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Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies

2017년 4월 24일 업데이트: HIV Prevention Trials Network

TLC-Plus: A Study to Evaluate the Feasibility of an Enhanced Test, Link to Care, Plus Treat Approach for HIV Prevention in the United States

This is a five-part study that will take place in the Bronx, NY, and Washington, D.C. The different components of the study will focus on increasing the number of people being tested for HIV, evaluating ways to link HIV-infected people to HIV care sites, evaluating methods to reinforce antiretroviral therapy (ART) adherence, and evaluating a counseling program that focuses on HIV prevention.

연구 개요

상세 설명

The five components of the study include the following:

Expanded HIV Testing: The purpose of this part of the study is to increase the number of people being tested for HIV. In select study sites in the Bronx, NY, and Washington, D.C., HIV testing will be expanded in emergency departments (EDs) and upon hospital admission. The study will provide additional resources to expand outreach and marketing efforts in these communities. This part of the study will take place over 36 months.

Linkage-to-Care: This part of the study will take place over a 24-month period. The purpose is to compare the effectiveness of a financial incentive (FI) program to link HIV-infected people from HIV test sites to HIV care sites versus standard of care (SOC). Each HIV test site will be randomly assigned to either the FI program or SOC. At the FI sites, people who receive an HIV positive test result will receive a coupon that can be redeemed for gift cards at participating HIV care sites.

Viral Suppression: This part of the study will assess the effectiveness of an FI program at helping HIV-infected people achieve and maintain a viral load of less than 400 copies/mL compared to SOC. Each HIV care site will be randomly assigned to either the FI program or SOC. At the FI sites, HIV-infected people will receive gift cards if their viral load remains below 400 copies/mL. People are eligible to receive FIs once every 3 months throughout the 24-month study period.

Prevention for Positives: The purpose of this component of the study is to evaluate the effectiveness of a computer-delivered counseling program that focuses on HIV risk reduction behaviors for HIV-infected people. Participants will be randomly assigned to the counseling program and SOC or SOC alone. All participants will answer questions on the computer about HIV testing and care at baseline and Months 3, 6, 9, 12, and 18. Study researchers will review participants' medical records at study entry and every 3 months up to Month 18.

Survey of Patients and Providers: Participants in the Prevention for Positives component of the study will complete a computerized survey at the baseline and Month 12 visit, which will assess knowledge and attitudes about ART. Health care providers at the HIV care sites will complete Web-based surveys before and after the Viral Suppression component of the study.

연구 유형

중재적

등록 (실제)

299038

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • District of Columbia
      • Washington, D.C., District of Columbia, 미국, 20007
        • DC clinics
    • New York
      • New York, New York, 미국, 10453
        • Bronx clinics

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

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria for Expanded HIV Testing Component:

  • People who are permitted to consent for HIV testing according to New York State or Washington, D.C. law
  • Capacity to understand and provide consent for HIV testing
  • Admission to a Bronx, NY or Washington, D.C. emergency department and/or a Bronx, NY or Washington, D.C. hospital

Exclusion Criteria for Expanded HIV Testing Component:

  • Lacks the capacity to provide consent for HIV testing
  • Acute or urgent medical condition that might be adversely affected by the process of obtaining consent or performing HIV test

Inclusion Criteria for Prevention for Positives Component:

  • All people who are permitted to consent for HIV care according to New York State or Washington, D.C. law
  • Receiving care at the selected HIV care sites in the Bronx or Washington, D.C.
  • Have attended the clinic one or more times in the 7 months before study entry
  • Able to understand either spoken English or Spanish
  • Able and willing to provide informed consent
  • Participants enrolled into the Prevention for Positives component of the study will participate in the Patient Survey Component

Exclusion Criteria for Prevention for Positives Component:

  • Not seen in the clinic in the 7 months before study entry
  • History or evidence of altered mentation, inebriation, or substance use that would interfere with participation in the study
  • Unable or unwilling to provide informed consent
  • Participation in another study focusing on HIV prevention for positives

Inclusion Criteria for Patient Surveys Component:

  • All people who are permitted to consent for HIV care according to New York State or Washington, D.C. law
  • Receiving care at the selected HIV care sites in the Bronx or Washington, D.C.
  • Have attended the clinic one or more times in the 7 months before study entry
  • Able to understand either spoken English or Spanish
  • Able and willing to provide informed consent
  • Participation in the Prevention for Positives component of the study

Exclusion Criteria for Patient Surveys Component:

  • Not seen in the clinic in the 7 months before study entry
  • History or evidence of altered mentation, inebriation, or substance use that would interfere with participation in the study
  • Unable or unwilling to provide informed consent
  • Participation in another study focusing on HIV prevention for positives

Inclusion Criteria for Provider Surveys Component:

  • Prescribing clinical providers (e.g., physician, nurse practitioner/nurse-midwife, physician assistant) at select HIV care sites

