CClinicalTrials.gg
CompletedNCT04170374SPRINT-SAUpdated Dec 27, 2024

Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-South Africa

An observational study in HIV and Antiretroviral Therapy, sponsored by Boston University. Completed at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Boston University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
831
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • HIV
  • Antiretroviral Therapy
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In context

Lead sponsor

Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • ≥18 years old
  • HIV-positive

Exclusion criteria

Exclusion Criteria:

  • Pregnant
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
831 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients who initiated HIV treatment

    Other: Routine medical record data collection

  • Service providers at study facilities

    Other: Interviews with service providers

Interventions

  • OtherRoutine medical record data collection

    The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.

  • OtherInterviews with service providers

    Clinicians and lay staff will be interviewed regarding the ART initiation process.

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What researchers measure

Primary outcomes

  1. Average numbers of visits required to start ART

    Number of health system interactions required between HIV diagnosis and first dispensing of ARVs

    Time frame: Up to 6 months after treatment eligibility determined

  2. Time to ART initiation

    Average number of days required between HIV diagnosis and first dispensing

    Time frame: Up to 6 months after treatment eligibility determined

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Study locations

1 site
  • Amy Huber
    Johannesburg, Gauteng 2193, South Africa
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References and documents

Publications

  • 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. PubMed 37153118 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04170374
Lead sponsor
Boston University
Collaborators
Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa
Responsible party
Sponsor
First posted
Nov 20, 2019
Start date
Nov 1, 2020
Primary completion
Apr 30, 2021
Completion
Dec 1, 2024
Last update
Dec 27, 2024

Study contacts

Sydney B Rosen, MPA
principal investigator · BU School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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