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ASK-PrEP (Assistance Services Knowledge-PrEP)

A legfontosabb adatok

Ki végzi
Friends Research Institute, Inc.
Hol
Los Angeles (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Leállítva
Résztvevők
152 fő vett részt
Kezdés
2023. máj. 11.
Befejezés
2025. márc. 19.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • PrEP navigation + text messaging
  • Standard of Care
  • Contingency Management
A regiszteradat frissítve
2026. február 11.
Miért állt le
President Trump's Executive Order

Ki vehet részt

Életkor
18 év felett
Nem
Csak férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 17 feltétel megnézéseKevesebb

Ki vehet részt

  • self-identified transgender woman or MSM
  • ≥18 years old
  • verified HIV negative
  • identified as high risk for HIV based on the Los Angeles County criteria
  • SUD (injection and non-injection; excluding cannabis (CUD) only; For those who have already initiated PrEP there is an additional eligibility criterion:
  • non-protective prophylaxis defined as missed ≥4 doses of PrEP/week during any week in the previous 30 days
  • no PrEP care visits in the past 3 months
  • willing to provide informed consent; and
  • willing to comply with study requirements; Should a participant be identified as having kidney or liver dysfunction sufficient to contraindicate PrEP use (creatinine clearance <60 mL/min), that individual will be withdrawn from study participation but may re-screen for eligibility once adequate renal and/or liver function has been established and medically documented (≥60 mL/min)

Ki nem vehet részt

  • HIV positive status
  • not identified as high risk for HIV based on the Los Angeles County criteria
  • under 18 years of age
  • does not identify as a trans woman or male who has sex with men
  • no verified SUD or only CUD
  • if already initiated PrEP: PrEP adherent and PrEP care visits in the past 3 months
  • unwilling to provide informed consent
  • unwilling to comply with study requirements

Helyszínek itt: Egyesült Államok

  • Friends Community CenterLos Angeles, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in the ASK-PrEP Stepped Care arm will receive 5 PrEP navigation sessions, with weekly text-messaging support, delivered over 3 months, at which point they will be assessed for intervention response. Responders will be maintained for an additional 3 months in ASK-PrEP to receive an additional 5 PrEP navigation session with weekly text-messaging support, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone) for an additional 3 months.

A vizsgálat 2 csoportja

  • ASK-PrEPA vizsgált kezelés

    ASK-PrEP is a 5-session PrEP navigation intervention, with text-messaging support, to advance through the PrEP Care Continuum by identifying the individual needs and barriers to PrEP care, including substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Intervention/treatment: PrEP navigation + text messaging Participants receive 5 PrEP navigation sessions within 3 months plus a weekly culturally specific, scripted text message. Participants that do not respond to the ASK-PrEP intervention at the 3-month assessment are re-randomized (1:1) and stepped up to receive ASK-PrEP plus CM or CM alone.

    Kezelés: PrEP navigation + text messaging és Contingency Management

  • Education and InformationA vizsgált kezelés

    The Standard of Care (SOC) intervention includes a 20-30-minute session of PrEP information and where to access PrEP in Los Angeles. The same session is repeated at the 3-month assessment. Participants randomized to the SOC arm receive 2 educational/informational sessions on PrEP misconceptions, uptake, and adherence. The sessions occur at baseline and the 3-month assessment.

    Kezelés: Standard of Care

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Optimizing PrEP Implementation and Cost-effectiveness Among Sexual and Gender Minority Individuals With a Substance Use Disorder
Publikációk
A regiszteradat frissítve
2026. február 11.