Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214910
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-01-08
Brief Title:
ThiPhiSA New Pathways to Prevention From Community TB Screening in South Africa
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
ThiPhiSA New Pathways to Prevention From Community TB Screening in South Africa
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ThiPhiSA
Brief Summary:
This study will compare community-delivered multi-month dispensing of tuberculosis preventive therapy TPT to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB preventive therapy
We hypothesize that persons receiving multi-month dispensing of TPT in the community will have a higher rate of TPT completion at 3 months than persons receiving TPT via standard of care with monthly clinic-based refills
We hypothesize that persons receiving multi-month dispensing of TPT in the community will have a higher rate of TPT completion at 3 months than persons receiving TPT via standard of care with monthly clinic-based refills
Detailed Description:
The research objective is to understand and overcome key barriers to tuberculosis preventive therapy TPT delivery and completion in South Africa in the setting of 3HP scale-up 3HP short-course TPT consisting of 3 months weekly isoniazidH plus rifapentine P The study will investigate these factors through a trial comparing community-delivered TPT to clinic-based TPT and qualitative research investigating barriers to TPT completion and exploring task-shifted TPT delivery
Aim 1 To determine the effect of community-based initiation and delivery of TPT on TPT completion
Hypothesis Community-delivered TPT will be associated with higher initiation and completion of TPT than standard of care clinic-based TPT
Approach Persons eligible for TPT will be identified through the Triage TB study and other community-based TB screening activities Eligible persons will be randomized at the household level to 1 Immediate initiation of TPT full 12 weeks delivery at once or 2 Immediate initiation of TPT 2-week supply and referral to clinic for TPT completion TPT adherence and completion will be measured by a combination of self-report pill count and serum drug level indicators
Aim 2 To determine factors associated with TPT initiation and completion in people eligible for TPT identified in community settings
Hypothesis People with HIV PWH will have better rates of initiation and completion of TPT than people without HIV
Approach Participant interviews and surveys at baseline and end-of-study will assess willingness to take TPT barriers and facilitators for individuals experience taking TPT and experience of interactions in clinic settings Focus groups will be purposively selected based on end-of-study survey responses to elicit factors determining patient experience
Aim 3 To determine feasibility and acceptability of differentiated service delivery DSD approaches including task-shifting for TPT delivery and scale-up
Hypothesis DSD TPT will be feasible and acceptable Approach Participatory qualitative research and implementation science approaches including workflow mapping will be used to assess clinician-level barriers and inefficiencies in providing clinic-based TPT In-depth interviews and focus groups will be conducted with pharmacy assistants nurses clinic operational managers and district program managers to assess acceptability Clinic flow will be mapped to determine effect of task-shifted pharmacy assistant TPT delivery on workflow and patient experience in the clinic
Aim 1 To determine the effect of community-based initiation and delivery of TPT on TPT completion
Hypothesis Community-delivered TPT will be associated with higher initiation and completion of TPT than standard of care clinic-based TPT
Approach Persons eligible for TPT will be identified through the Triage TB study and other community-based TB screening activities Eligible persons will be randomized at the household level to 1 Immediate initiation of TPT full 12 weeks delivery at once or 2 Immediate initiation of TPT 2-week supply and referral to clinic for TPT completion TPT adherence and completion will be measured by a combination of self-report pill count and serum drug level indicators
Aim 2 To determine factors associated with TPT initiation and completion in people eligible for TPT identified in community settings
Hypothesis People with HIV PWH will have better rates of initiation and completion of TPT than people without HIV
Approach Participant interviews and surveys at baseline and end-of-study will assess willingness to take TPT barriers and facilitators for individuals experience taking TPT and experience of interactions in clinic settings Focus groups will be purposively selected based on end-of-study survey responses to elicit factors determining patient experience
Aim 3 To determine feasibility and acceptability of differentiated service delivery DSD approaches including task-shifting for TPT delivery and scale-up
Hypothesis DSD TPT will be feasible and acceptable Approach Participatory qualitative research and implementation science approaches including workflow mapping will be used to assess clinician-level barriers and inefficiencies in providing clinic-based TPT In-depth interviews and focus groups will be conducted with pharmacy assistants nurses clinic operational managers and district program managers to assess acceptability Clinic flow will be mapped to determine effect of task-shifted pharmacy assistant TPT delivery on workflow and patient experience in the clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21AI179276-01 | NIH | None | httpsreporternihgovquickSearch1R21AI179276-01 |