Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR

Phase 2Not Yet RecruitingNCT07288190

HIV Prevention Trials Network300 enrolled

Overview

To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.

To evaluate adherence to a single DPP consisting of co-formulated Tenofovir Disoproxil Fumarate and Emtricitabine (FTC/TDF) plus combined ethinyl estradiol/levonorgestrel oral contraceptive (COC), compared with a two-pill regimen (2PR) consisting of daily oral FTC/TDF pill and combined COC pill, for pre-exposure prophylaxis PrEP and pregnancy prevention in women without HIV.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Pregnancy HIV Infections

Interventions

DPPDRUG

Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill

2PRDRUG

Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill

Free ChoiceDRUG

Choice of either DPP or 2PR

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 16 through 39 years old (inclusive) at Screening. * Adults must be able and willing to provide informed consent. Adolescents (16- and 17-year-olds) will be consented according to applicable local guidelines, by obtaining participant assent and where applicable parental or guardian permission. * Able and willing to provide adequate locator information. * Able and willing to comply with all study procedures. * Must be post-menarche and pre-menopausal and could potentially become pregnant. * Sexually active, defined as having had penile-vaginal sex within the 3 months before Screening (per self-report) * Negative pregnancy test at Screening and Enrollment. * Does not intend to become pregnant within the next 12 months. * Willing to use COCs for at least 48 weeks as their method of contraception. * HIV negative at Screening and Enrollment. * Willing to use oral PrEP for at least 48 weeks. * Hepatitis B (HBV) surface antigen (HbsAg) negative per blood test at Screening. * Hepatitis C (HCV) negative at Screening. * Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening. Exclusion Criteria: * Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past. * Unable to become pregnant e.g., had a tubal ligation or hysterectomy or otherwise lacks a uterus, or is currently using another form of contraception. * Medically ineligible for combined hormonal contraception and specifically COCs per World Health Organization (WHO) medical eligibility criteria for contraceptive use or similar local medical eligibility guidelines (e.g., Centers for Disease Control and Prevention eligibility criteria). * Medically ineligible for PrEP based on WHO and/or local guidelines. * Using or planning to use another pregnancy prevention product other than oral contraception (condoms are permitted) during the next 48 weeks. * Using or planning to use another HIV prevention product other than condoms during the next 48 weeks. * Any other condition the clinician feels would jeopardize the health and wellbeing of the participant

Locations (3)

Eswatini Prevention Center CRS

Mbabane, Eswatini

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

Kampala, Uganda

Spilhaus CRS

Harare, Zimbabwe

Outcomes

Primary Outcomes

PrEP adherence to DPP during randomized crossover period 1

Intraerythrocytic Tenofovir Diphosphate (TFV-DP) concentrations in dried blood spot (DBS)

Time frame: Week 12

PrEP adherence to 2PR during randomized crossover period 1

Intraerythrocytic TFV-DP concentrations in DBS

Time frame: Week 12

PrEP adherence to DPP during randomized crossover period 2

Intraerythrocytic TFV-DP concentrations in DBS

Time frame: Week 24

PrEP adherence to 2PR during randomized crossover period 2

Intraerythrocytic TFV-DP concentrations in DBS

Time frame: Week 24

Secondary Outcomes

PrEP adherence to DPP during Choice period

TFV-DP concentrations in DBS

Time frame: Week 48

PrEP adherence to 2PR during Choice period

TFV-DP concentrations in DBS

Time frame: Week 48

PrEP adherence to DPP during Choice period

Self-reported adherence

Time frame: Week 48

PrEP adherence to 2PR during Choice period

Self-reported adherence

Time frame: Week 48

Acceptability of DPP during crossover period

Central Contacts

Scott Rose

CONTACT

919-321-3530 srose@fhi360.org

Michelle Robinson

CONTACT

919-321-3585 mrobinson@fhi360.org

Data from ClinicalTrials.gov

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Answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.)

Acceptability of 2PR during crossover period

Answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.)

Time frame: Week 24

Acceptability of DPP during Choice period

Answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.)

Time frame: Week 48

Acceptability of 2PR during Choice period

Acceptability of 2PR based on answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.)

Time frame: Week 48

Preference for DPP

Preference of DPP at enrollment

Time frame: Day 0

Preference for DPP

Preference of DPP at completion of the crossover phase of the study

Time frame: Week 24

Preference for 2PR

Preference of 2PR at enrollment

Time frame: Day 0

Preference for 2PR

Preference of 2PR at completion of the crossover phase of the study

Time frame: Week 24

PrEP persistence on DPP during the Choice period

Proportion of participants still using their chosen regimen at end of the Choice period

Time frame: Week 48

PrEP persistence on 2PR during the Choice period

Proportion of participants still using their chosen regimen at end of the Choice period

Time frame: Week 48

Overall tolerability of DPP

Tolerability

Time frame: Week 48

Overall tolerability of 2PR

Tolerability

Time frame: Week 48

Tolerability of DPP during the crossover period

Tolerability

Time frame: Week 24

Tolerability of 2PR during the crossover period

Tolerability

Time frame: Week 24

Tolerability of DPP during the Choice period

Tolerability

Time frame: Week 48

Tolerability of 2PR during the Choice period

Tolerability

Time frame: Week 48

Overall side effects of DPP

Grade 2+ Adverse Events (AE)

Time frame: Week 48

Overall side effects of 2PR

Grade 2+ AE

Time frame: Week 48

Side effects of DPP during the crossover period

Grade 2+ AE

Time frame: Week 24

Side effects of 2PR during the crossover period

Grade 2+ AE

Time frame: Week 24

Side effects of DPP during the Choice period

Grade 2+ AE

Time frame: Week 48

Side effects of 2PR during the Choice period

Grade 2+ AE

Time frame: Week 48

Overall unintended IPV of DPP

Intimate Partner Violence (IPV)

Time frame: Week 48

Overall unintended IPV of 2PR

IPV

Time frame: Week48

Unintended IPV of DPP during the crossover period

IPV

Time frame: Week 24

Unintended IPV of 2PR during the crossover period

IPV

Time frame: Week 24

Unintended IPV of DPP during the Choice period

IPV

Time frame: Week 48

Unintended IPV of 2PR during the Choice period

IPV

Time frame: Week 48

Overall unintended pregnancy of DPP

Pregnancy

Time frame: Week 48

Overall unintended pregnancy of 2PR

Pregnancy

Time frame: Week 48

Unintended pregnancy of DPP during the crossover period

Pregnancy

Time frame: Week 24

Unintended pregnancy of 2PR during the crossover period

Pregnancy

Time frame: Week 24

Compare unintended pregnancy of DPP during the Choice period

Pregnancy

Time frame: Week 48

Compare unintended pregnancy of 2PR during the Choice period

Pregnancy

Time frame: Week 48

Overall unintended HIV incidence of DPP

HIV incidence

Time frame: Week 48

Overall unintended HIV incidence of 2PR

HIV incidence

Time frame: Week 48

Unintended HIV incidence of DPP during the crossover period

HIV incidence

Time frame: Week 24

Unintended HIV incidence of 2PR during the crossover period

HIV incidence

Time frame: Week 24

Unintended HIV incidence of DPP during the Choice period

HIV incidence

Time frame: Week 48

Unintended HIV incidence of 2PR during the Choice period

HIV incidence

Time frame: Week 48