PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)

NCT07620730 | Not Yet Recruiting

• 1 other identifier: 369413
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this 12-month implementation science study is to generate the evidence required to ensure long-acting cabotegravir (LA CAB) as pre-exposure prophylaxis (PrEP) can be delivered in an equitable manner within the NHS. This study will recruit both PrEP users and healthcare professionals (HCPs). The main questions it aims to answer are:

• What do healthcare providers think about the feasibility of delivering LA CAB PrEP within sexual health services in the NHS?
• How many participants stay on/remain consistent with LA CAB PrEP injections at Month 12 (PrEP persistence)? Participants (200 PrEP users) will be followed for 12-months and asked to complete surveys at 3 study visits. A subset of 20 participants will also be asked to complete interviews about their experiences. We will also ask 20 HCPs at participating locations to complete surveys and interviews at both baseline and month 12. A core principle of equity (understanding any difference in impact on underserved populations) will be applied throughout the study. To ensure representation of a diverse group of participants that reflects the demographic groups most affected by incident HIV and most underserved by PrEP in the UK, enrolment targets will be applied and meticulously managed by the central study team, as follows:
• A cap of 30% (n=60) will be applied to recruitment of White cisgender men who have sex with men who are not otherwise part of other under-represented groups (as defined below),
• At least 70%% (n=140) of participants will represent groups currently underserved by PrEP and fall into one (or more) of the following socio-demographic categories: women (defined cisgender or transgender) OR as transgender men OR non-binary individuals OR age\<25 yrs, OR sex workers OR people who inject drugs OR racially minoritised heterosexual men.

Conditions

PrEP; PrEP Adherence Experiences; PrEP Adherence Perspectives; PrEP Uptake; Equity; Community Setting

Keywords

PrEP; Patient and public involvement and engagement; PrEP-LANA; LA CAB; Cabotegravir; Long-acting PrEP; Equity; community setting

Outcome Measures

Primary Outcomes (2)

• Feasibility of LA CAB delivery (HCP perspective): Mean Feasibility of Intervention Measure (FIM) score among healthcare professionals

  Mean score on the validated Feasibility of Intervention Measure (5-point Likert scale; higher scores indicate greater perceived feasibility) assessing delivery of long-acting cabotegravir PrEP in NHS sexual health services, supplemented by qualitative thematic analysis of semi-structured interviews with HCPs.

  Month 12

• PrEP persistence on long-acting cabotegravir: Proportion of participants remaining on long-acting cabotegravir PrEP at Month 12 without interruption

  Persistence defined as the proportion of participants who remain on long-acting cabotegravir injections at Month 12 with no documented interruption; interruption defined as two missed consecutive injections without oral bridging per Summary of Product Characteristics (SmPC).

  Month 12

Secondary Outcomes (14)

• Acceptability of LA CAB (HCPs and PrEP users): Mean Acceptability of Intervention Measure (AIM) score

  Month 12

• Appropriateness of LA CAB (HCPs and PrEP users): Mean Intervention Appropriateness Measure (IAM) score

  Month 12

• Feasibility of LA CAB (PrEP user perspective): Mean Feasibility of Intervention Measure (FIM) score among PrEP users

  Month 12

• Implementation fidelity and adaptation: Proportion of sites adhering to implementation blueprints and description of adaptations

  Baseline to Month 12

• Adoption and penetration of LA CAB: Proportion of eligible individuals initiated on LA CAB and proportion of total PrEP users receiving LA CAB

  Baseline to Month 12

Other Outcomes (3)

• HIV incidence and status: HIV incidence rate and proportion remaining HIV-negative

  Baseline to Month 12

• Sexually transmitted infection (STI) incidence: Incidence of STIs

  Baseline to Month 12

• Injection site reactions: Incidence and severity of injection site reactions

  Baseline to Month 12

Study Arms (3)

Existing PrEP user participants

This group will consist of participants who already have experience with taking PrEP. They will make up 85% (n=170) of the overall recruitment target for the PrEP user participants. Existing PrEP users will have a baseline visit at M0 and the next visit will take place two months later at M2, followed by visits every two months until M12

New PREP-user participants

This group will consist of participants who are new to using PrEP. They will make up 15% (n=30) of the overall recruitment target for the PrEP user participants. Those who are new to using PrEP will have a baseline visit at M0 and additional visit at M1 and the next visit will take place one month later at M2, followed by visits every two months until M12

Healthcare Professionals

This group will consist of 20 HCPs recruited from participating study sites. HCP participants will be asked to complete the following validated open-access questionnaires at baseline and M12: * Intervention Measure (AIM), * Intervention Appropriateness Measure (IAM), * Feasibility of Intervention Measure (FIM) They will also be asked to complete qualitative interviews at baseline and month-12.

