Trial Outcomes & Findings for Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa (NCT NCT03529409)
NCT ID: NCT03529409
Last Updated: 2022-05-18
Results Overview
Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Results posted on
2022-05-18
Participant Flow
Participant milestones
| Measure |
Project Khanya
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
Pre-Randomization
Participants enrolled in the study at the baseline assessment, but who were never randomized (approximately 2 weeks post-baseline) and therefore did not continue with the study.
|
|---|---|---|---|
|
Randomized
STARTED
|
30
|
31
|
5
|
|
Randomized
COMPLETED
|
30
|
31
|
0
|
|
Randomized
NOT COMPLETED
|
0
|
0
|
5
|
|
Post-treatment Assessment
STARTED
|
30
|
31
|
0
|
|
Post-treatment Assessment
COMPLETED
|
26
|
26
|
0
|
|
Post-treatment Assessment
NOT COMPLETED
|
4
|
5
|
0
|
|
Follow-up Assessment
STARTED
|
28
|
30
|
0
|
|
Follow-up Assessment
COMPLETED
|
27
|
29
|
0
|
|
Follow-up Assessment
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Project Khanya
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
Pre-Randomization
Participants enrolled in the study at the baseline assessment, but who were never randomized (approximately 2 weeks post-baseline) and therefore did not continue with the study.
|
|---|---|---|---|
|
Randomized
Lost to Follow-up
|
0
|
0
|
4
|
|
Randomized
Excluded
|
0
|
0
|
1
|
|
Post-treatment Assessment
Death
|
1
|
0
|
0
|
|
Post-treatment Assessment
Lost to Follow-up
|
1
|
1
|
0
|
|
Post-treatment Assessment
Unable to contact for this assessment, but attended later assessments
|
2
|
4
|
0
|
|
Follow-up Assessment
Death
|
1
|
0
|
0
|
|
Follow-up Assessment
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
HIV medication adherence was assessed between baseline and randomization visits. As the pre-randomization participants did not attend randomization, HIV medication adherence could not be calculated.
Baseline characteristics by cohort
| Measure |
Project Khanya
n=30 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=31 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
Pre-Randomization
n=5 Participants
Participants enrolled in the study at the baseline assessment, but who were never randomized (approximately 2 weeks post-baseline) and did not continue with the study.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.80 years
STANDARD_DEVIATION 10.47 • n=30 Participants
|
34.29 years
STANDARD_DEVIATION 7.99 • n=31 Participants
|
31.60 years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
36.59 years
STANDARD_DEVIATION 9.66 • n=66 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=30 Participants
|
20 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
36 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=30 Participants
|
11 Participants
n=31 Participants
|
2 Participants
n=5 Participants
|
30 Participants
n=66 Participants
|
|
Race/Ethnicity, Customized
Black African
|
29 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
5 Participants
n=5 Participants
|
65 Participants
n=66 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
1 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=66 Participants
|
|
Region of Enrollment
South Africa
|
30 participants
n=30 Participants
|
31 participants
n=31 Participants
|
5 participants
n=5 Participants
|
66 participants
n=66 Participants
|
|
HIV medication adherence
|
53.6 percentage of days adherent
STANDARD_DEVIATION 32.1 • n=30 Participants • HIV medication adherence was assessed between baseline and randomization visits. As the pre-randomization participants did not attend randomization, HIV medication adherence could not be calculated.
|
49.3 percentage of days adherent
STANDARD_DEVIATION 29.8 • n=31 Participants • HIV medication adherence was assessed between baseline and randomization visits. As the pre-randomization participants did not attend randomization, HIV medication adherence could not be calculated.
|
—
|
46.60 percentage of days adherent
STANDARD_DEVIATION 31.56 • n=61 Participants • HIV medication adherence was assessed between baseline and randomization visits. As the pre-randomization participants did not attend randomization, HIV medication adherence could not be calculated.
