Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT) (NCT06356974) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)
2,500 participantsStarted 2024-04-08
Plain-language summary
This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study.
The investigators hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, that it will be able to arrive at a zero prevalence over a three-year period.
The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative.
Who can participate
Age range
11 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:
* • Participants able to give signed informed consent and assent form for adolescents, which includes willingness to comply with the schedule of follow-up visits and other requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* All sexes
* 11 years of age or older at the start of the study and weight ≥30 kg at the screening of Part B
* Participants who are CATT test or HAT RDT positive (information provided by the mobile team and included into TrypElim (see Part A)
* Participants who are able to ingest oral tablets
* Participants with known address and/or contact details provided
* Participants who are able to comply with the schedule of follow-up visits and other requirements of the study
* Participants must agree not take part in any other clinical trials during the participation in part B of this study
* Participants of child-bearing potential must be willing to use appropriate contraceptive methods.
Exclusion Criteria:
* • Individuals with a positive parasitological exam on the spot at baseline (mAECT or lymph gland puncture)
* Participants previously treated for g-HAT or previously treated because of gHAT seropositive results
* Pregnant women
* Breast-feeding women
* Children ≥11 years, but under 30kg body weight at the screening for part B
* Clinically significant medical condition that could, in the opinion of the investigator, jeopardise the subject's safety or participation in t…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.