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Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care

Status
Ongoing
Phase
Open Label
Principal Investigator(s)
Serena P Koenig
Objective

The purpose of this study is to determine if same-day HIV testing and antiretroviral therapy (ART) initiation improves retention in care (as measured by the proportion of participants who are alive and in-care with an undetectable viral load 12 months after HIV testing), compared with standard of care (three visits prior to ART initiation). Secondary outcomes include comparisons of 6-month adherence and cost-effectiveness between the two groups.

Prevention Option(s)
Treatment
Study Design
Randomized
Arms and Assigned Interventions
Description
Same-Day HIV testing and ART initiation: All participants in the same-day ART group will receive rapid HIV antibody testing, CD4 cell testing, clinically relevant testing for OIs, WHO staging, counseling and social support, and ART initiation on the day of presentation for HIV testing.
ARMs
Experimental
Description
Standard ART Initiation: The standard group will receive the same services as the same-day ART group (including same-day HIV and CD4 cell testing) except that instead of same-day ART, they will receive the standard GHESKIO protocol of 3 sequential visits for ART readiness counseling and testing for OIs prior to ART initiation.
ARMs
Placebo Comparator
August 2013
January 2016
Enrollment
712
18
Years
Sites

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO)

Port-au-Prince
Haiti