Prevention of tuberculosis (TB) with 3 months of isoniazid and rifapentine in people living with HIV and in child household contacts of TB patients
- Conditions
- Health Condition 1: B20-B20- Human immunodeficiency virus [HIV] disease
- Registration Number
- CTRI/2020/07/026305
- Lead Sponsor
- ICMRNational Institute for Research in TB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <10 Kg
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Feasibility in terms of barriers and facilitators for 3HP implementation. <br/ ><br> <br/ ><br>2. Drug Adverse events - Proportion of participants with drug adverse events in those initiated on 3HP. <br/ ><br> <br/ ><br>3. Proportion with TB incidence and mortality among those who received 3HP. <br/ ><br>Timepoint: Months - 1,2 3,6 and 12