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Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529409
Recruitment Status : Completed
First Posted : May 18, 2018
Results First Posted : October 4, 2021
Last Update Posted : May 18, 2022
Sponsor:
Collaborators:
University of Cape Town
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jessica Magidson, University of Maryland, College Park

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).

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Alcohol-Related Disorders Drug Use Behavioral: Project Khanya Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : April 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Project Khanya
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
This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.

No Intervention: ESOC
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.



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Biological Measure of Substance Use [ Time Frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) ]
    Substance use measured with urinalysis.

  2. Biological Measure of Substance Use [ Time Frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up 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.

  3. 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) ]
    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.

  4. Intervention Acceptability [ Time Frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) ]

    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.


  5. Intervention Feasibility [ Time Frame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) ]

    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.


  6. Intervention Fidelity [ Time Frame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) ]
    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).

  7. Intervention Uptake [ Time Frame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment) ]
    Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants)


Other Outcome Measures:
  1. HIV Viral Load [ Time Frame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment) ]
    Percentage of patients with a suppressed viral load (<400 copies/ml)

  2. 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) ]
    Changes in percent days used any substance measured by timeline follow-back

  3. 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) ]
    Changes in number of drinks measured by timeline follow-back



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Not attained viral suppression from first line ART (VL>400 copies/mL)
    2. On second-line ART treatment
    3. Reinitiated first-line treatment within the past three months
    4. Had a pharmacy non-refill at least once in the past 3 months

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529409


Locations
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United States, Maryland
University of Maryland
College Park, Maryland, United States, 20742
South Africa
University of Cape Town
Cape Town, South Africa, 7700
Sponsors and Collaborators
University of Maryland, College Park
University of Cape Town
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Jessica F Magidson, PhD University of Maryland
  Study Documents (Full-Text)

Documents provided by Jessica Magidson, University of Maryland, College Park:
Study Protocol  [PDF] June 1, 2020
Statistical Analysis Plan  [PDF] December 9, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jessica Magidson, Assistant Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03529409    
Other Study ID Numbers: 187/2018
K23DA041901 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2018    Key Record Dates
Results First Posted: October 4, 2021
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After all primary analyses are complete, de-identified data will be available per request of outside individual.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Magidson, University of Maryland, College Park:
Immunologic Deficiency Syndromes
Substance Use
Acquired Immunodeficiency Syndrome
Immune System Diseases
Behavioral Symptoms
RNA Virus Infections
HIV Infections
Alcohol Use
Drug Use
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Substance-Related Disorders
Alcohol-Related Disorders
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases