| Primary | Changes in HIV Medication Adherence Throughout Intervention Phase | Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device | | Posted | | Mean | Standard Deviation | percentage of days adherent to Wisepill | | Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00060.0± 37.1
- OG00128.2± 32.1
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | .01 | | Mean Difference (Net) | -.287 | | | 2-Sided | 95 | -.507 | -.066 | | | | | Superiority | | |
|
| Primary | Biological Measure of Substance Use | Substance use measured with urinalysis. | | Posted | | Count of Participants | | Participants | | Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Primary | Biological Measure of Substance Use | 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. | | Posted | | Mean | Standard Deviation | ng/mL | | Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Primary | Changes in Self-reported Substance Use | 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. | | Posted | | Count of Participants | | Participants | | Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Biological Measure of Substance Use | Substance use measured with urinalysis. | | Posted | | Count of Participants | | Participants | | Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Biological Measure of Substance Use | 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. | | Posted | | Mean | Standard Deviation | ng/mL | | Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Changes in Self-reported Substance Use | 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. | | Posted | | Count of Participants | | Participants | | Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Intervention Acceptability | 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. | | Posted | | Mean | Standard Deviation | average score on a scale | | Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Intervention Feasibility | 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. | | Posted | | Mean | Standard Deviation | average score on a scale | | Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Intervention Fidelity | 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). | | Posted | | Mean | Standard Deviation | Percentage fidelity to treatment | | Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | Treatment session recordings | Treatment session recordings | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Intervention Uptake | Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants) | | Posted | | Mean | Standard Deviation | Sessions attended | | Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Other Pre-specified | HIV Viral Load | Percentage of patients with a suppressed viral load (<400 copies/ml) | | Posted | | Count of Participants | | Participants | | Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Other Pre-specified | Changes in Self-reported Substance Use | Changes in percent days used any substance measured by timeline follow-back | | Posted | | Mean | Standard Deviation | percentage of days used any substance | | Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Other Pre-specified | Changes in Self-reported Substance Use | Changes in number of drinks measured by timeline follow-back | | Posted | | Mean | Standard Deviation | number of drinks on days drinking | | Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|