Screen and Treat Implementation for HAT Control

NCT ID: NCT05645822

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-01-30

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.

Detailed Description

In this study, all gHAT suspects that attend participating health facilities with suggestive symptoms and test positive in an antibody detection rapid test, will presumptively be treated with fexinidazole. Blood samples will be collected for the post-hoc confirmation of the infection. Nine Health facilities have been selected in the health zones of Kasongo, Kibombo, Kunda and Samba (province of Maniema), Kongolo (province of Tanganyika) and Lubao (province of Lomami) by the PNLTHA, and ITM, based on both epidemiological data and operational considerations.

All patients that consult the selected facilities showing any symptom that could be attributed to gHAT will be offered to participate in the study and kindly requested to provide informed consent. Participants will be tested using the rapid diagnostic test (RDT) HAT Sero-K-SeT. All positive individuals will be asked to provide a venous blood sample, that will be sent to the Institut National de Recherche Biomédical (INRB) or Centre de Recherche en Santé de Kimpese (CRSK) for further serological testing with iELISA and/or immune trypanolysis (TL) and to confirm diagnosis with molecular testing. They will also be offered a 10-day fexinidazole treatment, as inpatient. After treatment, the study participants will be asked to return to the health facility after six months for a clinical follow-up.

Two follow -up visits (3 and 6 months) will be actively organized for all patients with a positive result in iELISA and/or molecular tests conducted at INRB/Kimpese laboratory, through active tracing by health facilities and community members. At the 3 month visit, a clinical examination and DNA/RNA sampling for molecular testing will be performed. At the 6 month visit, adverse events and disease status will be assessed based on clinical signs or symptoms. After the 6-month visit, all patients with a confirmed gHAT infection will be invited to come back to health facility 12, 18 and 24 months after treatment, following WHO guidelines, to confirm cure.

Conditions

Sleeping Sickness; Trypanosomiasis, African

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Screen&treat

Intervention Type: 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.

Interventions

Screen&treat

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Public Health, Democratic Republic of the Congo

OTHER_GOV

Sponsor Role: collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role: collaborator

SANRU Asbl, Soins de Santé Primaires en Milieu Rural, République Démocratique du Congo

UNKNOWN

Sponsor Role: collaborator

Drugs for Neglected Diseases

OTHER

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raquel Inocencio da Luz, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine

Other Identifiers

Screen&treat

Identifier Type: -

Identifier Source: org_study_id