NCT04170374: SPRINT-SA

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

Completed Last updated 27 December 2024

What this trial tests

trial testing Routine medical record data collection in HIV in 831 participants. Completed in 1 December 2024.

Timeline

1 November 2020

Primary endpoint
30 April 2021

1 December 2024

Quick facts

Lead sponsor	Boston University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	831
Start date	1 November 2020
Primary completion	30 April 2021
Estimated completion	1 December 2024
Sites	1 location across South Africa

Drugs / interventions tested

• Routine medical record data collection
• Interviews with service providers

Conditions studied

• HIV — all drugs for HIV →
• Antiretroviral Therapy — all drugs for Antiretroviral Therapy →

Sponsor

Boston University

Who can join

18 and older, any sex, with HIV or Antiretroviral Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Huber A, Hirasen K, Brennan AT, Phiri B, et al · · 2023 · cited 4× · PMID 37153118 · DOI 10.12688/gatesopenres.14424.2
2. Uptake of same-day initiation of HIV treatment in Malawi, South Africa, and Zambia: the SPRINT retrospective cohort study
   Huber A, Hirasen K, Brennan AT, Phiri B, et al · · 2022 · DOI 10.1101/2022.11.28.22282854