Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
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ClinicalTrials.gov Identifier: NCT01900080 |
Recruitment Status : Unknown
Verified October 2016 by Serena Patricia Koenig, Brigham and Women's Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 16, 2013
Last Update Posted : October 11, 2016
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | July 12, 2013 | |||||||||
First Posted Date ICMJE | July 16, 2013 | |||||||||
Last Update Posted Date | October 11, 2016 | |||||||||
Study Start Date ICMJE | August 2013 | |||||||||
Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Retention in care with undetectable viral load [ Time Frame: 12 months after HIV testing ] Proportion of patients who are alive and in-care with a plasma HIV-1 RNA level <50 copies at 12 months after HIV testing
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
Adherence to antiretroviral therapy (ART), measured by pharmacy refill records and self-report [ Time Frame: 6 months after ART initiation ] Comparison of adherence for the first 6 months of ART between the two groups using pharmacy refill records and 3-day self-report
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Original Secondary Outcome Measures ICMJE |
Adherence to antiretroviral therapy (ART), measured by pharmacy refill records [ Time Frame: 6 months after ART initiation ] Comparison of adherence for the first 6 months of ART between the two groups using pharmacy refill records
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
Cost-effectiveness [ Time Frame: 12 months after HIV testing ] To compare the cost and cost-effectiveness of standard and same-day ART, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with a plasma HIV-1 RNA level <50 copies/ml at 12 months after HIV testing
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Descriptive Information | ||||||||||
Brief Title ICMJE | Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care | |||||||||
Official Title ICMJE | Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care | |||||||||
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 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 survival, ART initiation, retention in care with viral load < 200 and < 1000 copies/ml, 6-month viral load, and adherence as measured by self-report and pharmacy refill records. Enrollment for the main study was completed in October 2015. In June 2015, enrollment was started for a new sub-study. This sub-study, funded by MAC AIDS, includes patients with WHO stage 1 or 2 disease and CD4 count >500 cells/mm3. The purpose of the sub-study is to compare 6-month retention for patients who receive same-day ART vs. standard pre-ART care. Secondary outcomes include adherence to INH and Bactrim, and cost-effectiveness between the two groups. Enrollment for the sub-study is ongoing. |
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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] stage 1 or 2) who qualify for ART by immunologic criteria (CD4 cell count ≤500 cells/mm3) with rapid CD4 cell testing at the GHESKIO Center in Port-au-Prince, Haiti. All patients in the intervention group received rapid HIV antibody testing, CD4 cell testing, clinically relevant testing for opportunistic infections, WHO staging, comprehensive counseling and social support, and ART initiation on the day of presentation. The standard group received the same services as the same-day ART group (including CD4 cell testing) except that instead of same-day ART, they received the standard GHESKIO protocol of three sequential visits for ART readiness counseling and testing for opportunistic infections prior to ART initiation. For the same-day ART group, these activities took place on the day of ART initiation and during the subsequent two weeks. Three specific aims are proposed. The first aim is to compare the proportion of patients in the standard and same-day ART groups that are alive and in-care with an undetectable HIV viral load at 12 months after HIV testing. The second aim is to compare six-month ART adherence between the two groups using pharmacy refill records. The third aim is to compare the cost and cost-effectiveness of standard and same-day ART, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with an undetectable viral load at 12 months after HIV testing. In a sub-study funded by MAC AIDS Foundation (enrollment started June 2015), patients with WHO stage 1 or 2 disease and CD4 count >500 cells/mm3 were included. They are being randomized to receive ART vs. standard pre-ART care. Participants are being enrolled in the study on the same day they receive CD4 count results, which is within 7 days of the date of HIV testing. All patients will receive additional tests as clinically indicated. All participants will receive prophylactic treatment with trimethoprim-sulfamethoxazole and isoniazid, and a daily multivitamin, as is standard of care at GHESKIO. Participants who are randomized to the standard pre-ART group will receive standard GHESKIO pre-ART care, which includes a monthly visit with a physician for 3 months, and then every other month physician visits. They will have a CD4 count annually, and start ART when they meet WHO criteria. Participants who are randomized to the same-day ART group will receive counseling and start ART on the day of study enrollment. They will have follow-up visits with the physician on Days 3, 10, 17, and 24, and with the social worker on Days 3, 10, and 17. They will have also have physician visits at weeks 8 and 12. Participants who are clinically stable, asymptomatic, and adherent at week 12 will then qualify for expedited care at future visits, which includes dispensing of ART directly by nurses in the clinic every four weeks, to reduce waiting time for patients. Participants who are symptomatic or non-adherent will be referred to a physician for evaluation. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV | |||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Koenig SP, Dorvil N, Dévieux JG, Hedt-Gauthier BL, Riviere C, Faustin M, Lavoile K, Perodin C, Apollon A, Duverger L, McNairy ML, Hennessey KA, Souroutzidis A, Cremieux PY, Severe P, Pape JW. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Med. 2017 Jul 25;14(7):e1002357. doi: 10.1371/journal.pmed.1002357. eCollection 2017 Jul. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Unknown status | |||||||||
Actual Enrollment ICMJE |
814 | |||||||||
Original Estimated Enrollment ICMJE |
712 | |||||||||
Estimated Study Completion Date ICMJE | January 2017 | |||||||||
Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Haiti | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT01900080 | |||||||||
Other Study ID Numbers ICMJE | AI104344-01A1 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Serena Patricia Koenig, Brigham and Women's Hospital | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | Brigham and Women's Hospital | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Brigham and Women's Hospital | |||||||||
Verification Date | October 2016 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |