N/A N=348 Monitoring Pre-exposure Prophylaxis for Young Adult Women
HIV/AIDS · Adherence
Primary: Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months — 40.2; 36.8; 27.0; 26.6 percentage of adherence
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=100 Point-of-care Urine Monitoring of Adherence: Testing a Real-Time Urine Assay of Tenofovir in PrEP
Risk Reduction
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
Early Phase 1 N=14 Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor
HIV/AIDS · Adherence, Medication · Drug Use
Primary: Baseline TFV (Tenofovir) Levels in Plasma
Phase 3 N=30 Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
HIV Infections · Substance Use Disorders
Primary: Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire — 14; 14 Participants
N/A N=63 PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men
Risk Reduction
Primary: Number of Participants Indicating the Intervention Was Acceptable — 37 Participants
N/A N=130 Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
HIV/AIDS · Medication Adherence
Primary: Adherence Measured by Sensor by Percentage of Prescribed Medications Taken — 87.5 percentage of prescribed medication
Phase 4 N=16 Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
HIV/AIDS · Substance Use Disorders · Adherence, Medication
Primary: Feasibility of Digital Pills to Measure PrEP Adherence — 411; 368; 320 Expected ingestions per pill counts
Phase 4 N=43 Biomarkers for Event-driven PrEP Adherence
Human Immunodeficiency Virus
Primary: Tenofovir-diphosphate (TFV-DP) Concentration — 217; 1041; 578; 789 femtomoles
Phase 2 N=52 Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
PrEP Adherence Monitoring
Primary: Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada — 530; 997; 1605 fmol/punch
Phase 4 N=136 Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women
HIV Prevention
Primary: Adherence to PrEP — 22; 11; 30; 54 Participants
N/A N=108 Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
Hiv
Primary: Wilson Self-reported Medication Adherence Scale — 77.48; 71.59 score on a scale
N/A N=217 Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
Pre-exposure Prophylaxis
Primary: Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up — 17; 7 Participants
N/A N=25 Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation
Healthy Volunteers · Pharmacokinetics
Primary: Peak Plasma Concentration (Cmax) — 222; 229; 1567; 1684 ng/mL
N/A N=106 Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP
HIV-1-infection
Primary: Recent PrEP Adherence — 33; 18 Participants — p=<0.001
Phase 4 N=100 DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
Adherence, Medication · Risk Behavior · Pre-Exposure Prophylaxis
Primary: Effect of DOT Diary App on PrEP Adherence — 39; 19 Participants — p=0.94
Phase 4 N=20 DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
Adherence, Medication · Risk Behavior · Pre-Exposure Prophylaxis
Primary: DOT Diary Mobile App Acceptability — 79.8 Score on scale
N/A N=131 Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India
HIV · Medication Adherence
Primary: Tel-me-box Adherence — 10; 16.5; 1.5; 7 days (out of 30)
N/A N=786 Kenya HIV Self-Testing in PrEP Delivery
HIV-1-infection
Primary: Number of Participants With Adherence to PrEP at 6 Months — 95; 106; 94 Participants
N/A N=60 mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
Adherence, Patient · Pre-Exposure Prophylaxis · HIV/AIDS
Primary: Intervention Feasibility: Average Number of Days of Any App Use — 68 days
N/A N=318 Pre-exposure Prophylaxis (PrEP) at Home
HIV/AIDS
Primary: Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up — 78; 39 Participants
Phase 4 N=240 Parrying the Pitfalls of PrEP: Project PEACH
HIV · STI
Primary: Number of Men Who Discontinue Daily Oral PrEP — 18 Participants
N/A N=360 The PrEP (Pre-exposure Prophylaxis) SMART Study
HIV/AIDS
Primary: PrEP Adherence — 34; 32 Participants
Phase 4 N=427 Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
HIV
Primary: Number of Participants With High Adherence at Six Months — 36; 40 Participants
N/A N=82 A Multilevel Gaming Intervention for Persons on PrEP
MSM · PrEP · HIV Risk
Primary: Self-Report of PrEP Adherence — 22; 26; 9; 8 Participants
N/A N=60 Care4Today v2.0 Application for Improving Adherence to HIV Medications
HIV · AIDS
Primary: Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings — 9; 5 Participants — p=0.32
N/A N=40 Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications
Adherence
Primary: Use of Portal724-MEMS Service on Medication Adherence in the Treatment of Hepatitis C in Patients, Defined as Compliance to Regimen 95% of the Time. — 19; 18…
Phase 4 N=212 Alignment of PrEP Use With HIV Risk in Young Women and Men
Pre-Exposure Prophylaxis · Sexually Transmitted Diseases, Bacterial · HIV Infections
Primary: Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms — 211 Visits
N/A N=80 PrEP iT! Mobile App Intervention
Treatment Adherence and Compliance
Primary: High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels — 13; 15 Participants
N/A N=63 HIV Adherence Bottle Intervention Trial
HIV-1-infection · Adherence, Medication
Primary: Change in Tenofovir Diphosphate (TFV-DP) Drug Levels — 1230; 1108; 1887; 1084 fmol/punch — p=0.070
N/A N=73 Game Plan for PrEP
Human Immunodeficiency Virus Exposure · Alcohol; Harmful Use
Primary: Pre-exposure Prophylaxis (PrEP) Lapse Days — 3; 3 Participants