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

16. Mai 2022 aktualisiert von: Jessica Magidson, University of Maryland, College Park

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

66

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Südafrika
      • Cape Town, Südafrika, 7700
        • University of Cape Town
  • Vereinigte Staaten
    • Maryland
      • College Park, Maryland, Vereinigte Staaten, 20742
        • University of Maryland

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: Project Khanya
This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in HIV Medication Adherence Throughout Intervention Phase
Zeitfenster: 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
Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Zeitfenster: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Substance use measured with urinalysis.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Zeitfenster: 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.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Changes in Self-reported Substance Use
Zeitfenster: 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.
Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Biological Measure of Substance Use
Zeitfenster: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Substance use measured with urinalysis.
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Biological Measure of Substance Use
Zeitfenster: 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.
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
Zeitfenster: 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.
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Intervention Acceptability
Zeitfenster: 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.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Feasibility
Zeitfenster: 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.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Fidelity
Zeitfenster: 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).
Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Uptake
Zeitfenster: 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)
Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HIV Viral Load
Zeitfenster: 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)
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
Zeitfenster: 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
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
Zeitfenster: 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
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Maryland, College Park

Mitarbeiter

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Juli 2018

Primärer Abschluss (Tatsächlich)

12. Februar 2020

Studienabschluss (Tatsächlich)

7. April 2020

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Mai 2018

Zuerst gepostet (Tatsächlich)

18. Mai 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Mai 2022

Zuletzt verifiziert

1. Mai 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 187/2018
  • K23DA041901 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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