Project Engage: Oral PrEP Acceptability

• emtricitabine/tenofovir alafenamide (Drug), also known as Descovy: 200mg/25mg tablet, once daily dosing for 24 weeks
• Emtricitabine / Tenofovir Disoproxil Oral Tablet (Drug), also known as Truvada: 200mg/300mg tablet, once daily dosing for 24 weeks

Primary outcomes

• Compare the discontinuation rate between arms [3 months]: Acceptability will be assessed by discontinuation of study product

Secondary outcomes

• Adherence to study product [3 months]: Concentrations of TFV-DP and FTC-TP in dried blood spots (DBS)

Other outcomes

• Psychometric scales predictive validity of adherence to study product [3 and 6 months]: Participant classifications based on correlations between screening scales and DBS drug concentrations

Sex: Female, ages: 15 Years to 24 Years, accepts healthy volunteers

Inclusion Criteria:

1. Female, age 15 to 24 years (inclusive)
2. Literate, per local standards, to English and/or local language
3. 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.
4. Willing to give voluntary informed consent and sign an informed consent form
5. Sexually active or considered at risk of acquiring HIV
6. Willing and able to comply with protocol requirements, including swallowing tablets
7. Total body weight >35 kg
8. eGFR or Creatinine Clearance of >60 mL/min according to the Cockcroft-Gault formula
9. Has not used oral PrEP ever (PrEP naïve) or in the past 6 months
10. If pregnant, must be considered a healthy, singleton pregnancy, considered low risk by local standard of obstetric practices

Exclusion Criteria:

1. Positive test for HIV or HBsAg
2. Signs or symptoms of acute HIV infection
3. Use of ARV PrEP within the past 180 days
4. History of sensitivity or allergy to any component of the study drug products
5. Systemic use in the last two (2) weeks or anticipated use during the course of the study of any restricted products
6. Known current drug or alcohol abuse which could impact study compliance
7. 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
8. 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
9. 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
10. History of pathological bone fracture
11. Pregnant <33 weeks gestation; breastfeeding with infant >6 months old
12. Has a sexual partner confirmed to be HIV positive per participant report

• Gustavo Doncel, MD,PhD, Study director, CONRAD/EVMS
• Homaira Hanif, PhD, Principal investigator, CONRAD/EVMS