HIV Reengagement and Assessment Mobile Program (Project RAMP)

NCT04151498 | Completed

• 1 other identifier: 19-0664
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to approximately 1 hour at Exit Interview

Secondary Outcomes (3)

• Number of participants who are successfully reengaged following the intervention.

  6 months following the participants' last intervention visit

• Number of participants who are successfully retained following the intervention.

  6 months following the participants' last intervention visit

• Number of participants who have viral suppression following the intervention.

  6 months following participants' last intervention visit

Study Arms (3)

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.

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.

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.

Interventions

Reengagement and Assessment Mobile Program BEHAVIORAL

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.

Also known as: Project RAMP

Intervention Group

Qualitative Interview OTHER

Qualitative interview about barriers and facilitators to HIV care, and experience at most recent clinic visit.

Intervention Group; Usual Care Reengagement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• ViiV Healthcare: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Christopher Sellers, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 5, 2019
• Study Start: May 29, 2020
• Primary Completion: November 12, 2022
• Study Completion: April 28, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 9 to 36 months following publication.
• Access Criteria: Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.

Locations

US (1)