NCT04316715Completed
Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 19 Mar 2020
- Start date
- 3 Sept 2020
- Primary completion date
- 8 Jul 2025
- Lead sponsor
- University of Miami
- Diseases
- HIV
- NCT number
- NCT04316715
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 3 Sept 2020 to the primary completion date, 8 Jul 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
- 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)
Lab values
- Laboratory or clinical findings that would preclude PrEP initiation (e.g. decreased creatinine clearance)
Who the study is looking for
- Age: 18 years or older
- Male sex at birth or trans man (current gender identity is male) assigned female sex at birth
- Self-reports as a person who has sex with men
- PrEP naïve or is currently prescribed PrEP and reports uncertainty about future adherence
- Medical providers at each site will determine that the participant is indicated for PrEP per Centers for Disease Control (CDC) guidelines
- 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
- Owns a cell phone that has texting and internet / data capacity
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fenway Health Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.