Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04151498 |
| Other study ID # |
19-0664 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2020 |
| Est. completion date |
April 28, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The North Carolina Bridge Counselor system is designed to help link out of care HIV positive
patients back into HIV care. It has improved initial linkages and patient re-engagement
overall, but for a sizable group of patients, the current system has not been effective,
leaving a population of hard-to-reach, lost-to-care patients who remain out of care. There is
limited understanding of the lived experiences of patients who fall out of HIV care and
become recalcitrant to re-engagement because they are difficult to reach and therefore
underrepresented in research. Out of care HIV+ patients who have not reengaged in care
following the standard of care who chose to enroll in the study will participate in 2
semi-structured interviews and receive a field-based HIV re-engagement and treatment
intervention (Project RAMP). Project RAMP will consist of up to 4 visits from an outreach
research nurse designed to serve as an "on-ramp" to HIV care. At these visits, the outreach
number will counsel on HIV care and treatment and obtain a medical history and labs. Results
will be communicated to the participant's clinic provider in an effort to both encourage the
patient to return to care and facilitate more rapid antiretroviral therapy (ART) initiation
by the clinic provider. The research team will also provide the participant in-person
assistance with scheduling a clinic visit. Clinic providers may re-initiate ART prior to the
reengagement clinic visit, with adherence support provided by the outreach nurse.
Description:
The overall purpose of the Project RAMP intervention is to find out what challenges make it
hard for people living with HIV to keep their in-person clinic appointments. The
investigators also hope to learn how much a mobile HIV treatment van may help patients who
have been out of care for a minimum of 6 months, to re-start keeping regular clinic visits.
The investigators also hope this information will help be useful in learning best practices
for providing health care to people living with HIV.
This study will recruit a total of 30 participants, 20 for the intervention and 10 for the
usual care group. Participants will be recruited through bridge counselors at the partnering
clinic, whose roles and responsibilities consist of finding and reaching out to patients who
have been out of HIV care in an attempt to get them reengaged.
Participants will have up to 5 study visits that are between 1- 4 weeks apart. Each visit
will last about 1 to 1.5 hours. Participants will also be asked to participate in two in
depth interview: a baseline interview at the start of the study that will ask questions about
each participant's experience with their past clinic visits and an exit interview at the end
of the study regarding their experience participating in the HIV mobile treatment program
(Project RAMP). The pre-intervention visit (Visit 0) includes the first interview, providing
some brief information about you, a urine pregnancy test for participants who are female, and
a brief meeting with a financial technician who will help participants complete their
insurance information. Intervention Visit 1 will include a nurse from the partnering clinic
administering the video educational intervention, HIV medication adherence counseling, a
health history form, blood draws for standard reengagement labs (CD4 count, HIV viral load,
comprehensive metabolic panel, complete blood count with differential, rapid plasma reagin
and HIV genotype). Specimens from these visits will be delivered to partnering clinic for
analysis. Notes from the mobile visit will be shared with the study PI, who will in term
communicate these notes with the assigned clinic provider of each participant. Visits 2-4
will include a study nurse conducting additional blood draws if recommended by their assigned
provider, and a review of adherence counseling and health history forms.
At the end of each intervention visit, participants will be if they would like to make an in
person clinic appointment. Those who decline at the end of intervention Visits 1-3 will be
offered an additional field visit appointment. Those who decline an in person clinic
appointment at the end of Visit 4 will move on to completing the exit interview in person at
this time and will complete the study following the exit interview. Participants who schedule
a clinic appointment will have their exit interview in person or via phone within 3 months of
their clinic visit. All participants will be follow up to 6 months after their last study
visit to to access their viral load, if this information is available.
