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

Completed

• Conditions: Antiretroviral Therapy; HIV
• Interventions: Other: Routine medical record data collection; Other: Interviews with service providers

• Registration Number: NCT04468399
• Lead Sponsor: Boston University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Primary Completion: 2021-04-30
• Status Verified: 2024-12
• Study Completion: 2024-12-01
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1781

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who initiated HIV treatment	Routine medical record data collection	-
Service providers at study facilities	Interviews with service providers	-

Primary Outcome Measures

Name	Time	Method
Time to ART initiation	Up to 6 months after treatment eligibility determined	Average number of days required between HIV diagnosis and first dispensing
Average numbers of visits required to start ART	Up to 6 months after treatment eligibility determined	Number of health system interactions required between HIV diagnosis and first dispensing of ARVs

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who initiate by specified time intervals	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

Trial Locations

Locations (2)

Amy Huber; 🇿🇦 Johannesburg, Gauteng, South Africa

Clinton Health Access Initiative; 🇲🇼 Lilongwe, Malawi