Alcohol-Related Disorders, Drug Use, Human Immunodeficiency Virus, Substance Use
Conditions
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
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.
Interventions
BEHAVIORALKhanya
"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.
Sponsors
University of Maryland, College Park
University of Cape Town
National Institute on Drug Abuse (NIDA)
Weill Medical College of Cornell University
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HIV Medication Adherence | Assessed from baseline through 12-month assessment | Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device (Wisepill) |
| Biological Measure of Substance Use | Assessed from baseline across 3-, 6-, and 12-month assessments | Biomarker-verified substance use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Clinic Attendance | Assessed from baseline across 3-, 6-, and 12-month assessments | Number of days participants in each condition were on-time to, late to, or missed an HIV clinic appointment (extracted from clinic records). |
| Changes in Self-Reported Substance Use | Assessed from baseline across 3-, 6-, and 12-month assessments | 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. |
| Employment Status Questionnaire | Assessed from baseline across 3-, 6-, and 12-month assessments | Employment status of the participant with a range of locally appropriate response options including, but not limited to: working full-time, working part-time, unemployed or laid off and looking for work, in school or training, retired, disabled, in the military. |
| HIV Viral Load | Assessed from baseline across 6-, and 12-month assessments | Percentage of patients with a detectable viral load |
| Biological Measure of Adherence | Assessed from baseline across 3-, 6-, and 12-month assessments | Biomarker-confirmed ART adherence will be measured with Dried Blood Spot (DBS) testing |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORJessica F Magidson, MS, PhD
University of Maryland
Outcome results
None listed