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

NCT ID: NCT04470011

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Antiretroviral Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients who initiated HIV treatment

Routine medical record data collection

Intervention Type OTHER

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

Interviews with service providers

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Interviews with service providers

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥18 years old
* HIV-positive

Exclusion Criteria

* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

University of Witwatersrand, South Africa

OTHER

Sponsor Role collaborator

Clinton Health Access Initiative Inc.

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sydney B Rosen, MPA

Role: PRINCIPAL_INVESTIGATOR

BU School of Public Health

Locations

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Health Economics and Epidemiology Research Office

Johannesburg, Gauteng, South Africa

Site Status

Clinton Health Access Initiative

Lusaka, , Zambia

Site Status

Countries

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South Africa Zambia

References

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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.

Reference Type BACKGROUND
PMID: 37153118 (View on PubMed)

Other Identifiers

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OPP1136158

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-40488

Identifier Type: -

Identifier Source: org_study_id