HIV Infections, Pregnancy
Conditions
Keywords
Pre-exposure Prophylaxis (PrEP), Contraception, Dual Prevention Pill (DPP), Pregnancy Prevention
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.
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
DRUGDPP
Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
DRUG2PR
Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
DRUGFree Choice
Choice of either DPP or 2PR
Sponsors
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Phase 2b, open label, multisite, randomized crossover study of DPP versus 2PR
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP adherence to DPP during randomized crossover period 2 | Week 24 | Intraerythrocytic TFV-DP concentrations in DBS |
| PrEP adherence to 2PR during randomized crossover period 2 | Week 24 | Intraerythrocytic TFV-DP concentrations in DBS |
| PrEP adherence to DPP during randomized crossover period 1 | Week 12 | Intraerythrocytic Tenofovir Diphosphate (TFV-DP) concentrations in dried blood spot (DBS) |
| PrEP adherence to 2PR during randomized crossover period 1 | Week 12 | Intraerythrocytic TFV-DP concentrations in DBS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unintended IPV of 2PR during the Choice period | Week 48 | IPV |
| Overall unintended pregnancy of DPP | Week 48 | Pregnancy |
| Overall unintended pregnancy of 2PR | Week 48 | Pregnancy |
| Unintended pregnancy of DPP during the crossover period | Week 24 | Pregnancy |
| Unintended pregnancy of 2PR during the crossover period | Week 24 | Pregnancy |
| Compare unintended pregnancy of DPP during the Choice period | Week 48 | Pregnancy |
| Compare unintended pregnancy of 2PR during the Choice period | Week 48 | Pregnancy |
| Overall unintended HIV incidence of DPP | Week 48 | HIV incidence |
| Overall unintended HIV incidence of 2PR | Week 48 | HIV incidence |
| Unintended HIV incidence of DPP during the crossover period | Week 24 | HIV incidence |
| Unintended HIV incidence of 2PR during the crossover period | Week 24 | HIV incidence |
| Unintended HIV incidence of DPP during the Choice period | Week 48 | HIV incidence |
| Unintended HIV incidence of 2PR during the Choice period | Week 48 | HIV incidence |
| Side effects of DPP during the crossover period | Week 24 | Grade 2+ AE |
| Side effects of 2PR during the crossover period | Week 24 | Grade 2+ AE |
| Side effects of DPP during the Choice period | Week 48 | Grade 2+ AE |
| Side effects of 2PR during the Choice period | Week 48 | Grade 2+ AE |
| Overall unintended IPV of DPP | Week 48 | Intimate Partner Violence (IPV) |
| PrEP adherence to DPP during Choice period | Week 48 | TFV-DP concentrations in DBS |
| PrEP adherence to 2PR during Choice period | Week 48 | TFV-DP concentrations in DBS |
| Acceptability of DPP during crossover period | Week 24 | Answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.) |
| Acceptability of 2PR during crossover period | Week 24 | Answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.) |
| Acceptability of DPP during Choice period | Week 48 | Answers to acceptability questionnaire based on overall acceptability measure as well as a range of acceptability dimensions (e.g., product size, color, dosing, etc.) |
| Acceptability of 2PR during Choice period | Week 48 | 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.) |
| Preference for DPP | Day 0 | Preference of DPP at enrollment |
| Preference for 2PR | Day 0 | Preference of 2PR at enrollment |
| PrEP persistence on DPP during the Choice period | Week 48 | Proportion of participants still using their chosen regimen at end of the Choice period |
| PrEP persistence on 2PR during the Choice period | Week 48 | Proportion of participants still using their chosen regimen at end of the Choice period |
| Overall tolerability of DPP | Week 48 | Tolerability |
| Overall tolerability of 2PR | Week 48 | Tolerability |
| Tolerability of DPP during the crossover period | Week 24 | Tolerability |
| Tolerability of 2PR during the crossover period | Week 24 | Tolerability |
| Tolerability of DPP during the Choice period | Week 48 | Tolerability |
| Tolerability of 2PR during the Choice period | Week 48 | Tolerability |
| Overall side effects of DPP | Week 48 | Grade 2+ Adverse Events (AE) |
| Overall unintended IPV of 2PR | Week48 | IPV |
| Overall side effects of 2PR | Week 48 | Grade 2+ AE |
| Unintended IPV of DPP during the crossover period | Week 24 | IPV |
| Unintended IPV of 2PR during the crossover period | Week 24 | IPV |
| Unintended IPV of DPP during the Choice period | Week 48 | IPV |
Countries
Eswatini, Uganda, Zimbabwe
Contacts
CONTACTScott Rose
CONTACTMichelle Robinson
STUDY_CHAIRLisa Haddad, MD
Population Council
STUDY_CHAIRHarriet Nuwagaba-Biribonwoha, MD
ICAP at Columbia University
Outcome results
None listed