Clinical trial NCT06214910: ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
Official title: ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tuberculosis
HIV I Infection
Keywords: Tuberculosis
TPT
3HP
differentiated service delivery
multi-month dispensing
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Human Sciences Research Council
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-01-22
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Household-level randomization -- all individuals in a household will be randomized to the same study arm of medication delivery.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

Eligibility criteria: 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:

* Less than 18 years of age.
* Pregnant or planning on pregnancy within next three months
* Planning on moving or relocating from the area within the next three months
* Positive for active TB
* Currently on TB treatment

Primary outcomes:
measure: Completion of a course of TB preventive therapy (TPT)
timeFrame: 3 months, extended to 16 weeks as needed
Secondary outcomes:
Other outcomes:
Locations:
city: Sweetwaters
country: South Africa
facility: Human Sciences Research Council
state: KwaZulu-Natal
Study officials:
affiliation: University of Washington
name: Adrienne E Shapiro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: