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HPTN 065 (TLC-Plus)

Status
Completed
Phase
Other
Principal Investigator(s)
Wafaa M El-Sadr & Bernard Branson
Objective

A study to evaluate the feasibility of an enhanced test, link to care, plus treat approach for HIV prevention in the United States. 

Prevention Option(s)
Treatment
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Linkage-to-Care Component: Financial Incentive (FI) HIV test sites will provide financial incentives to encourage linkage to HIV care.
ARMs
Experimental
Description
Linkage-to-Care Component: Standard of Care (SOC) HIV test sites will provide the standard-of-care to their patients for linkage to HIV care.
ARMs
Placebo Comparator
Description
Viral Suppression Component: FI HIV care sites will provide financial incentives to encourage viral load suppression.
ARMs
Experimental
Description
Viral Suppression Component: SOC HIV care sites will provide the standard-of-care to their patients for viral load suppression.
ARMs
Placebo Comparator
Description
Prevention for Positives Component: Counseling and SOC Participants will take part in a computerized HIV risk reduction counseling program and receive SOC for HIV infection.
ARMs
Experimental
Description
Prevention for Positives Component: SOC Participants will receive SOC for HIV infection.
ARMs
Placebo Comparator
Results
Financial incentives had no overall effect on viral suppression, but may influence control of HIV in some clinical settings.
Official Code
NCT01152918
Trial Sponsors
HIV Prevention Trials Network & NIAID
September 2010
December 2014
Enrollment
22 000
Population
Women
Men
HIV positive
Sites

DC Clinics

Washington, District of Columbia
United States of America

Bronx clinics

New York, New York
United States of America