HC-HMP: Healthy Choices Implementation Trial (HC-HMP)
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sara Green, MSW
- Telefonnummer: 850-644-2334
- E-post: sara.green@med.fsu.edu
Studera Kontakt Backup
- Namn: Sylvie Naar, PhD
- Telefonnummer: 850-644-2334
- E-post: sylvie.naar@med.fsu.edu
Studieorter
-
-
Florida
-
Tallahassee, Florida, Förenta staterna, 32310
- Florida State University, Center for Translational Behavioral Science
-
Kontakt:
- Sara Green, MSW
- Telefonnummer: 8506442334
- E-post: sara.green@med.fsu.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Healthy Choices Direct-to-Consumer Fidelity
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HealthMpowerment Fidelity
Tidsram: Baseline through 6 months
|
Engagement with the HealthMpowerment platform assessed using platform-generated usage paradata, including frequency of logins, time spent on the platform, and use of individual HMP features. |
Baseline through 6 months
|
|
Maximum Alcohol Consumption Over a 3-Day Period
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Sylvie Naar, PhD, Florida State University
- Huvudutredare: Lisa Hightow-Weidman, MD, MPH, Florida State University College of Nursing
- Studierektor: Sara Green, MSW, Florida State University College of Medicine, Center for Translational Behavioral Science
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Blodburna infektioner
- Urogenitala sjukdomar
- Genitala sjukdomar
- Immunsystemets sjukdomar
- Infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Dricksbeteende
- Beteende
- HIV-infektioner
- Alkohol dricka
Andra studie-ID-nummer
- STUDY00007968
- 1R01AA033555-01 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .