Tuberculosis Clinical Trial
OBJECTIVES: I. Recruit 300 injection drug users with positive tuberculin skin tests who are
candidates for isoniazid chemoprophylaxis into a trial of several interventions to enhance
adherence to preventive therapy.
II. Compare the effectiveness of self-administered isoniazid chemoprophylaxis supplemented
with peer education and support groups versus directly observed preventive therapy delivered
by a licensed nurse versus self-administered therapy with standard clinic follow-up and
education. Outcome measures are adherence to prescribed doses of medication and the
proportion of patients who complete therapy.
III. Compare the impact of monetary incentives on therapy adherence by random assignment to
immediate vs. deferred financial incentive.
IV. Assess attitudes, knowledge, and beliefs about tuberculosis and preventive therapy in
these patients and determine the association of these factors with demographic, social, and
clinical characteristics.
V. Assess attitudes and beliefs about tuberculosis susceptibility, seriousness, benefits of
preventive therapy, barriers to therapy, and self-efficacy as predictors of health-related
behaviors as measured by adherence with therapy, and determine the impact of the assigned
interventions on these attitudes and beliefs.
PROTOCOL OUTLINE: This is a randomized study. Patients in the first group self-administer
oral isoniazid following the standard clinic protocol for 6 months. They receive individual
counseling and education by a peer educator at entry and at week 2, participate in a monthly
support group cofacilitated by a peer counselor and health educator, and make a monthly
clinic visit.
Patients in the second group receive oral isoniazid twice a week. Therapy is administered by
the nurse, who observes ingestion and swallowing. Nursing education and support per standard
clinic procedures is provided at each monthly clinic visit.
Patients in the third group self-administer oral isoniazid, without enhanced education and
peer support, following the standard clinic protocol for 6 months. Nursing education and
support per standard clinic procedures is provided at each monthly clinic visit.
Within each group, patients are randomly assigned to an immediate or deferred financial
compensation schedule. Immediate compensation for compliance with medication and clinical
visit is given during the monthly clinic visit, while deferred compensation is given at
study completion.
It is recommended that HIV-seropositive patients receive 6 additional months of standard
isoniazid therapy.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |