ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa

Tuberculosis Clinical Trial

— ThiPhiSA  

Official title:

ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214910
• Other study ID #: STUDY00018448
• Secondary ID: 1R21AI179276-01
• Status: Recruiting
• Phase: Phase 4
• Start date: February 20, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: Jason S Caucutt
• Phone: 12063538069
• Email: jcaucutt[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 isoniazid[H] 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: December 31, 2026
• Est. primary completion date: February 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Meet eligibility criteria for TB preventive therapy by South African national guidelines: is a person living with HIV -or- is a household contact of someone with active TB.

• Screened negative for active TB disease through TB screening activities within 6 months.

• Negative symptom screen at the time of enrollment if TB screening was more than 3 months prior to enrollment.

• Reside in the study community.

• Willing and able to complete informed consent

Exclusion Criteria:

• There are no separate exclusion criteria for adults >=18 years of age.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP)
Participants randomized to this arm will receive a 2-week supply of TB preventive therapy (TPT) at enrollment.

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Sweetwaters	KwaZulu-Natal

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Human Sciences Research Council, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of a course of TB preventive therapy (TPT)	TPT completion defined as taking 11 doses of 3HP (3 months weekly isoniazid [H] plus rifapentine [P] ) within 16 weeks of 3HP initiation. The outcome will be measured as a composite outcome including: self-report of doses taken, periodic pill counts, one-time serum drug level of isoniazid.	3 months, extended to 16 weeks as needed