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CompletedNCT02213328Updated Jul 3, 2023Results posted

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

A Phase 2 interventional study of Truvada in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in South Africa. Open to participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
148
Allocation
Not applicable
Ages
15 Years to 19 Years
Sex
All
01

Study summary

Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of age.

Read the detailed description

Truvada PrEP is an approach used to protect HIV-uninfected adults against possible infection with HIV. The approach involves taking Truvada every day to prevent HIV infection in case the person is exposed to HIV (for example, through sex with an HIV-infected person). The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years old. In addition to Truvada PrEP, the HIV prevention package will include HIV testing, management of sexually transmitted infections (STIs), risk reduction counseling, access to condoms, post-exposure prophylaxis (PEP), and circumcision counseling and referral for male participants.

The study will enroll 150 healthy, HIV-uninfected adolescents 15 to 19 years of age. The study will last for 12 months (52 weeks) and involve scheduled clinic visits at study entry (Week 0) and Weeks 4, 8, 12, 24, 36, 48, and 52.

For the first 12 weeks of the study, all participants will be provided with a supply of Truvada tablets to take once daily as part of the comprehensive HIV prevention package. At Weeks 12, 24, 36, and 48, participants will be offered the following options: to continue with the full HIV prevention package plus Truvada PrEP, to stop Truvada PrEP and continue with rest of the HIV prevention package, or to re-start Truvada PrEP if previously stopped. After Week 12 of the study, Truvada tablets will be given only to those participants who decide to take PrEP and who do not have any medical reasons not to do so. Regardless whether they choose to use Truvada PrEP after Week 12, all study participants will be followed through Week 52 of the study.

All study visits will include blood collection, counseling before and after HIV testing, urine collection for pregnancy testing (female participants only), completion of a sexual risk behavior questionnaire, receipt of a supply of condoms, contraceptive counseling, a medical history review, and disclosure of available test results. Select study visits may include a physical exam, blood and urine collection, testing and treatment of STIs, adherence counseling, and an acceptability assessment. Between Months 11 and 12 of the study, some participants will be randomly selected to participate in focus groups to discuss their experiences while taking Truvada PrEP.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 148 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 15 to 19 years (inclusive) at screening, verified per study site standard operating procedures (SOPs)
  • Able and willing to provide written informed consent/assent (age dependent) to be screened for and to take part in the study
  • Have a guardian who is able and willing to provide written informed consent for his or her child to be screened for and to take part in the study
  • Able and willing to provide adequate locator information, as defined in site standard operating procedures (SOPs)
  • HIV-uninfected based on testing performed by study staff at screening and enrollment
  • Sexually active, as defined as a minimum of one act of (penile vaginal) sexual intercourse in the last 12 months, per self-report
  • (For female participants) Negative pregnancy test at screening and enrollment and, per participant report, does not intend to become pregnant in the next 12 months
  • (For female participants) Using an effective method of contraception at enrollment, and intending to use an effective method for the study duration; effective methods include low dose oral, implant, or injectable hormonal methods.
  • Does not report intention to relocate out of the study area during the course of the study
  • Does not have job or other obligations that would require long absences from the area (for more than 4 weeks at a time)
  • Willing to undergo all study-required procedures
  • At screening and enrollment, agrees not to participate in other research studies involving drugs or medical devices for the next 12 months

Exclusion criteria

Exclusion Criteria:

Participants who meet any of the following criteria, at baseline, are excluded from the study:

  • As determined by the Site Investigator, any significant uncontrolled active or chronic disease process such as but not limited to diabetes, hypertension, and other diseases involving the cardiovascular, pulmonary, gastrointestinal, genitourinary, musculoskeletal, and central nervous systems
  • Confirmed Grade 2 or greater hypophosphatemia
  • Presence of serious psychiatric symptoms (e.g., active hallucinations)
  • Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting violent behavior)
  • Intoxicated or under the influence of alcohol or other drugs at the time of consent
  • Acute or chronic hepatitis B infection (i.e., if hepatitis B surface antigen positive)
  • Hepatitis B seronegative and refuses vaccination
  • Renal dysfunction (creatinine clearance less than 75 ml/min); Use Cockroft-Gault equation as detailed in the protocol
  • Urine dipstick for protein and glucose, excluding values of "1 +" or greater
  • Any history of bone fractures not explained by trauma
  • Any Grade 2 or greater toxicity on screening tests and assessments
  • Concurrent participation in an HIV vaccine study or other investigational drug study
  • Known allergy/sensitivity to the study drug or its components
  • Use of disallowed medications (as detailed in the protocol)
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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    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 52.

    Drug: Truvada

Interventions

  • DrugTruvada

    Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.

    Also known as: emtricitabine/tenofovir disoproxil fumarate, FTC/TDF

06

What researchers measure

Primary outcomes

  1. 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

    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

    Time frame: Measured through Week 48

  2. Number of Participants With Acceptability as Per Questionnaire Administered at Week 48

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

    Time frame: Measured at Week 48

  3. Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period

    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

    Time frame: Measured through Week 48

  4. Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events

    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.

    Time frame: Measured through Week 48

  5. Number of Adolescents Enrolled and Retained in the Study

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

    Time frame: Measured through Week 52

Secondary outcomes

  1. Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36

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

    Time frame: Measured through Week 48

  2. Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP

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

    Time frame: Measured though Week 48

  3. Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment

    Participants reporting multiple partners during interviewer administered questionnaires

    Time frame: Baseline

  4. Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit

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

    Time frame: Baseline

  5. Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit

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

    Time frame: Baseline visit

  6. Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 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.