Eligibility Criteria

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

Study Population

The participants in this study are 1) PrEP users and 2) NHS healthcare providers (HCPs) recruited from 12 study sites (sexual health clinics and associated non-specialist service delivery sites) that currently deliver PrEP. HCP participants will include doctors, nurses and pharmacists who currently provide injectable PrEP. Note: PrEP user participants are those who are both naive (new to ) to any PrEP modality, and PrEP experienced (former or current oral and/ or injectable PrEP users), on PrEP in accordance with NHS and NICE guidelines (28).

You may qualify if:

• Adults who are aged \> 18 years at time of consent (including people of child-bearing capacity and age, non-pregnant or pregnant adults)
• Attending a participating NHS sexual healthcare service
• Prescribed LA CAB for PrEP according to NICE and NHS eligibility criteria (including those newly prescribed and those already using LA CAB)
• Non-reactive / negative HIV Antigen/Antibody test and HIV RNA test at time of LA CAB for PrEP initiation (performed under routine care)

You may not qualify if:

• One or more reactive or positive HIV test results at enrolment visit, even if HIV infection is not confirmed.
• Currently enrolled in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.
• Plan to relocate out of the area during the study period. Note: "Plan to relocate out of the area" is defined as a stated intention at enrolment to move residence outside the catchment area of a participating study site during the study period, such that ongoing clinical management would likely transfer to a non-participating team.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• Queen Mary University of London: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Barts Helth NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Homerton University Hospital NHS Foundation Trust: collaborator
• University Hospital of Wales, Cardiff: collaborator
• University Hospitals Sussex NHS Foundation Trust: collaborator
• Barking, Havering and Redbridge University Hospitals NHS Trust: collaborator

Related Publications (30)

• Woodward EN, Matthieu MM, Uchendu US, Rogal S, Kirchner JE. The health equity implementation framework: proposal and preliminary study of hepatitis C virus treatment. Implement Sci. 2019 Mar 12;14(1):26. doi: 10.1186/s13012-019-0861-y.

  PMID: 30866982 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, Kayange N, Makhema J, Mandima P, Mathew C, Spooner E, Mpendo J, Mukwekwerere P, Mgodi N, Ntege PN, Nair G, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Singh N, Siziba B, Farrior J, Rose S, Anderson PL, Eshleman SH, Marzinke MA, Hendrix CW, Beigel-Orme S, Hosek S, Tolley E, Sista N, Adeyeye A, Rooney JF, Rinehart A, Spreen WR, Smith K, Hanscom B, Cohen MS, Hosseinipour MC; HPTN 084 study group. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022 May 7;399(10337):1779-1789. doi: 10.1016/S0140-6736(22)00538-4. Epub 2022 Apr 1.

  PMID: 35378077 BACKGROUND

• Marzinke MA, Grinsztejn B, Fogel JM, Piwowar-Manning E, Li M, Weng L, McCauley M, Cummings V, Ahmed S, Haines CD, Bushman LR, Petropoulos C, Persaud D, Adeyeye A, Kofron R, Rinehart A, St Clair M, Rooney JF, Pryluka D, Coelho L, Gaur A, Middelkoop K, Phanuphak N, Cohen MS, Hendrix CW, Anderson P, Hanscom B, Donnell D, Landovitz RJ, Eshleman SH. Characterization of Human Immunodeficiency Virus (HIV) Infection in Cisgender Men and Transgender Women Who Have Sex With Men Receiving Injectable Cabotegravir for HIV Prevention: HPTN 083. J Infect Dis. 2021 Nov 16;224(9):1581-1592. doi: 10.1093/infdis/jiab152.

  PMID: 33740057 BACKGROUND

• Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013 May 10;8:51. doi: 10.1186/1748-5908-8-51.

  PMID: 23663819 BACKGROUND

• Orkin C. Beyond the Clinic. In: A119. Liverpool, UK; 2026.

  BACKGROUND

• Orkin C. PrEPosition. In: O32. Liverpool, UK; 2026.

  BACKGROUND

• SHARE Collaborative. Beyond the Clinic. SHARE [Internet]. 2025 Mar 12 [cited 2026 Apr 14]. Available from: https://shareresearch.org.uk/beyond-the-clinic/

  BACKGROUND

• Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009 Jan;36(1):24-34. doi: 10.1007/s10488-008-0197-4. Epub 2008 Dec 23.

