Trial Outcomes & Findings for ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa (NCT NCT06214910)
NCT ID: NCT06214910
Last Updated: 2026-07-30
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
3 months, extended to 16 weeks as needed
Results posted on
2026-07-30
Participant Flow
Recruitment for the trial occurred in conjunction with the Triage+ TB Study, a study of TB screening based at the study site. TB Triage+ participants and other community TB screening participants who were potentially eligible for the ThiPhiSA RCT, were identified by study recruiters, at the time of delivery of TB screening results to the participants and through review of study records to identify persons who were found to be eligible for TPT but did not initiate TPT at the time of TB testing.
268 households of 301 participants were enrolled in the study.
Unit of analysis: Households
Participant milestones
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT) Arm
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
Overall Study
STARTED
|
142 134
|
159 134
|
|
Overall Study
COMPLETED
|
142 134
|
158 134
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 0
|
Reasons for withdrawal
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT) Arm
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
Baseline characteristics by cohort
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT)
n=142 Participants
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
n=159 Participants
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
137 Participants
n=20 Participants
|
149 Participants
n=20 Participants
|
286 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=20 Participants
|
111 Participants
n=20 Participants
|
211 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=20 Participants
|
48 Participants
n=20 Participants
|
90 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
142 Participants
n=20 Participants
|
159 Participants
n=20 Participants
|
301 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=20 Participants
|
159 Participants
n=20 Participants
|
301 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 3 months, extended to 16 weeks as neededTPT 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)
Outcome measures
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT)
n=142 Participants
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
n=159 Participants
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
Completion of a Course of TB Preventive Therapy (TPT)
|
122 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: Enrollment to week 16Population: Number of TPT doses taken by week 16
The number of TPT doses taken by week 16
Outcome measures
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT)
n=142 Participants
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
n=159 Participants
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
Number of TPT Doses by Week 16
|
12 Number of TPT doses taken
Inter-Quartile Range 2.6 • Interval 12.0 to 12.0
|
2 Number of TPT doses taken
Inter-Quartile Range 4.4 • Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: 3 months, extended to 16 weeks as neededNumber of doses taken by 16 weeks (N= 8 participants received 6H TPT excluded from this analysis)
Outcome measures
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT)
n=155 Participants
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
n=138 Participants
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
Overall Adherence With TPT
|
2 Number of doses taken
Inter-Quartile Range 36 • Interval 2.0 to 11.0
|
12 Number of doses taken
Inter-Quartile Range 22 • Interval 12.0 to 12.0
|
SECONDARY outcome
Timeframe: 3 months, extended to 16 weeks as neededNumber of participants who answered "somewhat motivated" or "very motivated" to take TPT in exit questionnaire
Outcome measures
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT)
n=133 Participants
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
n=147 Participants
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
Participant Satisfaction With the Assigned TPT Delivery Method
|
131 Participants
|
146 Participants
|
SECONDARY outcome
Timeframe: 3 months, extended to 16 weeks as neededAssessed by adverse event reporting
Outcome measures
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT)
n=142 Participants
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
n=159 Participants
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
Adverse Events
|
1 Participants
|
4 Participants
|
Adverse Events
Investigational: Community-based TB Preventive Therapy (TPT)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Investigational: Community-based TB Preventive Therapy (TPT)
n=142 participants at risk
Participants in the community arm received a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
|
Active Comparator: Standard-of-Care Tuberculosis Preventative Therapy (TPT)
n=159 participants at risk
Participants in the standard of care arm received a referral letter to their local Department of Health (DoH) clinic to continue TPT. They were 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).
|
|---|---|---|
|
General disorders
Multiple stab wounds
|
0.70%
1/142 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
0.00%
0/159 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
|
Psychiatric disorders
Acute psychosis due to general medicine condition
|
0.00%
0/142 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
0.63%
1/159 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
|
General disorders
Sudden death
|
0.00%
0/142 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
0.63%
1/159 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization due to ankle injury
|
0.00%
0/142 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
0.63%
1/159 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
|
Psychiatric disorders
Hospitalization for depression
|
0.00%
0/142 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
0.63%
1/159 • From enrollment until the end of follow up, up to 16 weeks
There are no differences in adverse event definitions.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place