Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa (NCT04066036) | Clinical Trial Compass
CompletedNot Applicable
Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa
South Africa, Uganda999 participantsStarted 2019-05-14
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied how well dolutegravir works in real-world settings across Sub-Saharan Africa rather than in a controlled lab setting — can you explain what the results showed about virologic failure rates, and whether those findings are relevant to my situation?
2Since this was a population-level effectiveness study rather than a randomized controlled trial testing a new drug, does that mean dolutegravir is already an established treatment option I could access outside of a trial, and would it be appropriate for me?
3The trial measured virologic failure as having an HIV-1 RNA level of 200 copies/mL or higher — can you help me understand what that threshold means for my own treatment goals and how my current or potential regimen compares?
4Since this trial has already been completed, are the results published or available, and how might the findings influence which antiretroviral regimen you would recommend for me?
5Dolutegravir-based regimens have been discussed in terms of certain side effects like weight gain — based on what this trial found in a real-world African population, are there any safety signals you think I should be aware of before considering this medication?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants With Virologic Failure (HIV-1 RNA >= 200 Copies/mL)