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Mobile-Based Application "MyChoices"

19 november 2020 bijgewerkt door: Kenneth H. Mayer, MD, Fenway Community Health

Mobile-Based Application "MyChoices" to Increase Uptake of HIV Testing, Detection of New HIV Infections, and Linkage to Care and Prevention Services by Young Men Who Have Sex With Men

This study is testing the acceptability and feasibility of MyChoices, a mobile application (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who have sex with men (YMSM).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

"MyChoices", an app adapted from HealthMindr and developed using iterative feedback from youth, is being refined to to maximize acceptability among YMSM. "MyChoices" was guided by the Social Cognitive Theory (SCT) model and includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences in order to impact behavior change. (1) Tracking and Self-Monitoring HIV Risk: In order to target self-regulation, brief surveys within the app are used to assess behavioral patterns of YMSM, particularly around sexual relationships, which are then used to help customize the app for each user. (2) HIV and sexually transmitted infection (STI) Prevention Information: In order to improve self-efficacy for HIV testing and HIV prevention overall, quizzes and infographics that appeal to YMSM have been incorporated into the app, focusing on promotion of HIV prevention and regular HIV testing. The app also allows users to order OraQuick HIV home testing kits and STI home collection kits (for rectal and urethral gonorrhea and Chlamydia and syphilis). Additionally, the app includes information on testing sites and local PrEP clinics (e.g., telephone, address, hours of testing, etc), and external links to specific site webpages that are near the user (determined using GPS technology). (3) HIV Testing Plan: Acknowledging the central role of goal setting and environmental influences on health behavior, the app allows users to create a HIV testing plan by allowing them to compare and choose different screening options (e.g., home self-testing, antigen, rapid). Questions about HIV transmission behaviors and testing history are then asked to create a tailored testing plan. After a HIV testing plan is developed, users have the option to customize reminders for the timeframe selected (e.g., user is pinged every 3 months as a reminder to get tested). Users are able to select from a list of phrases or create their own to ensure privacy. Moreover, geofencing technology allows users to be notified when in the vicinity of testing locations, based on the Geo Positioning System (GPS) location, during the testing timeframe.

This study is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Fenway Health Center
    • New York
      • Bronx, New York, Verenigde Staten, 10467
        • Montefiore Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar tot 24 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • No HIV test in the past 3 months (self-reported).
  • Not known to be HIV-infected (self-reported).
  • Not currently taking PrEP (self-report).
  • Owns or leases a phone with Android platform (for Aims 2 and 3) or iOS platform (Aim 3 only), has an active data plan, and willing to download the MyChoices application.
  • Willing to attend an in-person baseline study visit in Boston or the Bronx and complete online follow-up visits.
  • Able to understand, read, and speak English.
  • Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months.

  • Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:

    1. at least one episode of condomless anal intercourse with an HIV-infected or unknown HIV status male or transfemale partner during the last 6 months; or
    2. anal intercourse with 2 or more male or transfemale sex partners during the last 6 months; or
    3. exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or
    4. sex with a male or transfemale partner and has had an STI during the last 6 months.

Exclusion Criteria:

  • Any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions.
  • Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product and evidence of vaccine-induced seropositivity.
  • Known to be HIV-infected.
  • Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MyChoices
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Gedragsmatig: Mijn keuzes
Toegang tot de MyChoices mobiele app met daarin het hiv-testplan met herinneringen, soa-informatie, PrEP-bronnen, links naar test- en PrEP-sites en geolocatiefuncties.
Geen tussenkomst: Standard of Care
Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acceptability: System Usability Scale
Tijdsspanne: 3 months
System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average.
3 months
Feasibility: Frequency of Logins
Tijdsspanne: 3 months
Number of individuals who logged into app at least one time after set up
3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
Tijdsspanne: 6 months
Self-report having tested for HIV over follow up
6 months
Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
Tijdsspanne: 6 months
Self-report of participants reporting PrEP initiation anytime over study follow up
6 months
Number of Times Participants Used Distinct App Components
Tijdsspanne: 3 months
The total number of times that participants selected distinct components (e.g., testing plan, ordering, FAQs) of the app were summed
3 months
App Content and Functionality Most Utilized
Tijdsspanne: 3 months
We a priori identified the primary app components (i.e., HIV test plan, location search, ordering supplies, FAQs) and report the number of participants using these app components at least once over follow up
3 months
Number of HIV Home Testing Kits Ordered
Tijdsspanne: 6 months
Number of Participants who ordered at least one HIV home testing kit over follow up
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fenway Community Health

Medewerkers

Brown University
Emory University
Montefiore Medical Center
University of North Carolina

Onderzoekers

  • Hoofdonderzoeker: Katie B Biello, PhD, MPH, Protocol Co-Chair, Research Study MPI
  • Hoofdonderzoeker: Kenneth H Mayer, MD, Fenway Health Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2017

Primaire voltooiing (Werkelijk)

28 december 2019

Studie voltooiing (Werkelijk)

31 januari 2020

Studieregistratiedata

Eerst ingediend

1 juni 2017

Eerst ingediend dat voldeed aan de QC-criteria

6 juni 2017

Eerst geplaatst (Werkelijk)

7 juni 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 december 2020

Laatste update ingediend die voldeed aan QC-criteria

19 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1U19HD089881 (SubProject 8784)
  • 1U19HD089881 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Raw data will be available to outside individuals through contacting the multiple principal investigators (MPIs) at two different times. The first will be after all of the baseline data is collected. The investigators will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators will welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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