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Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa

Primary Purpose

Human Immunodeficiency Virus, Alcohol-Related Disorders, Drug Use

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Khanya
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Immunodeficiency Virus focused on measuring Immunologic Deficiency Syndrome, Substance Use, Acquired Immunodeficiency Syndrome, Immune system diseases, behavioral symptoms, RNA Virus Infections, HIV Infections, Alcohol Use, Drug Use, Treatment Adherence and Compliance, Delivery and Health Care, Task Sharing, Mental Health, Global Health, South Africa, Cost Effectiveness, Implementation Science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV positive and on ART ≥18 years of age At least moderate substance use risk in the past 3 months for at least one non-tobacco substance (measured by the WHO- ASSIST: score ≥11 for alcohol, ≥4 for non-tobacco drugs) ART nonadherence and/or risk of virologic failure, defined as at least one of the following in the past 12 months 1) re-engaging in care after ≥1 month of being out of care (confirmed by pharmacy refill data) 2) ≥1 episodes of VL >400 copies/mL 3) on second- or third-line ARTs. Exclusion Criteria: Severe risk/likely dependence for opiates (WHO ASSIST score >26) because opiate substitution therapy is largely not available Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms/stabilization prior to study participation Inability to provide informed consent or complete study procedures in isiXhosa or English In third trimester of pregnancy during baseline Currently enrolled in another study or treatment program focused on substance use (including Matrix) or ART adherence. Untreated or undertreated major mental illness that would interfere with study procedures

Sites / Locations

  • University of Cape TownRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Khanya

Enhanced Standard of Care (ESOC)

Arm Description

Khanya is a peer-delivered, behavioral intervention to improve HIV medication adherence and reduce problematic SUD symptoms. Khanya is delivered as a stepped-care package in which the least resource-intensive part of the intervention (i.e., Life-Steps, a single session problem solving intervention for HIV medication adherence) will be delivered first. Only individuals randomized to the Khanya intervention who are still struggling with HIV medication adherence after the first session will be stepped up to receive the more comprehensive, resource-intensive part of the intervention (i.e., six additional sessions of the intervention). Khanya Step 2 includes evidence-based treatment components to improve ART adherence and SU, including motivational interviewing, behavioral activation, and mindfulness-based relapse prevention strategies, which have previously been piloted in this community.

Enhanced Standard of Care (ESOC) includes the local standard of care, which is referral to a free local outpatient substance use treatment program, enhanced with facilitated referrals. To enhance the standard of care, study staff will provide participants with a detailed description of the program's referral process and offer to help the participant set up an intake at the program. Additionally, the team will follow up on the referral. Participants in this arm will also receive Wisepill, a wireless adherence monitoring advice, at the baseline assessment.

Outcomes

Primary Outcome Measures

Changes in HIV Medication Adherence Throughout Intervention Phase
Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device
Biological Measure of Substance Use After intervention
Urine toxicology-verified substance use at the acute post-intervention assessment.

Secondary Outcome Measures

Changes in HIV Medication Adherence Over Follow-Up
Percentage of prescribed antiretroviral therapy (medications) taken as prescribed measured using real-time wireless monitoring (Wisepill)
Biological Measure of Substance Use Over Follow-Up
Urine toxicology-verified substance use
Changes in Self-Reported Substance Use
Self-reported substance use will be assessed primarily by the 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.
Biological Measure of Adherence
Biomarker-confirmed ART adherence will be measured with Dried Blood Spot (DBS) analysis of tenofovir diphosphate (TDF-DiP).
HIV Clinic Attendance
Number of days participants in each condition were on-time to, late to, or missed an HIV clinic appointment (extracted from clinic records).
HIV Viral Load
Percentage of patients with a detectable viral load

