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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

3-months post-baseline assessment

Results posted on

2025-02-10

Participant Flow

Participant milestones

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

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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Population: 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

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 assessment

Patient 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 assessment

Population: 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

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 assessment

Population: 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

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Siyakhana - P (Healthcare Workers)

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Enhanced Treatment as Usual (Patients)

Serious events: 4 serious events
Other events: 0 other events
Deaths: 3 deaths

Siyakhana - P (Patients)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 301-405-5095

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place