Trial Outcomes & Findings for Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care (NCT NCT05907174)
NCT ID: NCT05907174
Last Updated: 2025-02-10
Results Overview
Healthcare worker stigma towards substance use measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (higher stigma).
COMPLETED
NA
91 participants
3-months post-baseline assessment
2025-02-10
Participant Flow
Participant milestones
| Measure |
Enhanced Treatment as Usual (Healthcare Workers)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Patients)
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
|---|---|---|---|---|
|
Baseline & COPC Team-Level Randomization
STARTED
|
20
|
21
|
25
|
25
|
|
Baseline & COPC Team-Level Randomization
COMPLETED
|
20
|
21
|
25
|
25
|
|
Baseline & COPC Team-Level Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
3-Month Assessment
STARTED
|
20
|
21
|
25
|
25
|
|
3-Month Assessment
COMPLETED
|
19
|
20
|
24
|
23
|
|
3-Month Assessment
NOT COMPLETED
|
1
|
1
|
1
|
2
|
|
6-Month Assessment
STARTED
|
20
|
21
|
25
|
24
|
|
6-Month Assessment
COMPLETED
|
20
|
20
|
20
|
22
|
|
6-Month Assessment
NOT COMPLETED
|
0
|
1
|
5
|
2
|
Reasons for withdrawal
| Measure |
Enhanced Treatment as Usual (Healthcare Workers)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Patients)
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
|---|---|---|---|---|
|
3-Month Assessment
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
3-Month Assessment
Lost to Follow-up
|
1
|
1
|
1
|
1
|
|
6-Month Assessment
Death
|
0
|
0
|
3
|
0
|
|
6-Month Assessment
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
6-Month Assessment
Lost to Follow-up
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care
Baseline characteristics by cohort
| Measure |
Enhanced Treatment as Usual (Healthcare Workers)
n=20 Participants
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
n=21 Participants
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
n=25 Participants
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Patients)
n=25 Participants
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.10 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
43.33 years
STANDARD_DEVIATION 8.59 • n=7 Participants
|
44.88 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
41.84 years
STANDARD_DEVIATION 10.91 • n=4 Participants
|
42.86 years
STANDARD_DEVIATION 9.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black African
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Coloured (South African category)
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
91 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3-months post-baseline assessmentPopulation: Only healthcare worker participants completed this measure.
Healthcare worker stigma towards substance use measured using the Social Distance Scale (SDS). SDS scores range from 6 to 24, with higher scores indicating more desired social distance (higher stigma).
Outcome measures
| Measure |
Siyakhana - P (Patients)
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Healthcare Workers)
n=19 Participants
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
n=20 Participants
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
|---|---|---|---|---|
|
Healthcare Worker Substance Use Stigma
|
—
|
11.63 score on a scale
Standard Deviation 2.87
|
9.95 score on a scale
Standard Deviation 2.93
|
—
|
SECONDARY outcome
Timeframe: 6-months post-integration assessmentPopulation: Only healthcare participants in the Siyakhana-P condition completed this measure. Of the n = 20 who completed the 6-month assessment, n = 2 never worked directly with the PRC and therefore did not complete this measure. Therefore, data from n = 18 participants was analyzed.
Feasibility subscale of the JHU Applied Mental Health Research (AMHR) D\&I Measure, a 10-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by healthcare worker participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower feasibility and higher scores (closer to 3) indicating higher feasibility. Findings will be supplemented with qualitative interviews.
Outcome measures
| Measure |
Siyakhana - P (Patients)
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Healthcare Workers)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
n=18 Participants
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
|---|---|---|---|---|
|
Healthcare Worker Feasibility (Intervention Arm Only)
|
—
|
—
|
2.35 score on a scale
Standard Deviation 0.63
|
—
|
SECONDARY outcome
Timeframe: 6-months post-integration assessmentPopulation: Only healthcare participants in the Siyakhana-P condition completed this measure. Of the n = 20 who completed the 6-month assessment, n = 2 never worked directly with the PRC and therefore did not complete this measure. Therefore, data from n = 18 participants was analyzed.
Acceptability subscale of the JHU Applied Mental Health Research (AMHR) D\&I Measure, a 14-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by healthcare worker participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower acceptability and higher scores (closer to 3) indicating higher acceptability. Findings will be supplemented with qualitative interviews.
