Human Immunodeficiency VirusNCT05933226
Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa
A study testing Khanya in people with Human Immunodeficiency Virus and Alcohol-Related Disorders, run by University of Maryland, College Park at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Alcohol-Related Disorders, Drug Use
- What is being tested?
- Khanya
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Africa
- Study dates
- 21 Jun 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care
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.
Read the 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.
- Being tested
- Khanya
- 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcohol-Related Disorders, Substance-Related Disorders, Immunologic Deficiency Syndromes, Immune System Diseases, Behavioral Symptoms, RNA Virus Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KhanyaBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HIV Medication Adherence
Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device (Wisepill)
Measured: Assessed from baseline through 12-month assessment
Biological Measure of Substance Use
Biomarker-verified substance use
Measured: Assessed from baseline across 3-, 6-, and 12-month assessments
Secondary outcomes (5)
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.
Measured: 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
Measured: 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).
Measured: Assessed from baseline across 3-, 6-, and 12-month assessments
HIV Viral Load
Percentage of patients with a detectable viral load
Measured: 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.
Measured: Assessed from baseline across 3-, 6-, and 12-month assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start21 Jun 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami
- Responsible party
- Sponsor
- Investigators
- Jessica F Magidson, MS, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933226
- Sponsor's protocol ID
- 077/2022
- Other IDs
- R01DA056102
- Status last verified
- May 2026
- First submitted
- 27 Jun 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Magidson JF, Hines AC, Majokweni SH, Tokwe L, Myers B, Du Toit S, Regenauer K, Andersen LS, Burnhams W, Orrell C, Murphy SM, Sibeko G, Triplett N, Ndwandwa E, Kotelo NN, Ma T, Safren S, Joska J. A Stepped Care, Peer-Delivered Intervention to Improve Substance Use and HIV Medication Adherence in Primary Care in South Africa (Project Khanya): Protocol for a Hybrid Type 2 Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 2;15:e94153. doi: 10.2196/94153.
PubMed 42390468
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care
- ClinicalTrials.gov ID
- NCT05933226
- Acronym / sponsor ID
- 077/2022
- Keywords
- Immunologic Deficiency Syndrome, Substance Use, Acquired Immunodeficiency Syndrome, Immune system diseases, behavioral symptoms, RNA Virus Infections, HIV Infections, Alcohol Use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- University of Cape Town, National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Khanya | Experimental | Behavioral: KhanyaKhanya 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Khanya"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. | Behavioural | Khanya |
Primary outcome
Changes in HIV Medication Adherence
Time frame: 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
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
Biomarker-verified substance use
5 secondary outcomes
Changes in Self-Reported Substance Use
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
Biological Measure of Adherence
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
HIV Clinic Attendance
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
HIV Viral Load
Time frame: Assessed from baseline across 6-, and 12-month assessments
Employment Status Questionnaire
Time frame: Assessed from baseline across 3-, 6-, and 12-month assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 42390468Magidson JF, Hines AC, Majokweni SH, Tokwe L, Myers B, Du Toit S, Regenauer K, Andersen LS, Burnhams W, Orrell C, Murphy SM, Sibeko G, Triplett N, Ndwandwa E, Kotelo NN, Ma T, Safren S, Joska J. A Stepped Care, Peer-Delivered Intervention to Improve Substance Use and HIV Medication Adherence in Primary Care in South Africa (Project Khanya): Protocol for a Hybrid Type 2 Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 2;15:e94153. doi: 10.2196/94153.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica F Magidson, MS, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Khanya in people with Human Immunodeficiency Virus and Alcohol-Related Disorders, run by University of Maryland, College Park at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HIV Medication Adherence (time frame: Assessed from baseline through 12-month assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.