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)

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 Overview

• Status: Active, not recruiting
• Conditions: Adherence, Medication; Acceptability of Health Care
• Intervention / Treatment: Drug: emtricitabine/tenofovir alafenamide; Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Homaira Hanif, PhD; Phone Number: 7574465600; Email: hhanif@conrad.org
• Study Contact Backup: Name: Karen Dominguez, MPH; Phone Number: 7574465994; Email: domingk@evms.edu

Study Locations

• South Africa
  • KZN
    • Durban, KZN, South Africa
      • MatCH Research Unit
    • Pietermaritzburg, KZN, South Africa, 3201
      • CAPRISA Vulindlela
• Zimbabwe
  • Harare, Zimbabwe
    • Harare Health and Research Consortium (HHRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: F/TAF; daily oral tablet	Drug: emtricitabine/tenofovir alafenamide; 200mg/25mg tablet, once daily dosing for 24 weeks; Other Names: Descovy
Active Comparator: F/TDF; daily oral tablet	Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; 200mg/300mg tablet, once daily dosing for 24 weeks; Other Names: Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the discontinuation rate between arms	Acceptability will be assessed by discontinuation of study product	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to study product	Concentrations of TFV-DP and FTC-TP in dried blood spots (DBS)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychometric scales predictive validity of adherence to study product	Participant classifications based on correlations between screening scales and DBS drug concentrations	3 and 6 months

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Collaborators: Gilead Sciences; United States Agency for International Development (USAID); FHI 360; CONRAD
• Investigators: Study Director: Gustavo Doncel, MD,PhD, CONRAD/EVMS; Principal Investigator: Homaira Hanif, PhD, CONRAD/EVMS

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): December 13, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HIV; PrEP
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: CONRAD B20-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes