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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04468399
Other study ID # H-40354
Secondary ID OPP1136158
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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