  PMID: 19104929 BACKGROUND

• Reardon CM, Damschroder LJ, Ashcraft LE, Kerins C, Bachrach RL, Nevedal AL, Domlyn AM, Dodge J, Chinman M, Rogal S. The Consolidated Framework for Implementation Research (CFIR) User Guide: a five-step guide for conducting implementation research using the framework. Implement Sci. 2025 Aug 16;20(1):39. doi: 10.1186/s13012-025-01450-7.

  PMID: 40819067 BACKGROUND

• Cabotegravir for preventing HIV-1 in adults and young people. London: National Institute for Health and Care Excellence (NICE); 2025 Nov 5. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK620397/

  PMID: 41570163 BACKGROUND

• Lewisham Council [Internet]. [cited 2026 Apr 14]. HIV prevention to be offered by GPs in ground-breaking PrEP pilot. Available from: https://lewisham.gov.uk/articles/news/hiv-prevention-to-be-offered-by-gps-in-ground-breaking-prep-pilot

  BACKGROUND

• Lamothe Y. London Borough of Havering [Internet]. The London Borough Of Havering; [cited 2026 Apr 14]. Residents to have easier access to HIV prevention medications. Located at: London, England. Available from: https://www.havering.gov.uk/news/article/1604/residents-to-have-easier-access-to-hiv-prevention-medications

  BACKGROUND

• Harrison C, Harryman L, Stockwell S, Family H, Kesten JM, Denford S, Scott J, Sabin C, Copping J, Saunders J, Hamilton-Shaw R, Symonds N, Dick OB, Tarmey E, Horwood J. Development and implementation of a pharmacy PrEP awareness-raising and referral pathway: acceptability and feasibility of a UK pilot. Sex Transm Infect. 2026 Feb 11:sextrans-2025-056711. doi: 10.1136/sextrans-2025-056711. Online ahead of print.

  PMID: 41672775 BACKGROUND

• Ogaz D, Ratna N, Vijayan H, Migchelsen SJ, Reid D, Mullen D, Phillips D, Bell E, Djuretic T, Nutland W, Mercer CH, Folkard K, Saunders J, Mohammed H. Thinking beyond the tablet: Acceptability of different HIV-PrEP modalities among GBMSM and gender-diverse individuals having sex with men in the UK. Int J STD AIDS. 2026 Jan;37(1):30-35. doi: 10.1177/09564624251369093. Epub 2025 Aug 22.

  PMID: 40842379 BACKGROUND

• Raccagni A. Preliminary results of long-acting injectable PrEP with cabotegravir at San Raffaele Institute in Milan. European AIDS Clinical Society (EACS). 2025 Oct 17.

  BACKGROUND

• Moschese D, Esvan R, Fusetti C, Barchi V, Cossu MV, Giacinta A, Lazzarin S, Terracini G, Caruso F, Micheli G, Maddalena D, Del Duca G, Petri F, Frate G, Matone M, Farinacci D, Giacomelli A, Faccendini P, Visigalli D, Passacantilli S, Riva A, Antinori A, Gori A, Mazzotta V. Early results from implementation of HIV pre-exposure prophylaxis (PrEP) with long-acting injectable cabotegravir for people with barriers to oral strategies, Italy, December 2024 to August 2025. Euro Surveill. 2025 Oct;30(39):2500739. doi: 10.2807/1560-7917.ES.2025.30.39.2500739.

  PMID: 41040064 BACKGROUND

• Gilead Sciences. A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP [Clinical trial registration] [Internet]. clinicaltrials.gov; 2025 Aug [cited 2026 Apr 14]. Clinical trial registration no.: NCT06513312. Available from: https://clinicaltrials.gov/study/NCT06513312

  BACKGROUND

• Kelley CF, Acevedo-Quinones M, Agwu AL, Avihingsanon A, Benson P, Blumenthal J, Brinson C, Brites C, Cahn P, Cantos VD, Clark J, Clement M, Creticos C, Crofoot G, Diaz RS, Doblecki-Lewis S, Gallardo-Cartagena JA, Gaur A, Grinsztejn B, Hassler S, Hinojosa JC, Hodge T, Kaplan R, Lacerda M, LaMarca A, Losso MH, Valdez Madruga J, Mayer KH, Mills A, Mounzer K, Ndlovu N, Novak RM, Perez Rios A, Phanuphak N, Ramgopal M, Ruane PJ, Sanchez J, Santos B, Schine P, Schreibman T, Spencer LY, Van Gerwen OT, Vasconcelos R, Vasquez JG, Zwane Z, Cox S, Deaton C, Ebrahimi R, Wong P, Singh R, Brown LB, Carter CC, Das M, Baeten JM, Ogbuagu O; PURPOSE 2 Study Team. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. N Engl J Med. 2025 Apr 3;392(13):1261-1276. doi: 10.1056/NEJMoa2411858. Epub 2024 Nov 27.

