HIV/AIDSNCT04151498
HIV Reengagement and Assessment Mobile Program (Project RAMP)
A study testing Reengagement and Assessment Mobile Program and Qualitative Interview in people with HIV/AIDS, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Reengagement and Assessment Mobile Program and Qualitative Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2020to 28 Apr 2023
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- HIV positive
- Referred to the bridge counselors by the partnering clinic as out of care for >=6 months and not successfully re-engaged in care by a bridge counselor
- Willing and able to give informed consent and adhere to study visits
Who cannot join
- Unwilling or physically unable to participate in study visits on the mobile van
- Lack of English language fluency
- Planning or preferring to transfer HIV care to an HIV clinic other than the partnering HIV clinic
- Pregnant women will be expedited into clinical care and will not be eligible for the study
- Presence of mobility or balance issues that prevent patient from safely stepping up onto the mobile unit without assistance
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Project RAMP (Reengagement and Assessment Mobile Program): A Field Visit Model for HIV Clinic Reengagement
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.
Read the detailed 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.
- Conditions
- HIV/AIDS
- Being tested
- Reengagement and Assessment Mobile Program, Qualitative Interview
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reengagement and Assessment Mobile ProgramBehavioural
Also called Project RAMP
Participants will participate in mobile clinic visit that will include an educational interview, adherence counseling, and standard blood draws for HIV reengagement. The goal of this intervention is to motivate participants to become reengaged in traditional HIV care by making an in person clinic appointment.
Qualitative InterviewOther
Qualitative interview about barriers and facilitators to HIV care, and experience at most recent clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will complete an HIV health reengagement intervention on a mobile van, in addition to a pre- and post-intervention qualitative interview. Receives: Behavioral: Reengagement and Assessment Mobile Program; Other: Qualitative Interview |
| Usual Care Reengagement Group | Other | This group will complete a qualitative interview about barriers and facilitators to HIV care. Receives: Other: Qualitative Interview |
| Non-enrolling Group | No intervention | This group will not be enrolled in the intervention, and will include de-identified data from clinic patients referred to bridge counselors during the study time period that do not participate in the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible persons screened that enroll.
Percentage of all eligible persons that are screened by the study team that enroll in Project RAMP during the intervention period.
Measured: Screening call through Visit 0 when consent occurs, approximately 2 - 3 weeks
Qualitative Summary of Participants' Experiences from In-depth Baseline Interview
Data will be obtained from in-depth qualitative interviews. Summary will include reasons why patients who have been out of care for more than 6 months have been lost to care.
Measured: Up to approximately 1 hour at Baseline
Qualitative Summary of Participants' Experiences from In-depth Exit Interview
Data will be obtained from in-depth qualitative interviews. Summary will include information evaluating participants' experiences in Project RAMP.
Measured: Up to approximately 1 hour at Exit Interview
Secondary outcomes (3)
Number of participants who are successfully reengaged following the intervention.
Reengagement is defined as 1 kept visit following the intervention. The investigators will collect this data from the participants' medical record.
Measured: 6 months following the participants' last intervention visit
Number of participants who are successfully retained following the intervention.
Retention is defined as 2 kept visits following the intervention. The investigators will collect this data from the participant's medical record.
Measured: 6 months following the participants' last intervention visit
Number of participants who have viral suppression following the intervention.
Viral suppression is defined as <200 copies/mL. The investigators will collect data on viral suppression from participant's medical record.
Measured: 6 months following participants' last intervention visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start29 May 2020
- Primary completion12 Nov 2022
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Christopher Sellers, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151498
- Sponsor's protocol ID
- 19-0664
- Status last verified
- Jun 2023
- First submitted
- 23 Oct 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be shared after publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project RAMP (Reengagement and Assessment Mobile Program): A Field Visit Model for HIV Clinic Reengagement
- ClinicalTrials.gov ID
- NCT04151498
- Acronym / sponsor ID
- 19-0664
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 29 May 2020 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 5 Nov 2019 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Reengagement and Assessment Mobile Program, Other: Qualitative InterviewThis group will complete an HIV health reengagement intervention on a mobile van, in addition to a pre- and post-intervention qualitative interview. |
| Usual Care Reengagement Group | Other | Other: Qualitative InterviewThis group will complete a qualitative interview about barriers and facilitators to HIV care. |
| Non-enrolling Group | No intervention | –This group will not be enrolled in the intervention, and will include de-identified data from clinic patients referred to bridge counselors during the study time period that do not participate in the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years
- HIV positive
- Referred to the bridge counselors by the partnering clinic as out of care for >=6 months and not successfully re-engaged in care by a bridge counselor
- Willing and able to give informed consent and adhere to study visits
Key exclusion criteria (5 listed)
- Unwilling or physically unable to participate in study visits on the mobile van
- Lack of English language fluency
- Planning or preferring to transfer HIV care to an HIV clinic other than the partnering HIV clinic
- Pregnant women will be expedited into clinical care and will not be eligible for the study
- Presence of mobility or balance issues that prevent patient from safely stepping up onto the mobile unit without assistance
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 |
|---|---|---|
| Reengagement and Assessment Mobile ProgramAlso: Project RAMPParticipants will participate in mobile clinic visit that will include an educational interview, adherence counseling, and standard blood draws for HIV reengagement. The goal of this intervention is to motivate participants to become reengaged in traditional HIV care by making an in person clinic appointment. | Behavioural | Intervention Group |
| Qualitative InterviewQualitative interview about barriers and facilitators to HIV care, and experience at most recent clinic visit. | Other | Intervention Group, Usual Care Reengagement Group |
Primary outcome
Percentage of eligible persons screened that enroll.
Time frame: Screening call through Visit 0 when consent occurs, approximately 2 - 3 weeks
Percentage of all eligible persons that are screened by the study team that enroll in Project RAMP during the intervention period.
Qualitative Summary of Participants' Experiences from In-depth Baseline Interview
Time frame: Up to approximately 1 hour at Baseline
Data will be obtained from in-depth qualitative interviews. Summary will include reasons why patients who have been out of care for more than 6 months have been lost to care.
Qualitative Summary of Participants' Experiences from In-depth Exit Interview
Time frame: Up to approximately 1 hour at Exit Interview
Data will be obtained from in-depth qualitative interviews. Summary will include information evaluating participants' experiences in Project RAMP.
3 secondary outcomes
Number of participants who are successfully reengaged following the intervention.
Time frame: 6 months following the participants' last intervention visit
Number of participants who are successfully retained following the intervention.
Time frame: 6 months following the participants' last intervention visit
Number of participants who have viral suppression following the intervention.
Time frame: 6 months following participants' last intervention visit
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 15 Jun 2023.
- Individual participant dataSharing planned: Yes. Participant data will be shared after publication.
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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.
Christopher Sellers, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reengagement and Assessment Mobile Program and Qualitative Interview in people with HIV/AIDS, run by University of North Carolina, Chapel Hill at 1 site 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 4 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Percentage of eligible persons screened that enroll. (time frame: Screening call through Visit 0 when consent occurs, approximately 2 - 3 weeks). The study lists 3 primary outcomes in all. 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 15 Jun 2023.