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

University of Washington

Status: Enrolling

Conditions: Tuberculosis; HIV I Infection

Treatments: Other: Clinic-link TPT; Other: Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06214910

1R21AI179276-01 (U.S. NIH Grant/Contract)

STUDY00018448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 525 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

525 participants in 2 patient groups

Investigational: Community-based TB preventive therapy (TPT)

Other group

Description:

Participants in the community arm will receive a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).

Treatment:

Other: Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP)

Standard-of-Care Tuberculosis Preventative Therapy (TPT)

Active Comparator group

Description:

Participants in the standard of care arm will receive a referral letter to their local Department of Health (DoH) clinic to continue TPT. They will be instructed to present to the DoH clinic within 2 weeks to receive their continuation doses of TPT per current South African DoH standard of care (refills administered monthly).

Treatment:

Other: Clinic-link TPT