Clinical trial NCT05933226: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: National Institute on Drug Abuse (NIDA)
name: Weill Medical College of Cornell University
name: University of Miami
First posted: 2023-07-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 outcomes.

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

Primary outcomes:
measure: Changes in HIV Medication Adherence
timeFrame: Assessed from baseline through 12-month assessment
measure: Biological Measure of Substance Use
timeFrame: Assessed from baseline across 3-, 6-, and 12-month assessments
Secondary outcomes:
measure: Changes in Self-Reported Substance Use
timeFrame: Assessed from baseline across 3-, 6-, and 12-month assessments
measure: Biological Measure of Adherence
timeFrame: Assessed from baseline across 3-, 6-, and 12-month assessments
measure: HIV Clinic Attendance
timeFrame: Assessed from baseline across 3-, 6-, and 12-month assessments
measure: HIV Viral Load
timeFrame: Assessed from baseline across 6-, and 12-month assessments
measure: Employment Status Questionnaire
timeFrame: Assessed from baseline across 3-, 6-, and 12-month assessments
Other outcomes:
measure: Acceptability using a quantitative assessment based on RE-AIM
timeFrame: 3-month assessment
measure: Feasibility using a quantitative assessment based on RE-AIM
timeFrame: 3-month assessment
measure: Implementation Fidelity
timeFrame: From baseline over 6-months
measure: Uptake
timeFrame: From baseline over 6-months
measure: Health-Related Quality of Life assessed by EQ-5D
timeFrame: Assessed from baseline across 3-, 6-, and 12-month assessments
measure: CD4 Count
timeFrame: Assessed from baseline across 6-, and 12-month assessments
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
state: Western Cape
Study officials:
affiliation: University of Maryland
name: Jessica F Magidson, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: