WISECAP Study

Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on Directly Observed Therapy: Non inferiority Randomized Controlled Trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202205876377808

Enrollment

164

Registered

2022-05-13

Start date

2021-10-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

MEMSCAP and EDP medicine box

Standard of Care Directly Observed Therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patient of pulmonary MDR-TB and or Rifampicin resistant TB aged 8 years and above. 2. Patients being initiated on the oral MDR-TB treatment 3. Evidence of a personally signed and dated informed consent document (or a legal representative).

Exclusion criteria

Exclusion criteria: 1. Patients with any condition that inhibits the use of the MEMS device e.g. dexterity or debilitating arthritis.

Design outcomes

Primary

Measure	Time frame
Overall adherence rates among MDR-TB patients on self-administered therapy and on DOT	—

Secondary

Measure	Time frame
1. Correlation between serum MDR_TB drug concentrations and adherence data for patients on self-administered therapy and DOT ;Sputum conversion ;MDR-TB outcomes (cure, treatment completion, loss to follow-up or death) in each arm	—

Countries

Uganda

Contacts

Public ContactRosalind Parkes Ratanshi

Director

rratanshi@idi.co.ug+256752323253

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026