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Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa

CompletedN/A

Sponsor: Massachusetts General Hospital

Conditions: HIV-1-infection

Interventions: This is an observational study only.

Countries: South Africa, Uganda

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 is known as TLD. We hope to better understand how effective TLD will be in sub-Saharan Africa. If treatment failure occurs, we seek to understand the possible reasons, including drug resistance and adherence challenges.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

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.

Locations (2)

Somkele, KwaZulu-Natal, South Africa
Mbarara, Uganda