Acceptability of Health CarePhase 2NCT05458765
Project Engage: Oral PrEP Acceptability
A Phase 2 study testing emtricitabine/tenofovir alafenamide and Emtricitabine / Tenofovir Disoproxil Oral Tablet in people with Acceptability of Health Care and Adherence, Medication, run by Eastern Virginia Medical School at 3 sites in 2 countries.
Trial summary
This study is a two-arm open label acceptability study that will examine acceptability of, and adherence to, once daily dosing regimen of F/TDF (Truvada) and an investigational once daily dosing regimen of F/TAF (Descovy) under standard of care counselling. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acceptability of Health Care, Adherence, Medication
- What is being tested?
- emtricitabine/tenofovir alafenamide and Emtricitabine / Tenofovir Disoproxil Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Jun 2022to 25 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female, age 15 to 24 years (inclusive)
- Literate, per local standards, to English and/or local language
- In general good health, per participant reported medical history and investigator judgement, without any clinically significant systemic disease including but not limited to: significant liver disease or hepatitis, gastrointestinal disease, kidney disease, osteoporosis or bone disease (e.g., pathologic bone fractures not related to trauma), autoimmune disorder, and diabetes.
- Willing to give voluntary informed consent and sign an informed consent form
- Sexually active or considered at risk of acquiring HIV
- Willing and able to comply with protocol requirements, including swallowing tablets
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- Total body weight >35 kg
- eGFR or Creatinine Clearance of >60 mL/min according to the Cockcroft-Gault formula
- Has not used oral PrEP ever (PrEP naïve) or in the past 6 months
- If pregnant, must be considered a healthy, singleton pregnancy, considered low risk by local standard of obstetric practices
Who cannot join
- Positive test for HIV or HBsAg
- Signs or symptoms of acute HIV infection
- Use of ARV PrEP within the past 180 days
- History of sensitivity or allergy to any component of the study drug products
- Systemic use in the last two (2) weeks or anticipated use during the course of the study of any restricted products
- Known current drug or alcohol abuse which could impact study compliance
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- Grade 2 or higher laboratory abnormality, except for CrCl 60-90 mL/min, per the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events, or clinically significant laboratory abnormality as determined by the clinician or study PI
- Abnormal finding on laboratory or physical examination or a social or medical condition in the volunteer, which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
- Participation in any other investigational trial with use of a drug/device within the last 30 days or planned participation in any other investigational trial with use of a drug/device during the study
- History of pathological bone fracture
- Pregnant <33 weeks gestation; breastfeeding with infant >6 months old
- Has a sexual partner confirmed to be HIV positive per participant report
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Africa2 sites
MatCH Research Unit
Durban, KwaZulu-Natal
CAPRISA Vulindlela
Pietermaritzburg, KwaZulu-Natal, 3201
About this study
Official title: A Phase II Acceptability Study of Oral Emtricitabine/Tenofovir Alafenamide (F/TAF) vs Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for the Prevention of HIV Acquisition in Adolescent Girls and Young Women (AGYW)
This study is a two-arm open label acceptability study that will examine acceptability of, and adherence to, once daily dosing regimen of F/TDF (Truvada) and an investigational once daily dosing regimen of F/TAF (Descovy) under standard of care counselling. The study will recruit approximately 330 healthy, HIV negative, AGYW in up to three sites in Africa. Eligible participants will be randomized 1:1 to receive F/TAF 200 mg/25 mg or F/TDF 200 mg/300 mg for once daily oral administration for 24 weeks.
Study visits will take place according to standard of care at month 1, month 3 and month 6. Acceptability and adherence will be assessed by questionnaires and DBS at months 3 and 6; questionnaires will assess acceptability of product attributes; perceived pill side effects; ease of pill-taking and reasons for missed pills, and future interest in PrEP use beyond the trial context. Exit interviews at the final visit and additional qualitative interviews and focus group discussions with a subset of participants as well as other key stakeholders will further inform potential differences in acceptability and adherence between the two products. Data collection will also focus on gathering insights and input from participants that will aid uptake and continuation and inform future programming of oral PrEP.
