Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

NCT03315962 | Completed Results

• 2 other identifiers: 16-21030R01AI125000
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis; HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• IPT Initiation Rate

  Incident rate of IPT initiation (events per person-year) among adults with HIV in facilities overseen by participants. Mean was calculated as the average rate across the clusters (groups of DHOs)

  2 years

Study Arms (2)

Aim 1: DHO Intervention Arm

EXPERIMENTAL

A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention.

Behavioral: SPIRIT Intervention

Aim 1: DHO Control Arm

NO INTERVENTION

A selection of DHO or TB district supervisors that are randomized to the country standard of care, but not to receive the study intervention.

Interventions

SPIRIT Intervention BEHAVIORAL

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.

Aim 1: DHO Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Planned departure from position as DHO or TB District Supervisor prior to randomization.
• DHOs from Kampala and Wakiso districts, Uganda.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Makerere University: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Cipla Ltd.: collaborator

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

Related Publications (3)

• 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 preventive therapy among people with HIV in Uganda: a cluster randomised trial. Lancet HIV. 2022 Sep;9(9):e607-e616. doi: 10.1016/S2352-3018(22)00166-7. Epub 2022 Jul 28.

  PMID: 35908553 RESULT

• Johnson-Peretz J, Christian C, Akatukwasa C, Atwine F, Kamya MR, Havlir DV, Chamie G, Camlin CS, Kakande E. Small-world challenges and solutions identified by mid-level managers within a decentralised healthcare system during a qualitative sub-study of a tuberculosis-prevention therapy rollout intervention in Uganda: "When a big drum like the District Health Officer talks". Res Sq [Preprint]. 2025 Jul 31:rs.3.rs-5046392. doi: 10.21203/rs.3.rs-5046392/v1.

  PMID: 40766233 DERIVED

• Christian C, Kakande E, Nahurira V, Akatukwasa C, Atwine F, Bakanoma R, Itiakorit H, Owaraganise A, DiIeso W, Rast D, Kabami J, Peretz JJ, Shade SB, Kamya MR, Havlir DV, Chamie G, Camlin CS. Mid-level managers' perspectives on implementing isoniazid preventive therapy for people living with HIV in Ugandan health districts: a qualitative study. BMC Health Serv Res. 2024 Mar 8;24(1):313. doi: 10.1186/s12913-024-10803-9.

  PMID: 38454501 DERIVED

MeSH Terms

Conditions

Tuberculosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Gabe Chamie
• Organization: UCSF

gabriel.chamie@ucsf.edu

(415) 476-4082

Study Officials

• Diane Havlir, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Gabriel Chamie, MD, MPH

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 20, 2017
• Study Start: November 15, 2017
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)