NCT03529409

Brief 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. 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2020

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 4, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 7, 2018

Results QC Date

April 1, 2021

Last Update Submit

May 16, 2022

Conditions

Human Immunodeficiency VirusAlcohol-Related DisordersDrug Use

Keywords

Immunologic Deficiency SyndromesSubstance UseAcquired Immunodeficiency SyndromeImmune System DiseasesBehavioral SymptomsRNA Virus InfectionsHIV InfectionsAlcohol UseDrug Use

Outcome Measures

Primary Outcomes (4)

  • Changes in HIV Medication Adherence Throughout Intervention Phase

    Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device

    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.

    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.

    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.

    Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

Secondary Outcomes (7)

  • Biological Measure of Substance Use

    Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

  • Biological Measure of Substance Use

    Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

  • Changes in Self-reported Substance Use

    Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

  • Intervention Acceptability

    Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

  • Intervention Feasibility

    Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

  • +2 more secondary outcomes

Other Outcomes (3)

  • HIV Viral Load

    Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

  • Changes in Self-reported Substance Use

    Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

  • Changes in Self-reported Substance Use

    Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

Study Arms (2)

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.

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.

Interventions

Project KhanyaBEHAVIORAL

This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.

Project Khanya

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive and on ART
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland

College Park, Maryland, 20742, United States

Location

University of Cape Town

Cape Town, 7700, South Africa

Location

Related Publications (7)

  • 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 Jan 22:1-10. doi: 10.1080/09540121.2026.2613989. Online ahead of print.

    PMID: 41567004DERIVED

  • Belus 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.

    PMID: 41312191DERIVED

  • Belus 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.

    PMID: 39577326DERIVED

  • Belus 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.

    PMID: 36171964DERIVED

  • Belus 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.

    PMID: 35895150DERIVED

  • Magidson 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.

    PMID: 34164935DERIVED

  • Magidson 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.

    PMID: 32607502DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeAlcohol-Related DisordersImmunologic Deficiency SyndromesSubstance-Related DisordersImmune System DiseasesBehavioral SymptomsRNA Virus InfectionsHIV InfectionsAlcohol Drinking

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesChemically-Induced DisordersMental DisordersBehaviorDrinking Behavior

Results Point of Contact

Title
Dr. Jessica Magidson
Organization
University of Maryland, College Park
jmagidso@umd.edu
301-405-5095

Study Officials

  • Jessica F Magidson, PhD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 18, 2018

Study Start

July 30, 2018

Primary Completion

February 12, 2020

Study Completion

April 7, 2020

Last Updated

May 18, 2022

Results First Posted

October 4, 2021

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

After all primary analyses are complete, de-identified data will be available per request of outside individual.

Locations

US(1)ZA(1)