Clinical Trial Search

Primary: User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means — 3.64; 3.86; 4.35; 3.83 units on a scale

Primary: Number of Colposcopic Findings (Baseline and After One Week of Product Use) — 3; 0; 2; 0 colposcopic findings — p=0.4870

Primary: PrEP Adherence — 12; 4 Participants

Primary: User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means — 3.67; 3.29; 3.86; 3.42 units on a scale

Primary: Number of Participants With High Adherence at Six Months — 36; 40 Participants

Primary: Acceptability of Future Product Use — 143; 132; 143; 56 Participants

Primary: Frequency of Use — 1.14; 1.31; 0.00; 0.00 units on a scale

Primary: Self-reported Adherence to Each Regimen — 94; 93.8; 93.9 percentage of expected doses

Primary: User Perception Scale Scores — 3.31; 3.36; 2.12; 2.62 units on a scale

Primary: Tel-me-box Adherence — 10; 16.5; 1.5; 7 days (out of 30)

Primary: Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir. — 33; 26; 31; 19 Participants

Primary: USPE Scale Scores — 3.73; 3.63; 1.85; 2.02 score on a scale

Primary: Change in PrEP Uptake and Adherence — 0; 1; 2; 3 Participants

Primary: Number of Participants That Successfully Insert Vaginal Film — 8; 8; 22; 22 Participants — p=>.99

Primary: Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session. — 1.7621; 2.4113; 1.9446; 5.5571 (ng/mL)

Primary: Grade 2 or Higher Urogenital System Adverse Event Related to Film Use — 2 Participants

Primary: Feasibility of Digital Pills to Measure PrEP Adherence — 411; 368; 320 Expected ingestions per pill counts

Primary: Tenofovir Diphosphate (TFV-DP) Concentration — 2441; 3472; 406 femtomole/million cells

Primary: Delivery System Success Rate (DSSR) — 66.67; 66.67; 100.00; 100.00 percentage of participants

Primary: Number of Female Participants With Positive PSA at 2-Month Visit — 18; 20 Participants

Primary: Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months — 40.2; 36.8; 27.0; 26.6 percentage of adherence

Primary: Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) — 5.2; 5.7; 5.5; 5.8 Used gel applicators per month

Primary: Adherence Measured by Sensor by Percentage of Prescribed Medications Taken — 87.5 percentage of prescribed medication

Primary: Safety: Grade 2 or Higher Adverse Events — 64; 61; 56 participants — p=0.88

Primary: Acceptability: System Usability Scale — 75.76 score on a scale

Primary: Number of Participants With Grade 2 or Higher Adverse Events — 2; 5 Participants — p=.025

Primary: Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled — 30 Eligible persons screened who enrolled

Primary: Retention in the Cohort — 88; 84; 87 Participants

Primary: Number of Participants With a Grade 2 or Higher Adverse Event by Cohort — 230; 0 Participants

Primary: Baseline TFV (Tenofovir) Levels in Plasma