Ondersteuning integreren om Prep te promoten voor zwarte adolescenten die met apps werken
Adolescent Speaks Study: Integratie van ondersteuning om de voorbereiding te promoten voor zwarte adolescenten die met apps werken
This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infections, reducing the risk by over 90%. However, adherence among AYAs remains suboptimal, with only 34% maintaining adherence at 48 weeks. Studies suggest that adult support can improve adherence in pediatric HIV treatment, but this approach has not been systematically evaluated for PrEP use in AYAs. Prior research indicates that Black AYAs and their families are open to incorporating adult support for PrEP adherence.
Given the success of mobile health (mHealth) interventions in promoting sexual health, this study aims to enhance the HealthMPowerment (HMP) app-an existing mHealth platform designed for HIV prevention-to facilitate dyadic communication between Black AYAs and trusted adult support persons.
The study addresses the high rates of HIV among Black adolescents and young adults (AYAs) in Alabama, where AYAs (ages 13-24) account for 31% of new HIV diagnoses, with Black gay and bisexual males, transgender individuals, and heterosexual young women being disproportionately affected. Nearly half of new infections occur in rural areas. The U.S. Department of Health and Human Services Ending the HIV Epidemic initiative prioritizes Alabama as a geographic hotspot, emphasizing the need for patient-centered interventions to reduce HIV incidence.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Samantha Hill, MD, MPH
- Telefoonnummer: 404-778-1537
- E-mail: svhill2@emory.edu
Studie Contact Back-up
- Naam: Stephanie Wallace, MD, MPH
- Telefoonnummer: (205) 638-9345
- E-mail: stepheni@uab.edu
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 25294-0111
- University of Alabama
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Contact:
- Stephenie Wallace, MD
- Telefoonnummer: (205) 638-9345
- E-mail: stepheni@uab.edu
-
Onderonderzoeker:
- Stephanie Wallace, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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African Americans
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Living in the state of Alabama
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Have a PrEP indication (e.g. sex with a partner living with HIV, condomless sex, sex with multiple partners, engagement in transactional sex, or at least one sexually transmitted infection in the past 6 months)
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Support Person:
- >21 years old
- self-reported provision of instrumental, informational, or emotional support for a Black AYA 14-21 years old
Exclusion Criteria:
- HIV positive
- Inability to provide informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: AYA group
All enrolled participants (AYAs and support persons) will receive a demonstration of the app including all of its features. All participants will use the app for 6 months. Each dyad of participants will instructed to use the app to communicate with each other and AYAs will be instructed to use the app to keep track of their PrEP. Data from the medication tracker will be collected at 1-, 3-, and 6-months |
A mobile health app designed to facilitate increased PrEP use and adherence among AYAs |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acceptability/Usability
Tijdsspanne: 1 month, 3 months, and 6 months
|
The study evaluates an app's impact through post-intervention interviews, focusing on user experience, ethical concerns, and future usage intentions. It explores burden, satisfaction, attitudes, and how the app influences communication and adherence. Sekhon's Theoretical Framework of Acceptability will be utilized to measure this outcome. |
1 month, 3 months, and 6 months
|
|
Feasibility: Communication
Tijdsspanne: 1 month, 3 months, and 6 months
|
Communication between adolescents and young adults (AYA) and support person (i.e., Experience using chat features; Experience using forums). A modified version of Structured Assessment of FEasibility (SAFE) will be utilized to measure this outcome. |
1 month, 3 months, and 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Medication Adherence Tracker
Tijdsspanne: 1 month, 3 months, and 6 months
|
This will be measured by analyzing the percent of dates with data entered into the medication tracker and correlating that data with reasons why participants did not take their medication (when applicable) |
1 month, 3 months, and 6 months
|
|
Data Usage
Tijdsspanne: 1 month, 3 months, and 6 months
|
This will be measured by comparing the amount of time (minutes) spent using distinct features of the app (e.g. forums, educational resources, avatars, side effect trackers, chat features) |
1 month, 3 months, and 6 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Samantha Hill, MD, MPH, Emory University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00007320
- 7K23MH128128-03 (Subsidie/contract van de Amerikaanse NIH)
- 2024P007023 (Andere identificatie: Emory IRB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data that underlie the results in the article, after deidentification (text, tables, figures, and appendices).
IPD-tijdsbestek voor delen
Beginning 3 months and ending 5 years following article publication
IPD-toegangscriteria voor delen
Proposals should be directed to svhill2@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are delivered electronically to investigators.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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