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 : HPTN 065

Study objectives

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.

Modelling objectives

HIV viral suppression (VS) is associated with individual and societal health and economic benefits. We  developed a markov model combined with a transmission risk equations to simulate the cohort of HIV patients in care at study sites and their sexual partners during the two-year intervention in order to evaluate the clinical and preventive effectiveness  and cost-effectiveness of providing the $70 financial incentives for VS to HIV patients in Bronx, NY, and Washington, DC, compared to standard care.

Collaborators

Study PIs:

Wafaa El-Sadr, M.D., MPH
Columbia University and Harlem Hospital
New York, NY, USA

Bernard Branson, M.D.
Centers for Disease Control and Prevention (CDC)
Atlanta, GA, USA

Health economist:

Blythe J. Adamson

Additional Funding

Resources

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