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Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden (SEARCH-IPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315962
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : September 22, 2021
Sponsor:
Collaborators:
Makerere University
National Institute of Allergy and Infectious Diseases (NIAID)
Cipla Ltd.
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Tuberculosis HIV/AIDS Behavioral: SPIRIT Intervention Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Simplified Isoniazid Preventive Therapy (SPIRIT) Strategy to Reduce TB Burden
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Aim 1: DHO Intervention Arm
A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT 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.

No Intervention: Aim 1: DHO Control Arm
A selection of DHO or TB district supervisors that are randomized to the country standard of care, but not to receive the study intervention.



Primary Outcome Measures :
  1. IPT Uptake [ Time Frame: 12-36 Months ]
    Rate at which eligible HIV-infected adults receive a prescription for INH



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315962


Contacts
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Contact: Canice Christian, MS 415-476-4082 ext 206-3321 canice.christian@ucsf.edu

Locations
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Uganda
Infectious Diseases Research Collaboration Recruiting
Kampala, Uganda
Contact: Elijah Kakande, MBChB       rkakande@idrc-uganda.org   
Principal Investigator: Moses R. Kamya, MBChB, PhD         
Sponsors and Collaborators
University of California, San Francisco
Makerere University
National Institute of Allergy and Infectious Diseases (NIAID)
Cipla Ltd.
Investigators
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Principal Investigator: Diane Havlir, MD University of California, San Francisco
Study Chair: Gabriel Chamie, MD, MPH University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03315962    
Other Study ID Numbers: 16-21030
R01AI125000 ( U.S. NIH Grant/Contract )
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections