NCT01152918

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18,442 (actual)
• Sponsor: HIV Prevention Trials Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a five-part study that will take place in the Bronx, New York (NY), and Washington, District of Columbia (DC). 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. (Details for only three components of this study are included in ClinicalTrials.gov (Linkage-to-Care, Viral Suppression and Prevention for Positives) because they are the only ones that were randomized and had prescriptive interventions.)

Detailed description

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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
BEHAVIORAL	Linkage-to-Care Component: Financial Incentive (FI)	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.
BEHAVIORAL	Linkage-to-Care Component: Standard of Care (SOC)	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.
BEHAVIORAL	Viral Suppression Component: FI	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).
BEHAVIORAL	Viral Suppression Component: SOC	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.
BEHAVIORAL	Prevention for Positives Component: Counseling and SOC	Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.
BEHAVIORAL	Prevention for Positives Component: SOC	Participants will receive SOC from their HIV care site.

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-06-29
• Last updated: 2025-04-01

Locations

2 sites across 1 country: United States