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

NCT04468399 | Completed

• 2 other identifiers: H-40354OPP1136158
• Study Type: observational
• Target: 1,781
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV; Antiretroviral Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Proportion of patients who initiate by specified time intervals

  Up to 6 months after treatment eligibility determined

Other Outcomes (1)

• Procedures for ART initiation

  Up to 6 months after treatment eligibility determined

Study Arms (2)

Patients who initiated HIV treatment

Other: Routine medical record data collection

Service providers at study facilities

Other: Interviews with service providers

Interventions

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.

Patients who initiated HIV treatment

Interviews with service providers OTHER

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

Service providers at study facilities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Pregnant

Sponsors & Collaborators

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

Study Sites (2)

Clinton Health Access Initiative

Lilongwe, Malawi

Location

Amy Huber

Johannesburg, Gauteng, 2193, South Africa

Location

Related 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.

  PMID: 37153118 BACKGROUND

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sydney B Rosen, MPA

  BU School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: May 21, 2020
• Primary Completion: April 30, 2021
• Study Completion: December 1, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); MA (1)