TuberculosisSEARCH-IPTNCT03315962

Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

A study testing SPIRIT Intervention in people with Tuberculosis and HIV/AIDS, run by University of California, San Francisco at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tuberculosis, HIV/AIDS
What is being tested?: SPIRIT Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 1 siteUganda
Study dates: 15 Nov 2017to 30 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Infectious Diseases Research Collaboration
Kampala

Other trials in Uganda

About this study

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

Read the 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).

Conditions: Tuberculosis, HIV/AIDS
Being tested: SPIRIT Intervention
Medical subject headings: Tuberculosis, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPIRIT InterventionBehavioural
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.

Study groups in NCT03315962
Study group	Role	What they receive
Aim 1: DHO Intervention Arm	Experimental	A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201730 Nov 2023

First posted20 Oct 2017
Study start15 Nov 2017
Primary completion30 Nov 2023
Study completion30 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03315962
Sponsor's protocol ID: 16-21030
Other IDs: R01AI125000
Acronym: SEARCH-IPT
Status last verified: Jun 2025
First submitted: 26 Sep 2017
Last updated: 18 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35908553
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.
PubMed 40766233
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.
PubMed 40313133
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.
PubMed 39552330
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.
PubMed 38454501

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Simplified Isoniazid Preventive Therapy (SPIRIT) Strategy to Reduce TB Burden
ClinicalTrials.gov ID: NCT03315962
Acronym / sponsor ID: SEARCH-IPT / 16-21030
Conditions: Tuberculosis, HIV/AIDS
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Makerere University, National Institute of Allergy and Infectious Diseases (NIAID), Cipla Ltd.
Study start: 15 Nov 2017 (actual)
Primary completion: 30 Nov 2023 (actual)
Study completion: 30 Nov 2023 (actual)
First posted: 20 Oct 2017 (actual)
Results: Posted 18 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Aim 1: DHO Intervention Arm	Experimental	Behavioral: SPIRIT InterventionA selection of DHO or TB district supervisors that are randomized to the multicomponent 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPIRIT InterventionThe 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.	Behavioural	Aim 1: DHO Intervention Arm

Primary outcome

IPT Initiation Rate
Time frame: 2 years
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)

Results and safety

Results posted to the registry on 18 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aim 1: DHO Intervention Arm	86	86
Aim 1: DHO Control Arm	77	77

Primary outcome: IPT Initiation Rate

Time frame: 2 years. Mean (95% Confidence Interval). Unit: events per person-years

Measure	Aim 1: DHO Intervention Arm n = 86	Aim 1: DHO Control Arm n = 77
Value	0.74 (0.59 to 0.88)	0.65 (0.55 to 0.75)

Population analysed: 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).

Adverse events

Time frame: 36 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aim 1: DHO Intervention Arm	0 of 86 (0%)	0 of 86 (0%)	0 of 86
Aim 1: DHO Control Arm	0 of 77 (0%)	0 of 77 (0%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35908553Kakande 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.
Derived from this study: PubMed 40766233Johnson-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.
Derived from this study: PubMed 40313133Nugent 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.
Derived from this study: PubMed 39552330Johnson-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.
Derived from this study: PubMed 38454501Christian 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Diane Havlir, MD principal investigator

University of California, San Francisco

Gabriel Chamie, MD, MPH study chair

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SPIRIT Intervention in people with Tuberculosis and HIV/AIDS, run by University of California, San Francisco at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IPT Initiation Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03315962, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.