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NCT04468399Completed

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

Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in Malawi

Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. However, to date neither the WHO nor the Malawi Ministry of Health has provided detailed guidance on how to implement this 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 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.

Status (registry)
Completed
Study type
Observational
Enrollment
1781 (actual)
First submitted
8 Jul 2020
Start date
21 May 2020
Primary completion date
30 Apr 2021
Lead sponsor
Boston University
Diseases
HIV
NCT number
NCT04468399

What you commit to

  • Study type: Observational
  • Participants enrolled: 1781
  • From 21 May 2020 to the primary completion date, 30 Apr 2021
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Pregnant

Who the study is looking for

  • Adult patients (at least 18 years old)
  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinton Health Access Initiative
Coordinator of this site? Confirm its status
LilongweMalawiUnknown status
Amy Huber
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.