Outcome measures
| Measure |
Siyakhana - P (Patients)
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Healthcare Workers)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
n=18 Participants
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
|---|---|---|---|---|
|
Healthcare Worker Acceptability (Intervention Arm Only)
|
—
|
—
|
2.46 score on a scale
Standard Deviation 0.58
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-months post-baseline assessmentPatient HIV care re-engagement (dichotomous yes/no), assessed via clinic records.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-months post-baseline assessmentPopulation: Only patient participants in the Siyakhana - P intervention condition completed this measure. Of the n=23 Siyakhana - P patient participants who completed the 3-Month Assessment, n=1 never met with the PRC and therefore did not answer the questions. Therefore, a total of n=22 participants are included in this analysis.
Feasibility subscale of the JHU Applied Mental Health Research (AMHR) D\&I Measure, a 14-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by patient participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower feasibility and higher scores (closer to 3) indicating higher feasibility. Findings will be supplemented with qualitative interviews.
Outcome measures
| Measure |
Siyakhana - P (Patients)
n=22 Participants
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Healthcare Workers)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
|---|---|---|---|---|
|
Patient Feasibility (Intervention Arm Only)
|
2.77 score on a scale
Standard Deviation 0.24
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-months post-baseline assessmentPopulation: Only patient participants in the Siyakhana - P intervention condition completed this measure. Of the n=23 Siyakhana - P patient participants who completed the 3-Month Assessment, n=1 never met with the PRC and therefore did not answer the questions. Therefore, a total of n=22 participants are included in this analysis.
Acceptability subscale of the JHU Applied Mental Health Research (AMHR) D\&I Measure, a 12-item measure for assessing dissemination and implementation outcomes in low- and middle-income settings, completed by patient participants. Items are rated on a 0-3 scale, and averaged, with lower scores (closer to 0) indicating lower acceptability and higher scores (closer to 3) indicating higher acceptability. Findings will be supplemented with qualitative interviews.
Outcome measures
| Measure |
Siyakhana - P (Patients)
n=22 Participants
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Healthcare Workers)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
|---|---|---|---|---|
|
Patient Acceptability (Intervention Arm Only)
|
2.86 score on a scale
Standard Deviation 0.28
|
—
|
—
|
—
|
Adverse Events
Enhanced Treatment as Usual (Healthcare Workers)
Siyakhana - P (Healthcare Workers)
Enhanced Treatment as Usual (Patients)
Siyakhana - P (Patients)
Serious adverse events
| Measure |
Enhanced Treatment as Usual (Healthcare Workers)
n=20 participants at risk
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
n=21 participants at risk
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
n=25 participants at risk
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Patients)
n=25 participants at risk
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/20 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
4.8%
1/21 • Number of events 1 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
12.0%
3/25 • Number of events 3 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
0.00%
0/25 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/20 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
0.00%
0/21 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
4.0%
1/25 • Number of events 1 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
0.00%
0/25 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
Other adverse events
| Measure |
Enhanced Treatment as Usual (Healthcare Workers)
n=20 participants at risk
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Healthcare Workers)
n=21 participants at risk
Providers working with PRC. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
Enhanced Treatment as Usual (Patients)
n=25 participants at risk
Monitoring of treatment as usual (i.e., routine interactions between healthcare workers and patients). Treatment as usual will be enhanced by providing healthcare workers with a substance use psychoeducation and screening training.
|
Siyakhana - P (Patients)
n=25 participants at risk
Patients seen by the team of health care workers with an integrated PRC. Patients will have the opportunity to meet with the PRC for about 3-months after their baseline assessment. Siyakhana - P healthcare workers will also receive a substance use psychoeducation and screening training, and a workshop for healthcare workers to get to know the PRC and learn more about the PRC role.
Siyakhana - P: A trained peer recovery coach (PRC) will be integrated onto the healthcare worker team randomized to Siyakhana - P. The PRC on this team will work with eligible and consenting patients who are seen by members of this healthcare team.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Birth in hospital, infant death
|
0.00%
0/20 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
0.00%
0/21 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
0.00%
0/25 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
4.0%
1/25 • Number of events 1 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
|
Psychiatric disorders
Suicidal Thoughts
|
0.00%
0/20 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
0.00%
0/21 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
0.00%
0/25 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
4.0%
1/25 • Number of events 1 • Adverse events are monitored an average of 15 months for each participant, from signing of informed consent to the final follow-up.
|
Additional Information
Dr. Jessica Magidson
University of Maryland, College Park
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place