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

Human Immunodeficiency Virus Clinical Trial

Official title:

A Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933226
• Other study ID #: 077/2022
• Secondary ID: R01DA056102
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Maryland, College Park
• Contact: Jessica F Magidson, MS, PhD
• Phone: 301-405-5095
• Email: jmagidso[@]umd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol-Related Disorders
• Drug Use
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Khanya
"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.

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town	Western Cape

Sponsors (5)

Lead Sponsor	Collaborator
University of Maryland, College Park	National Institute on Drug Abuse (NIDA), University of Cape Town, University of Miami, Weill Medical College of Cornell University

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability using a quantitative assessment based on RE-AIM	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.	3-month assessment
Other	Feasibility using a quantitative assessment based on RE-AIM	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.	3-month assessment
Other	Implementation 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).	6-month assessment
Other	Uptake	Uptake will be measured as an implementation outcome, including the % of patients who initiate treatment and treatment attendance.	6-month assessment
Other	Health-Related Quality of Life assessed by EQ-5D	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.	Aggregate across 3-, 6-, and 12-month assessments
Other	Biological Measure of Alcohol Use	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.	Aggregate across 3-, 6-, and 12-month assessments
Primary	Changes in HIV Medication Adherence Throughout Intervention Phase	Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device	Assessed between baseline and 3-month assessment
Primary	Biological Measure of Substance Use After intervention	Urine toxicology-verified substance use at the acute post-intervention assessment.	3-month assessment
Secondary	Changes in HIV Medication Adherence Over Follow-Up	Percentage of prescribed antiretroviral therapy (medications) taken as prescribed measured using real-time wireless monitoring (Wisepill)	Aggregate across 3-, 6-, and 12-month assessments
Secondary	Biological Measure of Substance Use Over Follow-Up	Urine toxicology-verified substance use	Aggregate across 3-, 6-, and 12-month assessments
Secondary	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.	Aggregate across 3-, 6-, and 12-month assessments
Secondary	Biological Measure of Adherence	Biomarker-confirmed ART adherence will be measured with Dried Blood Spot (DBS) analysis of tenofovir diphosphate (TDF-DiP).	Aggregate across 3-, 6-, and 12-month assessments
Secondary	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).	Aggregate across 3-, 6-, and 12-month assessments
Secondary	HIV Viral Load	Percentage of patients with a detectable viral load	Aggregate across 3-, 6-, and 12-month assessments