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Survey of Procedures and Resources for Initiating Treatment of HIV in Africa (South Africa) (SPRINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Boston University

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 2708 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who became eligible for ART at a study facility between 1 January 2018 and 31 December 2018.
Criteria

Inclusion Criteria:

  • ≥18 years old
  • HIV-positive

Exclusion Criteria:

  • Pregnant

Information from the National Library of Medicine

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


Locations
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South Africa
Amy Huber
Johannesburg, Gauteng, South Africa, 2193
Sponsors and Collaborators
Boston University
Bill and Melinda Gates Foundation
University of Witwatersrand, South Africa
Investigators
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Principal Investigator: Sydney B Rosen, MPA BU School of Public Health
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT04170374    
Other Study ID Numbers: H-39330
OPP1136158 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No