Youth mHealth Adherence Intervention for HIV+ YMSM
3 september 2019 uppdaterad av: Children's Hospital of Philadelphia
Feasibility Testing of a Novel mHealth Intervention to Improve Adherence to Antiretroviral Therapy Among HIV+ Men Who Have Sex With Men (MSM) Youth
This study will help determine feasibility, acceptability, and preliminary efficacy of an app for HIV medication adherence over a 3-month period.
Participation is 3 months consisting of two study visits: An initial study visit and a 3 month follow up visit with both visits lasting about 60-90 minutes.
The participant must use the study application (app) at least once daily, and at study visits, must complete surveys.
Studieöversikt
Detaljerad beskrivning
Young men who have sex with men (YMSM) are disproportionately affected by HIV in the US and fewer than half of youth who are prescribed antiretroviral therapy (ART) achieve viral suppression. Yet few interventions have been developed to address adherence in this population with unique developmental/psychosocial needs. Mobile technology, which is constantly consumed by youth, has the potential to deliver interventions that provide support and feedback in real time as youth go about their daily lives.
This pilot study will test a theory-driven, patient-centered, mobile phone-based intervention (mHealth app) targeting medication adherence among HIV+ youth. It is a three-month prospective feasibility trial to test a medication adherence mobile application consisting of two study visits: baseline and 3-month follow up.
Data collection consists of app usage, Computer Assisted Self-Interview (CASI) for participant satisfaction with the app, demographics, and mental health and risk behaviors, as well as medical chart abstraction of disease biomarkers (CD4, viral load) and pharmacy refill data.
Studietyp
Interventionell
Inskrivning (Faktisk)
6
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Children's Hospital of Philadelphia
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
14 år till 24 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Males (sex at birth male) age 14 to 24 years.
- HIV-positive
- Owns an Android smart phone
- Within 1-month of initiating antiretroviral therapy (ART) medication, previously failed ART and about to restart an ART regimen, or currently on ART having trouble with adherence (defined as having a detectable viral load above 200 copies/ml).
- MSM (men who have sex with men)
- Receiving care at the Children's Hospital of Philadelphia (CHOP) Adolescent HIV clinic at the time of the study
Exclusion Criteria:
- Females (sex at birth; not gender)
- Males age 13 years or younger or 25 years and older.
- HIV-negative or status unknown
- Not in care at the CHOP Adolescent HIV clinic at the time of the study.
- Does not own an Android smart phone (iPhone, Blackberry, etc. phone users)
- Is already ART adherent (defined as having an undetectable or suppressed, <200 copies/ml, viral load) or is not on or going to be on ART during the study period.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: HIV medication adherence app
Youth in this arm will receive a medication adherence application to help them remember to take their HIV treatment medication (antiretroviral therapy) as a supplement to current HIV standard of care.
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A medication adherence mobile application for HIV+ youth.
It is a theory-driven, patient-centered, mobile phone-based intervention targeting medication adherence and engagement in care among HIV+ youth with features including, but not limited to: custom avatar, medication reminders, calendar tracking of medication adherence, and anonymous chat function for social support.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Suppressed viral load at 3-months
Tidsram: 3 months
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Percentage of participants with suppressed HIV viral load (≤ 200 copies/mL) at the 3-month follow-up study visit.
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3 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Self-reported medication adherence rates by participants at 3 months
Tidsram: 3 months
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Measure participants' self-reported rate of adherence at 3-month study visit using the AIDS Clinical Trials Group (ACTG) adherence 4-day recall question administered through computer-assisted self-interview (CASI) survey.
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3 months
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Medication adherence measure using prescription refill information
Tidsram: 3 months
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Percentage of participants who refilled their ART medication determined from medical chart abstraction at 3-month study visit.
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3 months
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Self-reported medication adherence rates by participants over 3-months within the medication adherence application
Tidsram: 3 months
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Percentage participants self-reported medication adherence over a 3-month period within the mHealth app where participants recorded yes/no on whether they adhered to their ART daily.
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3 months
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Measure participant satisfaction of the medication adherence application at 3-months
Tidsram: 3 months
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Measure participant satisfaction with the medication adherence application at the 3-month study visit measured by a xx-item questionnaire that includes likert scales and open-ended qualitative questions administered through computer-assisted self-interview (CASI) survey.
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3 months
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Suppressed viral load at 6-months
Tidsram: 6 months
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a. Percentage of participants with suppressed HIV viral load (≤ 200 copies/mL) at 6-months through medical chart abstraction to determine if participants remained virally suppressed or reached viral suppression since 3-months.
No study visit for participant at 6-months, medical abstraction conducted by study team as labs are conducted as part of routine HIV care.
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6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Nadia L Dowshen, MD, MSHP, Children's Hospital of Philadelphia
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 maj 2017
Primärt slutförande (Faktisk)
31 maj 2019
Avslutad studie (Faktisk)
31 maj 2019
Studieregistreringsdatum
Först inskickad
3 mars 2017
Först inskickad som uppfyllde QC-kriterierna
21 mars 2017
Första postat (Faktisk)
27 mars 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 september 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2019
Senast verifierad
1 september 2019
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 15-012173
- P30AI045008 (U.S.S. NIH-anslag/kontrakt)
- K23MH102128 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
individual participant data will not be shared with other researchers.
If shared, datasets will be deidentified of participant health information.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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