NCT05458765CompletedPhase 2
Project Engage: Oral PrEP Acceptability
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)
Source: ClinicalTrials.gov · Last updated 29 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 330 (actual)
- First submitted
- 10 Jun 2022
- Start date
- 21 Jun 2022
- Primary completion date
- 13 Dec 2023
- Lead sponsor
- Eastern Virginia Medical School
- Diseases
- HIV
- NCT number
- NCT05458765
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 330
- From 21 Jun 2022 to the primary completion date, 13 Dec 2023
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known current drug or alcohol abuse which could impact study compliance
- 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
Other illness
- Positive test for HIV or HBsAg
- Signs or symptoms of acute HIV infection
- History of sensitivity or allergy to any component of the study drug products
- History of pathological bone fracture
- Has a sexual partner confirmed to be HIV positive per participant report
Lab values
- 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
Other
- Use of ARV PrEP within the past 180 days
- Systemic use in the last two (2) weeks or anticipated use during the course of the study of any restricted products
- Pregnant \<33 weeks gestation; breastfeeding with infant \>6 months old
Who the study is looking for
- 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
- 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
Age in the registry: 15 years to 24 years · Sex: Female · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MatCH Research Unit Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| CAPRISA Vulindlela Coordinator of this site? Confirm its status | Pietermaritzburg | South Africa | Unknown status |
| Harare Health and Research Consortium (HHRC) Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.