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Table 1 Study inclusion and exclusion criteria

From: Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial

Inclusion criteria
 • Confirmed HIV-1 infection based on country standard of care for testing algorithm
 • Stable on ART, defined as:
  − on ART for at least 6 months
  − on a first-line ART regimen as defined by country-specific guidelines (efavirenz, tenofovir, and emtricitabine or lamivudine)
  − no drug toxicity/tolerability issues within the prior 6 months
  − no period of more than 1 month without medication possession within the last 6 months
   − no active opportunistic infection (OI) suspected (including tuberculosis (TB)) and not treated for an OI within the last 30 days
   − undetectable viral load (as defined by country guidelines) within the last 6 months:
    ▪ Malawi: less than 1000 copies/mL
    ▪ Zambia: less than 20 copies/mL
 • Willing and able to provide written informed consent
 • Planning to receive HIV care from the same facility for at least 1 year
Exclusion criteria
 • Co-morbid condition(s) for which the individual is treated at the ART clinic (hypertension, diabetes mellitus, chronic lung disease, etc.)
 • Pregnant or breastfeeding, or if not breastfeeding, less than 6 months postpartum
 • Already receiving care within a differentiated model in which care is received as a group or in a community, such as a community-based adherence group or adherence club
 • Enrolled in any other research studies that would influence ART adherence, retention, or dispensing interval