HIV Clinical Trial
Official title:
Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)
Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific
symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low
sensitivity of available diagnostic tools.
This project aims at evaluating two innovative immunological methods for diagnosing of
active TB among HIV-infected and uninfected children.
The study is designed as a prospective study for the evaluation of diagnostic tests.
Children admitted with probable TB based on clinical and radiological symptoms are
recruited. Gastric lavage or sputum on two to three consecutive days will be collected as
per routine practise. Active TB will be defined as a positive GeneXpert diagnostic test or
MTB culture.
In addition, children with no sign of TB will be recruited to estimate the specificity of
the diagnostic tests. These children will be recruited from the surgical ward of the
hospital, and matched for age group and HIV status.
In all children, blood samples will be drawn and stored to perform quantiferon (R) and the
new tests under evaluation.
The analysis will evaluate the sensitivity and specificity of the tests against the current
gold standard (detection of Mycobacterium tuberculosis (MTB) in any specimen obtained from
the patient). Identification of diagnosis algorithms, including these tests if they prove to
be informative, will be elaborated and evaluated.
;
Time Perspective: Prospective
| 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 |