- Being tested
- emtricitabine/tenofovir alafenamide, Emtricitabine / Tenofovir Disoproxil Oral Tablet
- Keywords
- PrEP, HIV
- Medical subject headings
- Patient Acceptance of Health Care, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emtricitabine/tenofovir alafenamideDrug
Also called Descovy
200mg/25mg tablet, once daily dosing for 24 weeks
Emtricitabine / Tenofovir Disoproxil Oral TabletDrug
Also called Truvada
200mg/300mg tablet, once daily dosing for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| F/TAF | Active comparator | daily oral tablet Receives: Drug: emtricitabine/tenofovir alafenamide |
| F/TDF | Active comparator | daily oral tablet Receives: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the discontinuation rate between arms
Acceptability will be assessed by discontinuation of study product
Measured: 3 months
Secondary outcomes (1)
Adherence to study product
Concentrations of TFV-DP and FTC-TP in dried blood spots (DBS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start21 Jun 2022
- Primary completion13 Dec 2023
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptability of Health CareStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- CONRAD, FHI 360, United States Agency for International Development (USAID), Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Gustavo Doncel, MD,PhD, Study director, CONRAD/EVMSHomaira Hanif, PhD, Principal investigator, CONRAD/EVMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458765
- Sponsor's protocol ID
- CONRAD B20-151
- Status last verified
- Aug 2023
- First submitted
- 10 Jun 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Acceptability Study of Oral Emtricitabine/Tenofovir Alafenamide (F/TAF) vs Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for the Prevention of HIV Acquisition in Adolescent Girls and Young Women (AGYW)
- ClinicalTrials.gov ID
- NCT05458765
- Acronym / sponsor ID
- CONRAD B20-151
- Keywords
- PrEP, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- CONRAD, FHI 360, United States Agency for International Development (USAID), Gilead Sciences
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a two-arm open label acceptability study that will examine acceptability of, and adherence to, once daily dosing regimen of F/TDF (Truvada) and an investigational once daily dosing regimen of F/TAF (Descovy) under standard of care counselling. The study will recruit approximately 330 healthy, HIV negative, AGYW in up to three sites in Africa. Eligible participants will be randomized 1:1 to receive F/TAF 200 mg/25 mg or F/TDF 200 mg/300 mg for once daily oral administration for 24 weeks.
Study visits will take place according to standard of care at month 1, month 3 and month 6. Acceptability and adherence will be assessed by questionnaires and DBS at months 3 and 6; questionnaires will assess acceptability of product attributes; perceived pill side effects; ease of pill-taking and reasons for missed pills, and future interest in PrEP use beyond the trial context. Exit interviews at the final visit and additional qualitative interviews and focus group discussions with a subset of participants as well as other key stakeholders will further inform potential differences in acceptability and adherence between the two products. Data collection will also focus on gathering insights and input from participants that will aid uptake and continuation and inform future programming of oral PrEP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F/TAF | Active comparator | Drug: emtricitabine/tenofovir alafenamidedaily oral tablet |
| F/TDF | Active comparator | Drug: Emtricitabine / Tenofovir Disoproxil Oral Tabletdaily oral tablet |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Female, age 15 to 24 years (inclusive)
- Literate, per local standards, to English and/or local language
- In general good health, per participant reported medical history and investigator judgement, without any clinically significant systemic disease including but not limited to: significant liver disease or hepatitis, gastrointestinal disease, kidney disease, osteoporosis or bone disease (e.g., pathologic bone fractures not related to trauma), autoimmune disorder, and diabetes.
- Willing to give voluntary informed consent and sign an informed consent form
- Sexually active or considered at risk of acquiring HIV
Key exclusion criteria (12 listed)
- Positive test for HIV or HBsAg
- Signs or symptoms of acute HIV infection
- Use of ARV PrEP within the past 180 days
- History of sensitivity or allergy to any component of the study drug products
- Systemic use in the last two (2) weeks or anticipated use during the course of the study of any restricted products
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 |
|---|---|---|
| emtricitabine/tenofovir alafenamideAlso: Descovy200mg/25mg tablet, once daily dosing for 24 weeks | Drug | F/TAF |
| Emtricitabine / Tenofovir Disoproxil Oral TabletAlso: Truvada200mg/300mg tablet, once daily dosing for 24 weeks | Drug | F/TDF |
Primary outcome
Compare the discontinuation rate between arms
Time frame: 3 months
Acceptability will be assessed by discontinuation of study product
1 secondary outcome
Adherence to study product
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Gustavo Doncel, MD,PhD study director
CONRAD/EVMS
Homaira Hanif, PhD principal investigator
CONRAD/EVMS
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing emtricitabine/tenofovir alafenamide and Emtricitabine / Tenofovir Disoproxil Oral Tablet in people with Acceptability of Health Care and Adherence, Medication, run by Eastern Virginia Medical School at 3 sites in 2 countries.
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 10 inclusion and 12 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa, Zimbabwe. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the discontinuation rate between arms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2024.