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Supporting Treatment Adherence Readiness Through Training (START) (START)

5. oktober 2020 oppdatert av: RAND

Controlled Evaluation of the Adherence Readiness Program for ART Adherence

Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression. Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will evaluate the effects of the Adherence Readiness Program (ARP) intervention on the primary outcomes of dose-taking HIV antiretroviral (ART) adherence and undetectable HIV viral load in a multi-site randomized controlled trial. The ARP is based on the Information Motivation Behavioral skills (IMB) model of behavior change and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patient and conserve limited resources. Participants will be randomized to receive either the ARP (adherence counseling sessions) or usual care. Primary assessments will be administered at screening and every 6 months after ART initiation over a 24-month follow-up, making it one of the few studies to examine intervention effects longer than one year. Secondary outcomes include dose-timing adherence and CD4 count. If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination. This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention and its potential for more wide scale use and sustainability if effective.

Studietype

Intervensjonell

Registrering (Forventet)

240

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Long Beach, California, Forente stater
        • CaRe Clinic
      • Los Angeles, California, Forente stater
        • T.H.E. Clinic
      • Los Angeles, California, Forente stater
        • UCLA CARE Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. The patient's provider views the patient as medically appropriate to begin (ART naïve) or restart ART (has been off ART for at least 2 months), and either

    • plans to start the patient on ART
    • would like to start the patient on ART but the provider or patient is uncertain about the patient's readiness to adhere well.

    Patients who are currently on ART are also eligible if they meet the following criteria, which are specific only to this type of patient:

    i) the patient has 2 or more HIV viral load tests in the past year > 1000 copies/ml ii) the patient has had no HIV viral load tests that were undetectable in the past year iii) the patient has a genotype in the past year that does not show resistance as a reason for virologic failure (detectable viral load) iv) primary care provider views the patient as a good candidate for the study, with the understanding that the patient will interrupt ART if assigned to the intervention.

    Criteria i to iii are intended to define a subgroup of nonadherent patients who are taking very little of their ART medications, as evidenced by the combination of consistently high viral load and no drug resistance. If the patient was taking at least a moderate level of drug and still had consistently high viral load, than they would have evidence of drug resistance. Providers are generally comfortable with this type of patient stopping their medication in order to facilitate the pre-treatment, adherence readiness assessment and training phase of the intervention prior to restarting the patient on treatment.

  2. The patient's health status is stable. There is no current acute OI or medical condition that calls for immediate ART, as determined by the patient's provider.
  3. Most recent HIV viral load is detectable.
  4. If CD4 < 200, the patient is on or will be prescribed prophylactic medication
  5. Patient is 18 or older.
  6. Patient is able and willing to give informed consent.
  7. English speaking.

Exclusion Criteria:

1. Patient just tested HIV+ and their provider suspects the patient may be acutely or recently infected (within past 6 months).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ARP intervention
Adherence counseling intervention
Atferdsmessig: Adherence Readiness Program
The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases
Ingen inngripen: usual care
no intervention, standard care practices regarding adherence support

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HIV virologic suppression
Tidsramme: Month 24
undetectable HIV viral load at time of assessment
Month 24
log change in HIV viral load (log change in HIV RNA levels)
Tidsramme: Month 24
log change in HIV RNA levels from baseline to Month 24.
Month 24
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Tidsramme: Month 24
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 24
Month 24
percent dose-taking adherence
Tidsramme: Month 24
percent of prescribed doses taken between baseline and Month 24
Month 24
HIV virologic suppression
Tidsramme: Month 6
undetectable HIV viral load at time of assessment
Month 6
log change in HIV viral load (log change in HIV RNA levels)
Tidsramme: Month 6
log change in HIV RNA levels from baseline to Month 6
Month 6
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Tidsramme: month 6
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 6
month 6
percent dose-taking adherence
Tidsramme: month 6
percent of prescribed doses taken between baseline and Month 6
month 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
dose-timing adherence
Tidsramme: Month 24
percent of prescribed doses taken within correct time-window between baseline and Month 24
Month 24
dose-timing adherence
Tidsramme: Month 6
percent of prescribed doses taken within correct time-window between baseline and Month 6
Month 6
optimal dose-timing adherence
Tidsramme: Month 24
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 24
Month 24
optimal dose-timing adherence
Tidsramme: Month 6
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 6
Month 6
change in CD4 count
Tidsramme: Month 24
change in CD4 count from baseline to Month 24
Month 24
change in CD4 count
Tidsramme: Month 6
change in CD4 count from baseline to Month 6
Month 6
clinic attendance (number of missed clinic appointments)
Tidsramme: Month 24
number of missed clinic appointments between baseline and Month 24
Month 24
clinic attendance (number of missed clinic appointments)
Tidsramme: Month 6
number of missed clinic appointments between baseline and Month 6
Month 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

RAND

Samarbeidspartnere

University of California, Los Angeles
Long Beach Education and Research Consultants

Etterforskere

  • Hovedetterforsker: Glenn Wagner, PhD, RAND

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2015

Primær fullføring (Faktiske)

30. mars 2020

Studiet fullført (Faktiske)

30. mars 2020

Datoer for studieregistrering

Først innsendt

22. desember 2014

Først innsendt som oppfylte QC-kriteriene

31. desember 2014

Først lagt ut (Anslag)

1. januar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • MH104086

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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