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?
The main purpose of this study is to assess the feasibility of a community-level test, link to care, plus treat strategy in the United States (U.S.). The study will involve evaluation of the feasibility of some components and the effectiveness of others.
The primary outcomes of the TLC-Plus package of interventions will be determined through measurement of change over the duration of the study in key parameters in two intervention communities. Observations in the four non-intervention control communities will help assess the influence of current trends in HIV testing and care expansion in the U.S.
TLC-Plus uses innovative approaches, including:
a community focus
multi-component strategies that include behavioral and biomedical interventions
the use of routinely reported HIV surveillance data to determine key outcomes
a partnership with local Departments of Health and the Centers for Disease Control and Prevention
This study will serve as a proof-of-concept formative study. It will provide key information that could guide the design and anticipate the costs of a future, large, randomized, community-level clinical trial of full implementation of a test-and-treat strategy in the U.S. Findings from this study could also inform test-and-treat efforts in other developed countries with epidemics similar to that in the U.S.
Protocol Status: Enrolling
Study Purpose: The main purpose of this study is to evaluate the feasibility of an enhanced community-level test, link to care, plus treat strategy in the U.S. The study includes the following components:
Expanded HIV Testing
Prevention for Positives
- Patient and Provider Surveys
Study Design: Each component of the study involves an independent design but is interrelated to the other components.
The Expanded HIV Testing component involves social mobilization, with targeted messaging to promote testing for men who have sex with men (MSM), and implementation of the universal offer of HIV testing in emergency departments (EDs) and hospital inpatient admissions.
The Linkage-to-Care and Viral Suppression components involve site randomization to test the effectiveness of a financial incentive (FI) intervention compared with the standard of care (SOC).
The Prevention for Positives component uses individual randomization to compare the SOC plus a computer-delivered intervention with the SOC.
The Patient and Provider Surveys will be administered at specific time points during the study to assess knowledge, attitudes and practices regarding early initiation of antiretroviral therapy (ART) and the FI interventions.
Study Sites: The study will be conducted in two intervention communities (the Bronx, New York and Washington D.C.) and surveillance data from these communities will be compared with that from four non-intervention communities (Chicago, Illinois; Houston, Texas; Miami, Florida; and Philadelphia, Pennsylvania).
Study Population: This study will primarily target individuals age 18 years and older, and will also include younger individuals who are legally able to consent for HIV testing and care according to the local law in the two intervention communities. All of the study components will include HIV-positive individuals, with the exception of the provider survey sub-component.
Study Size: Each of the five study components has a target sample size.
The universal offer of Expanded HIV Testing will be made in EDs and during hospital admission at 16 facilities in the Bronx, NY and Washington, DC. Additionally, focused messages promoting testing for MSM will be targeted to the appropriate population of each intervention community.
The Linkage-to-Care component includes 37 HIV test sites (18 in the Bronx, NY and 19 in Washington, D.C.) and 39 HIV care sites (20 in the Bronx, NY and 19 in Washington, D.C.). We project that, by the end of the study, approximately 3000 new individuals in the two intervention communities will have tested positive for HIV.
The Viral Suppression component includes the 39 HIV care sites (20 in the Bronx, NY and 19 in Washington, D.C.). Throughout the study duration, approximately 30,000 HIV-positive individuals will be in care, with an estimated 75% (22,500) eligible for ART in the two intervention communities.
The Prevention for Positives component will be conducted at a total of twelve sites (six in each intervention community) with up to a total of 1320 patients participating.
The Patient Survey will be administered to all patients participating in the Prevention for Positives component. Providers at all participating HIV care sites will be invited to complete the provider survey.
Study Duration: The study will take place over 36 months.
Primary Objectives: The main objective of the study is to determine the feasibility of a community focused enhanced test and link-to-care strategy in the United States. The study includes feasibility objectives for the Expanded HIV Testing, Linkage-to-Care and Viral Suppression components, and effectiveness objectives for the Linkage-to-Care, Viral Suppression and Prevention for Positive components.
Chair: Wafaa El-Sadr get info
Co-Chair: Bernard Branson get info
CORE Protocol Specialist: Theresa Gamble get info
CORE Protocol Specialist: Jennifer Farrior get info
CORE Protocol Specialist: Elizabeth Greene get info
CORE Protocol Specialist: Jill Stanton get info