    Time frame: Measured through Week 52

07

Results

Posted Jul 3, 2023

Participant flow

Participant flow — Overall Study
MilestoneTruvada
Started148
Completed120
Not completed28
Withdrew: Withdrawal by subject10
Withdrew: Physician decision2
Withdrew: Lost to follow-up16

Outcome measures

PrimaryThe 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

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

Time frame:
Measured through Week 48
Reported as:
Count of participants · 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
ParticipantsTruvada
Percentage of partcipants who reported willingness to use the study regimen148
Percentage of participants who took up PrEP148
Percentage of participants who remained on PrEP at 12 weeks122
Percentage of participants who remained on PrEP at 24 weeks87
Percentage of participants who remained on PrEP at 36 weeks85
Percentage of participants who remained on PrEP at week 4885
PrimaryNumber of Participants With Acceptability as Per Questionnaire Administered at Week 48

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

Time frame:
Measured at Week 48
Reported as:
Count of participants · Participants
Number of Participants With Acceptability as Per Questionnaire Administered at Week 48
ParticipantsTruvada
Number of Participants With Acceptability as Per Questionnaire Administered at Week 4897
PrimaryNumber of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period

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

Time frame:
Measured through Week 48
Reported as:
Count of participants · Participants
Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period
ParticipantsTruvada
Participants with truvada in DBS at week 2474
Participants with truvada in DBS at week 3631
Participants with truvada in DBS at week 4822
PrimaryNumber of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events

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.

Time frame:
Measured through Week 48
Reported as:
Count of participants · Participants
Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events
ParticipantsTruvada
Grade 214
Grade 34
Grade 42
PrimaryNumber of Adolescents Enrolled and Retained in the Study

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

Time frame:
Measured through Week 52
Reported as:
Count of participants · Participants
Number of Adolescents Enrolled and Retained in the Study
ParticipantsTruvada
Number of participants enrolled148
Number of participants completing the study120
SecondaryNumber of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36

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

Time frame:
Measured through Week 48
Reported as:
Count of participants · Participants
Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36
ParticipantsTruvada
Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36141
SecondaryProportion of Adolescents With Detectable Drug Levels Who Report Using PrEP

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

Time frame:
Measured though Week 48
Reported as:
Count of participants · Participants
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP
ParticipantsTruvada
total enrolled participants148
week 12107
week 2474
week 3631
week 4822
SecondaryNumber of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment

Participants reporting multiple partners during interviewer administered questionnaires

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment
ParticipantsTruvada
Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment49
SecondaryReported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit

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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit
ParticipantsTruvada
Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit100
SecondaryReported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit

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

Time frame:
Baseline visit
Reported as:
Count of participants · Participants
Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit
ParticipantsTruvada
No. of participants reporting alcohol use83
No. of participants reporting drug use25
SecondaryPercentage of Study Participants Who Seroconverted During the Study, Measured Until Month 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.

Time frame:
Measured through Week 52
Reported as:
Count of participants · Participants
Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52
ParticipantsTruvada
Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 521

Adverse events

Collected over Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Truvada0/148 (0%)4/148 (2.7%)15/148 (10.1%)
Most frequent serious events
Most frequent serious events
EventTruvada
HaemothoraxInjury, poisoning and procedural complications1/148
Para suicide attemptInjury, poisoning and procedural complications1/148
CholecystitisHepatobiliary disorders1/148
Incarcerated peri-umbilical herniaGastrointestinal disorders1/148
Most frequent other events
Most frequent other events
EventTruvada
HeadacheNervous system disorders4/148
NauseaGastrointestinal disorders2/148
VomitingGastrointestinal disorders2/148
Abdominal PainGastrointestinal disorders2/148
DiarrhoeaGastrointestinal disorders2/148
Weight LossGeneral disorders2/148
Drug RashSkin and subcutaneous tissue disorders1/148

Baseline characteristics

All participants are adolescent male and female 15-19 years old

Age, Continuous
Age, Continuous(years)Truvada
Median18 (17 to 19)
Sex: Female, Male
Sex: Female, Male(Participants)Truvada
Female99
Male49
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Truvada
Hispanic or Latino0
Not Hispanic or Latino148
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Truvada
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American148
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Truvada
South Africa148
08

Study locations

2 sites
  • Desmond Tutu HIV Foundation Non-Network CRS
    Cape Town, South Africa
  • Perinatal HIV Non-network Research CRS
    Soweto, 1862, South Africa
09

References and documents

Publications

  • Gill K, Johnson L, Dietrich J, Myer L, Marcus R, Wallace M, Pidwell T, Mendel E, Fynn L, Jones K, Wiesner L, Slack C, Strode A, Spiegel H, Hosek S, Rooney J, Gray G, Bekker LG. Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial. Lancet Child Adolesc Health. 2020 Dec;4(12):875-883. doi: 10.1016/S2352-4642(20)30248-0. Epub 2020 Oct 24. PubMed 33222803 ↗

Study documents

  • Study protocol · Dec 29, 2016
  • Statistical analysis plan · Dec 29, 2016
  • Informed consent form · Jul 24, 2015

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02213328
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 11, 2014
Start date
Apr 2015
Primary completion
Mar 6, 2017
Completion
Mar 6, 2017
Results posted
Jul 3, 2023
Last update
Jul 3, 2023

Study contacts

Linda-Gail Bekker, MBChB, PhD
principal investigator · Desmond Tutu HIV Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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