Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).
9. juli 2018 opdateret af: Matthew Mimiaga, Brown University
Pepped on Pre-exposure Prophylaxis (PrEP): Pilot-randomized Controlled Trial (RCT) to Assess the Feasibility/Acceptability of the Pepped-for-PrEP Package (Counseling and Problem-solving PrEP Adherence Intervention With Behavioral Activation (BA) Approach) Among Stimulant Abusing MSM.
Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as associated factors including depression, as barriers to optimal PrEP adherence.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Enrolled participants will receive a referral to the Miriam Hospital for standard of care PrEP treatment.
Once prescribed PrEP through the Miriam Hospital, the study participants will be randomly assigned to one of two treatment conditions.
In the intervention condition, participants will receive a two-stepped intervention which could include up to 10 free BA and risk reduction (RR) counseling sessions.
Participants assigned to the comparison condition will receive the standard of care for PrEP treatment at the Miriam Hospital, which includes information about PrEP and how to obtain it, assistance from medical staff in obtaining health insurance for study participants, and information regarding local community resources.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Brown University School of Public Health
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Age: 18 years or older
- Sex: assigned male sex at birth
- Self-reports having sex with another man in the past month while using stimulants
- Self-reports behavioral risk for HIV infection (consistent with the Center for Disease Control guidelines) for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the preceding six months)
- Not currently prescribed PrEP at initial visit
- Able to speak and understand English (for consenting and counseling)
- Lives in New England
Exclusion Criteria:
1.) Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate.
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: Sekventiel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Pepped on PrEP
Using an efficient stepped care ("adaptive") model, all participants will receive three sessions of PrEP-STEPS counseling for PrEP adherence delivered by a Masters-level or above therapist.
Some individuals may require a more intensive approach.
These participants will receive an additional seven counseling sessions of behavioral activation with integrated cognitive behavioral therapy (CBT) designed to reduce stimulant use and promote positive behaviors.
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A counseling and problem-solving adherence intervention with a Behavioral Activation approach to re-engage participants in safe but pleasurable activities in life and addresses stimulant abuse as well as associated factors, including depression, as barriers to optimal PrEP adherence.
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Ingen indgriben: Standard of Care
PrEP adherence counseling from the Miriam Hospital PrEP Clinic.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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PrEP Uptake
Tidsramme: Baseline Stage 2
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>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.
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Baseline Stage 2
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Improve rate of PrEP adherence
Tidsramme: Daily beginning at Stage 2 Baseline up to the four month assessment visit
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Wisepill electronic pill dispenser will monitor when the pill dispenser is opened to measure medication adherence .
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Daily beginning at Stage 2 Baseline up to the four month assessment visit
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Improve rate of PrEP adherence
Tidsramme: Baseline Stage 2 and four month assessment
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Self report adherence to assess for change in adherence.
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Baseline Stage 2 and four month assessment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Reduce Unsafe Sex
Tidsramme: Baseline Stage 1,Baseline Stage 2 and four month assessment
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Self report sexual history to assess for change in sexual risk.
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Baseline Stage 1,Baseline Stage 2 and four month assessment
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Reduce Stimulant Use
Tidsramme: Baseline Stage 1,Baseline Stage 2 and four month assessment
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Self report stimulant use to assess for change in drug use.
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Baseline Stage 1,Baseline Stage 2 and four month assessment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. maj 2017
Primær færdiggørelse (Faktiske)
30. juni 2018
Studieafslutning (Faktiske)
30. juni 2018
Datoer for studieregistrering
Først indsendt
4. april 2017
Først indsendt, der opfyldte QC-kriterier
1. maj 2017
Først opslået (Faktiske)
2. maj 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1610001629
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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Kliniske forsøg med Pepped on PrEP Package
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Emory UniversityNational Institute of Mental Health (NIMH)Afsluttet