Health Condition 1: A15- Respiratory tuberculosis
Conditions
Interventions
Intervention1: Refill monitoring: Services that patients receive include -
(1.) Patients receive FDCs as prescribed by their physician and their prescription refill information is monitored for refil
Sponsors
Sarang Deo
World Health Partners
Eligibility
Inclusion criteria
Inclusion criteria: (1.) Patient has a residential address in the district of enrollment. Patient has a household address in the respective intervention district; patient is residing in the district at the time of enrollment, and patient plans to reside in the district for the six-month treatment duration period at the time of interview. (2.) Patient is initiated on FDCs upon notification: Patient is verified to have received their FDCs and is able to access regimen through the treatment duration. (3.) New, adult pulmonary case. (4.) Microbiologically confirmed case by any microbiological test (smear/culture/Xpert). (5.) DST for Rifampicin (Rif) / Isoniazid (INH) is negative. (6.) Patient has daily access to a mobile phone. Ownership of phone or daily access to a family memberâ??s phone for the treatment duration period, and able to maintain a minimum balance to make and receive calls. (7.) Has not been previously enrolled in the proposed intervention adherence monitoring methods. A history of prior TB treatment will be taken to ensure patient has not been previously exposed to adherence technologies. (8.) No other patient enrolled in the same household
Exclusion criteria
Exclusion criteria: (1.) Patients prescribed treatment duration for longerâ?¯than 6 monthsâ?¯â?? (2.) Patients whose follow-up is not feasible (i.e.,â?¯prisonâ?¯or other institutional settings prohibiting regularâ?¯access or communication with patient)â??
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of the trial, "Poor treatment outcome", which is defined as occurrence of at one of the following events: (i) treatment failure, (ii) lost to follow-up, (iii) not evaluated, or (iv) death.Timepoint: Determined at the end of 168 days of treatment of each patient | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome, i.e., mean dosing implementation, is calculated as the proportion of doses taken over the treatment duration using two sources of data â?? (a) prescription refill, and (b) urine isoniazid metabolite testing. The treatment duration is 168 days.â?¯Timepoint: Determined at the end of 168 days of treatment of each patient | — |
Countries
India
Contacts
Public ContactSarang Deo
Indian School of Business
Outcome results
None listed