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Linkage-to-Care Component: Financial Incentive (FI)
HIV test sites will provide financial incentives to encourage linkage to HIV care.
Test sites assigned to this arm will provide coupons to all people who are found to be HIV-infected after testing and who are not already linked to HIV care. The coupons can be redeemed at a participating HIV care site for gift cards.
활성 비교기: Linkage-to-Care Component: Standard of Care (SOC)
HIV test sites will provide the standard-of-care to their patients for linkage to HIV care.
Each person who receives an HIV positive test result, and is not currently in care, will be directed to HIV care sites using the site's SOC procedures.
실험적: Viral Suppression Component: FI
HIV care sites will provide financial incentives to encourage viral load suppression.
HIV-infected participants who are receiving ART will be offered FIs upon the confirmation of each suppressed viral load measurement (less than 400 copies/mL).
활성 비교기: Viral Suppression Component: SOC
HIV care sites will provide the standard-of-care to their patients for viral load suppression.
HIV-infected participants who are receiving ART will be offered support via the site's SOC procedures to attend HIV care site visits and remain adherent to their ART regimen in order to achieve and maintain viral load suppression.
실험적: Prevention for Positives Component: Counseling and SOC
Participants will take part in a computerized HIV risk reduction counseling program and receive SOC for HIV infection.
Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.
활성 비교기: Prevention for Positives Component: SOC
Participants will receive SOC for HIV infection.
Participants will receive SOC from their HIV care site.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Expanded HIV Testing Component: Number and results of HIV tests per month in publicly funded testing sites (local health department data)
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Number, transmission category, and testing source of newly identified cases in HIV surveillance data
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Initial CD4 cell count of newly identified HIV cases in surveillance data
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Number of newly identified HIV cases concomitantly diagnosed with AIDS in surveillance data
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Proportion of persons in the community tested for HIV in the last year (local population-based behavioral surveys)
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Proportion and number of total ED visits and admissions to hospital where patients receive HIV testing
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Number of HIV tests in EDs where HIV infection is newly identified
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Number of HIV tests in hospital admissions where patients receive HIV testing
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Proportion of hospital admissions who have newly identified HIV infection
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Number of tested patients identified with previously diagnosed HIV who are not in care
기간: Measured at Month 36
Measured at Month 36
Expanded HIV Testing Component: Cost of support for additional staff and HIV tests
기간: Measured at Month 36
Measured at Month 36
Linkage-to-Care Component: Number of individuals eligible for incentives and number of individuals receiving incentives (upon linkage to HIV care) at participating sites
기간: Measured at Month 24
Measured at Month 24
Linkage-to-Care Component: Cost of the program, including staffing, infrastructure, and incentives
기간: Measured at Month 24
Measured at Month 24
Linkage-to-Care Component: Proportion of HIV-infected people at each site with newly detected HIV infection or who were previously diagnosed but were out of care, and who are presently linked to care
기간: Measured at Month 24
Measured at Month 24
Linkage-to-Care Component: Mean time interval at each site from HIV diagnosis (Western Blot confirmation) to first CD4 cell count or viral load for those with newly detected HIV infection and those who were previously diagnosed but were out of care
기간: Measured at Month 24
Measured at Month 24
Linkage-to-Care Component: Proportion of HIV-infected people at a testing site with at least two CD4 cell count and viral load measurements in the prior year
기간: Measured at Month 24
Measured at Month 24
Viral Suppression Component: Number of individuals eligible for incentives and receiving incentives at a select subset of sites for select time points
기간: Measured at Month 24
Measured at Month 24
Viral Suppression Component: Cost of program, including staffing, infrastructure, and incentives
기간: Measured at Month 24
Measured at Month 24
Viral Suppression Component: Probability of an HIV-infected patient in care at a site having a suppressed viral load (less than 400 copies/mL) in the 12-month calendar assessment period beginning 12 months after initiation of the assessment period
기간: Measured at Month 24
Measured at Month 24
Viral Suppression Component: Number of identified HIV-infected patients in care who have sustained viral suppression
기간: Measured at Month 24
Measured at Month 24
Prevention for Positives Component: Proportion of participants reporting any unprotected vaginal or anal sex in the previous 3 months
기간: Measured at Month 12 and 18
Measured at Month 12 and 18

2차 결과 측정

결과 측정
기간
Prevention for Positives Component: Number of sex partners of discordant or unknown HIV status with whom participant had unprotected vaginal or anal sex in the previous 3 months
기간: Measured at Month 12 and 18
Measured at Month 12 and 18
Prevention for Positives Component: Number of sex partners with whom the participant had unprotected sex in the previous 3 months
기간: Measured at Month 12 and 18
Measured at Month 12 and 18
Prevention for Positives Component: Number of persons with whom the participant shared needles after self use in the previous 3 months
기간: Measured at Month 12 and 18
Measured at Month 12 and 18

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Wafaa El-Sadr, MD, MPH, Columbia University and Harlem Hospital
  • 연구 의자: Bernard Branson, MD, Centers for Disease Control and Prevention

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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

2010년 9월 1일

기본 완료 (실제)

2014년 12월 1일

연구 완료 (실제)

2014년 12월 1일

연구 등록 날짜

최초 제출

2010년 6월 28일

QC 기준을 충족하는 최초 제출

2010년 6월 28일

처음 게시됨 (추정)

2010년 6월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 24일

마지막으로 확인됨

2017년 4월 1일

추가 정보

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. .

HIV 감염에 대한 임상 시험

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