{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T04:53:39Z","timestamp":1782708819576,"version":"3.54.5"},"reference-count":34,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2025,7,16]],"date-time":"2025-07-16T00:00:00Z","timestamp":1752624000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"ViiV Healthcare","award":["#219546"],"award-info":[{"award-number":["#219546"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Long-acting (LA) antiretroviral therapies for human immunodeficiency virus (HIV), such as injectable formulations of cabotegravir and rilpivirine (CAB+RPV LA), are now available. Considering the limited data on the out-of-hospital administration of this combination, evaluating the implementation strategies needed is essential to support future clinical efforts. To gather data on barriers and facilitators of implementation for CAB+RPV LA in alternative outpatient facilities, this study used qualitative interviews informed by the Consolidated Framework for Implementation Research (CFIR), with 13 staff participating in the HOLA study (NCT06185452). Data analysis followed qualitative descriptive methods, assisted by Atlas.ti software version 22. The study adhered to the COREQ guidelines. Findings reveal five main factors to consider for implementation: operational and infrastructure adaptations, integrated management of human and organizational resources, need for coordination and follow-up, professional attitudes and work environment, and patient experience and patients\u2019 needs perceived by professionals. This study emphasizes the comprehensive operational and infrastructure adaptations, adequate staff training, and supportive professional environment required for the successful implementation of CAB+RPV LA, while considering patients\u2019 needs throughout the externalization process (trial registration number: NCT06643897).<\/jats:p>","DOI":"10.3390\/v17070993","type":"journal-article","created":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T14:13:43Z","timestamp":1752761623000},"page":"993","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Barriers and Facilitators of Implementation of the Non-Hospital-Based Administration of Long-Acting Cabotegravir Plus Rilpivirine in People with HIV: Qualitative Data from the HOLA Study"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-7377-7693","authenticated-orcid":false,"given":"Diana","family":"Hern\u00e1ndez-S\u00e1nchez","sequence":"first","affiliation":[{"name":"Lluita Contra les Infeccions, Hospital Universitari Germans Trias i Pujol, Ctra del Canyet S\/N, 08916 Badalona, Spain"},{"name":"Departamento de Medicina, Universitat Aut\u00f2noma de Barcelona, 08193 Bellaterra, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4241-4992","authenticated-orcid":false,"given":"Juan M.","family":"Leyva-Moral","sequence":"additional","affiliation":[{"name":"Grup de Recerca Infemera en Vulnerabilitat i Salut, Departament d\u2019Infermeria. Universitat Autonoma de Barcelona, 08015 Barcelona, Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Epidemiolog\u00eda y Salud P\u00fablica (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8577-3891","authenticated-orcid":false,"given":"Julian","family":"Olalla","sequence":"additional","affiliation":[{"name":"Hospital Universitario Costa del Sol, 29603 Marbella, M\u00e1laga, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eug\u00e8nia","family":"Negredo","sequence":"additional","affiliation":[{"name":"Lluita Contra les Infeccions, Hospital Universitari Germans Trias i Pujol, Ctra del Canyet S\/N, 08916 Badalona, Spain"},{"name":"Departamento de Medicina, Universitat Aut\u00f2noma de Barcelona, 08193 Bellaterra, Spain"},{"name":"Universitat de Vic-Universitat Central de Catalunya (UVic-UCC), 08500 Vic, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the HOLA Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1007\/s10461-024-04490-0","article-title":"Improvements in Patient-Reported Outcomes After 12 Months of Maintenance Therapy with Cabotegravir + Rilpivirine Long-Acting Compared with Bictegravir\/Emtricitabine\/Tenofovir Alafenamide in the Phase 3b SOLAR Study","volume":"29","author":"Mussini","year":"2024","journal-title":"AIDS Behav."},{"key":"ref_2","unstructured":"Jonsson-Oldenbuttel, C., Noe, S., Wyen, C., Borch, J., Ummard-Berger, K., Postel, N., Scholten, S., Dymek, K.M., Westermayer, B., and de los Rios, P. (2024, January 22\u201326). 12-Month Outcomes of Cabotegravir Plus Rilpivirine Long-Acting Every 2 Months in a Real-World Setting: Effectiveness, Adherence to Injections, and Patient-Reported Outcomes from People with HIV-1 in the German CARLOS Study Who Switched off Suppressive Oral Daily ART. Proceedings of the AIDS 2024, the 25th International AIDS Conference, Munich, Germany. Available online: https:\/\/www.natap.org\/2024\/IAS\/IAS_41.htm."