HIV/AIDS, Tuberculosis
Conditions
Brief 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 randomized trial in Uganda.
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).
Interventions
BEHAVIORALSPIRIT 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.
Sponsors
Makerere University
National Institute of Allergy and Infectious Diseases (NIAID)
Cipla Ltd.
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPT Initiation Rate | 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) |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 86 |
| 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. | 77 |
| Total | 163 |
Baseline characteristics
| Characteristic | Aim 1: DHO Control Arm | Total | Aim 1: DHO Intervention Arm |
|---|---|---|---|
| Age, Customized | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 77 Participants | 163 Participants | 86 Participants |
| Region of Enrollment Uganda | 77 participants | 163 participants | 86 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 71 Participants | 149 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 77 |
| other Total, other adverse events | 0 / 86 | 0 / 77 |
| serious Total, serious adverse events | 0 / 86 | 0 / 77 |
Outcome results
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aim 1: DHO Intervention Arm | IPT Initiation Rate | 0.74 events per person-years |
| Aim 1: DHO Control Arm | IPT Initiation Rate | 0.65 events per person-years |