Screen and Treat Implementation for HAT Control

NCT05645822 | Withdrawn

• 1 other identifier: Screen&treat
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Human African Trypanosomiasis (HAT), or sleeping sickness, is one of the parasitic diseases targeted for interruption of transmission by 2030 by the WHO. The development of fexinidazole as treatment is a huge step towards this achievement; however, the diagnostic algorithm remains complex due to limited sensitivity and specificity of the available tests. A combination of serological screening and confirmation of infection through parasite visualization remains the preferred strategy, although it can be difficult to ensure its full performance in areas that are hard to reach or have limited access to electricity and other means. The present study would like to test an approach of ensuring treatment with fexinidazole of sero-suspects without confirmation of disease, among patients that consult fixed health infrastructures in the provinces of Maniema, Lomami and Tanganyika. This should enable access to gHAT treatment for patients living in hard to reach areas, actively seeking health care.

Conditions

Sleeping Sickness; Trypanosomiasis, African

Keywords

Sleeping sickness; Human African Trypanosomiasis; Fexinidazole

Outcome Measures

Primary Outcomes (1)

• Assess the feasibility of an alternative operational approach for the diagnosis and treatment of gHAT patients in areas with limited access and diagnostic capacities.

  This qualitative study will assess: * Number of people with suggestive symptoms; * Number of participants that test positive in the rapid diagnostic test; * Number of sero-positive individuals who accept fexinidazole treatment and * Number of treated individuals who test positive in further serological/molecular tests.

  11 months

Secondary Outcomes (2)

• Assess gHAT transmission in the provinces of Maniema, Tanganyka and partially Lomami.

  11 months

• Contribute to the collection of evidence of the use of fexinidazole.

  11 months.

Study Arms (1)

People with symptoms attributable to gHAT

The study will include any person that attends any of the participating healthcare facilities with symptoms that could be attributed to gHAT (long-term fever (unless other obvious causes), headache for a long period (more than 14 days), presence of enlarged lymph nodes in the neck, severe weight loss, weakness, pruritus, amenorrhea, abortions or sterility, psychiatric problems (aggressiveness, apathy, mental confusion, anxiety), sleep disturbances, motor weakness, logorrhea, speech impairment, ataxia, abnormal gait, abnormal movements or seizures) and accepts to participate.

Other: Screen&treat

Interventions

Screen&treat OTHER

Study participants will be tested with an RDT to prove the presence of antibodies against Trypanosoma brucei gambiense. Should the RDT be positive, they will be offered the 10-day treatment with fexinidazole, and an additional blood sample will be taken for the post hoc confirmation of the disease.

People with symptoms attributable to gHAT

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

9 health facilities in the endemic health zones of Kasongo, Kikombo, Kunda and Samba in the province of Maniema, Kongolo in the province of Tanganyika and Lubao in the province of Lomami are selected based on reported HAT cases 3 years prior, where fexinidazole treatment has been provided through PNLTHA or DNDi and where sample transport will be ensured by the NGO SANRU, despite difficult accessibility. The study aims to include every person that attends the participating fixed healthcare facilitie with suggestive symptoms of gHAT (see above) and is willing to provide informed consent. Since the feasibility of this approach is being tested, as many participants as possible will be included from the pool of people that attend participating healthcare centers during the study period.

You may qualify if:

• Show any suggestive symptoms of gHAT, such as headache (\>14 days), long-term fever unless other obvious cause(s), malaise, weakness, arthralgia, facial edema, pruritus, lymphadenopathy, weight loss, mental confussion, abnormal behavior, logorrhea, speech impairment, anxiety, tremor, motor weakness, ataxia, abnormal gait, abnormal movements or seizures;
• Being older than 6 years old and weighing at least 20 kg;
• Willing and able to provide written informed consent (assent for minors);
• Minors (6 to 17 years old) willing and able to provide a written assent, after obtaining written informed consent from their parents.

You may not qualify if:

• Being younger than 6 years old or weighing less than 20 kg;
• Refusal to provide informed consent;
• Previously treated for HAT (questionnaire to patients and/or family members);
• Pregnant women.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Ministry of Public Health, Democratic Republic of the Congo: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• SANRU Asbl, Soins de Santé Primaires en Milieu Rural, République Démocratique du Congo: collaborator
• Drugs for Neglected Diseases: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from sero-positive study participants.

MeSH Terms

Conditions

Trypanosomiasis, African

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Raquel Inocencio da Luz, PhD

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 12, 2022
• Study Start: January 1, 2024
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01