Full Information

First Posted
June 27, 2023
Last Updated
July 7, 2023
Sponsor
University of Maryland, College Park
Collaborators
University of Cape Town, National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05933226
Brief Title
Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa
Official Title
A Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
Collaborators
University of Cape Town, National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate a stepped care behavioral intervention for HIV medication adherence and substance use ("Khanya") integrated into an HIV primary care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors with lived substance use experience (i.e., peers), using a task sharing, stepped care model in local primary care clinics. The Khanya stepped care package will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) over 12 months.
Detailed Description
South Africa is home the highest number of people living with HIV in the world and has a high burden of substance use disorder (SUD). Globally, a SUD treatment gap exists, particularly in low and middle-income countries (LMICs), such as South Africa, where only 1-4% of individuals receive minimally adequate treatment. Workforce shortages are also severe in LMICS, and countries such as South Africa have responded to this through the implementation of task sharing models to expand access to antiretroviral therapy (ART) and mental health services. However, efforts to implement task shared, SUD treatment and ART adherence interventions that can be feasibly and sustainably integrated into primary care are limited. Therefore, the purpose of this study is to help fill this gap in care by evaluating Khanya, a peer-delivered, behavioral intervention to improve HIV care outcomes and reduce substance use. The present study is a hybrid effectiveness-implementation trial designed to evaluate Khanya compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) over 12 months. To provide care for those most in need, participants will be patients with HIV who are struggling with ART adherence and have elevated SUD risk. In this study, Khanya will be delivered as a stepped-care package in which the least resource-intensive part of the intervention (i.e., a single session problem solving intervention for HIV medication adherence) will be delivered first. Only individuals randomized to the Khanya intervention who are still struggling with HIV medication adherence after the first session will be stepped up to receive the more comprehensive, resource-intensive part of the intervention (i.e., six additional sessions of the intervention). Primary effectiveness outcomes in this clinical trial include ART adherence and SUD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Alcohol-Related Disorders, Drug Use, Substance Use
Keywords
Immunologic Deficiency Syndrome, Substance Use, Acquired Immunodeficiency Syndrome, Immune system diseases, behavioral symptoms, RNA Virus Infections, HIV Infections, Alcohol Use, Drug Use, Treatment Adherence and Compliance, Delivery and Health Care, Task Sharing, Mental Health, Global Health, South Africa, Cost Effectiveness, Implementation Science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Khanya
Arm Type
Experimental
Arm Description
Khanya is a peer-delivered, behavioral intervention to improve HIV medication adherence and reduce problematic SUD symptoms. Khanya is delivered as a stepped-care package in which the least resource-intensive part of the intervention (i.e., Life-Steps, a single session problem solving intervention for HIV medication adherence) will be delivered first. Only individuals randomized to the Khanya intervention who are still struggling with HIV medication adherence after the first session will be stepped up to receive the more comprehensive, resource-intensive part of the intervention (i.e., six additional sessions of the intervention). Khanya Step 2 includes evidence-based treatment components to improve ART adherence and SU, including motivational interviewing, behavioral activation, and mindfulness-based relapse prevention strategies, which have previously been piloted in this community.
Arm Title
Enhanced Standard of Care (ESOC)
Arm Type
No Intervention
Arm Description
Enhanced Standard of Care (ESOC) includes the local standard of care, which is referral to a free local outpatient substance use treatment program, enhanced with facilitated referrals. To enhance the standard of care, study staff will provide participants with a detailed description of the program's referral process and offer to help the participant set up an intake at the program. Additionally, the team will follow up on the referral. Participants in this arm will also receive Wisepill, a wireless adherence monitoring advice, at the baseline assessment.
Intervention Type
Behavioral
Intervention Name(s)
Khanya
Intervention Description
"Khanya" is a peer-delivered, behavioral intervention to improve HIV medication adherence and reduce problematic SUD symptoms. Participants will either receive Khanya Step 1 or if they continue to struggle with ART adherence, they will be stepped up to the more intensive intervention, Khanya Step 2.
Primary Outcome Measure Information:
