Status:
UNKNOWN
Outcomes of Differentiated Models of Antiretroviral Treatment (ART) Provision
Lead Sponsor:
Equip, Lesotho
Collaborating Sponsors:
Ministry of Health, Lesotho
United States Agency for International Development (USAID)
Conditions:
HIV/AIDS
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological su...
Detailed Description
Background In 2015, sub-Saharan Africa was still the region most affected by the HIV epidemic, with 25.6 (23.1-28.5) million people living with HIV in 2015. It is estimated that 42% of all people livi...
Eligibility Criteria
Inclusion
- At least 18 years of age and willing and able to provide written informed consent for participation in this study.
- Willing to participate in the multi-month dispensing model that the patient's study site has been randomized to.
- On ART ≥ 6 months with no periods of defaulting from ART since the last viral load result (ART default defined as missing 7 or more consecutive days of ART)
- On first-line ART regimen (substitutions within the first-line regimen prior to the last viral load test are permissible).
- No ARV drug substitutions since the last viral load result \< 1,000 copies per ml
- Plasma or dried-blood spot viral load \< 1,000 copies/ml in a patient who has been on first-line ART for at least 6 months, with viral load drawn within last 12 months of enrollment while patient is receiving ART
Exclusion
- On second-line ART regimen.
- Patients with co-morbidities requiring facility visits more often than 6 monthly.
- ART substitutions since last VL test.
- Diagnosed with a WHO clinical stage 3 or 4 condition within the past 3 months.
- Pregnant or less than 12 months postpartum and breastfeeding mothers.
- Participating in another study that involves dispensing interval, adherence, or retention or involves receiving medications.
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
5760 Patients enrolled
Trial Details
Trial ID
NCT03438370
Start Date
August 7 2017
End Date
September 1 2019
Last Update
February 19 2018
Active Locations (1)
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1
Ha Tlali
Maseru, Lesotho, 100