Health Trials

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

ConditionsPregnancyHIV Infections
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age16-39
SponsorHIV Prevention Trials Network

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • DPP

    Drug

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

  • 2PR

    Drug

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

  • Free Choice

    Drug

    Choice of either DPP or 2PR

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: DPP/2PR/ChoiceExperimental treatment 3 interventions
Group B: 2PR/DPP/ChoiceExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

PrEP adherence to DPP during randomized crossover period 1

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

Time frame
Week 12
2

PrEP adherence to 2PR during randomized crossover period 1

Intraerythrocytic TFV-DP concentrations in DBS

Time frame
Week 12
3

PrEP adherence to DPP during randomized crossover period 2

Intraerythrocytic TFV-DP concentrations in DBS

Time frame
Week 24
4

PrEP adherence to 2PR during randomized crossover period 2

Intraerythrocytic TFV-DP concentrations in DBS

Time frame
Week 24

Secondary outcomes

1

PrEP adherence to DPP during Choice period

TFV-DP concentrations in DBS

Time frame
Week 48
2

PrEP adherence to 2PR during Choice period

TFV-DP concentrations in DBS

Time frame
Week 48
3

PrEP adherence to DPP during Choice period

Self-reported adherence

Time frame
Week 48
4

PrEP adherence to 2PR during Choice period

Self-reported adherence

Time frame
Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HIV Prevention Trials Network

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: