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

This study is currently recruiting participants.
Verified September 2012 by University of California, San Francisco
Sponsor:
Collaborators:
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
  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:


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
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
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
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014