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

HIV Clinical Trial

— SPRINT-Malawi  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04468399
• Other study ID #: H-40354
• Secondary ID: OPP1136158
• Status: Active, not recruiting
• Start date: May 21, 2020
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1781
• Est. completion date: December 2024
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Pregnant

Related Conditions & MeSH terms

• Antiretroviral Therapy
• HIV

Intervention

Other:
• Routine medical record data collection
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
• Interviews with service providers
Clinicians and lay staff will be interviewed regarding the ART initiation process.

Locations

Country	Name	City	State
Malawi	Clinton Health Access Initiative	Lilongwe
South Africa	Amy Huber	Johannesburg	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Bill and Melinda Gates Foundation, Clinton Health Access Initiative Inc., University of Witwatersrand, South Africa

Countries where clinical trial is conducted

Malawi,  South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedures for ART initiation	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.	Up to 6 months after treatment eligibility determined
Primary	Average numbers of visits required to start ART	Number of health system interactions required between HIV diagnosis and first dispensing of ARVs	Up to 6 months after treatment eligibility determined
Primary	Time to ART initiation	Average number of days required between HIV diagnosis and first dispensing	Up to 6 months after treatment eligibility determined
Secondary	Proportion of patients who initiate by specified time intervals	Proportion of patients who initiate ART within 0, 7, 14, and 28 days and 3 and 6 months of determination of treatment eligibility	Up to 6 months after treatment eligibility determined