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Lo studio clinico NCT07125235 (reSTART) per Behavioral Intervention, Viral Suppression of HIV Infection, Adesione alla terapia antiretrovirale (ART) è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial 270 Remoto

In arruolamento
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La sperimentazione clinica NCT07125235 (reSTART) è uno studio interventistico per Behavioral Intervention, Viral Suppression of HIV Infection, Adesione alla terapia antiretrovirale (ART), attualmente in arruolamento. Avviato il 9 febbraio 2026, prevede di arruolare 270 partecipanti. Sotto la guida di l'Università della California, San Francisco, dovrebbe concludersi entro il 30 luglio 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 marzo 2026.
Sommario breve
Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication. Forgetting to take HIV medication puts men living with HIV at a greater risk of becoming virally unsuppressed. Researchers are doing this study to test if a remote intervention can help participants improve remembering to take their HIV medications and reduce the HIV viral...Mostra di più
Descrizione dettagliata
A resurgent stimulant epidemic among men living with HIV could compromise the U.S. Ending the HIV Epidemic goals by interfering with HIV care engagement, adherence, and virologic suppression among men living with HIV. Prominent multi-level factors interfere with HIV virologic suppression for men living with HIV, particularly among those who use stimulants. This study is a nested randomized clinical trial to test a mu...Mostra di più
Titolo ufficiale

Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial

Patologie
Behavioral InterventionViral Suppression of HIV InfectionAdesione alla terapia antiretrovirale (ART)
Altri ID dello studio
Numero NCT
NCT07125235
Data di inizio (effettiva)
2026-02-09
Ultimo aggiornamento pubblicato
2026-03-13
Data di completamento (stimata)
2028-07-30
Arruolamento (previsto)
270
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
HIV
Stimulant Use
mHealth
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentalereSTART Intervention
The reSTART intervention will be administered to this group and includes: (1) adherence self-monitoring tools delivered during a single baseline motivational interviewing session; (2) the urine tenofovir point-of-care self-test with adherence feedback and visualizations with motivational messages; (3) a positive affect intervention delivered via a mobile health application which supports stimulant-using men in reduci...Mostra di più
reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention
The reSTART intervention integrates a mobile health application, a urine tenofovir point-of-care self-test, and adherence feedback with motivational messages to increase HIV medication intake, reduce stimulant use, and improve HIV virologic suppression.
urine tenofovir point-of-care self-test
urine tenofovir point-of-care self-test
Nessun interventoStandard of Care
The control group will receive standard of care and will not receive the reSTART intervention.
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR
The primary endpoint will be change in viral suppression comparing baseline to post-intervention viral load results measured by HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 50 copies/mL.
Baseline to 6-months post-intervention
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Stimulant Use measured quantitatively by stimulant levels in hair
Stimulant levels will be compared pre- and post-intervention and measured quantitatively using liquid chromatography-mass spectrometry laboratory techniques.
Baseline to 6-months post-intervention
Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR.
As a secondary endpoint, long-term viral suppression will be measured at 12-months and compared to baseline viral load results from HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 50 copies/mL.
Baseline to 12-months post-intervention
Adherence to Tenofovir-based antiretroviral therapy
Urine tenofovir levels measured by the urine tenofovir point-of-care self-test lateral flow assay at baseline and 6-months post-intervention will be compared to assess the presence or absence of tenofovir and changes in adherence to HIV medications.
Baseline to 6-months post-intervention
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Maschio
  • Prescribed antiretroviral therapy (ART) with a tenofovir-based regimen.
  • Documented virologic non-suppression, urine tenofovir testing without tenofovir detected, or self-reported adherence <100%.
  • Reports stimulant use.
  • Has a mailing address within the U.S.
  • Currently has a smartphone with photo capabilities.

  • Have any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions.
  • Not prescribed ART.
  • Unwilling to perform urine self-testing or to attend a local Quest site for viral load monitoring.
  • Unable to provide a hair sample of ~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
University of California, San Francisco logoUniversità della California, San Francisco701 studi clinici attivi da esplorare
Contatti principali dello studio
Contatto: Shivani Mahuvakar, 415-878-6384, [email protected]
Contatto: Kevin Sassaman
1 Centri dello studio in 1 paesi

California

University of California, San Francisco, San Francisco, California, 94110, United States
Matthew Spinelli, MD, MAS, Contatto, 415-806-8554, [email protected]
In arruolamento