Clinical trial NCT04468399: Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Malawi
Official title: Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Antiretroviral Therapy
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: University of Witwatersrand, South Africa
name: Clinton Health Access Initiative Inc.
First posted: 2020-07-13
Enrollment: 1781
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average numbers of visits required to start ART
timeFrame: Up to 6 months after treatment eligibility determined
measure: Time to ART initiation
timeFrame: Up to 6 months after treatment eligibility determined
Secondary outcomes:
measure: Proportion of patients who initiate by specified time intervals
timeFrame: Up to 6 months after treatment eligibility determined
Other outcomes:
measure: Procedures for ART initiation
timeFrame: Up to 6 months after treatment eligibility determined
Locations:
city: Lilongwe
country: Malawi
facility: Clinton Health Access Initiative
city: Johannesburg
country: South Africa
facility: Amy Huber
state: Gauteng
Study officials:
affiliation: BU School of Public Health
name: Sydney B Rosen, MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.