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Antinori, A., Vergori, A., Ripamonti, D., Valenti, D., Esposito, V., Carleo, M.A., Rusconi, S., Cascio, A., Manzillo, E., and Andreoni, M. (2023). Investigating coping and stigma in people living with HIV through narrative medicine in the Italian multicentre non-interventional study DIAMANTE. Sci. Rep., 13.","DOI":"10.1038\/s41598-023-44768-2"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Gutner, C., Harrington, C., Bontempo, G., Pazhamalai, S., Kumar, A., Rimler, K., Davis, K., Williams, W., Merrill, D., and Petty, L. (2024, January 16\u201319). P545. Feasibility, Fidelity, and Effectiveness of Administering Cabotegravir + Rilpivirine Long-Acting (CAB + RPV LA) in Infusion Centers. Proceedings of the ID Week 2024, Los Angeles, CA, USA.","DOI":"10.1093\/ofid\/ofae631.744"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"e26243","DOI":"10.1002\/jia2.26243","article-title":"Implementation of long-acting cabotegravir and rilpivirine: Primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations","volume":"27","author":"Gutner","year":"2024","journal-title":"J. Int. AIDS Soc."},{"key":"ref_6","unstructured":"van Welzen, B.J., Vandekerckhove, L., and Jonsson-Oldenb\u00fcttel, C. (2025, April 24). Implementation of Cabotegravir and Rilpivirine Long-Acting (CAB + RPV LA): Primary Results from the CAB + RPV Implementation Study in European Locations (CARISEL). Available online: https:\/\/www.natap.org\/2022\/Glascow\/GLASGOW_03.htm."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"De Wit, S., Rami, A., Bonnet, F., DeMoor, R., Bontempo, G., Latham, C., Gill, M., Hadi, M., Cooper, O., and Anand, S.B. (2022). 1584. CARISEL A Hybrid III Implementation Effectiveness Study of implementation of Cabotegravir plus Rilpivirine Long Acting (CAB+RPV LA) in EU Health Care Settings Key Clinical and Implementation Outcomes by Implementation Arm. Open Forum Infect. Dis., 9.","DOI":"10.1093\/ofid\/ofac492.107"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1103","DOI":"10.1093\/cid\/ciae523","article-title":"Perspectives of People with Human Immunodeficiency Virus on Implementing Long-acting Cabotegravir Plus Rilpivirine in Clinics and Community Settings in the United Kingdom: Results from the Antisexist, Antiracist, Antiageist Implementing Long-acting Novel Antiretrovirals Study","volume":"80","author":"Orkin","year":"2024","journal-title":"Clin. Infect. Dis."},{"key":"ref_9","unstructured":"Cabello, A., Carrillo, I., Al-Hayani, A., L\u00f3pez De Las Heras, M., Algar, C., Burillo, I., \u00c1lvarez-\u00c1lvarez, B., Prieto-P\u00e9rez, L., Mahillo-Fern\u00e1ndez, I., and Bonilla, M. (2025, January 11\u201315). ACCEPTABILITY & FEASIBILITY interventions measures (AIM & FIM) of the implementation of long-acting cabotegravir plus rilpivirine (CAB LA + RPV LA) administration out of HIV units: The IMADART study. Proceedings of the ESCMID Global, Vienna, Austria."},{"key":"ref_10","unstructured":"Cabello, A. (2024, January 10\u201313). Feasibility and satisfaction of interventions measures (FIM and HIVTSQ) of implementation of long-acting CAB + RPV administration out of HIV units: The IMADART study. Proceedings of the HIV Glasgow, Glasgow, UK."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"e185","DOI":"10.1016\/S2352-3018(20)30340-4","article-title":"Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study","volume":"8","author":"Orkin","year":"2021","journal-title":"Lancet HIV"},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Kadu, M.K., and Stolee, P. (2015). Facilitators and barriers of implementing the chronic care model in primary care: A systematic review. BMC Fam. Pract., 16.","DOI":"10.1186\/s12875-014-0219-0"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e062158","DOI":"10.1136\/bmjopen-2022-062158","article-title":"Barriers and enablers to implementing clinical practice guidelines in primary care: An overview of systematic reviews","volume":"13","author":"Wang","year":"2023","journal-title":"BMJ Open"},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Davy, C., Bleasel, J., Liu, H., Tchan, M., Ponniah, S., and Brown, A. (2015). Effectiveness of chronic care models: Opportunities for improving healthcare practice and health outcomes: A systematic review. BMC Health Serv. Res., 15.","DOI":"10.1186\/s12913-015-0854-8"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e088514","DOI":"10.1136\/bmjopen-2024-088514","article-title":"Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA study)\u2014A hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study: Study protocol","volume":"15","author":"Negredo","year":"2025","journal-title":"BMJ Open"},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Naeem, M., Ozuem, W., Howell, K., and Ranfagni, S. (2024). Demystification and Actualisation of Data Saturation in Qualitative Research Through Thematic Analysis. Int. J. Qual. Methods, 23.","DOI":"10.1177\/16094069241229777"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1002\/nur.21768","article-title":"Characteristics of Qualitative Descriptive Studies: A Systematic Review","volume":"40","author":"Kim","year":"2017","journal-title":"Res. Nurs. Health"},{"key":"ref_18","first-page":"16","article-title":"Qualitative Descriptive Methods in Health Science Research","volume":"9","author":"Colorafi","year":"2016","journal-title":"HERD Health Environ. Res. Des. J."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1002\/nur.20362","article-title":"What\u2019s in a name? Qualitative description revisited","volume":"33","author":"Sandelowski","year":"2010","journal-title":"Res. Nurs. Health"},{"key":"ref_20","unstructured":"Polit, D., and Beck, C. (2018). Essentials of Nursing Research, Lippincott Williams & Wilkins. [9th ed.]."