HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
13 mai 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
8572
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
San Francisco, California, États-Unis, 94122
- San Francisco General Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
13 ans à 64 ans (Enfant, Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: Active Choice
In the active choice treatment, there is no default; patients must actively accept or actively decline the test.
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HIV Test will be offered as opt-in, opt-out, or active choice.
|
|
Expérimental: $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
|
|
Expérimental: $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
|
|
Expérimental: $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
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
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Expérimental: 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.
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Proportion of patients offered an HIV test who accept
Délai: Monthly
|
Monthly
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Proportion testing HIV positive of those tested
Délai: Monthly
|
Monthly
|
|
Proportion testing HIV positive among those offered a test
Délai: Monthly
|
Monthly
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: William H Dow, PhD, University of California, Berkeley
- Chercheur principal: Beth Kaplan, MD, University of California, San Francisco
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2011
Achèvement primaire (Réel)
1 décembre 2013
Achèvement de l'étude (Réel)
1 décembre 2013
Dates d'inscription aux études
Première soumission
18 juin 2011
Première soumission répondant aux critères de contrôle qualité
20 juin 2011
Première publication (Estimation)
21 juin 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 mai 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 mai 2015
Dernière vérification
1 mai 2015
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 10562983
- 1RC4AG039078-01 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .