- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03529409
Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cape Town, South Africa, 7700
- University of Cape Town
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Maryland
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College Park, Maryland, United States, 20742
- University of Maryland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV positive and on ART
- 18-65 years of age
- Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or greater than or equal to 11 for alcohol)
Have at least one of the following:
- Not attained viral suppression from first line ART (VL>400 copies/mL)
- On second-line ART treatment
- Reinitiated first-line treatment within the past three months
- Had a pharmacy non-refill at least once in the past 3 months
Exclusion Criteria:
- Inability to provide informed consent or complete procedures in English or isiXhosa
- Severe risk/likely dependence for opiates (ASSIST score >26) because opiate substitution therapy may not be available
- Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms
- Active, untreated, major mental illness (with untreated psychosis or mania) that would interfere with the paraprofessional adapted intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Changes in HIV Medication Adherence Throughout Intervention Phase
Time Frame: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
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Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Biological Measure of Substance Use
Time Frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Substance use measured with urinalysis.
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Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Biological Measure of Substance Use
Time Frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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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.
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Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Changes in Self-reported Substance Use
Time Frame: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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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.
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Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biological Measure of Substance Use
Time Frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Substance use measured with urinalysis.
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Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Biological Measure of Substance Use
Time Frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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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.
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Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in Self-reported Substance Use
Time Frame: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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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.
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Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Intervention Acceptability
Time Frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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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. |
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention Feasibility
Time Frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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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. |
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention Fidelity
Time Frame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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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).
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Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention Uptake
Time Frame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants)
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Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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HIV Viral Load
Time Frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Percentage of patients with a suppressed viral load (<400 copies/ml)
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Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in Self-reported Substance Use
Time Frame: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in percent days used any substance measured by timeline follow-back
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Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in Self-reported Substance Use
Time Frame: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Changes in number of drinks measured by timeline follow-back
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Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
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Collaborators and Investigators
Publications and helpful links
General Publications
- Belus JM, Rose AL, Andersen LS, Ciya N, Joska JA, Myers B, Safren SA, Magidson JF. Adapting a Behavioral Intervention for Alcohol Use and HIV Medication Adherence for Lay Counselor Delivery in Cape Town, South Africa: A Case Series. Cogn Behav Pract. 2022 May;29(2):454-467. doi: 10.1016/j.cbpra.2020.10.003. Epub 2020 Nov 10.
- Belus JM, Joska JA, Bronsteyn Y, Rose AL, Andersen LS, Regenauer KS, Myers B, Hahn JA, Orrell C, Safren SA, Magidson JF. Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa. AIDS Behav. 2022 Nov;26(11):3630-3641. doi: 10.1007/s10461-022-03765-8. Epub 2022 Jul 27.
- Magidson JF, Joska JA, Belus JM, Andersen LS, Regenauer KS, Rose AL, Myers B, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa. J Int AIDS Soc. 2021 Jun;24 Suppl 2:e25720. doi: 10.1002/jia2.25720.
- Magidson JF, Joska JA, Myers B, Belus JM, Regenauer KS, Andersen LS, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa. Implement Sci Commun. 2020;1:23. doi: 10.1186/s43058-020-00004-w. Epub 2020 Mar 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- Substance-Related Disorders
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Alcohol-Related Disorders
Other Study ID Numbers
- 187/2018
- K23DA041901 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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