Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
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
2 other identifiers
interventional
300
3 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pregnancy
Started May 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
December 17, 2025
CompletedStudy Start
First participant enrolled
May 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2028
Study Completion
Last participant's last visit for all outcomes
May 15, 2028
February 19, 2026
February 1, 2026
2 years
February 18, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
PrEP adherence to DPP during randomized crossover period 1
Intraerythrocytic Tenofovir Diphosphate (TFV-DP) concentrations in dried blood spot (DBS)
Week 12
PrEP adherence to 2PR during randomized crossover period 1
Intraerythrocytic TFV-DP concentrations in DBS
Week 12
PrEP adherence to DPP during randomized crossover period 2
Intraerythrocytic TFV-DP concentrations in DBS
Week 24
PrEP adherence to 2PR during randomized crossover period 2
Intraerythrocytic TFV-DP concentrations in DBS
Week 24
Secondary Outcomes (44)
PrEP adherence to DPP during Choice period
Week 48
PrEP adherence to 2PR during Choice period
Week 48
PrEP adherence to DPP during Choice period
Week 48
PrEP adherence to 2PR during Choice period
Week 48
Acceptability of DPP during crossover period
Week 24
- +39 more secondary outcomes
Study Arms (2)
DPP/2PR/Choice
EXPERIMENTALDaily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
2PR/DPP/Choice
EXPERIMENTALDaily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Eswatini Prevention Center CRS
Mbabane, Eswatini
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda
Spilhaus CRS
Harare, Zimbabwe
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lisa Haddad, MD
Population Council
- STUDY CHAIR
Harriet Nuwagaba-Biribonwoha, MD
ICAP at Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2025
First Posted
December 17, 2025
Study Start (Estimated)
May 15, 2026
Primary Completion (Estimated)
May 15, 2028
Study Completion (Estimated)
May 15, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Investigators may request de-identified datasets in order to duplicate published results, as required by specific journals. Otherwise, de-identified datasets will be made available upon request, two years following publication of the primary results manuscript.
- Access Criteria
- Researchers aiming to duplicate published results or who provide a methodologically sound proposal for use of the data may submit a request for access to data that has informed published results by sending an email to HPTN-Data-Access@scharp.org. To access available de-identified datasets, investigators must complete the request form on the Atlas website. Researchers of approved requests will need to sign an HIV Prevention Trials Network (HPTN) Data Use Agreement before receiving the data and agree to use the provided acknowledgement statement.
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).