Clinical trial NCT04170374: Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-South Africa
Official title: Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in South Africa
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
First posted: 2019-11-20
Enrollment: 831
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 January 2018 and 31 December 2018.

Brief summary: In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. The South African National Department of Health adopted this recommendation in October 2017. Neither organization provided detailed guidance, however, on how to implement the 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 clinics across 3 provinces in South Africa (KwaZuluNatal Province, Gauteng Province, and Limpopo Province). The survey will elicit detailed information about current procedures through structured interviews with clinic staff. 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:

* ≥18 years old
* HIV-positive

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:
Other outcomes:
Locations:
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.