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Completed

NCT Number: NCT03529409

Effectiveness & Implementation of a Behavioral Intervention for 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).

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Alcohol Drinking Alcohol-Related Disorders Behavior Behavioral Symptoms Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Drinking Behavior Drug Use Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cape Town, Cape Town, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

Project Khanya

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Cape Town

Registry information

Official study title

Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 18, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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