARY outcome

Timeframe: 16 months post-training

Population: 12 PCP/3 health facility from PRIME and 10 PCP/2 health facility from RESHAPE dropped out between baseline to 16 months-post training follow-up

Health worker outcome: Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=14 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=15 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Mental Health Gap Action Programme - Knowledge Test - 16 Months Post-training	77.6 Score on a Scale Standard Deviation 10.1	80.4 Score on a Scale Standard Deviation 9.57

SECONDARY outcome

Timeframe: Baseline

Computer-based neuropsychological assessment of implicit bias related to mental illness, minimum -1 to maximum 1. , score is D-score based on comparison of timing; positive scores equal more bias. Related to harmful domain. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=17 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=17 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Implicit Association Test (IAT) Harmful - Baseline	0.17 d score Standard Deviation 0.43	0.12 d score Standard Deviation 0.33

SECONDARY outcome

Timeframe: 4 months post training

Population: 5 PCP/1 health facility from PRIME and 5 PCP/1 health facility from RESHAPE dropped out between baseline to 4 months-post training follow-up

Computer-based neuropsychological assessment of implicit bias related to mental illness, minimum -1 to maximum 1. , score is D-score based on comparison of timing; positive scores equal more bias. Related to harmful domain. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=16 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=16 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Implicit Association Test (IAT) Harmful - 4 Months Post Training	0.08 d score Standard Deviation 0.39	0.06 d score Standard Deviation 0.30

SECONDARY outcome

Timeframe: 16 months post training

Population: 12 PCP/3 health facility from PRIME and 10 PCP/2 health facility from RESHAPE dropped out between baseline to 16 months-post training follow-up

Computer-based neuropsychological assessment of implicit bias related to mental illness, minimum -1 to maximum 1. , score is D-score based on comparison of timing; positive scores equal more bias. Related to harmful domain. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=14 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=15 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Implicit Association Test (IAT) Harmful - 16 Months Post Training	0.04 d score Standard Deviation 0.31	0.03 d score Standard Deviation 0.32

SECONDARY outcome

Timeframe: Baseline

Observed structured clinical evaluation using a standardized role play, shows clinical competence. minimum score = 0, maximum = 100, higher scores are better. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=17 Primary care facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=17 Primary care facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Enhancing Assessment of Common Therapeutic Factors - Baseline	48.2 Score on a scale Standard Deviation 26.7	39.6 Score on a scale Standard Deviation 24.4

SECONDARY outcome

Timeframe: 4 months post-training

Population: 5 PCP/1 health facility from PRIME and 5 PCP/1 health facility from RESHAPE dropped out between baseline to 4 months-post training follow-up

Observed structured clinical evaluation using a standardized role play, shows clinical competence. minimum score = 0, maximum = 100, higher scores are better

Outcome measures

Outcome measures
Measure	PRIME n=16 Primary care facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=16 Primary care facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Enhancing Assessment of Common Therapeutic Factors - 4 Months Post-training	78.3 Score on a scale Standard Deviation 8.93	83.7 Score on a scale Standard Deviation 7.18

SECONDARY outcome

Timeframe: 16 months post-training

Population: 12 PCP/3 health facility from PRIME and 10 PCP/2 health facility from RESHAPE dropped out between baseline to 16 months-post training follow-up

Observed structured clinical evaluation using a standardized role play, shows clinical competence. minimum score = 0, maximum = 100, higher scores are better

Outcome measures

Outcome measures
Measure	PRIME n=14 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=15 Primary Health Facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Enhancing Assessment of Common Therapeutic Factors - 16 Months Post-training	90.9 Score on a scale Standard Deviation 10.6	87.2 Score on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline

Health Provider Outcome: attitudinal questions related to mental illnesses including depression, psychosis, epilepsy, and alcohol use. Minimum = 1, Maximum = 3 \[Higher number means more stigma\]. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=17 Primary health facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=17 Primary health facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Mental Health Gap Action Program - Attitudes Questionnaire - Baseline	1.77 Score on a scale Standard Deviation 0.30	1.72 Score on a scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: 4 months post-training

Population: 5 PCP/1 health facility from PRIME and 5 PCP/1 health facility from RESHAPE dropped out between baseline to 4 months-post training follow-up

Health Provider Outcome: attitudinal questions related to mental illnesses including depression, psychosis, epilepsy, and alcohol use. Minimum = 1, Maximum = 3 \[Higher number means more stigma\]. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=16 Primary health facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=16 Primary health facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Mental Health Gap Action Program - Attitudes Questionnaire - 4 Months Post-training	1.62 Score on a scale Standard Deviation 0.23	1.47 Score on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: 16 months post-training

Population: 12 PCP/3 health facility from PRIME and 10 PCP/2 health facility from RESHAPE dropped out between baseline to 16 months-post training follow-up

Health Provider Outcome: attitudinal questions related to mental illnesses including depression, psychosis, epilepsy, and alcohol use. Minimum = 1, Maximum = 3 \[Higher number means more stigma\]. Data collected at 3 points: Pre-training , 4 months post-training, 16 months post-training.

Outcome measures

Outcome measures
Measure	PRIME n=14 Primary health facilities The behavioral intervention will be the PRIME/mhGAP training. This is standard mental health training for prescribers (primary care workers who can prescribe psychotropic medication, e.g., health assistants) and non-prescribers (primary care workers who cannot prescribe medications, e.g., auxilliary nurse midwives). For prescribers, training includes introduction to psychosocial techniques and mhGAP. For non-prescribers, training includes psychosocial techniques.	PRIME+RESHAPE n=15 Primary health facilities The behavioral intervention will be the PRIME/mhGAP training plus the RESHAPE training adjunct. This is the PRIME training plus social contact component in which mental health service users participate as training co-facilitators. The intended goal of the additional component is to reduce stigma against persons with mental illness.
Mental Health Gap Action Program - Attitudes Questionnaire - 16 Months Post-training	1.51 Score on a scale Standard Deviation 0.23	1.48 Score on a scale Standard Deviation 0.22

Adverse Events

PRIME

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRIME+RESHAPE

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

Brandon Kohrt

George Washington University

Phone: 2027412896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place