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PregnancyPhase 2NCT07288190

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

A Phase 2 study testing DPP, 2PR and Free Choice in people with Pregnancy and HIV Infections, run by HIV Prevention Trials Network at 3 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, HIV Infections
What is being tested?
DPP, 2PR and Free Choice
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesin 3 countries
Study dates
15 May 2026to 15 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Scott Rose contact

919-321-3530

srose@fhi360.org

Michelle Robinson contact

919-321-3585

mrobinson@fhi360.org

3 sites in 3 countries

Eswatini1 site

  • Eswatini Prevention Center CRS

    Mbabane

    Harriet Nuwagaba-Biribonwoha, MD, PhD, 268-76024678, hn2158@cumc.columbia.edu

Other trials in Eswatini

Uganda1 site

  • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

    Kampala

    Clemensia Nakabiito, MD, 256-41-541044, cnakabiito@mujhu.org

Other trials in Uganda

Zimbabwe1 site

  • Spilhaus CRS

    Harare

    Felix Mhlanga, MBChB, MMED, 263-772-335232, fmhlanga@uz-ucsf.co.zw

Other trials in Zimbabwe

About this study

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

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.

Read the 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.

Being tested
DPP, 2PR, Free Choice
Keywords
Pre-exposure Prophylaxis (PrEP), Contraception, Dual Prevention Pill (DPP), Pregnancy Prevention
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT07288190
Study groupRoleWhat they receive
DPP/2PR/ChoiceExperimentalDaily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
Receives: Drug: DPP; Drug: 2PR; Drug: Free Choice
2PR/DPP/ChoiceExperimentalDaily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice
Receives: Drug: DPP; Drug: 2PR; Drug: Free Choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP adherence to DPP during randomized crossover period 1

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

    Measured: Week 12

  2. PrEP adherence to 2PR during randomized crossover period 1

    Intraerythrocytic TFV-DP concentrations in DBS

    Measured: Week 12

  3. PrEP adherence to DPP during randomized crossover period 2

    Intraerythrocytic TFV-DP concentrations in DBS

    Measured: Week 24

  4. PrEP adherence to 2PR during randomized crossover period 2

    Intraerythrocytic TFV-DP concentrations in DBS

    Measured: Week 24

Secondary outcomes (44)

  1. PrEP adherence to DPP during Choice period

    TFV-DP concentrations in DBS

    Measured: Week 48

  2. PrEP adherence to 2PR during Choice period

    TFV-DP concentrations in DBS

    Measured: Week 48

  3. PrEP adherence to DPP during Choice period

    Self-reported adherence

    Measured: Week 48

  4. PrEP adherence to 2PR during Choice period

    Self-reported adherence

    Measured: Week 48

  5. Acceptability of DPP 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.)

    Measured: Week 24

  6. 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.)

    Measured: Week 24

  7. 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.)

    Measured: Week 48

  8. 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.)

    Measured: Week 48

  9. Preference for DPP

    Preference of DPP at enrollment

    Measured: Day 0

  10. Preference for DPP

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

    Measured: Week 24

  11. Preference for 2PR

    Preference of 2PR at enrollment

    Measured: Day 0

  12. Preference for 2PR

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

    Measured: Week 24

  13. PrEP persistence on DPP during the Choice period

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

    Measured: Week 48

  14. PrEP persistence on 2PR during the Choice period

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

    Measured: Week 48

  15. Overall tolerability of DPP

    Tolerability

    Measured: Week 48

  16. Overall tolerability of 2PR

    Tolerability

    Measured: Week 48

  17. Tolerability of DPP during the crossover period

    Tolerability

    Measured: Week 24

  18. Tolerability of 2PR during the crossover period

    Tolerability

    Measured: Week 24

  19. Tolerability of DPP during the Choice period

    Tolerability

    Measured: Week 48

  20. Tolerability of 2PR during the Choice period

    Tolerability

    Measured: Week 48

  21. Overall side effects of DPP

    Grade 2+ Adverse Events (AE)

    Measured: Week 48

  22. Overall side effects of 2PR

    Grade 2+ AE

    Measured: Week 48

  23. Side effects of DPP during the crossover period

    Grade 2+ AE

    Measured: Week 24

  24. Side effects of 2PR during the crossover period

    Grade 2+ AE

    Measured: Week 24

  25. Side effects of DPP during the Choice period

    Grade 2+ AE

    Measured: Week 48

  26. Side effects of 2PR during the Choice period

    Grade 2+ AE

    Measured: Week 48

  27. Overall unintended IPV of DPP

    Intimate Partner Violence (IPV)

    Measured: Week 48

  28. Overall unintended IPV of 2PR

    IPV

    Measured: Week48

  29. Unintended IPV of DPP during the crossover period

    IPV

    Measured: Week 24

  30. Unintended IPV of 2PR during the crossover period

    IPV

    Measured: Week 24

  31. Unintended IPV of DPP during the Choice period

    IPV

    Measured: Week 48

  32. Unintended IPV of 2PR during the Choice period

    IPV

    Measured: Week 48

  33. Overall unintended pregnancy of DPP

    Pregnancy

    Measured: Week 48

  34. Overall unintended pregnancy of 2PR

    Pregnancy

    Measured: Week 48

  35. Unintended pregnancy of DPP during the crossover period

    Pregnancy

    Measured: Week 24

  36. Unintended pregnancy of 2PR during the crossover period

    Pregnancy

    Measured: Week 24

  37. Compare unintended pregnancy of DPP during the Choice period

    Pregnancy

    Measured: Week 48

  38. Compare unintended pregnancy of 2PR during the Choice period

    Pregnancy

    Measured: Week 48

  39. Overall unintended HIV incidence of DPP

    HIV incidence

    Measured: Week 48

  40. Overall unintended HIV incidence of 2PR

    HIV incidence

    Measured: Week 48

  41. Unintended HIV incidence of DPP during the crossover period

    HIV incidence

    Measured: Week 24

  42. Unintended HIV incidence of 2PR during the crossover period

    HIV incidence

    Measured: Week 24

  43. Unintended HIV incidence of DPP during the Choice period

    HIV incidence

    Measured: Week 48

  44. Unintended HIV incidence of 2PR during the Choice period

    HIV incidence

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start15 May 2026 (estimated)
  3. Primary completion15 May 2028 (estimated)
  4. Study completion15 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Phase 2b, open label, multisite, randomized crossover study of DPP versus 2PR
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288190
Sponsor's protocol ID
HPTN 104
Other IDs
UM1AI068619
Status last verified
Feb 2026
First submitted
18 Feb 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For studies within two years of primary objective(s) publication, de-identified individual participant data that underlie results in a publication will be provided upon request. For studies more than two years from the primary objective(s) publication, de-identified datasets will be available upon request (Public Use Datasets).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DPP, 2PR and Free Choice in people with Pregnancy and HIV Infections, run by HIV Prevention Trials Network at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Eswatini, Uganda, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Scott Rose (919-321-3530, srose@fhi360.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP adherence to DPP during randomized crossover period 1 (time frame: Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07288190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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Clinical Trial NCT07288190 | AzTrials