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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI125000 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Makerere University | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Cipla Ltd. | INDUSTRY |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1: DHO Intervention Arm | Experimental | A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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AIM 1 - Spirit Intervention:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Havlir, MD | University of California, San Francisco | Principal Investigator |
| Gabriel Chamie, MD, MPH | University of California, San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Research Collaboration | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35908553 | Result | 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. | |
| 40766233 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aim 1: DHO Intervention Arm | A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 1: DHO Intervention Arm | A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age at Baseline was not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Adults with HIV in facilities overseen by DHOs in 14 clusters (between 4 and 7 districts per cluster), based on geographical adjacency, number of urban versus rural districts, number of people with HIV in care, and region. Clusters were pair-matched on characteristics expected to be predictive of IPT initiation: region, number of adults in HIV care, presence of large urban centres, and a community that had participated from 2013 to 2017 in the SEARCH HIV test-and-treat trial (NCT01864603). | Posted | Mean | 95% Confidence Interval | events per person-years | 2 years | clusters of DHOs | clusters of DHOs |
|
36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aim 1: DHO Intervention Arm | A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabe Chamie | UCSF | (415) 476-4082 | gabriel.chamie@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2022 | Apr 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2021 | Apr 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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|
| 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. |
| 40313133 | Derived | Nugent JR, Kakande E, Chamie G, Kabami J, Owaraganise A, Havlir DV, Kamya M, Balzer LB. Causal inference in randomized trials with partial clustering. Clin Trials. 2025 Oct;22(5):547-558. doi: 10.1177/17407745251333779. Epub 2025 May 2. |
| 39552330 | Derived | Johnson-Peretz J, Christian C, Akatukwasa C, Atwine F, Kakande E, Kamya MR, Havlir DV, Camlin CS, Chamie G. Five lessons from a mid-level health manager intervention to increase uptake of tuberculosis prevention therapy in Uganda: 'it is a completely different thing to implement what you know.'. Glob Health Action. 2024 Dec 31;17(1):2427434. doi: 10.1080/16549716.2024.2427434. Epub 2024 Nov 18. |
| 38454501 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | 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. | 0 | 77 | 0 | 77 | 0 | 77 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |