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HC-HMP: Healthy Choices Implementation Trial (HC-HMP)

3. November 2026 aktualisiert von: Sylvie Naar, Florida State University

Scaling Up Integrated Youth Alcohol and HIV Prevention Interventions: The Healthy Choices Implementation Trial

This study is a national, fully virtual Type 3 hybrid implementation-effectiveness clinical trial using the Multiphase Optimization Strategy (MOST) to evaluate implementation strategies designed to optimize delivery of the Healthy Choices (HC) behavioral intervention through the HealthMpowerment (HMP) digital health platform. A total of 360 emerging adults ages 18-29 who are eligible for antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) and report recent alcohol use will be randomized using a factorial design to combinations of three implementation strategies: a personalized video introduction to an HC peer counselor, tailored digital messaging, and asynchronous support from an HC counselor. All participants receive HC-HMP. The primary implementation outcome is HC direct-to-consumer fidelity, measured by the number of HC counseling sessions completed. Secondary outcomes include HMP fidelity assessed using platform-generated paradata, alcohol use, and HIV transmission risk. Participants complete assessments at baseline, 3 months, and 6 months.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

360

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Florida
      • Tallahassee, Florida, Vereinigte Staaten, 32310
        • Florida State University, Center for Translational Behavioral Science
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 29 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age 18-29 years
  • Resident of the United States
  • Able to read and understand English
  • Self-reported as eligible for HIV pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART)
  • Self-reported alcohol use within the past 30 days
  • Regular access to an internet-connected smartphone capable of supporting the HMP mobile application (Android version 7.0 or higher or iPhone iOS version 16.4 or higher)

Exclusion Criteria:

  • Pregnant at the time of screening
  • Currently incarcerated
  • Unable to provide legally effective informed consent
  • Self-reported unmanaged moderate-to-severe mental health symptoms or concerns that would interfere with safe study participation, including active psychosis
  • Active heavy illegal drug use that is unmanaged/not currently in treatment, as defined by the study eligibility screener
  • Moderate-to-severe suicide risk, including suicidal ideation with plan, as defined by study eligibility and safety procedures

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Factorial Condition 1

Participants receive HC-HMP without any of the three implementation strategies (Video Introduction, Tailored Digital Messaging, or Asynchronous Support).

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Experimental: Factorial Condition 2

Participants receive HC-HMP with the Low-Touch implementation strategy (Video Introduction) and without the Medium-Touch or High-Touch implementation strategies.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

Experimental: Factorial Condition 3

Participants receive HC-HMP with the Medium-Touch implementation strategy (Tailored Digital Messaging) and without the Low-Touch or High-Touch implementation strategies.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

Experimental: Factorial Condition 4

Participants receive HC-HMP with the High-Touch implementation strategy (Asynchronous Support) and without the Low-Touch or Medium-Touch implementation strategies.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

Experimental: Factorial Condition 5

Participants receive HC-HMP with the Low-Touch (Video Introduction) and Medium-Touch (Tailored Digital Messaging) implementation strategies and without the High-Touch implementation strategy.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

Experimental: Factorial Condition 6

Participants receive HC-HMP with the Low-Touch (Video Introduction) and High-Touch (Asynchronous Support) implementation strategies and without the Medium-Touch implementation strategy.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

Experimental: Factorial Condition 7

Participants receive HC-HMP with the Medium-Touch (Tailored Digital Messaging) and High-Touch (Asynchronous Support) implementation strategies and without the Low-Touch implementation strategy.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

Experimental: Factorial Condition 8

Participants receive HC-HMP with all three implementation strategies: Low-Touch (Video Introduction), Medium-Touch (Tailored Digital Messaging), and High-Touch (Asynchronous Support).

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Healthy Choices Direct-to-Consumer Fidelity
Zeitfenster: Baseline through 3 months

Number of Healthy Choices counseling sessions completed by each participant during the 3-month intervention period. Participants may complete 0 to 4 sessions. A session is considered completed when the participant attends at least 15 minutes of the 30-minute virtual session.

Baseline through 3 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximum Alcohol Consumption Over a 3-Day Period
Zeitfenster: Baseline, 3 months, and 6 months

Alcohol use assessed using the Timeline Followback (TLFB), which assesses daily alcohol consumption during the prior 14 days. The outcome is the maximum number of drinks consumed during a 3-day period.

Baseline, 3 months, and 6 months
HIV Transmission Risk
Zeitfenster: Baseline, 3 months, and 6 months

Dichotomous status-neutral HIV transmission risk measure based on participant self-report. Participants reporting no condomless anal or vaginal intercourse, PrEP adherence of more than four doses per week, or self-reported viral suppression are classified as low risk (0); participants not meeting any of these criteria are classified as higher risk (1).

Baseline, 3 months, and 6 months
Number of HealthMpowerment Platform Logins
Zeitfenster: Baseline through 6 months

Total number of times a participant logs into the HealthMpowerment (HMP) platform during the 6-month study period, measured using platform-generated usage paradata.

Baseline through 6 months
Total Time Spent on the HealthMpowerment Platform (Minutes)
Zeitfenster: Baseline through 6 months

Total cumulative time, measured in minutes, that a participant spends using the HealthMpowerment (HMP) platform during the 6-month study period, measured using platform-generated usage paradata.

Baseline through 6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Ermittler

  • Hauptermittler: Sylvie Naar, PhD, Florida State University
  • Hauptermittler: Lisa Hightow-Weidman, MD, MPH, Florida State University College of Nursing
  • Studienleiter: Sara Green, MSW, Florida State University College of Medicine, Center for Translational Behavioral Science

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2027

Primärer Abschluss (Geschätzt)

31. August 2030

Studienabschluss (Geschätzt)

30. November 2030

Studienanmeldedaten

Zuerst eingereicht

28. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Oktober 2026

Zuerst gepostet (Tatsächlich)

3. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • STUDY00007968
  • 1R01AA033555-01 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .