INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV
- Conditions
- HIV/AIDS
- Registration Number
- PACTR201706002336105
- Lead Sponsor
- EQUIP, Right to Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 8200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Retention in care
- Secondary Outcome Measures
Name Time Method Virologic suppression;Cost-effectiveness of ART dipensing