|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
24 October 2016 |
|
Main ID: |
NCT01900080 |
|
Date of registration:
|
12/07/2013 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
|
|
Scientific title:
|
Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care |
|
Date of first enrolment:
|
August 2013 |
|
Target sample size:
|
814 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT01900080 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Haiti
| | | | | | | |
|
Contacts
|
|
Name:
|
Serena P Koenig, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Brigham and Women's Hospital |
|
|
Name:
|
Jean W Pape, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
GHESKIO; Weill Medical College of Cornell University |
|
|
Name:
|
Marie Marcelle Deschamps, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Haitian Group for the Study for Kaposi’s Sarcome and Opportunistic Infections |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age =18 years;
- Ability and willingness of participant to give written informed consent;
- CD4 cell count
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV
|
|
Intervention(s)
|
|
Other: Same-Day HIV testing and ART initiation
|
|
Other: Sub-Study: Same-Day ART, CD4 Count >500
|
|
Other: Sub-Study: Standard Pre-ART Care, CD4 Count >500
|
|
Other: Standard ART Initiation
|
|
Primary Outcome(s)
|
|
Retention in care with undetectable viral load
[Time Frame: 12 months after HIV testing]
|
|
Secondary Outcome(s)
|
|
Adherence to antiretroviral therapy (ART), measured by pharmacy refill records and self-report
[Time Frame: 6 months after ART initiation]
|
|
Secondary ID(s)
|
|
AI104344-01A1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|