Adherence, Medication Clinical Trial
Official title:
Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age: 18 years or older 2. Male sex at birth or trans man (current gender identity is male) assigned female sex at birth 3. Self-reports as a person who has sex with men 4. PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence 5. Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines 6. Screens in for currently having one or more of the following psychosocial syndemic problems: depression; heavy alcohol use; problematic substance use or polydrug use; history of trauma or abuse; and/or current interpersonal violence 7. Owns a cell phone that has texting and internet / data capacity Exclusion Criteria: 1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview 2. Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of enrollment (these patients will be referred immediately for treatment, but may join the study when this is resolved) 3. Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance) |
Country | Name | City | State |
---|---|---|---|
United States | Fenway Health | Boston | Massachusetts |
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TFV-DP concentrations | Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing. | 3, 6, 9, 12, 15, and 18 months | |
Primary | Wilson Medication Adherence self-report | Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a total score ranging from 0-40, with a higher score indicating greater adherence. | up to 18 months | |
Secondary | Retention in PrEP care | The percentage of participant attendance at follow up visits over 18 month study participation | 3, 6, 9, 12, 15, and 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04602468 -
Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
|
Phase 4 | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Enrolling by invitation |
NCT04676204 -
Relationship Between Oral DMT Burden and Adherence in MS
|
||
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Completed |
NCT05168449 -
The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients
|
N/A | |
Active, not recruiting |
NCT04612088 -
Intervention for Multivitamin Adherence on Bariatric Patients
|
N/A | |
Completed |
NCT03958331 -
Behavioral Economics and Adherence in Teens (BEAT!)
|
N/A | |
Completed |
NCT05233644 -
Medication Adherence in Heart Failure After Hospitalisation
|
||
Completed |
NCT03837496 -
Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03683966 -
MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study
|
||
Withdrawn |
NCT04754867 -
Pre-Test of For the Future Self and Smoking Cessation
|
N/A | |
Recruiting |
NCT05996094 -
Antiretroviral Adherence and Drug-level Monitoring
|
||
Not yet recruiting |
NCT06056037 -
Making ART Work Among Brazilian Youth
|
N/A | |
Completed |
NCT03658252 -
Efficacy of Targeted Intervention for Topical Steroid Phobia.
|
N/A | |
Completed |
NCT03651596 -
Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
|
N/A | |
Completed |
NCT03842436 -
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
|
Phase 4 | |
Completed |
NCT03081559 -
Improving Engagement in HIV Care for High-risk Women
|
N/A | |
Recruiting |
NCT05515497 -
BMT4me: Post-HSCT Medication Adherence mHealth App
|
N/A | |
Active, not recruiting |
NCT04065347 -
Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)
|