Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

Tuberculosis Clinical Trial

— SEARCH-IPT  

Official title:

Simplified Isoniazid Preventive Therapy (SPIRIT) Strategy to Reduce TB Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315962
• Other study ID #: 16-21030
• Secondary ID: R01AI125000
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this study is to determine if a multi-component implementation intervention (SPIRIT) and additional leadership and management training that targets District Health Officers (DHOs) can increase IPT initiation among HIV-infected persons, as compared to country standard practices, in a cluster randomized trial in Uganda.

Description:

The failure to use isoniazid (INH) preventative therapy (IPT) in HIV-infected individuals in Sub-Saharan Africa represents one of the single biggest implementation gaps between evidence and practice in today's response to the HIV epidemic. The proposed study will evaluate the effectiveness of a multi-component intervention to improve IPT uptake in two regions of Uganda. The study design is a randomized controlled trial (RCT) where the unit of randomization is clusters of districts in Uganda. The clusters consist of 5-7 districts and the District Health Officer (DHO) and District TB and Leprosy Supervisor (DTLS) from each district is invited to participate. The SPIRIT intervention is based on the PRECEDE framework which outlines the importance of social networks, social influence, and behavior change.

The SEARCH-IPT multi-component intervention includes:

• A teaching collaborative which will be formed within the randomized clusters of district DHOs and DTLSs to create a mini-collaborative, which will be led by an opinion leader with HIV and TB expertise, to spread new scientific knowledge about IPT and the clinical ability to rule out TB, and to facilitate discussion between DHOs.

• A "toolkit" of options to ease IPT implementation will support DHOs to scale up IPT through the study of the comparative effectiveness of material contributions to their day-to-day function of managing front line providers and clinics.

• A reporting collaborative comprised of the teaching collaborative groups, will define targets as a group, and reconvening every 6 months for 3 years (with the additional option of 36 months for a final report back), where each collaborative has an opportunity to share progress and results.

In addition, an enhanced business training & 'training-of-trainers' curriculum will be conducted to evaluate the effect of enhanced business training among intervention group DHOs from Phase 1 (Years 1-3 of trial follow-up) in the southwestern Uganda region on IPT initiation during years 4-5 of trial follow-up (Phase 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

AIM 1 - Spirit Intervention:

Inclusion Criteria:

• District Health Officer or TB District Supervisor (or other DHO-appointed TB focal person) in Uganda.

• By definition, the DHO or TB District Supervisor are all =18 years of age.

Exclusion Criteria:

• Planned departure from position as DHO or TB District Supervisor prior to randomization.

• DHOs from Kampala and Wakiso districts, Uganda.

Related Conditions & MeSH terms

• HIV/AIDS
• Tuberculosis

Intervention

Behavioral:
• SPIRIT Intervention
The intervention will include implementing a teaching collaborative among group of DHOs and TB Supervisors, enabling text messaging between DHOs and front line providers, and establishing a report collaborative where DHOs will receive feedback on the performance of their district in administering IPT compared to other districts.

Locations

Country	Name	City	State
Uganda	Infectious Diseases Research Collaboration	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Cipla Ltd., Makerere University, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

Kakande E, Christian C, Balzer LB, Owaraganise A, Nugent JR, DiIeso W, Rast D, Kabami J, Johnson Peretz J, Camlin CS, Shade SB, Geng EH, Kwarisiima D, Kamya MR, Havlir DV, Chamie G. A mid-level health manager intervention to promote uptake of isoniazid pr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPT Uptake	Rate at which eligible HIV-infected adults receive a prescription for INH	12-36 Months