Survey of Procedures and Resources for Initiating Treatment of HIV in Africa (South Africa) (SPRINT)
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|ClinicalTrials.gov Identifier: NCT04170374|
Recruitment Status : Suspended (Currently suspended due to COVID-19 policies)
First Posted : November 20, 2019
Last Update Posted : April 29, 2020
In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. The South African National Department of Health adopted this recommendation in October 2017. Neither organization provided detailed guidance, however, on how to implement the recommendation.
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 clinics across 3 provinces in South Africa (KwaZuluNatal Province, Gauteng Province, and Limpopo Province). The survey will elicit detailed information about current procedures through structured interviews with clinic staff. 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.
|Condition or disease||Intervention/treatment|
|HIV Antiretroviral Therapy||Other: Routine medical record data collection Other: Interviews with service providers|
|Study Type :||Observational|
|Estimated Enrollment :||2708 participants|
|Official Title:||Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in South Africa|
|Actual Study Start Date :||January 15, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
|Patients who initiated HIV treatment||
Other: 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||
Other: Interviews with service providers
Clinicians and lay staff will be interviewed regarding the ART initiation process.
- Average numbers of visits required to start ART [ Time Frame: Up to 6 months after treatment eligibility determined ]Number of health system interactions required between HIV diagnosis and first dispensing of ARVs
- Time to ART initiation [ Time Frame: Up to 6 months after treatment eligibility determined ]Average number of days required between HIV diagnosis and first dispensing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170374
|Johannesburg, Gauteng, South Africa, 2193|
|Principal Investigator:||Sydney B Rosen, MPA||BU School of Public Health|