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Motivational Interviewing for PrEP Uptake

20. juli 2017 opdateret af: Richard Crosby

A Pilot Study Assessing a Single Motivational Interviewing Session to Improve Uptake of PrEP Among Young Black Men Who Have Sex With Men

The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes.

Studieoversigt

Detaljeret beskrivelse

The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to determine whether previous assignment to study condition moderates these outcomes. In the parent study we had the foresight to include a cross-sectional survey of men's attitudes toward PrEP use as part of their first follow-up assessment. Using that data, we will identify the predictors of readiness to accept PrEP and we will use these findings to inform the design of a brief Motivational Interviewing session (MI-PrEP) that will promote uptake of PrEP. We will enroll 65 YBMSM who have completed the 12-month follow-up assessment from the parent study and 35 YBMSM (same inclusion criteria) from either of two clinics used in the parent study (the Crossroads Clinic or the Open Arms Clinic) who did not participate in the parent study. Using small block randomization, these 100 men will be assigned to the MI-PrEP condition or to the standard of care only control condition. At the conclusion of the enrollment session men will be asked if they would like to schedule an appointment to begin taking PrEP. This same offer will be made again approximately 14 days after the enrollment session. The dependent variables will thus include measures of whether men made/kept an appointment to begin PrEP and, if so, how much time elapsed before doing so and whether they filled the prescription for PrEP. For those who do fill the prescription we will test their blood for levels of tenofovir and emtricitabine after 3 months of time has elapsed. Group differences (Intervention vs. Control) in uptake, time to uptake, and actual use/adherence of PrEP are hypothesized to favor those receiving the MI-PrEP intervention program. If this is the case then an initial body of evidence will exist supporting the potential efficacy of a Motivational Interviewing-based, single session intervention that can be delivered to YBMSM in clinical settings.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

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 29 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

self-identify as being Black/African American and they must be 18 to 29 years of age. In addition, these men must answer yes to the following screening question: "have you had anal sex with a male in the past 6 months?" Also, to be eligible all men (including those having completed the 12-month follow-up assessment in the parent study) must have an HIV-negative test result in the past 30 days.

Exclusion Criteria:

already taking PrEP

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: Intervention Group
This group receives a brief motivational interviewing session about PrEP
Ingen indgriben: Control Group
This group receives standard of care clinic based counseling about PrEP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Obtains first prescription for PrEP
Tidsramme: 3 months
first prescription will be determined by self report
3 months

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

3. januar 2016

Primær færdiggørelse (Faktiske)

30. marts 2017

Studieafslutning (Faktiske)

30. marts 2017

Datoer for studieregistrering

Først indsendt

20. juli 2017

Først indsendt, der opfyldte QC-kriterier

20. juli 2017

Først opslået (Faktiske)

21. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • #2015-0210

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 .

Kliniske forsøg med motiverende samtale

3
Abonner