Title
Changes in HIV Medication Adherence Throughout Intervention Phase
Description
Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device
Time Frame
Assessed between baseline and 3-month assessment
Title
Biological Measure of Substance Use After intervention
Description
Urine toxicology-verified substance use at the acute post-intervention assessment.
Time Frame
3-month assessment
Secondary Outcome Measure Information:
Title
Changes in HIV Medication Adherence Over Follow-Up
Description
Percentage of prescribed antiretroviral therapy (medications) taken as prescribed measured using real-time wireless monitoring (Wisepill)
Time Frame
Aggregate across 3-, 6-, and 12-month assessments
Title
Biological Measure of Substance Use Over Follow-Up
Description
Urine toxicology-verified substance use
Time Frame
Aggregate across 3-, 6-, and 12-month assessments
Title
Changes in Self-Reported Substance Use
Description
Self-reported substance use will be assessed primarily by the 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.
Time Frame
Aggregate across 3-, 6-, and 12-month assessments
Title
Biological Measure of Adherence
Description
Biomarker-confirmed ART adherence will be measured with Dried Blood Spot (DBS) analysis of tenofovir diphosphate (TDF-DiP).
Time Frame
Aggregate across 3-, 6-, and 12-month assessments
Title
HIV Clinic Attendance
Description
Number of days participants in each condition were on-time to, late to, or missed an HIV clinic appointment (extracted from clinic records).
Time Frame
Aggregate across 3-, 6-, and 12-month assessments
Title
HIV Viral Load
Description
Percentage of patients with a detectable viral load
Time Frame
Aggregate across 3-, 6-, and 12-month assessments
Other Pre-specified Outcome Measures:
Title
Acceptability using a quantitative assessment based on RE-AIM
Description
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.
Time Frame
3-month assessment
Title
Feasibility using a quantitative assessment based on RE-AIM
Description
16-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 acceptability.
Time Frame
3-month assessment
Title
Implementation Fidelity
Description
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).
Time Frame
6-month assessment
Title
Uptake
Description
Uptake will be measured as an implementation outcome, including the % of patients who initiate treatment and treatment attendance.
Time Frame
6-month assessment
Title
Health-Related Quality of Life assessed by EQ-5D
Description
Health-related quality of life (HRQoL) will be measured with the EQ-5D which is the most widely used of the major HRQoL instruments capable of generating a single health utility index value to calculate quality-adjusted life-years (QALYs), and one of the most sensitive to changes in pain, physical and mental health functioning. This instrument measures HRQoL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
Aggregate across 3-, 6-, and 12-month assessments
Title
Biological Measure of Alcohol Use
Description
Biomarker-verified alcohol use will be measured with phosphatidylethanol (PEth) concentration from dried blood samples, 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.
Time Frame
Aggregate across 3-, 6-, and 12-month assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV positive and on ART ≥18 years of age At least moderate substance use risk in the past 3 months for at least one non-tobacco substance (measured by the WHO- ASSIST: score ≥11 for alcohol, ≥4 for non-tobacco drugs) ART nonadherence and/or risk of virologic failure, defined as at least one of the following in the past 12 months 1) re-engaging in care after ≥1 month of being out of care (confirmed by pharmacy refill data) 2) ≥1 episodes of VL >400 copies/mL 3) on second- or third-line ARTs. Exclusion Criteria: Severe risk/likely dependence for opiates (WHO ASSIST score >26) because opiate substitution therapy is largely not available Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms/stabilization prior to study participation Inability to provide informed consent or complete study procedures in isiXhosa or English In third trimester of pregnancy during baseline Currently enrolled in another study or treatment program focused on substance use (including Matrix) or ART adherence. Untreated or undertreated major mental illness that would interfere with study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica F Magidson, MS, PhD
Phone
301-405-5095
Email
jmagidso@umd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lea J Simms, MPH
Email
lsimms1@umd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica F Magidson, MS, PhD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cape Town
City
Cape Town
State/Province
Western Cape
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Joska, MBChB, PhD
Phone
901127214042154
Email
john.joska@uct.ac.za
First Name & Middle Initial & Last Name & Degree
Stefani Du Toit, Psy M
Email
stefani.hugo@uct.ac.za

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and available by request with appropriate permissions from PI.

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Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa

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