HIV InfectionsPhase 2NCT02213328
Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
A Phase 2 study testing Truvada in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Truvada
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Apr 2015to 6 Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- (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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Desmond Tutu HIV Foundation Non-Network CRS
Cape Town
Perinatal HIV Non-network Research CRS
Soweto, 1862
About this study
Official title: CHAMPS: Choices For Adolescent Prevention Methods For South Africa. Pilot Study B: 'PlusPills'
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.
- Conditions
- HIV Infections
- Being tested
- Truvada
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Also called emtricitabine/tenofovir disoproxil fumarate, FTC/TDF
Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Truvada | Experimental | 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. Receives: Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measured through Week 48
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
Measured: Measured at Week 48
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
Measured: Measured through Week 48
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.
Measured: Measured through Week 48
Number of Adolescents Enrolled and Retained in the Study
Count of participants who had been enrolled in the study and successfully completed the study
Measured: Measured through Week 52
Secondary outcomes (6)
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
Measured: Measured through Week 48
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
Measured: Measured though Week 48
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline visit
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.
Measured: Measured through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startApr 2015
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Linda-Gail Bekker, MBChB, PhD, Principal investigator, Desmond Tutu HIV Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213328
- Sponsor's protocol ID
- CHAMPS PrEP
- Other IDs
- 11931
- Status last verified
- Jun 2023
- First submitted
- 7 Aug 2014
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHAMPS: Choices For Adolescent Prevention Methods For South Africa. Pilot Study B: 'PlusPills'
- ClinicalTrials.gov ID
- NCT02213328
- Acronym / sponsor ID
- CHAMPS PrEP
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2015
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Truvada | Experimental | Drug: TruvadaAll 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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruvadaAlso: emtricitabine/tenofovir disoproxil fumarate, FTC/TDFFixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth. | Drug | Truvada |
Primary outcome
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
Time frame: Measured through Week 48
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
Number of Participants With Acceptability as Per Questionnaire Administered at Week 48
Time frame: Measured at Week 48
Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit
Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period
Time frame: 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
Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events
Time frame: 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.
Number of Adolescents Enrolled and Retained in the Study
Time frame: Measured through Week 52
Count of participants who had been enrolled in the study and successfully completed the study
6 secondary outcomes
Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36
Time frame: Measured through Week 48
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP
Time frame: Measured though Week 48
Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment
Time frame: Baseline
Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit
Time frame: Baseline
Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit
Time frame: Baseline visit
Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52
Time frame: Measured through Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33222803Gill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda-Gail Bekker, MBChB, PhD principal investigator
Desmond Tutu HIV Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Truvada in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Measured through Week 48). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02213328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.