HIV Clinical Trial
Official title:
Evaluation of Rapid Diagnostic Tests (RDT) in Association With Clinical and Laboratory Predictors for the Diagnosis of Neglected Tropical Diseases (NTD) in Patients Presenting With Persistent Fever (≥1 Week) in Cambodia, Nepal, Democratic Republic of the Congo and Sudan
Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the
availability of good diagnostic capacities, undifferentiated febrile illnesses continue to
be a thorny problem for travel physicians. In developing countries, the scarcity of skilled
personnel and adequate laboratory facilities makes the differential diagnosis of fevers even
more complex. Health care workers must often rely on syndrome-oriented empirical approaches
to treatment and might overestimate or underestimate the likelihood of certain diseases. For
instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of
persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and
major disability. These diseases are however rarely diagnosed at primary health care (PHC)
level. The difficulty in establishing the cause of febrile illnesses has resulted in
omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost
and development of drug resistance.
In resource-limited settings, clinical algorithms constitute a valuable aid to health
workers, as they facilitate the therapeutic decision in the absence of good laboratory
capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of
NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain
empirical. Besides, they rarely take into account local prevalence data, do not adequately
represent the spectrum of patients and differential diagnosis at the primary care level and
often have not been properly validated. The purpose of the study is to develop
evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with
persistent fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia
and Nepal.
This study is part of a large European Union (EU)-funded research project called NIDIAG that
aims at developing integrated, evidence-based syndromic approach to improve management of
NTD-related clinical syndromes. NIDIAG targets three non-specific clinical syndromes: the
persistent fever, neurological, and intestinal syndrome. The objective of the project is to
establish diagnostic guidelines for each of this syndrome, with a particular focus on severe
and treatable neglected infectious diseases. The developed guidelines should integrate
relevant Point-of-Care (POC)tests.
The persistent fever syndrome targeted by NIDIAG is defined as presence of fever for at
least one week. The list of diseases - both NTD and other Infectious Diseases (ID) - that
frequently cause persistent (≥1 week) fever in the study countries includes: Visceral
Leishmaniasis (VL), Human Africa Trypanosomiasis (HAT), Enteric (typhoid, paratyphoid)
fever, Malaria, Brucellosis, Melioidosis, Tuberculosis, Amoebic liver abscess, Relapsing
fever, HIV, Rickettsial diseases, and Leptospirosis. The study will try to identify clinical
and laboratory predictors of these diseases as well as validate existing RDTs.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT02528773 -
Efficacy of ART to Interrupt HIV Transmission Networks
|
||
Active, not recruiting |
NCT05454839 -
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
|
||
Recruiting |
NCT05322629 -
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
|
N/A | |
Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
Active, not recruiting |
NCT01790373 -
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
|
N/A | |
Not yet recruiting |
NCT06044792 -
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
|
||
Completed |
NCT04039217 -
Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
|
Phase 4 | |
Active, not recruiting |
NCT04519970 -
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
|
N/A | |
Completed |
NCT04124536 -
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
|
N/A | |
Recruiting |
NCT05599581 -
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT02758093 -
Speed of Processing Training in Adults With HIV
|
N/A | |
Completed |
NCT02500446 -
Dolutegravir Impact on Residual Replication
|
Phase 4 | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Active, not recruiting |
NCT03902431 -
Translating the ABCS Into HIV Care
|
N/A | |
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 |