- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02008526
Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90028
- Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Self-identified MSM
- Between the ages of 18 and 65 years
- Methamphetamine use within the previous 3 months
- Unprotected anal intercourse (insertive or receptive) with a non-primary male partner in the previous 6 months
- Not currently in treatment or seeking methamphetamine abuse treatment
- Able and willing to fully charge a cellular phone daily
- Able and willing to provide informed consent
- Able and willing to comply with study requirements
Exclusion Criteria:
- Does not identify as a MSM
- Not between the ages of 18 and 65 years
- Has not used methamphetamine in the previous 3 months
- Has not had unprotected anal intercourse (insertive or receptive) with a non-primary male partner in the previous 6 months
- Currently in treatment or seeking methamphetamine abuse treatment
- Unable or unwilling to fully charge a cellular phone daily
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study requirements
- Unable to understand the Informed Consent Form
- Determined to have a more serious psychiatric condition (SCID verified) that is beyond the safe enrollment of study procedures
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: TXT-PHE
Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) This condition is interactive and tailored to the needs of the individual participant. PHEs initiate (i.e., "push") text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages (i.e., "pull"). Participants receive five pre-written messages per day sent on a predetermined schedule. Participants who respond to the pre-written text messages or initiate queries or requests for support ("pull") are sent additional real-time messages back from the PHE. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days. |
Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule.
Participants who respond to the pre-written text messages or initiate queries or requests for support ("pull") are sent additional real-time messages back from the PHE.
Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities.
During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
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Sperimentale: TXT-Auto
Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto) Participants assigned to this group receive automatic text-messages. Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days. |
Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule.
During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
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Nessun intervento: Assessment Only (AO)
During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Methamphetamine Use
Lasso di tempo: 9-months post randomization
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Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
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9-months post randomization
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HIV Sexual Risk Behavior
Lasso di tempo: 9-months post randomization
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Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
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9-months post randomization
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Cost Effectiveness
Lasso di tempo: up to 36 months
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Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
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up to 36 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
HIV Primary Care
Lasso di tempo: 8-weeks post randomization, 3-/6-/9-months post randomization
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HIV-positive participants will be assessed according to their linkage/retention in HIV primary care and adherence to ART medication at 8-weeks, 3-, 6-, and 9-months post-randomization.
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8-weeks post randomization, 3-/6-/9-months post randomization
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- Reback CJ, Ling D, Shoptaw S, Rohde J. Developing a Text Messaging Risk Reduction Intervention for Methamphetamine-Using MSM: Research Note. Open AIDS J. 2010 May 14;4:116-22. doi: 10.2174/1874613601004030116.
- Reback CJ, Grant DL, Fletcher JB, Branson CM, Shoptaw S, Bowers JR, Charania M, Mansergh G. Text messaging reduces HIV risk behaviors among methamphetamine-using men who have sex with men. AIDS Behav. 2012 Oct;16(7):1993-2002. doi: 10.1007/s10461-012-0200-7. Erratum In: AIDS Behav. 2012 Oct;16(7):2003.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- R01DA035092 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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