An interventional study of SPIRIT Intervention in Tuberculosis and HIV/AIDS, sponsored by University of California, San Francisco. Completed at 1 site in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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Among 14 studies in Tuberculosis by University of California, San Francisco — 6 open to participants now, 7 under way, 1 of them phase 3. Tuberculosis · University of California, San Francisco.
Among the 14 studies in Tuberculosis by University of California, San Francisco, this one is the 13th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 with no phase, and was the 5th registered.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
Browse Tuberculosis studies →6 of the 14 studies in Tuberculosis by University of California, San Francisco are open now, in 12 countries. Recruiting first, the newest first:
University of California, San Francisco · Sites in Uganda, Vietnam
Ages 12+
University of California, San Francisco · Sites in Mongolia, Pakistan, Peru and 2 more countries
Ages 14+
University of California, San Francisco · Sites in Mozambique, South Africa, Uganda
Ages up to 65 · Healthy volunteers
University of California, San Francisco · Sites in Nigeria, Philippines, Zambia
Ages 12+
University of California, San Francisco · Sites in Georgia, India, Nigeria and 5 more countries
Ages 12+
By country, each count listing its studies:
Of the 111 Tuberculosis studies recruiting now, 65 (59%) set no upper age limit and 36 (32%) stop at 75 or younger; 48 take children under 18; 31 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 2 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 163 is close to the median of 150 across 820 interventional studies indexed under Tuberculosis.
Median enrollment 1,500 across the 13 interventional studies, 750 across the 1 observational. Of the 7 that completed or were terminated, 7 (100%) have results posted.
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University of California, San Francisco is the lead sponsor of 2,171 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
1 of the studies in Tuberculosis by University of California, San Francisco that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07018076University of California, San FranciscoCandidate Clinical Correlate of Prognostic Outcome for TB Study | 2027-05-31 |
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Among the 14 studies in Tuberculosis by University of California, San Francisco, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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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AIM 1 - Spirit Intervention:
Inclusion Criteria:
Exclusion Criteria:
A selection of DHO or TB district supervisors that are randomized to the multicomponent SPIRIT intervention.
Behavioral: SPIRIT 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.
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.
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)
Time frame: 2 years
| Milestone | Aim 1: DHO Intervention Arm | Aim 1: DHO Control Arm |
|---|---|---|
| Started | 86 | 77 |
| Completed | 86 | 77 |
| Not completed | 0 | 0 |
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)
| events per person-years | Aim 1: DHO Intervention Arm | Aim 1: DHO Control Arm |
|---|---|---|
| IPT Initiation Rate | 0.74 (0.59 to 0.88) | 0.65 (0.55 to 0.75) |
Collected over 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aim 1: DHO Intervention Arm | 0/86 (0%) | 0/86 (0%) | 0/86 (0%) |
| Aim 1: DHO Control Arm | 0/77 (0%) | 0/77 (0%) | 0/77 (0%) |
| Age, Customized(Participants) | Aim 1: DHO Intervention Arm | Aim 1: DHO Control Arm | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Aim 1: DHO Intervention Arm | Aim 1: DHO Control Arm | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 78 | 71 | 149 |
| Race/Ethnicity, Customized(Participants) | Aim 1: DHO Intervention Arm | Aim 1: DHO Control Arm | Total |
|---|---|---|---|
| Black | 86 | 77 | 163 |
| Region of Enrollment(participants) | Aim 1: DHO Intervention Arm | Aim 1: DHO Control Arm | Total |
|---|---|---|---|
| Uganda | 86 | 77 | 163 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Nov 2023, 72 months.
Results were first posted in Jun 2025, 1 year 6 months after primary completion.
Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's 72 months is above that.
Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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