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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- PrEP adherence to DPP during randomized crossover period 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
DPP/2PR/Choice
Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
干预措施: DPP (Drug)
DPP/2PR/Choice
Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
干预措施: 2PR (Drug)
DPP/2PR/Choice
Daily DPP for 12 weeks followed by daily 2PR for 12 weeks followed by 24 weeks of Choice
干预措施: Free Choice (Drug)
2PR/DPP/Choice
Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice
干预措施: DPP (Drug)
2PR/DPP/Choice
Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice
干预措施: 2PR (Drug)
2PR/DPP/Choice
Daily 2PR for 12 weeks followed by daily DPP for 12 weeks followed by 24 weeks of Choice
干预措施: Free Choice (Drug)
结局指标
主要结局
PrEP adherence to DPP during randomized crossover period 1
时间窗: Week 12
Intraerythrocytic Tenofovir Diphosphate (TFV-DP) concentrations in dried blood spot (DBS)
PrEP adherence to 2PR during randomized crossover period 1
时间窗: Week 12
Intraerythrocytic TFV-DP concentrations in DBS
PrEP adherence to DPP during randomized crossover period 2
时间窗: Week 24
Intraerythrocytic TFV-DP concentrations in DBS
PrEP adherence to 2PR during randomized crossover period 2
时间窗: Week 24
Intraerythrocytic TFV-DP concentrations in DBS
次要结局
- Side effects of DPP during the crossover period(Week 24)
- Unintended IPV of 2PR during the crossover period(Week 24)
- Unintended IPV of DPP during the Choice period(Week 48)
- Side effects of 2PR during the crossover period(Week 24)
- Unintended IPV of 2PR during the Choice period(Week 48)
- Unintended IPV of DPP during the crossover period(Week 24)
- Overall side effects of 2PR(Week 48)
- Acceptability of DPP during crossover period(Week 24)
- Acceptability of 2PR during crossover period(Week 24)
- Acceptability of DPP during Choice period(Week 48)
- Acceptability of 2PR during Choice period(Week 48)
- Preference for DPP(Week 24)
- Preference for 2PR(Week 24)
- PrEP persistence on DPP during the Choice period(Week 48)
- PrEP persistence on 2PR during the Choice period(Week 48)
- Overall tolerability of DPP(Week 48)
- Overall tolerability of 2PR(Week 48)
- Tolerability of DPP during the crossover period(Week 24)
- Tolerability of 2PR during the crossover period(Week 24)
- Tolerability of DPP during the Choice period(Week 48)
- Tolerability of 2PR during the Choice period(Week 48)
- Overall side effects of DPP(Week 48)
- Side effects of DPP during the Choice period(Week 48)
- Side effects of 2PR during the Choice period(Week 48)
- Overall unintended IPV of DPP(Week 48)
- Overall unintended IPV of 2PR(Week48)
- Overall unintended pregnancy of DPP(Week 48)
- Overall unintended pregnancy of 2PR(Week 48)
- Unintended pregnancy of DPP during the crossover period(Week 24)
- Unintended pregnancy of 2PR during the crossover period(Week 24)
- Compare unintended pregnancy of DPP during the Choice period(Week 48)
- Compare unintended pregnancy of 2PR during the Choice period(Week 48)
- Overall unintended HIV incidence of DPP(Week 48)
- Overall unintended HIV incidence of 2PR(Week 48)
- Unintended HIV incidence of DPP during the crossover period(Week 24)
- Unintended HIV incidence of 2PR during the crossover period(Week 24)
- Unintended HIV incidence of DPP during the Choice period(Week 48)
- Unintended HIV incidence of 2PR during the Choice period(Week 48)
- PrEP adherence to DPP during Choice period(Week 48)
- PrEP adherence to 2PR during Choice period(Week 48)
- Preference for DPP(Day 0)
- Preference for 2PR(Day 0)