HIV/AIDSNCT03789448
Early Access to ART for All in Swaziland: Effects on Economic Outcomes
A study testing Early Access to ART for All in people with HIV/AIDS, run by Till Bärnighausen.
Trial summary
The purpose of this study is to evaluate the impact of offering early antiretroviral therapy to HIV-positive individuals in government-managed health facilities in Swaziland on a range of economic outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Early Access to ART for All
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,019 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 31 Aug 2017
- Phase
- Interventional
- 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
Who may be able to join
- All HIV-positive individuals who are aged 18 years or older, are ART naïve and attend the health facilities included in the study
Who cannot join
- All HIV-positive individuals who are <18 years of age
- All HIV-positive pregnant or breastfeeding women
- All HIV-positive individuals who did not consent to participate
About this study
Official title: MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes
The purpose of this study is to evaluate the impact of offering early antiretroviral therapy to HIV-positive individuals in government-managed health facilities in Swaziland on a range of economic outcomes
Read the detailed description
The MaxART study is a three-year stepped-wedge randomized trial with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. The main trial registration is accessible at: https://clinicaltrials.gov/ct2/show/record/NCT02909218.
This registration is specific to the economic evaluation of the MaxART study which aims to quantify the causal impacts of early ART initiation (compared to national standard care) on a range of key economic outcomes, including healthcare expenditures, productivity, and household wealth.
- Conditions
- HIV/AIDS
- Being tested
- Early Access to ART for All
- Keywords
- Antiretroviral Treatment
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Access to ART for AllOther
All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines
| Study group | Role | What they receive |
|---|---|---|
| National HIV Treatment Guidelines | No intervention | HIV-positive individuals are offered ART per Swaziland's national treatment guidelines |
| Early Access to ART for All | Experimental | HIV-positive individuals who are aged 18 years or older are initiated on ART regardless of client's immunological and clinical staging (excluding pregnant or breastfeeding women) Receives: Other: Early Access to ART for All |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total healthcare expenditures (for hospitalization and primary care)
Including direct health care costs (e.g., surgery, medication, consultation) and indirect costs (e.g., transport to clinic, payment for someone to look after children, salary lost for time off...)
Measured: 12 months
Total productivity hours
Total Hours per day spent on income generation activities
Measured: 24 hours
Secondary outcomes (3)
Rate of participants with current employment
Employment rate among participants, including full-time and part-time salary work
Measured: At study completion, an average of 1.5 years
Total sum of self-reported monthly expenditures of the participant's household
Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.)
Measured: 12 months
Household Assets Ownership and Living Standards Index
Aggregated index based on ownership of assets (e.g., refrigerator, TV, table, phone...) and living standards (e.g., flush toilet, cooking facilites, floor/wall/roof material...), total scale score is determined via principal component analysis and averaged around 0
Measured: At study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Sep 2014
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Till Bärnighausen
- Sponsor type
- University, hospital or other
- Collaborators
- Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor-investigator, Till Bärnighausen, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789448
- Sponsor's protocol ID
- MaxART Economic Evaluation
- Status last verified
- Jan 2019
- First submitted
- 16 Dec 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Briggs J, Teyssier N, Nankabirwa JI, Rek J, Jagannathan P, Arinaitwe E, Bousema T, Drakeley C, Murray M, Crawford E, Hathaway N, Staedke SG, Smith D, Rosenthal PJ, Kamya M, Dorsey G, Rodriguez-Barraquer I, Greenhouse B. Sex-based differences in clearance of chronic Plasmodium falciparum infection. Elife. 2020 Oct 27;9:e59872. doi: 10.7554/eLife.59872.
PubMed 33107430Mobegi FM, Leong LE, Thompson F, Taylor SM, Harriss LR, Choo JM, Taylor SL, Wesselingh SL, McDermott R, Ivey KL, Rogers GB. Intestinal microbiology shapes population health impacts of diet and lifestyle risk exposures in Torres Strait Islander communities. Elife. 2020 Oct 19;9:e58407. doi: 10.7554/eLife.58407.
PubMed 33074097Steinert JI, Khan S, Mlambo K, Walsh FJ, Mafara E, Lejeune C, Wong C, Hettema A, Ogbuoji O, Vollmer S, De Neve JW, Mazibuko S, Okello V, Barnighausen T, Geldsetzer P. A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini. Elife. 2020 Aug 24;9:e58487. doi: 10.7554/eLife.58487.
PubMed 32831169
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes
- ClinicalTrials.gov ID
- NCT03789448
- Acronym / sponsor ID
- MaxART Economic Evaluation
- Conditions
- HIV/AIDS
- Keywords
- Antiretroviral Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,019 participants (actual)
- Lead sponsor
- Till BärnighausenUniversity, hospital or other
- Collaborators
- Clinton Health Access Initiative Inc.
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 28 Dec 2018 (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.
The purpose of this study is to evaluate the impact of offering early antiretroviral therapy to HIV-positive individuals in government-managed health facilities in Swaziland on a range of economic outcomes
Detailed description
The MaxART study is a three-year stepped-wedge randomized trial with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. The main trial registration is accessible at: https://clinicaltrials.gov/ct2/show/record/NCT02909218.
This registration is specific to the economic evaluation of the MaxART study which aims to quantify the causal impacts of early ART initiation (compared to national standard care) on a range of key economic outcomes, including healthcare expenditures, productivity, and household wealth.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| National HIV Treatment Guidelines | No intervention | –HIV-positive individuals are offered ART per Swaziland's national treatment guidelines |
| Early Access to ART for All | Experimental | Other: Early Access to ART for AllHIV-positive individuals who are aged 18 years or older are initiated on ART regardless of client's immunological and clinical staging (excluding pregnant or breastfeeding women) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All HIV-positive individuals who are aged 18 years or older, are ART naïve and attend the health facilities included in the study
Key exclusion criteria (3 listed)
- All HIV-positive individuals who are <18 years of age
- All HIV-positive pregnant or breastfeeding women
- All HIV-positive individuals who did not consent to participate
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 |
|---|---|---|
| Early Access to ART for AllAll HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines | Other | Early Access to ART for All |
Primary outcome
Total healthcare expenditures (for hospitalization and primary care)
Time frame: 12 months
Including direct health care costs (e.g., surgery, medication, consultation) and indirect costs (e.g., transport to clinic, payment for someone to look after children, salary lost for time off...)
Total productivity hours
Time frame: 24 hours
Total Hours per day spent on income generation activities
3 secondary outcomes
Rate of participants with current employment
Time frame: At study completion, an average of 1.5 years
Total sum of self-reported monthly expenditures of the participant's household
Time frame: 12 months
Household Assets Ownership and Living Standards Index
Time frame: At study completion, an average of 1.5 years
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 4 Jan 2019.
- Derived from this study: PubMed 33107430Briggs J, Teyssier N, Nankabirwa JI, Rek J, Jagannathan P, Arinaitwe E, Bousema T, Drakeley C, Murray M, Crawford E, Hathaway N, Staedke SG, Smith D, Rosenthal PJ, Kamya M, Dorsey G, Rodriguez-Barraquer I, Greenhouse B. Sex-based differences in clearance of chronic Plasmodium falciparum infection. Elife. 2020 Oct 27;9:e59872. doi: 10.7554/eLife.59872.
- Derived from this study: PubMed 33074097Mobegi FM, Leong LE, Thompson F, Taylor SM, Harriss LR, Choo JM, Taylor SL, Wesselingh SL, McDermott R, Ivey KL, Rogers GB. Intestinal microbiology shapes population health impacts of diet and lifestyle risk exposures in Torres Strait Islander communities. Elife. 2020 Oct 19;9:e58407. doi: 10.7554/eLife.58407.
- Derived from this study: PubMed 32831169Steinert JI, Khan S, Mlambo K, Walsh FJ, Mafara E, Lejeune C, Wong C, Hettema A, Ogbuoji O, Vollmer S, De Neve JW, Mazibuko S, Okello V, Barnighausen T, Geldsetzer P. A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini. Elife. 2020 Aug 24;9:e58487. doi: 10.7554/eLife.58487.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early Access to ART for All in people with HIV/AIDS, run by Till Bärnighausen.
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 1 inclusion and 3 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 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Total healthcare expenditures (for hospitalization and primary care) (time frame: 12 months). 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 NCT03789448, which also lists 3 linked publications.
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 4 Jan 2019.