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

16. juni 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

286

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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 indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Friends Research Institute, Inc.

Samarbejdspartnere

University of California, Los Angeles

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Faktiske)

1. januar 2017

Studieafslutning (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først indsendt

3. december 2013

Først indsendt, der opfyldte QC-kriterier

10. december 2013

Først opslået (Skøn)

11. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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