Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Tuberculosis, HIV/AIDS

Intervention / Treatment
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* Behavioral: SPIRIT Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 1: DHO Intervention Arm<br>A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention. | Behavioral: SPIRIT Intervention<br>* 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.<br>|
| No Intervention: Aim 1: DHO Control Arm<br>A selection of DHO or TB district supervisors that are randomized to the country standard of care, but not to receive the study intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPT Uptake | Rate at which eligible HIV-infected adults receive a prescription for INH | 12-36 Months |