An interventional study of PrEP Care Anywhere Services in Adherence, Patient, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to male participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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Among 240 studies in Patient Compliance with a site in United States — 9 open to participants now, 19 under way, 1 of them phase 3. Patient Compliance · United States.
Among the 240 studies in Patient Compliance with a site in United States, this one is the 173rd largest by enrollment of the 201 interventional ones that give a count, is one of 13 that started in 2018, is one of 160 with no phase, and was the 178th registered.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
Browse Patient Compliance studies →9 of the 240 studies in Patient Compliance with a site in United States are open now. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 18+ · Healthy volunteers
VA Office of Research and Development · Sites in United States
Ages 18–90
HiDO Technologies · Sites in United States
Ages 65+
University of California, San Francisco · Sites in United States
Ages 60+
University of Georgia · Sites in United States
Ages 18–26 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 99 Years · male · healthy volunteers too.
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240 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 14 · Phase 3 12 · Phase 4 10
First in 1993; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 116 across 527 interventional studies indexed under Patient Compliance.
Median enrollment 119 across the 201 interventional studies, 92 across the 37 observational. Of the 203 that completed or were terminated, 64 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 240 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,816 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 8 studies filed under Patient Compliance — fewer than ten, so there is no comparison to draw.
6 of the studies in Patient Compliance with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07520786University of GeorgiaChanges in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women | 2026-11 |
| NCT04238949Children's Hospital of PhiladelphiaCommunity Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes | 2027-01 |
| NCT05448560Georgetown UniversityA Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship | 2027-02-28 |
| NCT05157113University of California, San FranciscoEvaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population | 2027-06-01 |
| NCT06591182BayCare Health SystemEffects of Social Determinants of Health on IV Iron Treatments | 2027-07 |
Add all 6 to your calendar (.ics) → With an account.
Among the 240 studies in Patient Compliance with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This research is being done to learn more about the differences in engaging, recruiting, linking and adhering to pre-exposure prophylaxis (PrEP) services for men who have sex with other men at risk for HIV in Baltimore City.
In 2012, the U.S. Food and Drug Administration (FDA) approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. In the intervention, a virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be compared to standard clinic-based PrEP services with face-to-face peer navigation. The study will evaluate whether PrEP Care Anywhere, which is more patient-centered, will improve adherence and retention in PrEP care.
According to the Centers for Disease Control and Prevention (CDC), the estimated lifetime risk for HIV is 1 in 2 for Black men who have sex with men (MSM) and 1 in 4 for Latino MSM. In 2012, the U.S. Food and Drug Administration approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. However, PrEP uptake and adherence among MSM of color in particular remains low. Part of the challenge of increasing PrEP uptake and adherence among MSM of color is related to a historical lack of ethnic and sexual minority engagement in health care systems, perceptions of racism and negativity, and inequities in treatment.
In order to engage, recruit, link, and retain MSM at substantial risk of HIV infection, this study proposes a randomized controlled pilot trial among 100 HIV-negative MSM of color (50 per arm) in Baltimore City to determine differences in engagement, retention and adherence to Truvada along with PrEP services. In the intervention, a virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be compared to standard clinic-based PrEP services with face-to-face peer navigation. The study will evaluate whether PrEP Care Anywhere, as a more client-centered approach, will improve adherence and retention.
The specific aims of the Randomized Controlled Trial (RCT) pilot are:
Secondary Objectives
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The PrEP Care Anywhere intervention adapts peer PrEP case management for virtual delivery and provides clinical services through a tele-health program, delivered by the same clinic providers. After an initial face-to-face intake clinical evaluation within the clinic, will then receive the remaining PrEP clinical evaluations via telemedicine using the HIPPA compliant polycom platform. Case management interventions will be conducted virtually via the PrEPme application, telephone consultation, text, or email.
Other: PrEP Care Anywhere Services
PrEP Virtual Clinic Visits. PrEP clinical care will follow guidelines as established by the CDC for PrEP clinical evaluation and follow-up. Appointments will be set up in the same process as any practice visit and require the same clinical documentation and billing requirements, but will have a separate clinic designation for the visit type. At any time during the study, a patient can request a face-to-face visit with the provider. The provider may also request a face-to-face visit based on patient presentation and/or laboratory results. The typical visit options will include: * On demand peer interim visits- participants can text, chat (via PrEPme app) or call to access an on demand virtual support visit with a peer Case Manager (CM). * HIV and Sexually Transmitted Infection (STI) at Home Self-Testing
PrEP Uptake
Primary outcome 1 will examine PrEP uptake at Month 1, among those not already taking PrEP at baseline, defined as Tenofovir (TFV) levels of 35.5 ng/mL or greater, using students T-test
Time frame: 1 month
PrEP Adherence
Adherence at Month 12, defined as persistent TFV levels of 35.5 ng/mL between the arms will be evaluated by Cox Proportional Hazard models
Time frame: 12 months
PrEP Retention
Retention will be tested at 3, 6 and 9 months using chi-square test to compare retention between the two arms
Time frame: Month 3, 6 and 9 months
Plan to share: No
Ran from Jul 2018 to primary completion in Dec 2021, 41 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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