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

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; Alcohol-Related Disorders; Drug Use
• Interventions: Behavioral: Project Khanya

• Registration Number: NCT03529409
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Study Start: 2018-07-30
• Primary Completion: 2020-02-12
• Study Completion: 2020-04-07
• Results First Submitted: 2021-04-01
• Results First Submitted QC: 2021-09-30
• Results First Posted: 2021-10-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Project Khanya	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.

Primary Outcome Measures

Name	Time	Method
Changes in HIV Medication Adherence Throughout Intervention Phase	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	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	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

Name	Time	Method
Biological Measure of Substance Use	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.
Changes in Self-reported Substance Use	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.
Intervention Acceptability	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.
Intervention Feasibility	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.
Intervention Fidelity	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).
Intervention Uptake	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)

Trial Locations

Locations (2)

University of Maryland; 🇺🇸 College Park, Maryland, United States

University of Cape Town; 🇿🇦 Cape Town, South Africa