Trial Outcomes & Findings for Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents (NCT NCT02213328)

Results Overview

The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

Measured through Week 48

Results posted on

2023-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Truvada All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Overall Study STARTED	148
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Truvada All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Overall Study Withdrawal by Subject	10
Overall Study Physician Decision	2
Overall Study Lost to Follow-up	16

Baseline Characteristics

Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Age, Continuous	18 years n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	148 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment South Africa	148 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured through Week 48

Population: Enrolled participants

The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package Percentage of partcipants who reported willingness to use the study regimen	148 Participants
The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package Percentage of participants who took up PrEP	148 Participants
The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package Percentage of participants who remained on PrEP at 12 weeks	122 Participants
The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package Percentage of participants who remained on PrEP at 24 weeks	87 Participants
The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package Percentage of participants who remained on PrEP at 36 weeks	85 Participants
The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package Percentage of participants who remained on PrEP at week 48	85 Participants

PRIMARY outcome

Timeframe: Measured at Week 48

Population: Participants attending week 48 visit and completing acceptability questionnaire

Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit

Outcome measures

Outcome measures
Measure	Truvada n=117 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Number of Participants With Acceptability as Per Questionnaire Administered at Week 48	97 Participants

PRIMARY outcome

Timeframe: Measured through Week 48

Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period Participants with truvada in DBS at week 24	74 Participants
Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period Participants with truvada in DBS at week 36	31 Participants
Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period Participants with truvada in DBS at week 48	22 Participants

PRIMARY outcome

Timeframe: Measured through Week 48

Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011.

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events Grade 2	14 Participants
Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events Grade 3	4 Participants
Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events Grade 4	2 Participants

PRIMARY outcome

Timeframe: Measured through Week 52

Population: 15-19 year old boys and girls

Count of participants who had been enrolled in the study and successfully completed the study

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Number of Adolescents Enrolled and Retained in the Study Number of participants enrolled	148 Participants
Number of Adolescents Enrolled and Retained in the Study Number of participants completing the study	120 Participants

SECONDARY outcome

Timeframe: Measured through Week 48

Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36	141 Participants

SECONDARY outcome

Timeframe: Measured though Week 48

Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP total enrolled participants	148 Participants
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP week 12	107 Participants
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP week 24	74 Participants
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP week 36	31 Participants
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP week 48	22 Participants

SECONDARY outcome

Timeframe: Baseline

Participants reporting multiple partners during interviewer administered questionnaires

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment	49 Participants

SECONDARY outcome

Timeframe: Baseline

Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit	100 Participants

SECONDARY outcome

Timeframe: Baseline visit

Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit No. of participants reporting alcohol use	83 Participants
Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit No. of participants reporting drug use	25 Participants

SECONDARY outcome

Timeframe: Measured through Week 52

Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later.

Outcome measures

Outcome measures
Measure	Truvada n=148 Participants All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52	1 Participants

Adverse Events

Truvada

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Truvada n=148 participants at risk All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Injury, poisoning and procedural complications Haemothorax	0.68% 1/148 • Number of events 1 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Injury, poisoning and procedural complications Para suicide attempt	0.68% 1/148 • Number of events 1 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Hepatobiliary disorders Cholecystitis	0.68% 1/148 • Number of events 1 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Gastrointestinal disorders Incarcerated peri-umbilical hernia	0.68% 1/148 • Number of events 1 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.

Other adverse events

Other adverse events
Measure	Truvada n=148 participants at risk All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48. Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
Nervous system disorders Headache	2.7% 4/148 • Number of events 4 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Gastrointestinal disorders Nausea	1.4% 2/148 • Number of events 2 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Gastrointestinal disorders Vomiting	1.4% 2/148 • Number of events 2 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Gastrointestinal disorders Abdominal Pain	1.4% 2/148 • Number of events 2 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Gastrointestinal disorders Diarrhoea	1.4% 2/148 • Number of events 2 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
Skin and subcutaneous tissue disorders Drug Rash	0.68% 1/148 • Number of events 1 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.
General disorders Weight Loss	1.4% 2/148 • Number of events 2 • Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.

Additional Information

Dr Katherine Gill

Desmond Tutu HIV Foundation

Phone: +2721 785 3121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place