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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
160
"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.
University of Cape Town
Cape Town, Western Cape, South Africa
RECRUITINGChanges in HIV Medication Adherence
Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device (Wisepill)
Time frame: Assessed from baseline through 12-month assessment
Biological Measure of Substance Use
Biomarker-verified substance use
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
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.
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
Biological Measure of Adherence
Biomarker-confirmed ART adherence will be measured with Dried Blood Spot (DBS) testing
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
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).
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
HIV Viral Load
Percentage of patients with a detectable viral load
Time frame: Assessed from baseline across 6-, and 12-month assessments
Employment Status Questionnaire
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.
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
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