Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Malawi
NCT ID: NCT04468399
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1781 participants
OBSERVATIONAL
2020-05-21
2024-12-01
Brief Summary
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In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 health facilities in Malawi. The survey will elicit detailed information about current procedures through structured interviews with clinic staff at the selected health facilities. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients who initiated HIV treatment
Routine medical record data collection
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
Service providers at study facilities
Interviews with service providers
Clinicians and lay staff will be interviewed regarding the ART initiation process.
Interventions
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Routine medical record data collection
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
Interviews with service providers
Clinicians and lay staff will be interviewed regarding the ART initiation process.
Eligibility Criteria
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Inclusion Criteria
* Tested HIV-positive (or brought proof of positive HIV status) at a study site within the study period (1 July 2018 through 30 June 2019)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
University of Witwatersrand, South Africa
OTHER
Clinton Health Access Initiative Inc.
OTHER
Boston University
OTHER
Responsible Party
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Principal Investigators
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Sydney B Rosen, MPA
Role: PRINCIPAL_INVESTIGATOR
BU School of Public Health
Locations
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Clinton Health Access Initiative
Lilongwe, , Malawi
Amy Huber
Johannesburg, Gauteng, South Africa
Countries
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References
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Huber A, Hirasen K, Brennan AT, Phiri B, Tcherini T, Mulenga L, Haimbe P, Shakwelele H, Nyirenda R, Wilson Matola B, Gunda A, Rosen S. Uptake of same-day initiation of HIV treatment in Malawi, South Africa, and Zambia as reported in routinely collected data: the SPRINT retrospective cohort study. Gates Open Res. 2023 May 2;7:42. doi: 10.12688/gatesopenres.14424.2. eCollection 2023.
Other Identifiers
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OPP1136158
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-40354
Identifier Type: -
Identifier Source: org_study_id