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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA056102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Cape Town | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
| Weill Medical College of Cornell University | OTHER |
| University of Miami |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica F Magidson, MS, PhD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cape Town | Cape Town | Western Cape | South Africa |
After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and available by request with appropriate permissions from PI.
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| 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 | 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). | Assessed from baseline across 3-, 6-, and 12-month assessments |
| HIV Viral Load | Percentage of patients with a detectable viral load | 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. | Assessed from baseline across 3-, 6-, and 12-month assessments |
| 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 |
| 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). | From baseline over 6-months |
| Uptake | Uptake will be measured as an implementation outcome, including the % of patients who initiate treatment and treatment attendance. | From baseline over 6-months |
| 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. | Assessed from baseline across 3-, 6-, and 12-month assessments |
| CD4 Count | Absolute CD4 value in the blood to measure immune function and disease progression | Assessed from baseline across 6-, and 12-month assessments |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D012327 | RNA Virus Infections |
| D015658 | HIV Infections |
| D000428 | Alcohol Drinking |
| D000074822 | Treatment Adherence and Compliance |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
| D015438 | Health Behavior |
| D010549 | Personal Satisfaction |
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