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.
Name: Case Management
Description: Number of patients with virologic suppression, defined as HIV RNA <50 copies/ml at week 24 RNA.
Measure: Virologic Suppression Rates Time: 1 yearDescription: 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
Measure: Retention in Care Time: 1 yearDescription: Favorable outcomes concerning health and and social related determinants as assessed by responses to a series of Patient Reported Outcomes at 6 and 12 months. See full list in attached documents.
Measure: Patient Reported Outcomes concerning social and health related barriers Time: 1 yearAllocation: Non-Randomized
Parallel Assignment
There are 4 SNPs
No history of primary integrase inhibitor mutations, >3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing 2. Drug-drug interactions with Biktarvy 3. Pregnancy 4. Unable or unwilling to provide consent for study participation 5. 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. --- K70E --- --- Q151M --- --- K65R ---
No history of primary integrase inhibitor mutations, >3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing 2. Drug-drug interactions with Biktarvy 3. Pregnancy 4. Unable or unwilling to provide consent for study participation 5. 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. --- K70E ---
No history of primary integrase inhibitor mutations, >3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing 2. Drug-drug interactions with Biktarvy 3. Pregnancy 4. Unable or unwilling to provide consent for study participation 5. 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. --- K70E --- --- Q151M --- --- K65R --- --- M184V ---
No history of primary integrase inhibitor mutations, >3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing 2. Drug-drug interactions with Biktarvy 3. Pregnancy 4. Unable or unwilling to provide consent for study participation 5. 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. --- K70E --- --- Q151M ---