HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
13. mai 2015 oppdatert av: University of California, San Francisco
Over twenty percent of HIV-positive persons in the United States are unaware of their infection, leading the Institute of Medicine to recently urge further work to compare the effectiveness of HIV screening strategies.
This study will use a randomized trial to compare several variants of emergency-room-based HIV-testing policies in order to determine how HIV test acceptance rates can be increased.
The testing policies will be designed using principles from behavioral economics, varying the choice architecture and offering small monetary incentives.
This will be the first study to measure differences in take-up rates across a variety of promising but largely untested approaches within a unified randomized trial.
Three defaults will be tested: traditional opt-in (test only those patients who request testing), opt-out (routinely testing unless patients decline), and active-choice testing (patients are required to state whether they want to be tested).
The study will also be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up.
An additional novel study contribution will be to test the hypothesis that compliance with large requests (accept an HIV test) increases after making a small request or pre-commitment - this "foot in the door" technique has not been previously studied in this setting.
The factorial design will permit a direct comparison of all interventions, as well as interactions.
The study will contribute a nuanced empirical understanding of how testing protocols from behavioral economics theory affect the effectiveness and efficiency of screening programs in an actual scaled- up setting (San Francisco General Hospital).
This will assist in implementing and assessing recent CDC guidelines on HIV screening, while also more generally advancing scientific knowledge related to applying behavioral economics in comparative effectiveness research.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
8572
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
San Francisco, California, Forente stater, 94122
- San Francisco General Hospital
-
-
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
13 år til 64 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients aged 13 - 64 years who are awake, alert, not intoxicated, and understand the premise of the test will be offered the test and questionnaire according to their treatment group.
Exclusion Criteria:
- Patients who have altered levels of consciousness, are critically ill (e.g., serious trauma), are known to have preexisting HIV diagnosis, or who have been tested for HIV in the past 3 months will be excluded from the study.
- Pregnant patients will be excluded due to alternative guidelines for incorporating opt-out testing during prenatal care.
- Any patients who are in police custody will also be excluded due to their lack of control over study participation decisions and ethical concerns over possible coercion.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Opt-In
Opt-in refers to a default of no test - patients must ask for the test in order to receive it.
Patients are informed of the availability of rapid testing.
They are tested only if they request the test.
|
HIV Test will be offered as opt-in, opt-out, or active choice.
|
|
Eksperimentell: Opt-Out
Opt-out has a default to test - patients are informed that they will receive a rapid HIV screening test unless they decline it.
Patients will be tested unless they decline.
|
HIV Test will be offered as opt-in, opt-out, or active choice.
|
|
Eksperimentell: Active Choice
In the active choice treatment, there is no default; patients must actively accept or actively decline the test.
|
HIV Test will be offered as opt-in, opt-out, or active choice.
|
|
Eksperimentell: $1 Incentive
When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value.
|
$1, $5, or $10 incentive
|
|
Eksperimentell: $5 Incentive
When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value.
|
$1, $5, or $10 incentive
|
|
Eksperimentell: $10 Incentive
When offering the HIV test, study staff will inform subjects that the ED is offering cash incentives to promote HIV testing (and that the test is also free), and will inform them of that day's value.
|
$1, $5, or $10 incentive
|
|
Eksperimentell: Early Questionnaire
At a time that does not interfere with patients' medical care, patients will be approached by a member of the research team to consent to and complete a short (3 minutes) questionnaire.
The questionnaire is designed to elicit two things: subjective risk of infection (e.g., What are the chances you have HIV? [Not possible, Unlikely, Possible, Likely, Certain]) and objective risk of infection (e.g., In the past year, have you given anyone drugs or money for sex?).
The questionnaire will be administered as one of two timing treatments - a) at the beginning of care, before the patient is offered an HIV test (Early questionnaire) or b) after the patient has been offered an HIV test (Late questionnaire).
|
Timing of the questionnaire--either before or after testing is offered.
|
|
Eksperimentell: Late Questionnaire
At a time that does not interfere with patients' medical care, patients will be approached by a member of the research team to consent to and complete a short (3 minutes) questionnaire.
The questionnaire is designed to elicit two things: subjective risk of infection (e.g., What are the chances you have HIV? [Not possible, Unlikely, Possible, Likely, Certain]) and objective risk of infection (e.g., In the past year, have you given anyone drugs or money for sex?).
The questionnaire will be administered as one of two timing treatments - a) at the beginning of care, before the patient is offered an HIV test (Early questionnaire) or b) after the patient has been offered an HIV test (Late questionnaire).
|
Timing of the questionnaire--either before or after testing is offered.
|
|
Eksperimentell: FITD Questionnaire
There will be two versions of the early questionnaire: one standard Early questionnaire, and one with an additional question: "If you were offered an HIV test as part of your routine health care at no cost, would you get tested?"
The two questionnaires will be otherwise identical.
|
Timing of the questionnaire--either before or after testing is offered.
|
|
Eksperimentell: Free
When offering the HIV test, study staff will inform subjects that the ED is offering HIV testing (and that the test is also free); no monetary incentive will be offered.
|
$1, $5, or $10 incentive
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of patients offered an HIV test who accept
Tidsramme: Monthly
|
Monthly
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion testing HIV positive of those tested
Tidsramme: Monthly
|
Monthly
|
|
Proportion testing HIV positive among those offered a test
Tidsramme: Monthly
|
Monthly
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: William H Dow, PhD, University of California, Berkeley
- Hovedetterforsker: Beth Kaplan, MD, University of California, San Francisco
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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
1. mai 2011
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
18. juni 2011
Først innsendt som oppfylte QC-kriteriene
20. juni 2011
Først lagt ut (Anslag)
21. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2015
Sist bekreftet
1. mai 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 10562983
- 1RC4AG039078-01 (U.S. NIH-stipend/kontrakt)
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. .