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1002","DOI":"10.1080\/0142159X.2018.1497149","article-title":"Twelve tips for conducting qualitative research interviews","volume":"41","author":"McGrath","year":"2019","journal-title":"Med. Teach."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1080\/13814788.2017.1375092","article-title":"Series: Practical guidance to qualitative research. Part 4: Trustworthiness and publishing","volume":"24","author":"Korstjens","year":"2018","journal-title":"Eur. J. Gen. Pract."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1093\/intqhc\/mzm042","article-title":"Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups","volume":"19","author":"Tong","year":"2007","journal-title":"Int. J. Qual. Health Care"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"138","DOI":"10.5688\/ajpe7120","article-title":"A review of the quality indicators of rigor in qualitative research","volume":"84","author":"Johnson","year":"2020","journal-title":"Am. J. Pharm. Educ."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1186\/s43058-024-00631-7","article-title":"Patient and clinic staff perspectives on the implementation of a long-acting injectable antiretroviral therapy program in an urban safety-net health system","volume":"5","author":"Agovi","year":"2024","journal-title":"Implement. Sci. Commun."},{"key":"ref_26","unstructured":"McGowan, J.P., Fine, S.M., Vail, R.M., Merrick, S.T., Radix, A.E., Gonzalez, C.J., Hoffmann, C.J., and Medical Care Criteria Committee (2025, April 24). Use of Injectable CAB\/RPV LA as Replacement ART in Virally Suppressed Adults, Available online: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK572795\/."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"e26003","DOI":"10.1002\/jia2.26003","article-title":"Perspectives of healthcare providers on implementation of long-acting cabotegravir plus rilpivirine in US healthcare settings from a Hybrid III Implementation-effectiveness study (CUSTOMIZE)","volume":"25","author":"Czarnogorski","year":"2022","journal-title":"J. Int. AIDS Soc."},{"key":"ref_28","doi-asserted-by":"crossref","unstructured":"Jolayemi, O., Bogart, L.M., Storholm, E.D., Goodman-Meza, D., Rosenberg-Carlson, E., Cohen, R., Kao, U., Shoptaw, S., Landovitz, R.J., and Sued, O. (2022). Perspectives on preparing for long-acting injectable treatment for HIV among consumer, clinical and nonclinical stakeholders: A qualitative study exploring the anticipated challenges and opportunities for implementation in Los Angeles County. PLoS ONE, 17.","DOI":"10.1371\/journal.pone.0262926"},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Gutner, C.A., van der Valk, M., Portilla, J., Jeanmaire, E., Belkhir, L., Lutz, T., DeMoor, R., Trehan, R., Scherzer, J., and Pascual-Bern\u00e1ldez, M. (2024). Patient Participant Perspectives on Implementation of Long-Acting Cabotegravir and Rilpivirine: Results From the Cabotegravir and Rilpivirine Implementation Study in European Locations (CARISEL) Study. J. Int. Assoc. Provid. AIDS Care, 23.","DOI":"10.1177\/23259582241269837"},{"key":"ref_30","doi-asserted-by":"crossref","unstructured":"Mantsios, A., Murray, M., Karver, T.S., Davis, W., Galai, N., Kumar, P., Swindells, S., Bredeek, U.F., Garc\u00eda, R.R., and Antela, A. (2021). Multi-level considerations for optimal implementation of long-acting injectable antiretroviral therapy to treat people living with HIV: Perspectives of health care providers participating in phase 3 trials. BMC Health Serv. Res., 21.","DOI":"10.1186\/s12913-021-06214-9"},{"key":"ref_31","first-page":"16","article-title":"Increasing HIV treatment access, uptake and use among men who have sex with men in urban Indonesia: Evidence from a qualitative study in three cities","volume":"35","author":"Lazuardi","year":"2019","journal-title":"Health Policy Plan."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1186\/s12981-023-00585-1","article-title":"Addressing HIV stigma in healthcare, community, and legislative settings in Central and Eastern Europe","volume":"20","author":"Schweitzer","year":"2023","journal-title":"AIDS Res. Ther."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"e011453","DOI":"10.1136\/bmjopen-2016-011453","article-title":"Examining the associations between HIV-related stigma and health outcomes in people living with HIV\/AIDS: A series of meta-analyses","volume":"6","author":"Rueda","year":"2016","journal-title":"BMJ Open"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1007\/s10461-016-1451-5","article-title":"How Does Stigma Affect People Living with HIV? The Mediating Roles of Internalized and Anticipated HIV Stigma in the Effects of Perceived Community Stigma on Health and Psychosocial Outcomes","volume":"21","author":"Turan","year":"2017","journal-title":"AIDS Behav."}],"container-title":["Viruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4915\/17\/7\/993\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:10:32Z","timestamp":1760033432000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4915\/17\/7\/993"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,16]]},"references-count":34,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7]]}},"alternative-id":["v17070993"],"URL":"https:\/\/doi.org\/10.3390\/v17070993","relation":{},"ISSN":["1999-4915"],"issn-type":[{"value":"1999-4915","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,16]]}}}