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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/25/2017
Start Date:September 2010
End Date:December 2014

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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.

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.

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
We found this trial at
2
sites
New York, New York 10453
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New York, NY
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1010 Wisconsin Avenue Northwest
Washington, D.C., District of Columbia 20007
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Washington, D.C.,
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