Health Condition 1: B20-B20- Human immunodeficiency virus [HIV] disease
Conditions
Interventions
Intervention1: 3HP: 3 months of once-weekly Isoniazid and Rifapentine
Control Intervention1: Not applicable: Not applicable
Sponsors
ICMRNational Institute for Research in TB
BJMedical College and Sassoon General Hospitals
ICMRNational AIDS Research Institute
ICMRRegional Medical Research Institute
National Institute of TB and Respiratory Diseases
Eligibility
Inclusion criteria
Inclusion criteria: Study population: People living with HIV/AIDS (PLHIV) Child household contacts of sputum positive pulmonary TB patients treated under NTEP 1.Aged >2 years with laboratory confirmation of HIV as per the National guidelines (for PLHIV only) 2.Aged >2 years to less than 6 years (for child household contacts only) 3.No current evidence of active TB 4.Not currently on Isoniazid preventive therapy (IPT) or completion of IPT in the past 5.Not currently on anti-TB treatment or received anti-TB treatment in the past one year 6. Willing to provide written informed consent / parent or guardian consent for children
Exclusion criteria
Exclusion criteria: Study population: People living with HIV/AIDS (PLHIV) Child household contacts of sputum positive pulmonary TB patients treated under NTEP 1.Critically ill in the judgement of the Medical Officer 2.Unable to take oral medications 3.Body weight 4.Household contact of known MDR-TB / Rif or INH-resistant TB 5.Current or H/O seizure disorder 6.Abnormal clinically significant blood parameters prior to enrolment 7.Any social or medical condition which in the opinion of the investigator would make study participation unsafe In addition to above, in PLHIV 8.Alcohol use likely to interfere with adherence 9.On Nevirapine and or Protease Inhibitor based ART regimen, any medication known to interact with rifapentine 10. Peripheral neuropathy (Grade 3 or 4) 11. Pregnancy/lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Scale up of 3 HP in PLHIV and Child Contacts of smear positive pulmonary TB patients will be determined by demand, uptake, treatment completion and discontinuation of preventive therapy.Timepoint: Months - 1,2 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility in terms of barriers and facilitators for 3HP implementation. 2. Drug Adverse events - Proportion of participants with drug adverse events in those initiated on 3HP. 3. Proportion with TB incidence and mortality among those who received 3HP. Timepoint: Months - 1,2 3,6 and 12 | — |
Countries
India
Contacts
Public ContactDr VV Banurekha
ICMR National Institute for Research in TB
Outcome results
None listed