|
|
Positive alcohol or drug urine test result
|
27 Participants
n=30 Participants
|
29 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
60 Participants
n=66 Participants
|
|
Phosphatidylethanol (PEth) concentration
|
686.0 ng/ML
STANDARD_DEVIATION 639.9 • n=30 Participants
|
456.1 ng/ML
STANDARD_DEVIATION 530.8 • n=31 Participants
|
370.8 ng/ML
STANDARD_DEVIATION 418.4 • n=5 Participants
|
554.1 ng/ML
STANDARD_DEVIATION 582.0 • n=66 Participants
|
|
Moderate or high-risk on Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) measure
|
30 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
5 Participants
n=5 Participants
|
66 Participants
n=66 Participants
|
|
Suppressed viral load, <400 copies/ml
|
15 Participants
n=30 Participants
|
24 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
42 Participants
n=66 Participants
|
|
Consumed any substance on timeline followback
|
38.81 percentage of days
STANDARD_DEVIATION 24.58 • n=30 Participants
|
29.49 percentage of days
STANDARD_DEVIATION 21.72 • n=31 Participants
|
42.86 percentage of days
STANDARD_DEVIATION 35.36 • n=5 Participants
|
37.74 percentage of days
STANDARD_DEVIATION 24.29 • n=66 Participants
|
|
Number of drinks on days drinking on timeline followback
|
7.17 number of drinks
STANDARD_DEVIATION 3.79 • n=30 Participants • One participant did not complete the measure because reported no alcohol consumption
|
8.03 number of drinks
STANDARD_DEVIATION 5.59 • n=30 Participants • One participant did not complete the measure because reported no alcohol consumption
|
5.37 number of drinks
STANDARD_DEVIATION 6.24 • n=5 Participants • One participant did not complete the measure because reported no alcohol consumption
|
7.43 number of drinks
STANDARD_DEVIATION 4.86 • n=65 Participants • One participant did not complete the measure because reported no alcohol consumption
|
PRIMARY outcome
Timeframe: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
Outcome measures
| Measure |
Project Khanya
n=30 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=31 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Changes in HIV Medication Adherence Throughout Intervention Phase
|
60.0 percentage of days adherent to Wisepill
Standard Deviation 37.1
|
28.2 percentage of days adherent to Wisepill
Standard Deviation 32.1
|
PRIMARY outcome
Timeframe: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)Substance use measured with urinalysis.
Outcome measures
| Measure |
Project Khanya
n=26 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=26 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Biological Measure of Substance Use
Negative
|
1 Participants
|
3 Participants
|
|
Biological Measure of Substance Use
Positive
|
25 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
Outcome measures
| Measure |
Project Khanya
n=26 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=25 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Biological Measure of Substance Use
|
484.2 ng/mL
Standard Deviation 398.7
|
414.7 ng/mL
Standard Deviation 389.6
|
PRIMARY outcome
Timeframe: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (\> 26) for substance use-related problems.
Outcome measures
| Measure |
Project Khanya
n=26 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=26 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Changes in Self-reported Substance Use
moderate or high risk
|
23 Participants
|
25 Participants
|
|
Changes in Self-reported Substance Use
low risk
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)Substance use measured with urinalysis.
Outcome measures
| Measure |
Project Khanya
n=27 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=29 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Biological Measure of Substance Use
Positive
|
20 Participants
|
24 Participants
|
|
Biological Measure of Substance Use
Negative
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
Outcome measures
| Measure |
Project Khanya
n=25 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=29 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Biological Measure of Substance Use
|
538.4 ng/mL
Standard Deviation 554.4
|
386.1 ng/mL
Standard Deviation 392.6
|
SECONDARY outcome
Timeframe: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (\> 26) for substance use-related problems.
Outcome measures
| Measure |
Project Khanya
n=27 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=29 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Changes in Self-reported Substance Use
moderate or high risk
|
24 Participants
|
22 Participants
|
|
Changes in Self-reported Substance Use
low risk
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)15-item acceptability subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability. Qualitative interviews will also be conducted with intervention participants at the end of the study to assess acceptability guided by RE-AIM and the Proctor model.
Outcome measures
| Measure |
Project Khanya
n=26 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Intervention Acceptability
|
2.98 average score on a scale
Standard Deviation .04
|
—
|
SECONDARY outcome
Timeframe: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)14-item feasibility subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater feasibility. Qualitative interviews will also be conducted with intervention participants at the end of the study to assess feasibility guided by RE-AIM and the Proctor model.
Outcome measures
| Measure |
Project Khanya
n=26 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Intervention Feasibility
|
2.98 average score on a scale
Standard Deviation .18
|
—
|
SECONDARY outcome
Timeframe: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)Independent fidelity ratings of a randomly selected subset (20%) of intervention sessions using a fidelity assessment developed for each session that includes 15-19 items that map onto each core intervention component, and factors unique to the peer delivery implementation strategy (i.e., appropriate self-disclosure, stigmatizing behaviors, common factors including warmth and non-judgment).
Outcome measures
| Measure |
Project Khanya
n=36 Treatment session recordings
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Intervention Fidelity
|
91.7 Percentage fidelity to treatment
Standard Deviation 13.3
|
—
|
SECONDARY outcome
Timeframe: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants)
Outcome measures
| Measure |
Project Khanya
n=30 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Intervention Uptake
|
4.77 Sessions attended
Standard Deviation 1.96
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)Percentage of patients with a suppressed viral load (\<400 copies/ml)
Outcome measures
| Measure |
Project Khanya
n=27 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=29 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
HIV Viral Load
Suppressed
|
16 Participants
|
22 Participants
|
|
HIV Viral Load
Unsuppressed
|
11 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)Changes in percent days used any substance measured by timeline follow-back
Outcome measures
| Measure |
Project Khanya
n=27 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=29 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
|
|---|---|---|
|
Changes in Self-reported Substance Use
|
30.7 percentage of days used any substance
Standard Deviation 25.9
|
25.1 percentage of days used any substance
Standard Deviation 23.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)Changes in number of drinks measured by timeline follow-back
Outcome measures
| Measure |
Project Khanya
n=27 Participants
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
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ESOC
n=29 Participants
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
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|---|---|---|
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Changes in Self-reported Substance Use
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4.61 number of drinks on days drinking
Standard Deviation 3.29
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4.96 number of drinks on days drinking
Standard Deviation 4.25
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Adverse Events
Project Khanya
Serious events: 8 serious events
Other events: 0 other events
Deaths: 2 deaths
ESOC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-Randomization
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Project Khanya
n=30 participants at risk
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Project Khanya: This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
|
ESOC
n=31 participants at risk
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.
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Pre-Randomization
n=5 participants at risk
Participants enrolled in the study at the baseline assessment, but who were never randomized (approximately 2 weeks post-baseline) and did not continue with the study.
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|---|---|---|---|
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Psychiatric disorders
Hospitalization
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3.3%
1/30 • Number of events 1 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/31 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/5 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
|
Surgical and medical procedures
Hospitalization
|
3.3%
1/30 • Number of events 1 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/31 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/5 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization
|
3.3%
1/30 • Number of events 1 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/31 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/5 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
|
General disorders
Hospitalization
|
0.00%
0/30 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/31 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
20.0%
1/5 • Number of events 1 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
|
General disorders
Death
|
6.7%
2/30 • Number of events 2 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/31 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/5 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
|
Injury, poisoning and procedural complications
Hospitalization
|
3.3%
1/30 • Number of events 1 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/31 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/5 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
6.7%
2/30 • Number of events 2 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/31 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
0.00%
0/5 • While participants were active in the study (informed consent at baseline assessment until 6-month follow-up; approximately 6 months)
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jessica Magidson
University of Maryland, College Park
Phone: 301-405-5095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place