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NCT Number: NCT04470011

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Economics and Epidemiology Research Office, Johannesburg, Gauteng, South Africa

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old
  • HIV-positive

Exclusion criteria

  • Pregnant

Treatment and study plan

Routine medical record data collection

Other

The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.

Interviews with service providers

Other

Clinicians and lay staff will be interviewed regarding the ART initiation process.

Primary outcomes

  1. Average numbers of visits required to start ART

    Time frame: Up to 6 months after treatment eligibility determined

    Number of health system interactions required between HIV diagnosis and first dispensing of ARVs

  2. Time to ART initiation

    Time frame: Up to 6 months after treatment eligibility determined

    Average number of days required between HIV diagnosis and first dispensing

Secondary outcomes

  1. Proportion of patients who initiate by specified time intervals

    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

Other outcomes

  1. Procedures for ART initiation

    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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Clinton Health Access Initiative Inc.
  • University of Witwatersrand, South Africa

Registry information

Official study title

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

Acronym: SPRINT-Zambia

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Jul 14, 2020
Registry last updated
Dec 27, 2024

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.

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