Trial Outcomes & Findings for Prevent TB: Choice Architecture for TPT Delivery (NCT NCT04466488)
NCT ID: NCT04466488
Last Updated: 2026-03-27
Results Overview
Comparing choice architecture and standard of care prescribing arms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50798 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2026-03-27
Participant Flow
36 public clinics that provide antiretroviral therapy (ART) were randomized. Clinics are located in rural and peri-urban areas in Kenneth Kaunda and urban and rural areas of Mangaung.
Patient medical records were abstracted from both intervention and control clinics during the study period. All medical records for adult patients starting or re-starting ART during the study period were reviewed and abstracted as aggregate data without patient level data or identifiers.
Unit of analysis: clinics
Participant milestones
| Measure |
Standard of Care Study Arm
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Overall Study
STARTED
|
25045 18
|
25753 18
|
|
Overall Study
COMPLETED
|
25045 18
|
25753 18
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care Study Arm
n=18 Clinics
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=18 Clinics
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
Total
n=36 Clinics
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=25045 Participants
|
42 years
n=25753 Participants
|
42 years
n=50798 Participants
|
|
Sex: Female, Male
Female
|
17,140 Participants
n=25045 Participants
|
17,688 Participants
n=25753 Participants
|
34828 Participants
n=50798 Participants
|
|
Sex: Female, Male
Male
|
7,905 Participants
n=25045 Participants
|
8,065 Participants
n=25753 Participants
|
15970 Participants
n=50798 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
25045 Participants
n=25045 Participants
|
25753 Participants
n=25753 Participants
|
50798 Participants
n=50798 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Analysis was restricted to patients "Newly Starting ART" (never before initiated on ART)
Comparing choice architecture and standard of care prescribing arms
Outcome measures
| Measure |
Standard of Care Study Arm
n=2306 Participants
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=1979 Participants
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Percentage of Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation
|
70.1 Percentage of participants
Interval 65.3 to 74.9
|
71.5 Percentage of participants
Interval 64.5 to 78.5
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Analysis was restricted to patients "established on ART" (previously initiated on ART and defaulted)
Comparing choice architecture and standard of care prescribing arms
Outcome measures
| Measure |
Standard of Care Study Arm
n=23362 Participants
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=23448 Participants
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Percentage of Established ART Patients Also Initiating TPT
|
2.1 Percentage of participants
Interval 1.6 to 2.6
|
5.2 Percentage of participants
Interval 1.3 to 9.2
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Analysis was restricted to patients "newly initiated on ART" and eligible for TPT.
Comparing choice architecture and standard of care prescribing arms. TPT eligibility was defined as: No TB symptoms at ART initiation; no documentation of INH hypersensitivity, liver disease, alcohol abuse (both vars); no evidence of TB investigation within 3 months of ART initiation; no evidence of TPT completion within 12 months up to ART initiation; not currently on TB treatment, did not complete TB treatment in past 12 months.
Outcome measures
| Measure |
Standard of Care Study Arm
n=2138 Participants
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=1817 Participants
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Percentage of TPT-eligible Patients Newly Starting ART Also Initiating TPT Within 90 Days of ART Initiation
|
77.3 Percentage of participants
Interval 72.5 to 82.1
|
78.3 Percentage of participants
Interval 71.7 to 85.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Analysis was restricted to patients "established on ART" and eligible for TPT.
Comparing choice architecture and standard of care prescribing arms. TPT eligibility was defined as: No TB symptoms at ART initiation; no documentation of INH hypersensitivity, liver disease, alcohol abuse (both vars); no evidence of TB investigation within 3 months of ART initiation; no evidence of TPT completion within 12 months up to ART initiation; not currently on TB treatment, did not complete TB treatment in past 12 months.
Outcome measures
| Measure |
Standard of Care Study Arm
n=21521 Participants
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=21216 Participants
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Percentage of TPT-eligible Established ART Patients Also Initiating TPT
|
11.5 Percentage of participants
Interval 9.3 to 13.6
|
13.9 Percentage of participants
Interval 8.8 to 19.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Analysis was restricted to "new" and "established" ART patients initiated on TPT during the 12-month clinic implementation period
Comparing choice architecture and standard of care prescribing arms
Outcome measures
| Measure |
Standard of Care Study Arm
n=2404 Participants
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=3148 Participants
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Percentage of Patients Started on TPT With Subsequent Discontinuation
|
2.3 Percentage of participants
Interval 1.0 to 3.5
|
3.7 Percentage of participants
Interval 2.2 to 5.3
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Units analyzed: total number of HIV care visits across all patients receiving care in the \*intervention clinics/arm\* during the study period.
Adoption will be determined by the number of visits in which the choice architecture strategy was used (as measured by the use of the pre-printed/stamped prescription), in the intervention arm, regardless of the clinician's initiation decision.
Outcome measures
| Measure |
Standard of Care Study Arm
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=67479 Visits
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Clinic Implementation of Choice Architecture as Assessed by Adoption
|
0 Visits
|
44,504 Visits
|
Adverse Events
Standard of Care Study Arm
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Choice Architecture Study Arm
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care Study Arm
n=25045 participants at risk
The standard TPT implementation is for a clinician to screen for TB and to consider TPT for those who do not have "presumptive TB". Clinicians in the study district (and most districts in South Africa) have received training and job aids to assist in appropriate application of the TPT initiation algorithm. Prescribing for TPT and ART is done by writing, by hand, the prescription in the patient's paper file. As part of this study, all study clinic providers will have access to standard Department of Health printed material and clinical training.
|
Choice Architecture Study Arm
n=25753 participants at risk
In the choice architecture implementation strategy, all opt-out clinic providers and pharmacists will be trained on the approach. The fundamental tenant of this approach is that TPT will be prescribed with any ART initiation and any ART re-prescribing for 3-12 months of TPT (adherent to current guidelines) if TPT has not been previously prescribed. This will be facilitated by co-prescribing ART and TPT. That is when ART is being prescribed TPT is meant to be prescribed at the same time of the clinic visit.
The simultaneous prescribing will be facilitated through the introduction of an ink stamp or pre-printed sticker to use for quick entry of the ART prescription along with TPT and cotrimoxazole. The stamp/sticker for ART prescription, the prescription for TPT and for cotrimoxazole will be "automatically" included. Active canceling of these prescriptions (and indicating the reasons) will be needed to not have TPT dispensed.
Choice Architecture: 1. Providers will receive general training on TPT benefits, indications, and contra-indications.
2\. Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
3\. The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed
|
|---|---|---|
|
Infections and infestations
Incident TB among those prescribed TPT
|
0.11%
27/25045 • From enrollment up to 12 months
All events and all-cause mortality were identified through file abstraction and clinic reporting.
|
0.09%
22/25753 • From enrollment up to 12 months
All events and all-cause mortality were identified through file abstraction and clinic reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place