Clinical trial NCT01377857: HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
Official title: HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2011-06-21
Enrollment: 8572
Sex: ALL
Minimum age (years): 13
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients offered an HIV test who accept
timeFrame: Monthly
Secondary outcomes:
measure: Proportion testing HIV positive of those tested
timeFrame: Monthly
measure: Proportion testing HIV positive among those offered a test
timeFrame: Monthly
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Beth Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: William H Dow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montoy JC, Dow WH, Kaplan BC. Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial. BMJ. 2016 Jan 19;532:h6895. doi: 10.1136/bmj.h6895.