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

NCT06214910 | Completed

• 2 other identifiers: STUDY000184481R21AI179276-01
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; HIV I Infection

Keywords

Tuberculosis; TPT; 3HP; differentiated service delivery; multi-month dispensing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall adherence with TPT

  3 months, extended to 16 weeks as needed

• Predictors of TPT adherence

  3 months, extended to 16 weeks as needed

• Participant satisfaction with the assigned TPT delivery method

  3 months, extended to 16 weeks as needed

• Adverse events

  3 months, extended to 16 weeks as needed

Study Arms (2)

Investigational: Community-based TB preventive therapy (TPT)

OTHER

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).

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

Standard-of-Care Tuberculosis Preventative Therapy (TPT)

ACTIVE COMPARATOR

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).

Other: Clinic-link TPT

Interventions

Clinic-link TPT OTHER

Participants receive 2-week supply of TPT at initiation, then continue to receive remainder of TPT course at clinic (including refills).

Standard-of-Care Tuberculosis Preventative Therapy (TPT)

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

Participants randomized to this arm will receive the entire supply of TB preventive therapy (TPT) at enrollment.

Investigational: Community-based TB preventive therapy (TPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Living in the study catchment area
• Eligible for TPT according to South African National guidelines(5), i.e. are a) living with HIV or b) are a close contact of a person with TB disease (defined by a person that resides in the same house as a person with TB), c) and in either case
• Have screened negative for TB disease in the last 6 months, through TB TRIAGE+ Trial, other household contact tracing, or other community TB screening
• Negative TB screening at enrolment (if TB TRIAGE+ screening was more than 3 months ago)
• Willing and able to provide written or verbal consent
• Participants whom have not received TPT in the last 12 months; this was confirmed verbally with participants during the enrolment process.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Human Sciences Research Council: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Human Sciences Research Council

Sweetwaters, KwaZulu-Natal, South Africa

Location

Related Publications (1)

• Misra S, Madonsela T, Thomas KK, Grabow C, Lenn M, Morton JF, Reither K, Lynen L, van Heerden A, Essack Z, Bosman S, Shapiro AE. ThiPhiSA: new pathways to TB prevention from community screening - a household-randomised controlled trial in KwaZulu-Natal, South Africa. BMJ Open. 2025 Aug 12;15(8):e100927. doi: 10.1136/bmjopen-2025-100927.

  PMID: 40803739 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

9 alpha,11 alpha,15 alpha-trihydroxy-16-phenoxy-17,18,19,20-tetranorprosta-4,5,13-trienoic acid; rifapentine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Adrienne E Shapiro, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health

Model Details: Household-level randomization -- all individuals in a household will be randomized to the same study arm of medication delivery.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 22, 2024
• Study Start: February 20, 2024
• Primary Completion: May 30, 2025
• Study Completion: August 4, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)