Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Zambia (SPRINT-Zambia)

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

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 Zambia 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 Zambia. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV; Antiretroviral Therapy
• Intervention / Treatment: Other: Routine medical record data collection; Other: Interviews with service providers

• Study Type: Observational
• Enrollment (Actual): 2189

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Health Economics and Epidemiology Research Office
• Zambia
  • Lusaka, Zambia
    • Clinton Health Access Initiative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who became eligible for ART at a study facility between 1 July 2018 and 30 June 2019.

Description

Inclusion Criteria:

• ≥18 years old
• HIV-positive

Exclusion Criteria:

• Pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who initiated HIV treatment	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.
Service providers at study facilities	Other: Interviews with service providers; Clinicians and lay staff will be interviewed regarding the ART initiation process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to ART initiation	Average number of days required between HIV diagnosis and first dispensing	Up to 6 months after treatment eligibility determined

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 6 months after treatment eligibility determined

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Bill and Melinda Gates Foundation; University of Witwatersrand, South Africa; Clinton Health Access Initiative Inc.
• Investigators: Principal Investigator: Sydney B Rosen, MPA, BU School of Public Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H-40488; OPP1136158 (Other Grant/Funding Number: Bill and Melinda Gates Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No