Trial Outcomes & Findings for Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa (NCT NCT03848728)

NCT ID: NCT03848728

Last Updated: 2024-10-23

Results Overview

Percentage of study participants with virologic suppression (HIV RNA \<400 c/mL) at 2 years of follow-up. Mean was calculated as the average percentage across the clusters (clinics)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1988 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2024-10-23

Participant Flow

Unit of analysis: Clinics

Participant milestones

Measure	Intervention Clinics SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers SEARCH Youth combination intervention: * Administration of life-stage assessment tool * Structured choice clinic access * Rapid feedback of VL results * Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information	Control Clinics Optimized country standard of care
Overall Study STARTED	1012 14	976 14
Overall Study COMPLETED	865 14	809 14
Overall Study NOT COMPLETED	147 0	167 0

Reasons for withdrawal

Measure	Intervention Clinics SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers SEARCH Youth combination intervention: * Administration of life-stage assessment tool * Structured choice clinic access * Rapid feedback of VL results * Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information	Control Clinics Optimized country standard of care
Overall Study Death	16	13
Overall Study Outmigrated to non-study community	98	106
Overall Study Transfered to non-study clinic	32	48
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Data missing from 16 participants - 7 in intervention group, 9 in control group

Baseline characteristics by cohort

Measure	Intervention Clinics n=785 Participants SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers SEARCH Youth combination intervention: * Administration of life-stage assessment tool * Structured choice clinic access * Rapid feedback of VL results * Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information Information presented for participants included in primary analysis.	Control Clinics n=764 Participants Optimized country standard of care. Information presented for participants included in primary analysis.	Total n=1549 Participants Total of all reporting groups
Age, Customized Median age	21 years n=785 Participants	21 years n=764 Participants	21 years n=1549 Participants
Sex: Female, Male Female	643 Participants n=785 Participants	605 Participants n=764 Participants	1248 Participants n=1549 Participants
Sex: Female, Male Male	142 Participants n=785 Participants	159 Participants n=764 Participants	301 Participants n=1549 Participants
Race/Ethnicity, Customized African/Black	785 Participants n=785 Participants	764 Participants n=764 Participants	1549 Participants n=1549 Participants
Region of Enrollment Uganda	332 participants n=785 Participants	324 participants n=764 Participants	656 participants n=1549 Participants
Region of Enrollment Kenya	453 participants n=785 Participants	440 participants n=764 Participants	893 participants n=1549 Participants
Education (started or completed) No school	31 Participants n=785 Participants	24 Participants n=764 Participants	55 Participants n=1549 Participants
Education (started or completed) Primary school	507 Participants n=785 Participants	525 Participants n=764 Participants	1032 Participants n=1549 Participants
Education (started or completed) Secondary school	194 Participants n=785 Participants	175 Participants n=764 Participants	369 Participants n=1549 Participants
Education (started or completed) Tertiary school	53 Participants n=785 Participants	40 Participants n=764 Participants	93 Participants n=1549 Participants
Education (started or completed) At boarding school	56 Participants n=785 Participants	56 Participants n=764 Participants	112 Participants n=1549 Participants
Employment status Employed	283 Participants n=785 Participants	308 Participants n=764 Participants	591 Participants n=1549 Participants
Employment status In school	165 Participants n=785 Participants	155 Participants n=764 Participants	320 Participants n=1549 Participants
Employment status Unemployed	337 Participants n=785 Participants	301 Participants n=764 Participants	638 Participants n=1549 Participants
Marital status Single, never married	342 Participants n=785 Participants	291 Participants n=764 Participants	633 Participants n=1549 Participants
Marital status Married, monogamous	306 Participants n=785 Participants	327 Participants n=764 Participants	633 Participants n=1549 Participants
Marital status Married, polygamous	44 Participants n=785 Participants	51 Participants n=764 Participants	95 Participants n=1549 Participants
Marital status Widowed	3 Participants n=785 Participants	6 Participants n=764 Participants	9 Participants n=1549 Participants
Marital status Divorced	90 Participants n=785 Participants	89 Participants n=764 Participants	179 Participants n=1549 Participants
Number of children 0 children	330 Participants n=785 Participants	323 Participants n=764 Participants	653 Participants n=1549 Participants
Number of children 1 child	258 Participants n=785 Participants	227 Participants n=764 Participants	485 Participants n=1549 Participants
Number of children 2 children	129 Participants n=785 Participants	131 Participants n=764 Participants	260 Participants n=1549 Participants
Number of children 3-5 children	51 Participants n=785 Participants	64 Participants n=764 Participants	115 Participants n=1549 Participants
Drinks alcohol	137 Participants n=785 Participants	94 Participants n=764 Participants	231 Participants n=1549 Participants
Mobile	210 Participants n=785 Participants	229 Participants n=764 Participants	439 Participants n=1549 Participants
Antiretroviral regimen at enrolment TDF-3TC-EFV	591 Participants n=778 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	527 Participants n=755 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	1118 Participants n=1533 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group
Antiretroviral regimen at enrolment TDF-3TC-DTG	81 Participants n=778 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	101 Participants n=755 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	182 Participants n=1533 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group
Antiretroviral regimen at enrolment AZT-3TC-NVP	33 Participants n=778 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	42 Participants n=755 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	75 Participants n=1533 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group
Antiretroviral regimen at enrolment TDF-3TC-ATV/r	10 Participants n=778 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	18 Participants n=755 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	28 Participants n=1533 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group
Antiretroviral regimen at enrolment AZT-3TC-ATV/r	12 Participants n=778 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	14 Participants n=755 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	26 Participants n=1533 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group
Antiretroviral regimen at enrolment ABC-3TC-EFV	12 Participants n=778 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	11 Participants n=755 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	23 Participants n=1533 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group
Antiretroviral regimen at enrolment Other	39 Participants n=778 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	42 Participants n=755 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group	81 Participants n=1533 Participants • Data missing from 16 participants - 7 in intervention group, 9 in control group
Baseline viral load <400 copies per mL	573 Participants n=780 Participants • Data missing from 16 participants: 5 intervention participants, 11 control participants	574 Participants n=753 Participants • Data missing from 16 participants: 5 intervention participants, 11 control participants	1147 Participants n=1533 Participants • Data missing from 16 participants: 5 intervention participants, 11 control participants
Baseline care status Recently engaged - started treatment within 6 months of enrolment	252 Participants n=784 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant	214 Participants n=763 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant	466 Participants n=1547 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant
Baseline care status Engaged - started treatment > 6 months before enrolment with HIV care visit within 6 months	496 Participants n=784 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant	530 Participants n=763 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant	1026 Participants n=1547 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant
Baseline care status Re-engaging - started treatment > than 6 months before enrolment, no HIV care visit within 6 months	36 Participants n=784 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant	19 Participants n=763 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant	55 Participants n=1547 Participants • Data missing for 2 participants, 1 intervention participant, 1 control participant

