Trial Outcomes & Findings for Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden (NCT NCT03315962)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

163 participants

Primary outcome timeframe

2 years

Results posted on

2025-06-18

Participant Flow

Unit of analysis: clusters of DHOs

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	86 7	77 7
Overall Study COMPLETED	86 7	77 7
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age at Baseline was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aim 1: DHO Intervention Arm n=86 Participants 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.	Aim 1: DHO Control Arm n=77 Participants A selection of DHO or TB district supervisors that are randomized to the country standard of care, but not to receive the study intervention.	Total n=163 Participants Total of all reporting groups
Age, Customized	0 Participants Age at Baseline was not collected	0 Participants Age at Baseline was not collected	0 Participants Age at Baseline was not collected
Sex: Female, Male Female	8 Participants n=86 Participants	6 Participants n=77 Participants	14 Participants n=163 Participants
Sex: Female, Male Male	78 Participants n=86 Participants	71 Participants n=77 Participants	149 Participants n=163 Participants
Race/Ethnicity, Customized Black	86 Participants n=86 Participants	77 Participants n=77 Participants	163 Participants n=163 Participants
Region of Enrollment Uganda	86 participants n=86 Participants	77 participants n=77 Participants	163 participants n=163 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 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).

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)

Outcome measures

Outcome measures
Measure	Aim 1: DHO Intervention Arm n=7 clusters of DHOs 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.	Aim 1: DHO Control Arm n=7 clusters of DHOs A selection of DHO or TB district supervisors that are randomized to the country standard of care, but not to receive the study intervention.
IPT Initiation Rate	0.74 events per person-years Interval 0.59 to 0.88	0.65 events per person-years Interval 0.55 to 0.75

Adverse Events

Aim 1: DHO Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aim 1: DHO Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gabe Chamie

UCSF

Phone: (415) 476-4082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place