HIVSPRINT-MalawiNCT04468399
Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Malawi
An observational study of HIV and Antiretroviral Therapy, run by Boston University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Antiretroviral Therapy
- What is being tested?
- Routine medical record data collection and Interviews with service providers
- How many people
- 1,781 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 May 2020to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who became eligible for ART at a study facility between 1 July 2018 and 30 June 2019.
Who may be able to join
- 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)
Who cannot join
- Pregnant
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in Malawi
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
- Being tested
- Routine medical record data collection, Interviews with service providers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine medical record data collectionOther
The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
Interviews with service providersOther
Clinicians and lay staff will be interviewed regarding the ART initiation process.
| Study group | Role | What they receive |
|---|---|---|
| Patients who initiated HIV treatment | Not described Receives: Other: Routine medical record data collection | |
| Service providers at study facilities | Not described Receives: Other: Interviews with service providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average numbers of visits required to start ART
Number of health system interactions required between HIV diagnosis and first dispensing of ARVs
Measured: Up to 6 months after treatment eligibility determined
Time to ART initiation
Average number of days required between HIV diagnosis and first dispensing
Measured: Up to 6 months after treatment eligibility determined
Secondary outcomes (1)
Proportion of patients who initiate by specified time intervals
Proportion of patients who initiate ART within 0, 7, 14, and 28 days and 3 and 6 months of determination of treatment eligibility
Measured: Up to 6 months after treatment eligibility determined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start21 May 2020
- Primary completion30 Apr 2021
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa, Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor
- Investigators
- Sydney B Rosen, MPA, Principal investigator, BU School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468399
- Sponsor's protocol ID
- H-40354
- Other IDs
- OPP1136158
- Acronym
- SPRINT-Malawi
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2020
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37153118
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in Malawi
- ClinicalTrials.gov ID
- NCT04468399
- Acronym / sponsor ID
- SPRINT-Malawi / H-40354
- Conditions
- HIV, Antiretroviral Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,781 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa, Clinton Health Access Initiative Inc.
- Study start
- 21 May 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who initiated HIV treatment | – | Other: Routine medical record data collection |
| Service providers at study facilities | – | Other: Interviews with service providers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who became eligible for ART at a study facility between 1 July 2018 and 30 June 2019.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine medical record data collectionThe study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts. | Other | Patients who initiated HIV treatment |
| Interviews with service providersClinicians and lay staff will be interviewed regarding the ART initiation process. | Other | Service providers at study facilities |
Primary outcome
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
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
1 secondary outcome
Proportion of patients who initiate by specified time intervals
Time frame: Up to 6 months after treatment eligibility determined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 37153118Huber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney B Rosen, MPA principal investigator
BU School of Public Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Antiretroviral Therapy, run by Boston University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average numbers of visits required to start ART (time frame: Up to 6 months after treatment eligibility determined). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04468399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.