PRIMARY outcome

Timeframe: 2 years

Population: Study participants at year 2, excluding those who enrolled on/after Dec 1, 2019, transferred care, outmigrated, or withdrew.

Percentage of study participants with virologic suppression (HIV RNA <400 c/mL) at 2 years of follow-up. Mean was calculated as the average percentage across the clusters (clinics)

Outcome measures

Measure	Intervention Clinics n=785 Participants SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers SEARCH Youth combination intervention: * Administration of life-stage assessment tool * Structured choice clinic access * Rapid feedback of VL results * Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information	Control Clinics n=14 Clinics Optimized country standard of care
Effectiveness of SEARCH Youth Intervention Engaged	90.9 % of participants Interval 87.7 to 94.0	85.3 % of participants Interval 81.0 to 89.5
Effectiveness of SEARCH Youth Intervention All	88.2 % of participants Interval 84.8 to 91.7	80.5 % of participants Interval 76.9 to 84.1
Effectiveness of SEARCH Youth Intervention Recently engaged	80.1 % of participants Interval 72.7 to 87.5	73.5 % of participants Interval 67.1 to 79.8
Effectiveness of SEARCH Youth Intervention Re-engaging	84.8 % of participants Interval 72.7 to 97.0	53.2 % of participants Interval 29.5 to 76.9

Adverse Events

Intervention Clinics

Serious events: 48 serious events

Other events: 0 other events

Deaths: 16 deaths

Control Clinics

Serious events: 13 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Measure	Intervention Clinics n=1012 participants at risk SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers SEARCH Youth combination intervention: * Administration of life-stage assessment tool * Structured choice clinic access * Rapid feedback of VL results * Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information	Control Clinics n=976 participants at risk Optimized country standard of care
Metabolism and nutrition disorders Dehydration	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Urinary tract infection	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Gastrointestinal disorders Hernia	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Malaria	0.40% 4/1012 • Number of events 4 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Psychiatric disorders Depression	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Pneumonia	0.20% 2/1012 • Number of events 2 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Oral thrush	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Gastrointestinal disorders Abdominal distension	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Pregnancy, puerperium and perinatal conditions Spontaneous abortion	0.79% 8/1012 • Number of events 8 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Musculoskeletal and connective tissue disorders Injury	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Pregnancy, puerperium and perinatal conditions Cesarean infant delivery	0.20% 2/1012 • Number of events 2 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Blood and lymphatic system disorders Anemia	0.49% 5/1012 • Number of events 6 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Typhoid fever	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Nervous system disorders Seizures	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Suspected bacterial or tubercular respiratory infection resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Hepatobiliary disorders Liver disease resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Immune system disorders Presumed sepsis resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Respiratory, thoracic and mediastinal disorders Respiratory failure resulting in death	0.20% 2/1012 • Number of events 2 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
General disorders Death, cause unknown	0.30% 3/1012 • Number of events 3 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Suspected tuberculosis resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Blood and lymphatic system disorders Severe anemia resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Immune system disorders AIDS resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.20% 2/976 • Number of events 2 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Renal and urinary disorders Kidney disease resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Blood and lymphatic system disorders Sickle cell anemia resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Metabolism and nutrition disorders Severe malnutrition resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Pulmonary tuberculosis resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.20% 2/976 • Number of events 2 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
General disorders Organ failure, cause unknown, resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Pregnancy, puerperium and perinatal conditions Threatened abortion	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Encephalitis	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	— 0/0 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Nervous system disorders CNS-TB with possible brain tumor resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Renal and urinary disorders Renal failure resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal tumor resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia toxemia resulting in death	0.10% 1/1012 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.00% 0/976 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi sarcoma resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Infections and infestations Pneumonia resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.
Pregnancy, puerperium and perinatal conditions Complications following Cesarean childbirth resulting in death	0.00% 0/1012 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.	0.10% 1/976 • Number of events 1 • 2 years Non-fatal serious adverse events were reported regardless of relationship to the study intervention in the intervention arm only. Control arm participants were not contacted during the study except at baseline and endpoint. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms. Fatal serious adverse events were reported in both the intervention arm and the control arm regardless of relationship.

Other adverse events

Adverse event data not reported

Additional Information

Douglas Black

University of California, San Francisco

Phone: 4158063016

Email: douglas.black@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place