Trial Outcomes & Findings for Targeted Universal TB Testing With Simultaneous TPT Prescribing Among People Living With HIV in South Africa (NCT NCT06739915)
NCT ID: NCT06739915
Last Updated: 2026-07-22
Results Overview
Between-arm comparison of the proportion of PLHIV initiating TPT ≤7 days after ART initiation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
364 participants
Primary outcome timeframe
Within 7 days of ART initiation
Results posted on
2026-07-22
Participant Flow
Participants were enrolled from May 2024 - March 2025. Data collection was completed on July 21, 2025. 49 individuals (30 at intervention clinics, 19 at control clinics) were evaluated during periods of TPT stockout and were therefore censored from enrollment as they were unable to receive TPT.
Unit of analysis: clinics
Participant milestones
| Measure |
No Intervention: Standard of Care Study Arm
A clinical evaluation was conducted by the study nurse. All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
181 2
|
183 3
|
|
Overall Study
COMPLETED
|
181 2
|
183 3
|
|
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 |
No Intervention: Standard of Care Study Arm
n=181 Participants
All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
n=183 Participants
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
|
Total
n=364 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
37 years
n=181 Participants
|
37 years
n=183 Participants
|
37 years
n=364 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=181 Participants
|
75 Participants
n=183 Participants
|
159 Participants
n=364 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=181 Participants
|
108 Participants
n=183 Participants
|
205 Participants
n=364 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
181 Participants
n=181 Participants
|
183 Participants
n=183 Participants
|
364 Participants
n=364 Participants
|
PRIMARY outcome
Timeframe: Within 7 days of ART initiationBetween-arm comparison of the proportion of PLHIV initiating TPT ≤7 days after ART initiation.
Outcome measures
| Measure |
No Intervention: Standard of Care Study Arm
n=181 Participants
A clinical evaluation was done by the study nurse. All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
n=183 Participants
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
|
|---|---|---|
|
Participants Who Receive TPT Within 7 Days of ART Initiation
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119 Participants
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149 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days post-ART initiationPopulation: Participants who started TPT ≤ 7 days of ART initiation
Between-arm comparison of the proportion of PLHIV initiating TPT ≤7 days after ART initiation and have a subsequent positive TB test result.
Outcome measures
| Measure |
No Intervention: Standard of Care Study Arm
n=119 Participants
A clinical evaluation was done by the study nurse. All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
n=149 Participants
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
|
|---|---|---|
|
Participants Initiated TPT ≤ 7 Days of ART Initiation With Positive TB Test
|
5 Participants
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7 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days post-ART initiationPopulation: Started TPT and subsequent positive TB test
Safety evaluation of each TPT initiation approach based on the median time to TB treatment initiation among those who test positive for TB based on same day TPT or not.
Outcome measures
| Measure |
No Intervention: Standard of Care Study Arm
n=5 Participants
A clinical evaluation was done by the study nurse. All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
n=7 Participants
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
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|---|---|---|
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Time (Days) to TB Treatment Initiation
|
8 days
Interval 5.0 to 8.0
|
5 days
Interval 4.0 to 6.0
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PRIMARY outcome
Timeframe: Up to 90 days post-ART initiationPopulation: All participants
Between-arm comparison of the proportion of PLHIV with a positive TB test result.
Outcome measures
| Measure |
No Intervention: Standard of Care Study Arm
n=181 Participants
A clinical evaluation was done by the study nurse. All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
n=183 Participants
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
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|---|---|---|
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Participants With Positive TB Test
|
11 Participants
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12 Participants
|
Adverse Events
No Intervention: Standard of Care Study Arm
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
TUTT-PT Intervention
Serious events: 2 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
No Intervention: Standard of Care Study Arm
n=114 participants at risk；n=181 participants at risk
A clinical evaluation was conducted by the study nurse. All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
n=143 participants at risk；n=183 participants at risk
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
|
|---|---|---|
|
General disorders
Death
|
0.55%
1/181 • Number of events 1 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
1.1%
2/183 • Number of events 2 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
Other adverse events
| Measure |
No Intervention: Standard of Care Study Arm
n=114 participants at risk；n=181 participants at risk
A clinical evaluation was conducted by the study nurse. All laboratory investigations and ART and TPT prescribing occurred as per routine care in the facility prior to referral to the study nurse, who obtained written informed consent for study participation.
|
TUTT-PT Intervention
n=143 participants at risk；n=183 participants at risk
Participants had sputum collected for TB testing (if sputum was not already collected by the clinic nurse) and received a clinical evaluation for the presence of TB symptoms (cough, fever, weight loss, night sweats) and serious contraindications for TPT initiation (known liver disease, high alcohol intake (men: \>5 drinks/day or \>15 drinks/week; women: \>4 drinks/day or \>8 drinks/week), or strong clinical suspicion of TB disease as evidenced by severity of symptoms, including haemoptysis, or Karnofsky score ≤50. PLHIV for whom the study nurse did not have a strong clinical suspicion of TB nor evidence of serious TPT contraindications was referred back to clinic nurse for TPT initiation, irrespective of the presence or absence of TB symptoms.
|
|---|---|---|
|
General disorders
Fatigue, any severity
|
1.8%
2/114 • Number of events 2 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
0.00%
0/143 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
|
General disorders
Constitutional, any severity
|
0.00%
0/114 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
1.4%
2/143 • Number of events 2 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
|
General disorders
Headache, any severity
|
0.00%
0/114 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
2.1%
3/143 • Number of events 3 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
|
General disorders
Rash, any severity
|
0.00%
0/114 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
1.4%
2/143 • Number of events 2 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
|
General disorders
Gastrointestinal symptoms, any severity
|
0.00%
0/114 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
3.5%
5/143 • Number of events 5 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
|
General disorders
Dizziness, any severity
|
1.8%
2/114 • Number of events 2 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
0.00%
0/143 • All-Cause Mortality data was collected for all participants via medical record abstraction at 3 months post-enrollment. Adverse event data were collected at 1 month post-TPT initiation for participants prescribed TPT (119 control, 149 intervention); 114 control and 143 intervention participants were reached.
Participants prescribed TPT were contacted 1 month post-TPT initiation by a trained study team member to check for side effects and/or signs of any TPT-related adverse events. Presence or absence of the following side effects was recorded: Headache, Nausea/Vomiting, Rash, Fever, Other. Severity was measured as: Mild, Moderate, Severe, Potentially life-threatening.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place