Routine medical record data collection
OtherThe study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
NCT Number: NCT04468399
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Clinton Health Access Initiative, Lilongwe, Malawi
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
Clinicians and lay staff will be interviewed regarding the ART initiation process.
Time frame: Up to 6 months after treatment eligibility determined
Number of health system interactions required between HIV diagnosis and first dispensing of ARVs
Time frame: Up to 6 months after treatment eligibility determined
Average number of days required between HIV diagnosis and first dispensing
Time frame: Up to 6 months after treatment eligibility determined
Proportion of patients who initiate ART within 0, 7, 14, and 28 days and 3 and 6 months of determination of treatment eligibility
Time frame: Up to 6 months after treatment eligibility determined
Detailed descriptive information addressing such topics as patient flow, number of required clinic visits, intervals between visits, services provided, staffing cadres involved, and record keeping systems. This outcome includes multiple descriptive measures, by design.
Boston University
Other
Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in Malawi
Acronym: SPRINT-Malawi
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06647797
Antenatal Care, Antiretroviral Therapy
Gombe, Uganda
View Trial DetailsNCT04470011
Antiretroviral Therapy, HIV
Johannesburg, Gauteng, South Africa
View Trial DetailsNCT04170374
Antiretroviral Therapy, HIV
Johannesburg, Gauteng, South Africa
View Trial DetailsNCT02086630
Antiretroviral Therapy, HIV
New York, United States
View Trial Details