Clinical Trials Directory

Trials / Completed

CompletedNCT04468399

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,781 (actual)
Sponsor
Boston University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERRoutine medical record data collectionThe study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
OTHERInterviews with service providersClinicians and lay staff will be interviewed regarding the ART initiation process.

Timeline

Start date
2020-05-21
Primary completion
2021-04-30
Completion
2024-12-01
First posted
2020-07-13
Last updated
2024-12-27

Locations

2 sites across 2 countries: Malawi, South Africa

Source: ClinicalTrials.gov record NCT04468399. Inclusion in this directory is not an endorsement.