Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)

NCT04519970 | Completed

• 1 other identifier: IN-US-380-5725
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

COMEBACK is an investigator-initiated, 48-week study. The study will be conducted in 100 persons living with HIV (PLWH) who have been off ART for two or more weeks. All enrolled participants will be prescribed Biktarvy, if determined appropriate upon review of past historical resistance tests, for use throughout the study period. Participants will also complete a series of Patient Reported Outcomes (PROs) at screening and be assigned one of three tiers of case management intervention (Piggyback, Got Your Back, Backbone), with each tier increasing in intensity regarding intervention techniques and options provided. Participants will be assessed for virologic suppression, retention in care, and PROS throughout study follow up and at study end.

Conditions

Hiv

Keywords

Adherence; Case Management; Biktarvy

Outcome Measures

Primary Outcomes (2)

• Virologic Suppression Rates

  Number of patients with virologic suppression, defined as HIV RNA \<200 copies/ml at week 48 RNA.

  1 year

• Retention in Care

  Number of patients retained in study, defined as at least 2 visits or 2 HIV-1 RNA viral load reports occurring at least 3 months apart within the 12-month study time period

  1 year

Secondary Outcomes (1)

• Patient Reported Outcomes concerning social and health related barriers

  1 year

Study Arms (3)

Highest Tier of Case Management (Piggyback) and Biktarvy

ACTIVE COMPARATOR

The most intensive tier of case management. Includes three appointment reminders; check ins twice per week; travel compensation; housing support; food insecurity support; follow ups for missed appointments and off pill counts; connections with substance use programs; meetings with the benefits department for health insurance needs; childcare support to make appointments; mental healthcare referrals; open pool appointments as back-up options in case of rescheduling needs; late doctor's appointments and prescription pick up for those working during the day; meetings with the health educators to discuss HIV and ART; and re-motivation of HIV treatment every 3 months.

Behavioral: Case Management

Middle Tier of Case Management (Got Your Back) and Biktarvy

ACTIVE COMPARATOR

The middle tier (Got Your Back) will work closely with the CORE case managers to augment their work in housing support, transportation assistance, mental healthcare referrals, childcare assistance, substance use program referrals, food insecurity support and health insurance needs. The retention specialist will additionally provide this middle tier 2 reminders for appointments; check ins once per week; follow ups for missed appointments or off pill counts; support with scheduling appointments for limited availability; meetings with the health educators for information on HIV or ART; and re-motivation for treatment at the 6 and 9 month marks of participation.

Behavioral: Case Management

Lowest Tier of Case Management (Backbone) and Biktarvy

ACTIVE COMPARATOR

The top tier (Backbone) will need the least amount of support and also have a CORE Center case manager for a majority of the support in housing, food, insurance, transportation, childcare, substance use, and mental healthcare. The retention specialist will still provide an appointment reminder; check ins every other week; text checkups after missed appointments or off pill counts; support with scheduling for appointments or prescription pick up for limited availability; and re-motivation of treatment for HIV at the 9 month mark of study participation.

Behavioral: Case Management

Interventions

Case Management BEHAVIORAL

Each tier will have a different level of case management and support, all with the goal of increasing adherence to Biktarvy for HIV management.

Highest Tier of Case Management (Piggyback) and Biktarvy; Lowest Tier of Case Management (Backbone) and Biktarvy; Middle Tier of Case Management (Got Your Back) and Biktarvy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected
• Not on ART for \>2 weeks
• History of estimated eGFR \> 30 ml3/min
• Baseline labs (CBC, CMP, CD4+, HIV-1 RNA) and resistance genotype test collected \<2 weeks or on day of Biktarvy ART reinitiation
• years or older

You may not qualify if:

• No history of primary integrase inhibitor mutations, \>3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing
• Drug-drug interactions with Biktarvy
• Pregnancy
• Unable or unwilling to provide consent for study participation
• Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the study objective.
• Current participation in another ART adherence study
• Allergy to bictegravir, emtricitabine or tenofovir alafenamide
• Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of reinitiation of antiretroviral therapy
• Concomitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir

Sponsors & Collaborators

• Gregory Huhn: lead
• Gilead Sciences: collaborator

Study Sites (1)

Ruth M. Rothstein CORE Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Case Management

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

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Gregory Huhn, MD, MPHTM

  Ruth M. Rothstein CORE Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MPHTM Attending Physician

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 20, 2020
• Study Start: September 3, 2020
• Primary Completion: October 6, 2023
• Study Completion: April 6, 2024
• Last Updated: March 25, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)