HIV PreventionPhase 4e-PrEPNCT05528653
Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"
A Phase 4 study testing Descovy in people with HIV Prevention, run by Vivent Health at 3 sites in United States.
Trial summary
To evaluate if utilizing Telehealth medicine for access to HIV PrEP will engage more Black and Latino Men who have sex with Men (MSM) Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Descovy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jul 2022to 21 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV negative on any FDA approved HIV test within 10 days of starting PrEP 18 years and older
- No medical or mental health comorbidity that would preclude participating in a clinical study as deemed by the study investigator
- Able to understand and sign consent in English or with other language interpreter
- Able to stay in the state catchment area of the license health care provider
- No use of PrEP for more than 30 days in the last year
Who cannot join
- HIV positive
- If greater and equal to 50 years of age and Renal Glomerular Filtration Rate (GFR) <30 mg/g
- <18 years of age
- No access to Internet or devise for telehealth
- Cis-gender Women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vivent Health
Denver, Colorado, 80245
Viventh Health
Milwaukee, Wisconsin, 53203
Vivent Health
St Louis, Missouri, 63103
About this study
To evaluate if utilizing Telehealth medicine for access to HIV PrEP will engage more Black and Latino Men who have sex with Men (MSM)
Read the detailed description
The goal of this study is to determine whether incorporating a telehealth model that allows for same-day appointments for PrEP delivery with the support of navigation leads to increased uptake and persistence of PrEP in young MSM/transgender of color and individuals in rural communities that have disproportionately not used PrEP. The investigators will accomplish this by using an effectiveness-hybrid design that will allow us to both evaluate the interventions impact on relevant clinical outcomes as well as the effectiveness of the implementation strategy. Our hypothesis is that by removing some of the barriers to care such as transportation, childcare, work schedule and potentially stigma with repeated clinic visits, the investigators will increase the uptake and persistence of PrEP amongst communities who historically have had many barriers to care and have not started PrEP.
- Conditions
- HIV Prevention
- Being tested
- Descovy
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DescovyDrug
HIV infection pre-exposure prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Open Label Descovy | Other | Descovy for PrEP Receives: Drug: Descovy |
What is being measured
The primary outcome is the main question the study is designed to answer.
: To increase the number and proportion of individuals who start PrEP who have been under-represented in PrEP uptake including those who identify as Black and/or Latino MSM.
Offer PrEP care via tele-health to reduce obstacles that clients have in coming to clinic.
Measured: 18 months
Secondary outcomes (2)
To increase the number and proportion of individuals who are still taking PrEP and engaged in care at the end of 6 months by 30% and remain HIV negative including those who identify as Black and/or Latino MSM.
Facilitate maintenance of care by offering Tele-health for initial and ongoing PrEP care to reduce social and structural barriers.
Measured: 18 months
To assess the acceptability and implementation of the intervention by both patients and clinic staff.
Obtain quantitative feedback via survey about services provided via Telehealth from patients and clinic staff.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start19 Jul 2022
- Primary completion31 Jul 2024
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivent Health
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Cindy Firnhaber, Vivent Health
- Investigators
- Cindy Firnhaber, MD, Principal investigator, Vivent Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528653
- Sponsor's protocol ID
- IN-US-412-6419
- Acronym
- e-PrEP
- Status last verified
- Sep 2025
- First submitted
- 19 May 2022
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"
- ClinicalTrials.gov ID
- NCT05528653
- Acronym / sponsor ID
- e-PrEP / IN-US-412-6419
- Conditions
- HIV Prevention
- Keywords
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vivent HealthUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate if utilizing Telehealth medicine for access to HIV PrEP will engage more Black and Latino Men who have sex with Men (MSM)
Detailed description
The goal of this study is to determine whether incorporating a telehealth model that allows for same-day appointments for PrEP delivery with the support of navigation leads to increased uptake and persistence of PrEP in young MSM/transgender of color and individuals in rural communities that have disproportionately not used PrEP. The investigators will accomplish this by using an effectiveness-hybrid design that will allow us to both evaluate the interventions impact on relevant clinical outcomes as well as the effectiveness of the implementation strategy. Our hypothesis is that by removing some of the barriers to care such as transportation, childcare, work schedule and potentially stigma with repeated clinic visits, the investigators will increase the uptake and persistence of PrEP amongst communities who historically have had many barriers to care and have not started PrEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Descovy | Other | Drug: DescovyDescovy for PrEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV negative on any FDA approved HIV test within 10 days of starting PrEP 18 years and older
- No medical or mental health comorbidity that would preclude participating in a clinical study as deemed by the study investigator
- Able to understand and sign consent in English or with other language interpreter
- Able to stay in the state catchment area of the license health care provider
- No use of PrEP for more than 30 days in the last year
Key exclusion criteria (5 listed)
- HIV positive
- If greater and equal to 50 years of age and Renal Glomerular Filtration Rate (GFR) <30 mg/g
- <18 years of age
- No access to Internet or devise for telehealth
- Cis-gender Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DescovyHIV infection pre-exposure prophylaxis | Drug | Open Label Descovy |
Primary outcome
: To increase the number and proportion of individuals who start PrEP who have been under-represented in PrEP uptake including those who identify as Black and/or Latino MSM.
Time frame: 18 months
Offer PrEP care via tele-health to reduce obstacles that clients have in coming to clinic.
2 secondary outcomes
To increase the number and proportion of individuals who are still taking PrEP and engaged in care at the end of 6 months by 30% and remain HIV negative including those who identify as Black and/or Latino MSM.
Time frame: 18 months
To assess the acceptability and implementation of the intervention by both patients and clinic staff.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Firnhaber, MD principal investigator
Vivent Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Descovy in people with HIV Prevention, run by Vivent Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: To increase the number and proportion of individuals who start PrEP who have been under-represented in PrEP uptake including those who identify as Black and/or Latino MSM. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.