Status:
COMPLETED
Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Africa Health Research Institute
Mbarara University of Science and Technology
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which...
Detailed Description
This study is a prospective observational cohort study at three government-supported HIV clinics in rural South Africa and Uganda. We will enroll 1,000 adults living with HIV who are switched from fir...
Eligibility Criteria
Inclusion
- Age ≥18 years
- HIV-positive and in care at one of the study clinics
- Current use of NNRTI-based, first-line ART for a minimum of 6 months
- Prescribed change to TLD by clinic staff
- Residing within 100 kilometers of the treatment clinic without plans to change permanent residence in the next 48 weeks
- Consents to participation
Exclusion
- There are no specific exclusion criteria. Both men and women will be theoretically eligible. We note that decision to use TLD in patients at the recruitment clinic will be made by clinic staff, and referral for study procedures will not be made until after this decision is made. We also note that, as of the time of this protocol draft, TLD use might be limited to men, women of non-child bearing ages, and women confirmed to be on contraception. This study will follow both national guidelines and clinician discretion about use of TLD in the clinic population.
Key Trial Info
Start Date :
May 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04066036
Start Date
May 14 2019
End Date
May 31 2023
Last Update
October 23 2023
Active Locations (2)
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1
Africa Health Research Institute
Somkele, KwaZulu-Natal, South Africa
2
Mbarara University of Science and Technology
Mbarara, Uganda