NOTRE: Optimering af langtidsvirkende profylakse før eksponering (NOTRE)
Optimering af langtidsvirkende profylakse før eksponering
The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Study aims are: Aim 1 (R61): Develop the intervention protocol for delivery of LAI PrEP + XR-B. We will conduct interviews with stakeholders (staff at partner and other carceral and community sites, n=18:) and currently or recently incarcerated individuals (n=18). Interviews will focus on how to optimize intervention components for the R33 phase. Aim 2 (R33): Evaluate implementation facilitation as a strategy to support co-located LAI PrEP + XR-B in carceral and re-entry settings. Guided by the Consolidated Framework for Implementation Research (CFIR), implementation outcomes from Proctor et al.,including acceptability, appropriateness, adoption, feasibility, and sustainability will be assessed using surveys, interviews, and administrative records. Aim 3 (R33): Compare the effectiveness of co-located LAI PrEP + XR-B to oral PrEP + SL-B. Patient preference trial for 450 adults who are clinically indicated for both PrEP and MOUD and soon-to-be-released from a carceral setting to either LAI Prep + X-RB (n=150) or oral PrEP + SL-B (n=150) treatment initiated in jail or prison. A baseline assessment will be conducted prior to release followed by monthly follow-up for 7 months and a final long-term follow-up visit at 12-months.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Hannah Camp, MPH, MSW
- Telefonnummer: 9193600692
- E-mail: hannah.camp@duke.edu
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical System
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Ledende efterforsker:
- Michael Gordon, DPA
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Kontakt:
- Hannah Camp, MPH, MSW
- Telefonnummer: 9193600692
- E-mail: hannah.camp@duke.edu
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Kontakt:
- Lauren Brinkley-Rubinstein, PhD
- Telefonnummer: 919 668 1753
- E-mail: lauren.br@duke.edu
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Ledende efterforsker:
- Lauren Brinkley-Rubinstein, PhD
-
Ledende efterforsker:
- Curt Beckwith, MD, FIDSA, FACP
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adults (age 18) at a participating carceral site;
- Eligible for release within 120 days (sentenced and/or pretrial). Individuals who might be sentenced to federal prison will be excluded;
- History of OUD (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration);
- HIV negative (as confirmed by a HIV rapid test);
- Clinically indicated for PrEP based on CDC guidelines during incarceration and/or the year prior to incarceration;
- Willing to enroll in buprenorphine treatment and PrEP and be randomized to either study arm; and
- Report that, during community re-entry they will reside in the geographic locations of the study.
Exclusion Criteria:
- Liver function test levels greater than four times normal (if we are unable to obtain labs, a determination by our site partner physicians will be made to allow inclusion);
- Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);
- Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrhythmics, antipsychotics and antidepressants);
- Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);
- Known allergic reaction to PrEP or buprenorphine; and
- Suicidal ideation.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Daily Oral Pill Arm
Participants assigned to this arm will be administered daily oral pre-exposure prophylaxis for HIV prevention, as well as daily oral buprenorphine for opioid use disorder |
Oral PrEP + SL-B treatment initiated in jail or prison. Oral PrEP + SL-B treatment initiated in jail or prison. |
|
Eksperimentel: Long Acting Injectable Arm
Participants assigned to this arm will be administered the-long acting injectable formulation of pre-exposure prophylaxis every 1-2 months, as well as the long-acting injectable formulation of buprenorphine, at the same clinic visit. |
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison. Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PrEP adherence, time to dropout
Tidsramme: up to 12 months
|
Dropout is defined as missing treatment for 7 consecutive days. |
up to 12 months
|
|
Buprenorphine adherence, time to dropout
Tidsramme: up to 12 months
|
Dropout is defined as missing treatment for 7 consecutive days. |
up to 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Stofbrug som målt efter antal deltagere med positiv urinlægemiddelprøve (UDT)
Tidsramme: Op til 12 måneder
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Op til 12 måneder
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Antal deltagere med en dødelig eller ikke-dødelig overdosis
Tidsramme: Op til 12 måneder
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Op til 12 måneder
|
|
Antal deltagere, der deltager i HIV -risikoadfærd
Tidsramme: Op til 12 måneder
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Op til 12 måneder
|
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Antal deltagere med tidligere kriminelle systemengagement
Tidsramme: Baseline
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Baseline
|
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Antal deltagere med HIV -erhvervelse
Tidsramme: Op til 12 måneder
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Op til 12 måneder
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lauren Brinkley-Rubinstein, PhD, Duke University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Narkotika-relaterede lidelser
- Urogenitale sygdomme
- Genitale sygdomme
- Psykiske lidelser
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Stof-relaterede lidelser
- Kemisk inducerede lidelser
- HIV-infektioner
- Opioid-relaterede lidelser
- Heterocykliske forbindelser
- Heterocykliske forbindelser, smeltet ring
- Alkaloider
- Polycykliske aromatiske kulbrinter
- Polycykliske forbindelser
- Heterocykliske forbindelser, 4 eller flere ringe
- Morfinans
- Opiatalkaloider
- Heterocykliske forbindelser, bro-ring
- Fenanthrener
- Buprenorphin
- Cabotegravir
Andre undersøgelses-id-numre
- Pro00117590
- R61DA060583 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Our data and research findings will be shared with other researchers through the customary means of peer-reviewed publications and at national and international conferences and symposia, such as the annual meeting of the Academic Consortium on Criminal Justice Health, the American Public Health Association.
We will ensure that publications reporting on study data and results will be made available to interested scientists by submitting an electronic version of all papers, upon acceptance for publication, to the National Library of Medicine's PubMed Central.
In addition, we will cite this grant in any products emanating from this research study. Whenever possible, we will make resulting publications open access. In addition, our team, whenever possible, will make the data underlying the conclusions of peer-reviewed scientific research publications freely available in public repositories at the time of initial publication.
IPD-delingstidsramme
Scientific data will be made available after all longitudinal data is collected (baseline, follow-up data) and has undergone rigorous quality control. In addition, data will be made available after the primary outcome papers are accepted for publication. An exception to this will be sharing more routinely with the HIV/Justice Research Network Data Coordination Center.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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