- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01377857
HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
2015년 5월 13일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
8572
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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San Francisco, California, 미국, 94122
- San Francisco General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
13년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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HIV Test will be offered as opt-in, opt-out, or active choice.
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실험적: 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.
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HIV Test will be offered as opt-in, opt-out, or active choice.
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실험적: 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.
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실험적: $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.
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$1, $5, or $10 incentive
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실험적: $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.
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$1, $5, or $10 incentive
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실험적: $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.
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$1, $5, or $10 incentive
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실험적: 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).
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Timing of the questionnaire--either before or after testing is offered.
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실험적: 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).
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Timing of the questionnaire--either before or after testing is offered.
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실험적: 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.
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Timing of the questionnaire--either before or after testing is offered.
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실험적: 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.
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$1, $5, or $10 incentive
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Proportion of patients offered an HIV test who accept
기간: Monthly
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Monthly
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Proportion testing HIV positive of those tested
기간: Monthly
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Monthly
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Proportion testing HIV positive among those offered a test
기간: Monthly
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Monthly
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: William H Dow, PhD, University of California, Berkeley
- 수석 연구원: Beth Kaplan, MD, University of California, San Francisco
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 5월 1일
기본 완료 (실제)
2013년 12월 1일
연구 완료 (실제)
2013년 12월 1일
연구 등록 날짜
최초 제출
2011년 6월 18일
QC 기준을 충족하는 최초 제출
2011년 6월 20일
처음 게시됨 (추정)
2011년 6월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 13일
마지막으로 확인됨
2015년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 10562983
- 1RC4AG039078-01 (미국 NIH 보조금/계약)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .