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

NCT05933226 | Recruiting DMC

• 2 other identifiers: 077/2022R01DA056102
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Changes in HIV Medication Adherence

  Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device (Wisepill)

  Assessed from baseline through 12-month assessment

• Biological Measure of Substance Use

  Biomarker-verified substance use

  Assessed from baseline across 3-, 6-, and 12-month assessments

Secondary Outcomes (5)

• Changes in Self-Reported Substance Use

  Assessed from baseline across 3-, 6-, and 12-month assessments

• Biological Measure of Adherence

  Assessed from baseline across 3-, 6-, and 12-month assessments

• HIV Clinic Attendance

  Assessed from baseline across 3-, 6-, and 12-month assessments

• HIV Viral Load

  Assessed from baseline across 6-, and 12-month assessments

• Employment Status Questionnaire

  Assessed from baseline across 3-, 6-, and 12-month assessments

Other Outcomes (6)

• Acceptability using a quantitative assessment based on RE-AIM

  3-month assessment

• Feasibility using a quantitative assessment based on RE-AIM

  3-month assessment

• Implementation Fidelity

  From baseline over 6-months

Study Arms (2)

Khanya

EXPERIMENTAL

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 SUD, including motivational interviewing, behavioral activation, and mindfulness-based relapse prevention strategies, which have previously been piloted in this community.

Behavioral: Khanya

Enhanced Standard of Care (ESOC)

NO INTERVENTION

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.

Interventions

Khanya BEHAVIORAL

"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.

Khanya

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• University of Cape Town: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Weill Medical College of Cornell University: collaborator
• University of Miami: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, South Africa

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alcohol-Related Disorders; Substance-Related Disorders; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; RNA Virus Infections; HIV Infections; Alcohol Drinking; Treatment Adherence and Compliance; Psychological Well-Being

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Chemically-Induced Disorders; Mental Disorders; Behavior; Drinking Behavior; Health Behavior; Personal Satisfaction

Study Officials

• Jessica F Magidson, MS, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica F Magidson, MS, PhD

CONTACT

301-405-5095; jmagidso@umd.edu

Abigail C Hines, MPH

CONTACT

ahines01@umd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)