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Development of a Tailored HIV Prevention Intervention for Young Men (myDEx)

25 giugno 2019 aggiornato da: Jose Bauermeister, University of Pennsylvania
This study uses an interactive design and development process to develop tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The study includes a tailored online prevention, intervention, as well as an attention control non--tailored HIV prevention (NTHP) comparison intervention. The pilot RCT will compare the intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Follow-up assessments will be collected at thirty (30), sixty (60), and ninety (90) days post-intervention.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

A resurgence of new HIV cases among young men who have sex with men (YMSM; ages 18--24) has underscored the importance of developing culturally- and developmentally- informed HIV programs for YMSM. The investigators are developing and pilot testing a tailored, web- based intervention called myDEx that focuses on delivering HIV prevention messages based on single YMSM's relationship expectations and partner--seeking behaviors. To maximize intervention appeal and appropriateness, the investigators have convened a youth advisory board (YAB) to provide insight and feedback during the 3--stage intervention development process. Using an iterative design and development process, they have developed tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The investigators designed and developed the myDEx tailored online prevention intervention, as well as an attention- control non--tailored HIV/AIDS prevention (NTHP) comparison intervention. After developing both interventions, the investigators used usability testing procedures to collect preliminary data from 16 YMSM on the proposed intervention's design and acceptability. Recommended changes were added to the intervention prior to launching a small pilot randomized controlled trial (RCT). The pilot RCT will compare myDEx (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Assessments will be collected at 30, 60, and 90 days follow--up.

Specific Aims include:

  1. To develop a tailored (myDEx) and non-tailored (NTHP) HIV prevention intervention focused on addressing HIV risk behaviors among single YMSM;
  2. To collect preliminary data on the feasibility, acceptability, and intervention content of the myDEx (N=16) in preparation for a small pilot RCT; and,
  3. To implement a small pilot RCT of the refined myDEx (N=120) as compared to the NTHP (N=60) intervention, in order to evaluate its feasibility and acceptability and gather preliminary efficacy results in reducing sexual risk behaviors.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

180

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 24 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Cis-gender male
  • Self-report as being single
  • Self report as HIV-negative at baseline
  • Speak and read English
  • Report unprotected anal intercourse with a male partner in prior six (6) months
  • Have access to computer or smartphone device

Exclusion Criteria:

  • Transgender identity
  • HIV positive diagnosis
  • Not residing in the United States
  • Does not engage in male-to-male sexual behavior

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: myDEx Intervention
The proposed intervention will consist of a 6-session web-based program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, YMSM will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
Comportamentale: myDEx
myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
Comparatore attivo: Non-tailored HIV Prevention
The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites.
Comportamentale: NTHP
The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Change in Number of Risky Sexual Partnerships
Lasso di tempo: Count of participants from baseline to 90-day follow-up reported
The investigators estimated the change in the total number of participants who reported engaging in condomless anal intercourse from baseline to 90-day follow-up.
Count of participants from baseline to 90-day follow-up reported
Number of Participants With Change in HIV Testing Behavior
Lasso di tempo: Count of participants from baseline to 90-day follow-up reported
The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.
Count of participants from baseline to 90-day follow-up reported

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors
Lasso di tempo: Baseline to 90-day follow-up period
The investigators will measure the change in safer sex self-efficacy over time using the HIV Risk Behavior Self-Efficacy Scale by Fisher, Fisher, Misovich, Kimble & Malloy (1996). The scale is measured on a 4-point scale (range 1-4), where higher scores mean less self-efficacy to negotiate safer sex with partners met online.
Baseline to 90-day follow-up period
Changes in Psychological Well-being
Lasso di tempo: Baseline to 90-day follow-up period
The investigators will measure symptoms of depression and anxiety using the Brief Symptom Inventory by Derogatis & Spencer (1982). Higher mean scores (scale 1-4) indicate greater symptoms of psychological distress.
Baseline to 90-day follow-up period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pennsylvania

Collaboratori

University of Michigan

Investigatori

  • Investigatore principale: Jose A Bauermeister, PhD, University of Pennsylvania

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2016

Completamento primario (Effettivo)

1 maggio 2017

Completamento dello studio (Effettivo)

1 maggio 2017

Date di iscrizione allo studio

Primo inviato

16 luglio 2016

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2016

Primo Inserito (Stima)

22 luglio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R34MH101997 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

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SÌ

Descrizione del piano IPD

The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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