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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03101592 |
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Date of registration:
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18/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV
INTERVAL |
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Scientific title:
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INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV |
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Date of first enrolment:
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May 31, 2017 |
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Target sample size:
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9118 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03101592 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Malawi
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Zambia
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Contacts
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Name:
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Risa M Hoffman, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Los Angeles |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least 18 years of age.
- Willing and able to provide written informed consent for participation in this study.
- Confirmed HIV-1 infection based on country standard of care for testing.
- On antiretroviral treatment (ART) for at least six months.
- On a first-line ART regimen as defined by country-specific guidelines.
- No drug toxicity/tolerability issues with ART regimen within the prior six months.
- No period of more than one month without ART medication possession within the last six
months.
- No active opportunistic infection suspected (including tuberculosis) and not treated
for an opportunistic infection in the last 30 days.
- No active comorbidity (including hypertension) and not treated for a comorbidity in
the last 30 days.
- No viral load of more than 1000 copies/ml (using standard assay) within the last six
months.
- Not currently pregnant.
- At least six months postpartum if recently delivered a baby.
- Not currently breastfeeding or planning to breastfeed.
Exclusion Criteria:
- Under 18 years of age.
- Viral load of 1000 copies/ml or greater (using standard assay) within the last six
months.
- On alternative first-line or second-line ART regimen.
- One month or more without medication possession within the last six months.
- Experienced an ART toxicity/tolerability issue within the last six months.
- Currently receiving treatment for tuberculosis or receiving treatment for any other
opportunistic infection or comorbidity (including hypertension).
- Pregnant or less than six months postpartum.
- Women who are breastfeeding.
- Unwilling or unable to provide informed consent.
- Previously enrolled in the study.
- Currently enrolled in any other research study at the site that involves
adherence/retention or alters delivery of HIV care.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV-1-infection
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Intervention(s)
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Other: Six-month ART dispensing
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Other: Three-month ART dispensing
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Primary Outcome(s)
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Retention in Care at 12 Months
[Time Frame: 12 months]
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Secondary Outcome(s)
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Virologic Suppression at 12 Months
[Time Frame: 12 months]
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Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)
[Time Frame: 12 months]
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Secondary ID(s)
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16-001652
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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