Human Immunodeficiency VirusNCT03529409
Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
A study testing Project Khanya in people with Human Immunodeficiency Virus and Alcohol-Related Disorders, run by University of Maryland, College Park at 2 sites in 2 countries.
Trial summary
The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus, Alcohol-Related Disorders, Drug Use
- What is being tested?
- Project Khanya
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jul 2018to 7 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive and on ART
- 18-65 years of age
- Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or greater than or equal to 11 for alcohol)
- Have at least one of the following:
- Not attained viral suppression from first line ART (VL>400 copies/mL)
- On second-line ART treatment
- Reinitiated first-line treatment within the past three months
- Had a pharmacy non-refill at least once in the past 3 months
Who cannot join
- Inability to provide informed consent or complete procedures in English or isiXhosa
- Severe risk/likely dependence for opiates (ASSIST score >26) because opiate substitution therapy may not be available
- Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms
- Active, untreated, major mental illness (with untreated psychosis or mania) that would interfere with the paraprofessional adapted intervention
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Maryland
College Park, Maryland, 20742
About this study
Official title: Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).
Read the detailed description
The HIV epidemic in South Africa (SA) is among the highest in the world. SA has a large antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which increases the likelihood of developing drug resistance and failing the only available first and second line ART regimens in SA. ART nonadherence contributes to greater morbidity, mortality, and higher likelihood of sexual HIV transmission when virus is detectable. At the same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and associated with worse ART adherence, lower rates of viral suppression, and HIV transmission risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment outcomes and continued HIV transmission, there is little if any integration of substance use and HIV care services in SA, which creates a fragmented and incomplete system of care. This study had three phases, first being formative, qualitative work which led to a systematic treatment adaptation phase. This third phase, the clinical trial, is based on this formative work and other empirical support using behavioral interventions to improve ART adherence and reduce substance use in resource-limited settings, including SA. This study is a Type 1 hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral intervention for adherence and substance use integrated into the HIV primary care setting in SA. To ensure that those who need this intervention most will receive it, participants will be patients with HIV who are struggling with adherence (as defined in the investigator's inclusion criteria) and who have an elevated substance use risk.
- Being tested
- Project Khanya
- Keywords
- Immunologic Deficiency Syndromes, Substance Use, Acquired Immunodeficiency Syndrome, Immune System Diseases, Behavioral Symptoms, RNA Virus Infections, HIV Infections, Alcohol Use, Drug Use
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcohol-Related Disorders, Immunologic Deficiency Syndromes, Substance-Related Disorders, 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.
Project KhanyaBehavioural
This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
| Study group | Role | What they receive |
|---|---|---|
| Project Khanya | Experimental | Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device. Receives: Behavioral: Project Khanya |
| ESOC | No intervention | Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HIV Medication Adherence Throughout Intervention Phase
Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
Measured: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Substance use measured with urinalysis.
Measured: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
Measured: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Changes in Self-reported Substance Use
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 between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Secondary outcomes (7)
Biological Measure of Substance Use
Substance use measured with urinalysis.
Measured: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Biological Measure of Substance Use
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
Measured: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
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 between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Intervention Acceptability
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.
Qualitative interviews will also be conducted with intervention participants at the end of the study to assess acceptability guided by RE-AIM and the Proctor model.
Measured: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Feasibility
14-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 feasibility.
Qualitative interviews will also be conducted with intervention participants at the end of the study to assess feasibility guided by RE-AIM and the Proctor model.
Measured: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention 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).
Measured: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Uptake
Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants)
Measured: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start30 Jul 2018
- Primary completion12 Feb 2020
- Study completion7 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
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)
- Responsible party
- Principal investigator, Jessica Magidson, University of Maryland, College Park
- Investigators
- Jessica F Magidson, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529409
- Sponsor's protocol ID
- 187/2018
- Other IDs
- K23DA041901
- Status last verified
- May 2022
- First submitted
- 7 May 2018
- Last updated
- 18 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 available per request of outside individual.
Publications
Lu T, Belus JM, Majokweni S, Joska J, Regenauer KS, Rose AL, Myers B, Burnham W, Andersen LS, Ryan DA, Cadet T, Magidson JF, Murphy SM. Cost-effectiveness of a peer-delivered behavioral intervention for adherence to antiretroviral therapy and alcohol and drug use in South African HIV care. AIDS Care. 2026 Feb;38(2):287-296. doi: 10.1080/09540121.2026.2613989. Epub 2026 Jan 22.
PubMed 41567004Belus JM, Anvari MS, Ke H, Regenauer KS, Ma T, Myers B, Andersen LS, Joska JA, Magidson JF. Effects of HIV and alcohol stigma on biomarker-confirmed alcohol use following a peer-delivered intervention in South Africa. Addict Behav Rep. 2025 Nov 1;22:100640. doi: 10.1016/j.abrep.2025.100640. eCollection 2025 Dec.
PubMed 41312191Belus JM, Regenauer KS, Lu T, Murphy SM, Rose AL, Ochieng YA, Joska J, Majokweni S, Andersen LS, Myers B, Safren SA, Magidson JF. Increases in employment over six months following Khanya: A secondary analysis of a pilot randomized controlled trial of a peer-delivered behavioral intervention for substance use and HIV medication adherence in Cape Town, South Africa. Int J Drug Policy. 2024 Dec;134:104632. doi: 10.1016/j.drugpo.2024.104632. Epub 2024 Nov 21.
PubMed 39577326Belus JM, Rose AL, Andersen LS, Ciya N, Joska JA, Myers B, Safren SA, Magidson JF. Adapting a Behavioral Intervention for Alcohol Use and HIV Medication Adherence for Lay Counselor Delivery in Cape Town, South Africa: A Case Series. Cogn Behav Pract. 2022 May;29(2):454-467. doi: 10.1016/j.cbpra.2020.10.003. Epub 2020 Nov 10.
PubMed 36171964Belus JM, Joska JA, Bronsteyn Y, Rose AL, Andersen LS, Regenauer KS, Myers B, Hahn JA, Orrell C, Safren SA, Magidson JF. Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa. AIDS Behav. 2022 Nov;26(11):3630-3641. doi: 10.1007/s10461-022-03765-8. Epub 2022 Jul 27.
PubMed 35895150Magidson JF, Joska JA, Belus JM, Andersen LS, Regenauer KS, Rose AL, Myers B, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa. J Int AIDS Soc. 2021 Jun;24 Suppl 2(Suppl 2):e25720. doi: 10.1002/jia2.25720.
PubMed 34164935Magidson JF, Joska JA, Myers B, Belus JM, Regenauer KS, Andersen LS, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa. Implement Sci Commun. 2020;1:23. doi: 10.1186/s43058-020-00004-w. Epub 2020 Mar 4.
PubMed 32607502
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
- ClinicalTrials.gov ID
- NCT03529409
- Acronym / sponsor ID
- 187/2018
- Keywords
- Immunologic Deficiency Syndromes, Substance Use, Acquired Immunodeficiency Syndrome, Immune System Diseases, Behavioral Symptoms, RNA Virus Infections, HIV Infections, Alcohol Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- University of Cape Town, National Institute on Drug Abuse (NIDA)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 4 Oct 2021
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 test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).
Detailed description
The HIV epidemic in South Africa (SA) is among the highest in the world. SA has a large antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which increases the likelihood of developing drug resistance and failing the only available first and second line ART regimens in SA. ART nonadherence contributes to greater morbidity, mortality, and higher likelihood of sexual HIV transmission when virus is detectable. At the same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and associated with worse ART adherence, lower rates of viral suppression, and HIV transmission risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment outcomes and continued HIV transmission, there is little if any integration of substance use and HIV care services in SA, which creates a fragmented and incomplete system of care. This study had three phases, first being formative, qualitative work which led to a systematic treatment adaptation phase. This third phase, the clinical trial, is based on this formative work and other empirical support using behavioral interventions to improve ART adherence and reduce substance use in resource-limited settings, including SA. This study is a Type 1 hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral intervention for adherence and substance use integrated into the HIV primary care setting in SA. To ensure that those who need this intervention most will receive it, participants will be patients with HIV who are struggling with adherence (as defined in the investigator's inclusion criteria) and who have an elevated substance use risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project Khanya | Experimental | Behavioral: Project KhanyaThose assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device. |
| ESOC | No intervention | –Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV positive and on ART
- 18-65 years of age
- Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or greater than or equal to 11 for alcohol)
- Have at least one of the following:
Key exclusion criteria (4 listed)
- Inability to provide informed consent or complete procedures in English or isiXhosa
- Severe risk/likely dependence for opiates (ASSIST score >26) because opiate substitution therapy may not be available
- Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms
- Active, untreated, major mental illness (with untreated psychosis or mania) that would interfere with the paraprofessional adapted intervention
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 |
|---|---|---|
| Project KhanyaThis treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence. | Behavioural | Project Khanya |
Primary outcome
Changes in HIV Medication Adherence Throughout Intervention Phase
Time frame: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
Biological Measure of Substance Use
Time frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Substance use measured with urinalysis.
