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Innovative Approaches for Minor Consent: Consent 2.0

25. mars 2021 oppdatert av: Amelia Knopf, Indiana University

Innovative Approaches for Minor Consent: Consent 2.0 - A Multi-Center Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

The purpose of this study is to examine how the consent process affects the acceptability of participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk minors and the parents of minor adolescents.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Potential participants will be recruited from clinical settings and HIV testing centers. If interested in participation, they will take a short Computer Assisted Self-Interview (CASI) screening survey to determine eligibility. Those eligible will take part in the one-day study visit at that time or will provide contact information to set up the study visit at a later date.

All study participants will attend a one-day study visit at their respective study site. Upon arrival, participants will complete a CASI that collects demographic, social, behavioral, and attitudinal measures. Next, participants will take part in a simulated consent process for two hypothetical trials modeled after ATN 113 and HPTN 077. Study procedures differ for adolescents and parents, so each group is described separately below:

Adolescent Participants: For each hypothetical trial, research staff will lead the participant through a simulated consent process consistent with their randomized consent condition. Then, the participant will complete a CASI assessing Willingness to Participate (WTP) and will work with research staff to complete the University of San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC).

Parent Participants: For each hypothetical trial, research staff will review the informed consent forms with the parent. The parent will complete a CASI with three vignettes that describe each of the three possible consent conditions. Parents will rate the acceptability of each vignette. Then, the participant will work with research staff to complete the UCSD Brief Assessment of Capacity to Consent (UBACC). Finally, the participant will answer a series of questions via CASI.

A subset of 6-8 adolescents and 6-8 parents per study site will complete a debriefing interview assessing adolescent and parent perspectives on the various consent conditions in greater depth, and to better understand the role of study features, family, and adolescent characteristics in willingness to participate/willingness to support the hypothetical research studies.

Studietype

Intervensjonell

Registrering (Faktiske)

254

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Children's Hospital Colorado/Univ of Colorado SOM
    • Florida
      • Tampa, Florida, Forente stater, 33606
        • University of South Florida
    • Illinois
      • Chicago, Illinois, Forente stater, 60637
        • University of Chicago
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins University/SOM

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 17 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Note: Age limits apply to adolescent participants and to the adolescent children of parent participants.

Adolescent Inclusion Criteria

  • Age 14-17 inclusive
  • Able to read and speak English
  • HIV status is negative or unknown
  • Engaged in high-risk sexual activity in the last six months

Adolescent Exclusion Criteria

  • Child of a parent already enrolled in the study

Parent Inclusion Criteria

  • Able to read and speak English
  • Parent or guardian of an adolescent who is between ages 14-17
  • The parent/guardian's adolescent's HIV status is either negative or unknown

Parent Exclusion Criteria

  • Parent of a child already enrolled in the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Adolescents: Consent Condition 1
Autonomous minor consent
Annen: Autonomous minor consent
Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
Aktiv komparator: Adolescents: Consent Condition 2
Adult permission required
Annen: Adult permission required
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
Aktiv komparator: Adolescents: Consent Condition 3
Parental permission required
Annen: Parental permission required
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
Aktiv komparator: Parents: Consent Conditions 1-3
Autonomous minor consent, adult permission required, and parental permission required
Annen: Autonomous minor consent
Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
Annen: Adult permission required
Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
Annen: Parental permission required
Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Adolescent WTP Scores
Tidsramme: Day 1

Comparing mean adolescent Willingness to Participate (WTP) scores across the three consent conditions and two trial types.

WTP scores are based on the response to the question: "If offered the chance, how likely would you be to participate in the study?" Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.
Day 1
Mean Parent WTS Scores
Tidsramme: Day 1

Comparing mean parent Willingness to Support (WTS) scores across the three consent conditions and two trial types.

WTS scores are based on the response to the question: "This is an acceptable approach to consent for your teenager's participation in the study." Responses are collected using a Likert scale (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree) and converted to a numeric score with values ranging from 1 (strongly disagree) to 5 (strongly agree) for analysis.
Day 1
Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
Tidsramme: Day 1
This data reflects adolescent Willingness to Participate (WTP) scores by study agent/trial type. After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world studies ATN 113 and HPTN 077), adolescents are asked "If offered the chance, how likely would you be to participate in the study?" Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.
Day 1
Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
Tidsramme: Day 1
After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world trials ATN 113 and HPTN 077), parents are presented with vignettes for the 3 different consent conditions (autonomous minor consent, adult permission required, parental permission required) and asked "How acceptable is this approach to research consent?". Responses are collected on a Likert scale (completely unacceptable, unacceptable, neither unacceptable not acceptable, acceptable, completely acceptable) and converted to a numeric score with values ranging from 1 (definitely not acceptable) to 5 (definitely acceptable) for analysis.
Day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Indiana University

Samarbeidspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Etterforskere

  • Hovedetterforsker: Amy Knopf, PhD, MPH, RN, Indiana University School of Medicine
  • Studieleder: Matthew Psioda, PhD, University of North Carolina, Chapel Hill

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. november 2017

Primær fullføring (Faktiske)

15. september 2019

Studiet fullført (Faktiske)

15. september 2019

Datoer for studieregistrering

Først innsendt

3. august 2017

Først innsendt som oppfylte QC-kriteriene

3. august 2017

Først lagt ut (Faktiske)

8. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 17-0538
  • 5U24HD089880-02 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.

IPD-delingstidsramme

Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.

Tilgangskriterier for IPD-deling

Please see DASH guidelines for access criteria.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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