HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2012 by University of California, San Francisco.
Recruitment status was Recruiting

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Institute on Aging (NIA)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01377857

First received: June 18, 2011

Last updated: September 12, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention
HIV	Behavioral: Monetary Incentive Behavioral: Questionnaire Timing Behavioral: HIV Test Offering


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening
Official Title:	HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Proportion of patients offered an HIV test who accept [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion testing HIV positive of those tested [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Proportion testing HIV positive among those offered a test [ Time Frame: Monthly ] [ Designated as safety issue: No ]


Estimated Enrollment:	8000
Study Start Date:	May 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Behavioral: HIV Test Offering HIV Test will be offered as opt-in, opt-out, or active choice.
Experimental: 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.	Behavioral: HIV Test Offering HIV Test will be offered as opt-in, opt-out, or active choice.
Experimental: Active Choice In the active choice treatment, there is no default; patients must actively accept or actively decline the test.	Behavioral: HIV Test Offering HIV Test will be offered as opt-in, opt-out, or active choice.
Experimental: $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.	Behavioral: Monetary Incentive $1, $5, or $10 incentive
Experimental: $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.	Behavioral: Monetary Incentive $1, $5, or $10 incentive
Experimental: $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.	Behavioral: Monetary Incentive $1, $5, or $10 incentive
Experimental: 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).	Behavioral: Questionnaire Timing Timing of the questionnaire--either before or after testing is offered.
Experimental: 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).	Behavioral: Questionnaire Timing Timing of the questionnaire--either before or after testing is offered.
Experimental: 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.	Behavioral: Questionnaire Timing Timing of the questionnaire--either before or after testing is offered.
Experimental: 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.	Behavioral: Monetary Incentive $1, $5, or $10 incentive

Eligibility


Ages Eligible for Study:	13 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377857

Contacts


Contact: Beth Kaplan, MD	415-206-5757	beth.kaplan@emergency.ucsf.edu
Contact: Juan Carlos C Montoy	510-914-0786	jccmontoy@gmail.com

Locations


United States, California
San Francisco General Hospital	Recruiting
San Francisco, California, United States, 94122

Sponsors and Collaborators

University of California, San Francisco

National Institutes of Health (NIH)

National Institute on Aging (NIA)

Investigators


Principal Investigator:	Beth Kaplan, MD	University of California, San Francisco
Principal Investigator:	William H Dow, PhD	University of California, Berkeley

More Information

No publications provided


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01377857 History of Changes
Other Study ID Numbers:	10562983, 1RC4AG039078-01
Study First Received:	June 18, 2011
Last Updated:	September 12, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


HIV Antibodies Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015

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