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
What is HPTN 065?
HPTN 065, also known as the Test, Link-to-Care Plus Treat (TLC-Plus) study, was a three-year research study evaluating the feasibility of a community-focused strategy to expand HIV testing, diagnose HIV infection, link HIV-positive individuals to medical care, initiate treatment according to current guidelines and ensure that patients adhere to their treatment regimens. This continuum, which begins with HIV testing and ends with viral suppression, is essential for a successful community-wide strategy centered on the use of antiretroviral therapy for HIV prevention. HPTN 065 (TLC-Plus) was designed with the aim to increase testing, linkage and viral suppression, key steps of the continuum.
Who participated in the study?
The two intervention communities (Bronx, New York and Washington, D.C.) were selected because of their high rates of HIV and they had intensive, ongoing efforts to increase HIV testing and linkage-to-care. In addition, there were four non-intervention communities included in the study— Chicago, Houston, Miami, and Philadelphia—where expanded testing and linkage activities were also underway. Observations in the four non-intervention communities helped assess the influence of changing trends in HIV testing and care expansion in the United States.
What happened during the study?
HPTN 065 consisted of five interrelated study components:
1. Expanded HIV Testing involved social mobilization activities to promote HIV testing in the community and efforts to increase HIV screening of patients seen at participating hospitals in the intervention communities. The goal was to increase the proportion of patients admitted to hospital emergency rooms and inpatient units who were tested for HIV. Activities to expand hospital-based testing took place in 16 participating hospitals (9 in the Bronx and 7 in DC). Social mobilization, which targeted men who have sex with men (MSM) and encouraged HIV testing at least twice a year, took place via various media outlets (print, radio, web, social media) in both DC and the Bronx.
2. Linkage-to-Care used a site-randomized design to evaluate whether financial incentives would increase the likelihood that individuals would be linked with medical care after receiving an HIV diagnosis. A total of 37 HIV testing sites participated in the study (18 in Bronx and 19 in DC). Half of the sites, selected at random (by chance), gave coupons to people who tested positive for HIV. These coupons could be redeemed for $25 and $100 gift cards once they received medical care at HIV care sites. The other half of the test sites continued their usual methods for linking HIV-positive individuals to HIV clinics.
3. Viral Suppression used a site-randomized design to evaluate whether financial incentives would increase the number of patients who take their HIV medication consistently in order to achieve and maintain an undetectable viral load, also referred to as viral suppression. Viral suppression is defined as having an undetectable amount of HIV virus in the blood. A total of 39 HIV care clinics participated in the study (20 in Bronx and 19 in DC). Half of the HIV clinics, selected at random (by chance), gave financial incentives ($70 gift cards every three months) to patients who maintained an undetectable viral load. The other half of the HIV clinics continued their usual methods to help patients take their HIV medications regularly.
4. Prevention for Positives used an individual randomized design to evaluate whether a computerized prevention intervention would reduce risk behaviors, such as unsafe sex or injection drug use more than the standard-of-care prevention services offered by HIV care sites. This study component was conducted at 11 sites (5 in the Bronx and 6 in DC) and enrolled a total of 948 patients.
5. Patient and Provider Surveys assessed the knowledge and attitudes of patients receiving HIV care and HIV care providers about (1) the use of antiretroviral medications for both treatment and prevention of HIV and (2) the use of financial incentives.
HPTN 065 Public Use Data Set
- Financial Incentives Fact Sheet
- Expanded HIV Testing Results Fact Sheet
- Provider Survey Fact Sheet
- Overall Study Fact Sheet
- Community Information Sheet
HPTN 065 Version 3.0
HPTN 065 Version 2.0
- HPTN 065 Protocol V2.0 - 15 Jul 2010
- Summary of Changes to V2.0 - 15 Jul 2010
- LoA #4 - 20 Nov 2012
- LoA #3 - 09 Oct 2012
- LoA #2 - 20 Oct 2011
- LoA #1 - 24 June 2011
- CM 2 - 24 Jan 2013
- CM 1 - 7 Nov 2011
HPTN 065 Version 1.0
Presentations & Webinars
- CROI 2017: Cost-Effectiveness of Financial Incentives for Viral Suppression in HPTN 065
- R4P 2016: Encouraging Trends in HIV Diagnoses, Care and Viral Suppression in 5 US Cities, 2009-2013: Surveillance-based data from HPTN065 (TLC-Plus)
- R4P 2016: Role of Financial Incentives Along the ART Adherence Continuum: A Qualitative Analysis From the HPTN 065 Study
- CROI 2016: Prevention for HIV-infected Persons in HPTN 065: Room for Improvement
- CROI 2016: Computer-based Prevention Counseling for HIV-infected Persons
- CROI 2016: Clinician and Patient Attitudes toward Financial Incentives for HIV Care (HPTN 065)
- NHPC 2015: Evaluation of Process Indicators for Expanded HIV Testing at Hospitals in HPTN 065
- CROI 2015: Expanding HIV Testing in Hospital Emergency Departments and Inpatient Admissions
- CROI 2015: Costs of Expanded HIV Testing in Four Emergency Departments
- CROI 2015: Providers' Attitudes and Practices Related to ART Use for HIV Care and Prevention
- CROI 2015: W. El-Sadr Presentation
- HPTN 065 Qualitative Substudy: The Acceptability of Financial Incentives for Viral Suppression (June 2015)
- R4P 2014: Understanding of Viral Load Among Participants Receiving Financial Incentives for Viral Suppression
- R4P 2014: Acceptability of Financial Incentives for HIV Viral Suppression
- R4P 2014: Geographic Utilization of Gift Cards Used for Financial Incentives to Encourage Viral Suppression
- R4P 2014: The Impact of Implementing a Financial Incentive Program for Viral Suppression on the Clinic Environment
- R4P 2014: Unanticipated Impact of Financial Incentives on HIV Patients and Providers
- AIDS 2012: Community Engagement for the HPTN 065 (TLC-Plus) Study: A Community-Based Study Evaluating the Feasibility of a Combination of Interventions to Prevent HIV Transmission in the US
- AIDS 2012: Clinician Practices and Attitudes Regarding Early Antiretroviral Therapy in the US: Baseline Results from HPTN 065
- AIDS 2012: Linkage-to-Care and ART Adherence Practices at Participating Sites in the HPTN 065 (TLC-Plus) Study
- AIDS 2012: HIV Testing in Six U.S. Cities Using Behavioral Surveillance Data for the TLC-Plus (HPTN 065) Study
- AIDS 2012: Assessing Viral Suppression Amongst HIV Patients Accessing Care in Six Cities Using US HIV Surveillance Data for the TLC-Plus (HPTN 065) Study
- JUNE 2017: Financial Incentives Improve Viral Suppression Among People Living With HIV: Findings from the HPTN 065 Study