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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377857
• Other study ID #: 10562983
• Secondary ID: 1RC4AG039078-01
• Status: Completed
• Phase: N/A
• First received: June 18, 2011
• Last updated: May 13, 2015
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8572
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Monetary Incentive
$1, $5, or $10 incentive
• Questionnaire Timing
Timing of the questionnaire--either before or after testing is offered.
• HIV Test Offering
HIV Test will be offered as opt-in, opt-out, or active choice.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients offered an HIV test who accept		Monthly	No
Secondary	Proportion testing HIV positive of those tested		Monthly	No
Secondary	Proportion testing HIV positive among those offered a test		Monthly	No