Biological Measure of Substance Use
Time frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
Changes in Self-reported Substance Use
Time frame: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
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.
7 secondary outcomes
Biological Measure of Substance Use
Time frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Biological Measure of Substance Use
Time frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
Time frame: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Intervention Acceptability
Time frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Feasibility
Time frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Fidelity
Time frame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Uptake
Time frame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41567004Lu T, Belus JM, Majokweni S, Joska J, Regenauer KS, Rose AL, Myers B, Burnham W, Andersen LS, Ryan DA, Cadet T, Magidson JF, Murphy SM. Cost-effectiveness of a peer-delivered behavioral intervention for adherence to antiretroviral therapy and alcohol and drug use in South African HIV care. AIDS Care. 2026 Feb;38(2):287-296. doi: 10.1080/09540121.2026.2613989. Epub 2026 Jan 22.
- Derived from this study: PubMed 41312191Belus JM, Anvari MS, Ke H, Regenauer KS, Ma T, Myers B, Andersen LS, Joska JA, Magidson JF. Effects of HIV and alcohol stigma on biomarker-confirmed alcohol use following a peer-delivered intervention in South Africa. Addict Behav Rep. 2025 Nov 1;22:100640. doi: 10.1016/j.abrep.2025.100640. eCollection 2025 Dec.
- Derived from this study: PubMed 39577326Belus JM, Regenauer KS, Lu T, Murphy SM, Rose AL, Ochieng YA, Joska J, Majokweni S, Andersen LS, Myers B, Safren SA, Magidson JF. Increases in employment over six months following Khanya: A secondary analysis of a pilot randomized controlled trial of a peer-delivered behavioral intervention for substance use and HIV medication adherence in Cape Town, South Africa. Int J Drug Policy. 2024 Dec;134:104632. doi: 10.1016/j.drugpo.2024.104632. Epub 2024 Nov 21.
- Derived from this study: PubMed 36171964Belus JM, Rose AL, Andersen LS, Ciya N, Joska JA, Myers B, Safren SA, Magidson JF. Adapting a Behavioral Intervention for Alcohol Use and HIV Medication Adherence for Lay Counselor Delivery in Cape Town, South Africa: A Case Series. Cogn Behav Pract. 2022 May;29(2):454-467. doi: 10.1016/j.cbpra.2020.10.003. Epub 2020 Nov 10.
- Derived from this study: PubMed 35895150Belus JM, Joska JA, Bronsteyn Y, Rose AL, Andersen LS, Regenauer KS, Myers B, Hahn JA, Orrell C, Safren SA, Magidson JF. Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa. AIDS Behav. 2022 Nov;26(11):3630-3641. doi: 10.1007/s10461-022-03765-8. Epub 2022 Jul 27.
- Derived from this study: PubMed 34164935Magidson JF, Joska JA, Belus JM, Andersen LS, Regenauer KS, Rose AL, Myers B, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa. J Int AIDS Soc. 2021 Jun;24 Suppl 2(Suppl 2):e25720. doi: 10.1002/jia2.25720.
- Derived from this study: PubMed 32607502Magidson JF, Joska JA, Myers B, Belus JM, Regenauer KS, Andersen LS, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa. Implement Sci Commun. 2020;1:23. doi: 10.1186/s43058-020-00004-w. Epub 2020 Mar 4.
- Individual participant dataSharing planned: Yes. After all primary analyses are complete, de-identified data will be available per request of outside individual.
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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, PhD principal investigator
University of Maryland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Khanya in people with Human Immunodeficiency Virus and Alcohol-Related Disorders, run by University of Maryland, College Park at 2 sites in 2 countries.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Yes. Results are posted in the registry (first posted 4 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Throughout Intervention Phase (time frame: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)). The study lists 4 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 NCT03529409, which also lists 7 linked publications.
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 18 May 2022.