TuberculosisThiPhiSANCT06214910

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

A study testing Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP) and Clinic-link TPT in people with Tuberculosis and HIV I Infection, run by University of Washington at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tuberculosis, HIV I Infection
What is being tested?: Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP) and Clinic-link TPT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 1 siteSouth Africa
Study dates: 20 Feb 2024to 4 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Human Sciences Research Council
Sweetwaters, KwaZulu-Natal

Other trials in South Africa

About this study

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.

Read the 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.

Conditions: Tuberculosis, HIV I Infection
Being tested: Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP), Clinic-link TPT
Keywords: Tuberculosis, TPT, 3HP, differentiated service delivery, multi-month dispensing
Medical subject headings: Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06214910
Study group	Role	What they receive
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). Receives: 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). Receives: Other: Clinic-link TPT

What is being measured

The primary outcome is the main question the study is designed to answer.

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 is measured as a composite outcome including: self-report of doses taken, periodic pill counts, one-time serum drug level of isoniazid. (Eight participants with contraindication to 3HP received 6H TPT. Completion of 6H was defined as taking 24 weeks within 9 months)
Measured: 3 months, extended to 16 weeks as needed
Number of TPT Doses by Week 16
The number of TPT doses taken by week 16
Measured: Enrollment to week 16

Secondary outcomes (3)

Overall Adherence With TPT
Number of doses taken by 16 weeks (N= 8 participants received 6H TPT excluded from this analysis)
Measured: 3 months, extended to 16 weeks as needed
Participant Satisfaction With the Assigned TPT Delivery Method
Number of participants who answered "somewhat motivated" or "very motivated" to take TPT in exit questionnaire
Measured: 3 months, extended to 16 weeks as needed
Adverse Events
Assessed by adverse event reporting
Measured: 3 months, extended to 16 weeks as needed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 20244 Aug 2025

First posted22 Jan 2024
Study start20 Feb 2024
Primary completion30 May 2025
Study completion4 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Household-level randomization -- all individuals in a household will be randomized to the same study arm of medication delivery.
Masking: None (open label)
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06214910
Sponsor's protocol ID: STUDY00018448
Other IDs: 1R21AI179276-01
Acronym: ThiPhiSA
Status last verified: Jul 2026
First submitted: 8 Jan 2024
Last updated: 30 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40803739

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
ClinicalTrials.gov ID: NCT06214910
Acronym / sponsor ID: ThiPhiSA / STUDY00018448
Conditions: Tuberculosis, HIV I Infection
Keywords: Tuberculosis, TPT, 3HP, differentiated service delivery, multi-month dispensing
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Human Sciences Research Council, National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 20 Feb 2024 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 4 Aug 2025 (actual)
First posted: 22 Jan 2024 (actual)
Results: Posted 30 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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.

Aim 3: To determine feasibility and acceptability of differentiated service delivery (DSD) approaches, including task-shifting, for TPT delivery and scale-up.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Household-level randomization -- all individuals in a household will be randomized to the same study arm of medication delivery.

Arm	Type	Receives
Investigational: Community-based TB preventive therapy (TPT)	Other	Other: Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP)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).
Standard-of-Care Tuberculosis Preventative Therapy (TPT)	Active comparator	Other: Clinic-link TPTParticipants 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

≥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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP)Participants randomized to this arm will receive the entire supply of TB preventive therapy (TPT) at enrollment.	Other	Investigational: Community-based TB preventive therapy (TPT)
Clinic-link TPTParticipants receive 2-week supply of TPT at initiation, then continue to receive remainder of TPT course at clinic (including refills).	Other	Standard-of-Care Tuberculosis Preventative Therapy (TPT)

Primary outcome

Completion of a Course of TB Preventive Therapy (TPT)
Time frame: 3 months, extended to 16 weeks as needed
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 is measured as a composite outcome including: self-report of doses taken, periodic pill counts, one-time serum drug level of isoniazid. (Eight participants with contraindication to 3HP received 6H TPT. Completion of 6H was defined as taking 24 weeks within 9 months)
Number of TPT Doses by Week 16
Time frame: Enrollment to week 16
The number of TPT doses taken by week 16

3 secondary outcomes

Overall Adherence With TPT
Time frame: 3 months, extended to 16 weeks as needed
Participant Satisfaction With the Assigned TPT Delivery Method
Time frame: 3 months, extended to 16 weeks as needed
Adverse Events
Time frame: 3 months, extended to 16 weeks as needed

Results and safety

Results posted to the registry on 30 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational: Community-based TB Preventive Therapy (TPT) Arm	142	142
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)	159	158

Primary outcome: Completion of a Course of TB Preventive Therapy (TPT)

Time frame: 3 months, extended to 16 weeks as needed. Count of participants. Unit: Participants

Measure	Investigational: Community-based TB Preventive Therapy (TPT) n = 142	Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT) n = 159
Value	122	44

Investigational: Community-based TB Preventive Therapy (TPT) vs Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT): Risk Ratio (RR): 3.10 (95% CI 2.30 to 4.19), p <0.001, Modified Poisson

Primary outcome: Number of TPT Doses by Week 16

Time frame: Enrollment to week 16. Median (Inter-Quartile Range). Unit: Number of TPT doses taken

Measure	Investigational: Community-based TB Preventive Therapy (TPT) n = 142	Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT) n = 159
Value	12 (2.6)	2 (4.4)

Population analysed: Number of TPT doses taken by week 16

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until the end of follow up, up to 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational: Community-based TB Preventive Therapy (TPT)	1 of 142 (0.7%)	0 of 142 (0%)	0 of 142
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)	4 of 159 (2.5%)	0 of 159 (0%)	1 of 159

Limitations and caveats (from the sponsor): Most participants had HIV as primary indication for TPT, i.e. non-TPT reason to attend clinic. There were few household contacts without HIV. This may underestimate the benefit of the intervention. 8 participants had contraindication for 3HP TPT and received 6H (6m of daily isoniazid) as TPT. We evaluated completion but they were excluded from median # of doses completed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40803739Misra 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adrienne E Shapiro, MD, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of a Course of TB Preventive Therapy (TPT) (time frame: 3 months, extended to 16 weeks as needed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06214910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.