Status:
UNKNOWN
Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Weill Medical College of Cornell University
Conditions:
HIV
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 an...
Detailed Description
This study is a randomized trial to establish the effectiveness of same-day ART initiation for patients who present for HIV testing with early HIV clinical disease (World Health Organization \[WHO\] s...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Ability and willingness of participant to give written informed consent;
- CD4 cell count \</=500 cells/mm3
- WHO stage 1 or 2 disease as defined by the following conditions: Asymptomatic; Persistent generalized lymphadenopathy; Moderate unexplained weight loss (under 10% of presumed or measured body weight); Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis); Herpes zoster; Angular cheilitis; Recurrent oral ulcerations; Papular pruritic eruptions; Seborrheic dermatitis; Fungal nail infections
Exclusion
- Any use of ART in the past;
- Pregnancy or breastfeeding at the screening visit;
- Psychologically unprepared to start ART, based on ART readiness survey;
- Plans to transfer care to another clinic during the study period;
- WHO stage 3 or 4 disease.
- Note: For the sub-study that includes patients with WHO stage 1 or 2 disease and CD4 count \>500, the inclusion and exclusion criteria are the same; only CD4 count is different.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
814 Patients enrolled
Trial Details
Trial ID
NCT01900080
Start Date
August 1 2013
End Date
January 1 2017
Last Update
October 11 2016
Active Locations (1)
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1
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO)
Port-au-Prince, Haiti