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Not yet recruiting NCT07288190

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

Phase II Interventional Pregnancy HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DPP, 2PR, Free Choice.
Who it may be relevant to
Registry conditions: Pregnancy, HIV Infections. Basic parameters: 16 years — 39 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Eswatini, Uganda, Zimbabwe
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multisite, Open-label, Randomized Crossover Study Comparing Adherence to a Single Daily Dual Prevention Pill (DPP) Versus FTC/TDF and Combined Oral Contraception Separate Pill Dosing (2PR), Given for Pre-exposure Prophylaxis and Pregnancy Prevention in Women

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.

Detailed description

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.

Interventions

  • Drug DPP
    Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
  • Drug 2PR
    Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
  • Drug Free Choice
    Choice of either DPP or 2PR

Primary outcome measures

  • PrEP adherence to DPP during randomized crossover period 1 [Time frame: Week 12]
  • PrEP adherence to 2PR during randomized crossover period 1 [Time frame: Week 12]
  • PrEP adherence to DPP during randomized crossover period 2 [Time frame: Week 24]
  • PrEP adherence to 2PR during randomized crossover period 2 [Time frame: Week 24]
Secondary outcome measures (12)
  • PrEP adherence to DPP during Choice period [Time frame: Week 48]
  • PrEP adherence to 2PR during Choice period [Time frame: Week 48]
  • PrEP adherence to DPP during Choice period [Time frame: Week 48]
  • PrEP adherence to 2PR during Choice period [Time frame: Week 48]
  • Acceptability of DPP during crossover period [Time frame: Week 24]
  • Acceptability of 2PR during crossover period [Time frame: Week 24]
  • Acceptability of DPP during Choice period [Time frame: Week 48]
  • Acceptability of 2PR during Choice period [Time frame: Week 48]
  • Preference for DPP [Time frame: Day 0]
  • Preference for DPP [Time frame: Week 24]
  • Preference for 2PR [Time frame: Day 0]
  • Preference for 2PR [Time frame: Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Eswatini · 1 center
  • Eswatini Prevention Center CRS — Mbabane
Uganda · 1 center
  • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS — Kampala
Zimbabwe · 1 center
  • Spilhaus CRS — Harare

Identifiers

NCT: NCT07288190 · HPTN 104 · UM1AI068619

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