A Phase 2 interventional study of DPP and 2PR in Pregnancy and HIV Infections, sponsored by HIV Prevention Trials Network. Not yet recruiting at 3 sites in 3 countries. Open to female participants aged 16 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by HIV Prevention Trials Network · Phase 2, Interventional, and Prevention
Among 13 studies in HIV Infections by HIV Prevention Trials Network — 3 open to participants now, 3 under way, 1 of them phase 3. HIV Infections · HIV Prevention Trials Network.
Among the 13 studies in HIV Infections by HIV Prevention Trials Network, this one is the 8th largest by planned enrollment of the 11 interventional ones, is one of 2 that started in 2026, is one of 2 in phase 2, and was the 13th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →3 of the 13 studies in HIV Infections by HIV Prevention Trials Network are open now, in 7 countries. Each count lists the studies.
Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 16 Years to 39 Years · female · healthy volunteers too.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2026.
Median enrollment 447 across the 11 interventional studies, 1,585 across the 2 observational. Of the 10 that completed or were terminated, 3 (30%) have results posted.
HIV Prevention Trials Network is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in HIV Infections by HIV Prevention Trials Network, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
Drug: DPP · Drug: 2PR · Drug: Free Choice
Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice
Drug: DPP · Drug: 2PR · Drug: Free Choice
Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
Choice of either DPP or 2PR
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
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
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 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
Plan to share: 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).
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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