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Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM

16. juni 2017 oppdatert av: Friends Research Institute, Inc.
Participants receive culturally relevant and specifically tailored text messages based on the behavioral change theoretical constructs of Social Support Theory, Health Belief Model, and Social Cognitive Theory. Participants are randomized into one of three conditions for an 8-week intervention period: Group 1: culturally relevant theory-based text messages interactively transmitted by peer health educators (TXT-PHE); or, Group 2: the same culturally relevant theory-based text messages transmitted by automation (TXT-Auto); or, Group 3: assessment-only (AO) control with no theoretically based text messages.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The randomized three-group design uses repeated assessments at baseline, at the end of the 8-week intervention period, and at 3-, 6-, and 9-month post randomization follow-up. Participants in all three conditions receive brief weekly text-message assessments on their methamphetamine use and HIV sexual behaviors in the previous seven days. This study will determine the differential immediate and sustained effects of transmitting theory-based text messages by PHE (TXT-PHE) versus by automation (TXT-Auto), compared to an assessment-only (AO) control condition among out-of-treatment, methamphetamine-using MSM for reductions of methamphetamine use and HIV sexual risk behaviors. It is hypothesized that there will be significantly greater reductions in methamphetamine use and HIV sexual risk behaviors from text messages transmitted by PHE than by text messages transmitted by automation, which in turn will produce significantly greater reductions than the AO condition (PHE > TXT > AO). In addition, this study will determine the cost-effectiveness of TXT-PHE vs. TXT-Auto compared to AO for reducing methamphetamine use and HIV sexual risk behaviors. The investigators hypothesize that the TXT-PHE intervention will prove more cost-effective than TXT-Auto in reducing methamphetamine use and HIV sexual risk behaviors, while the TXT-Auto condition will prove more cost effective than the AO condition in reducing these same outcomes (PHE > TXT > AO).

Studietype

Intervensjonell

Registrering (Faktiske)

286

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
      • Los Angeles, California, Forente stater, 90028
        • Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028

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 til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: Text Messages Transmitted by Peer Health Educators (TXT-PHE)
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.
Eksperimentell: 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.
Atferdsmessig: Text Messages Transmitted by Automation (TXT-Auto)
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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Methamphetamine Use
Tidsramme: 9-months post randomization
Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
9-months post randomization
HIV Sexual Risk Behavior
Tidsramme: 9-months post randomization
Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
9-months post randomization
Cost Effectiveness
Tidsramme: up to 36 months
Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
up to 36 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HIV Primary Care
Tidsramme: 8-weeks post randomization, 3-/6-/9-months post randomization
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.
8-weeks post randomization, 3-/6-/9-months post randomization

Samarbeidspartnere og etterforskere

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

Sponsor

Friends Research Institute, Inc.

Samarbeidspartnere

University of California, Los Angeles

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

1. januar 2014

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først innsendt

3. desember 2013

Først innsendt som oppfylte QC-kriteriene

10. desember 2013

Først lagt ut (Anslag)

11. desember 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • R01DA035092 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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