HIV Infections Clinical Trial
— PCORI PrEPOfficial title:
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
NCT number | NCT04855773 |
Other study ID # | 20-32976 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 21, 2021 |
Est. completion date | August 2023 |
Verified date | September 2022 |
Source | Public Health Foundation Enterprises, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic. PrEP is the use of a daily anti-HIV medications by HIV-negative people to help prevent HIV infection.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | August 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - Self-identifies as a cisgender man, transgender man (assigned female at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum) - Report sex with a cisgender man or transgender woman or any individual assigned male sex at birth in the past 12 months - Age 15 years or older - Willing and able to provide written informed consent - Owns an iOS or Android mobile phone and able to access the internet and send and receive text messages - Able to understand, read, and speak English or Spanish - Newly initiated PrEP or currently on PrEP and at risk for PrEP discontinuation based on at least one of the following: - Initiated PrEP within the past 6 months, or - Has any of the following risk factors for PrEP discontinuation: missed clinic visits; age < 30; African-American or Latino; transgender gender identity; or self-reported illicit substance use Exclusion Criteria: - Currently enrolled in another PrEP intervention study - Unable to complete 12 month study participation - Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
United States | Bridge HIV, San Francisco Department of Public Health | San Francisco | California |
United States | San Francisco AIDS Foundation | San Francisco | California |
United States | Whitman-Walker Health | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Public Health Foundation Enterprises, Inc. | Patient-Centered Outcomes Research Institute, San Francisco AIDS Foundation, San Francisco Department of Public Health, University of California, San Francisco, University of Miami, WelTel, Whitman-Walker Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots | PrEP adherence will be measured by tenofovir diphosphate (TFV-DP) levels in dried blood spots (DBS). Adequate adherence will be defined as having a TFV-DP = 700 femtomoles/punch in DBS for daily PrEP users, which has been associated with high levels of protection in prior PrEP trials. | DBS measured through 12 months | |
Primary | Satisfaction with medical care | Satisfaction with medical care will be measured by the Consumer Assessment of Health Care Processes and Services (CAHPS), a critical tool for evaluating patient satisfaction and patient-centeredness of care | Satisfaction measured through 12 months | |
Primary | Patient engagement | Patient engagement will be measured by the short-version Patient Activation Measure (PAM). | Patient engagement measured through 12 months | |
Secondary | PrEP continuation based on medication refills | PrEP discontinuation will be defined as having a PrEP interruption of =30 days based on medication refill dates using blinded outcome ascertainment of electronic medical and pharmacy refill records. | PrEP continuation measured through 12 months | |
Secondary | Sexual satisfaction | Sexual satisfaction will be measured by the New Sexual Satisfaction Scale Short Version (NSSS-S), a validated 12-item questionnaire in which patients score their sexual satisfaction on five dimensions (sexual sensations, sexual presence/awareness, sexual exchange, emotional connection/closeness, and sexual activity) | Sexual satisfaction measured through 12 months | |
Secondary | Adherence self-efficacy | Patient-reported adherence self-efficacy will be measured by the self-efficacy scale for PrEP use, which has been validated for PrEP use | Adherence self-efficacy measured through 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |