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

16 maja 2022 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

66

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Afryka Południowa
      • Cape Town, Afryka Południowa, 7700
        • University of Cape Town
  • Stany Zjednoczone
    • Maryland
      • College Park, Maryland, Stany Zjednoczone, 20742
        • University of Maryland

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Project Khanya
This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes in HIV Medication Adherence Throughout Intervention Phase
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Biological Measure of Substance Use
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
HIV Viral Load
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Maryland, College Park

Współpracownicy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 lipca 2018

Zakończenie podstawowe (Rzeczywisty)

12 lutego 2020

Ukończenie studiów (Rzeczywisty)

7 kwietnia 2020

Daty rejestracji na studia

Pierwszy przesłany

7 maja 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 maja 2018

Pierwszy wysłany (Rzeczywisty)

18 maja 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 maja 2022

Ostatnia weryfikacja

1 maja 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 187/2018
  • K23DA041901 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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