  PMID: 39602624 BACKGROUND

• Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, Gill K, Harkoo I, Jaggernath M, Kigozi G, Kiwanuka N, Kotze P, Lebina L, Louw CE, Malahleha M, Manentsa M, Mansoor LE, Moodley D, Naicker V, Naidoo L, Naidoo M, Nair G, Ndlovu N, Palanee-Phillips T, Panchia R, Pillay S, Potloane D, Selepe P, Singh N, Singh Y, Spooner E, Ward AM, Zwane Z, Ebrahimi R, Zhao Y, Kintu A, Deaton C, Carter CC, Baeten JM, Matovu Kiweewa F; PURPOSE 1 Study Team. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192. doi: 10.1056/NEJMoa2407001. Epub 2024 Jul 24.

  PMID: 39046157 BACKGROUND

• Landovitz RJ, Donnell D, Clement ME, Hanscom B, Cottle L, Coelho L, Cabello R, Chariyalertsak S, Dunne EF, Frank I, Gallardo-Cartagena JA, Gaur AH, Gonzales P, Tran HV, Hinojosa JC, Kallas EG, Kelley CF, Losso MH, Madruga JV, Middelkoop K, Phanuphak N, Santos B, Sued O, Valencia Huamani J, Overton ET, Swaminathan S, Del Rio C, Gulick RM, Richardson P, Sullivan P, Piwowar-Manning E, Marzinke M, Hendrix C, Li M, Wang Z, Marrazzo J, Daar E, Asmelash A, Brown TT, Anderson P, Eshleman SH, Bryan M, Blanchette C, Lucas J, Psaros C, Safren S, Sugarman J, Scott H, Eron JJ, Fields SD, Sista ND, Gomez-Feliciano K, Jennings A, Kofron RM, Holtz TH, Shin K, Rooney JF, Smith KY, Spreen W, Margolis D, Rinehart A, Adeyeye A, Cohen MS, McCauley M, Grinsztejn B; HPTN 083 Study Team. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. N Engl J Med. 2021 Aug 12;385(7):595-608. doi: 10.1056/NEJMoa2101016.

  PMID: 34379922 BACKGROUND

• Kamya MR, Balzer LB, Ayieko J, Kabami J, Kakande E, Chamie G, Sutter N, Sunday H, Litunya J, Schwab J, Schrom J, Bacon M, Koss CA, Rinehart AR, Petersen M, Havlir DV; SEARCH Consortium. Dynamic choice HIV prevention with cabotegravir long-acting injectable in rural Uganda and Kenya: a randomised trial extension. Lancet HIV. 2024 Nov;11(11):e736-e745. doi: 10.1016/S2352-3018(24)00235-2. Epub 2024 Oct 9.

  PMID: 39395424 BACKGROUND

• GOV.UK [Internet]. [cited 2026 Apr 14]. HIV prevention barriers and facilitators: findings from qualitative interviews among people diagnosed with HIV, March 2021 to July 2022. Available from: https://www.gov.uk/government/publications/hiv-prevention-barriers-and-facilitators-qualitative-findings/hiv-prevention-barriers-and-facilitators-findings-from-qualitative-interviews-among-people-diagnosed-with-hiv-march-2021-to-july-2022

  BACKGROUND

• Cabecinha MA. Awareness, knowledge, and perceptions of HIV pre-exposure prophylaxis (PrEP) among women in England: A mixed methods exploration through an equity lens

  BACKGROUND

• Coukan F, Murray KK, Papageorgiou V, Lound A, Saunders J, Atchison C, Ward H. Barriers and facilitators to HIV Pre-Exposure Prophylaxis (PrEP) in Specialist Sexual Health Services in the United Kingdom: A systematic review using the PrEP Care Continuum. HIV Med. 2023 Aug;24(8):893-913. doi: 10.1111/hiv.13492. Epub 2023 Apr 19.

  PMID: 37078101 BACKGROUND

• Whelan I, Strachan S, Apea V, Orkin C, Paparini S. Barriers and facilitators to HIV pre-exposure prophylaxis for cisgender and transgender women in the UK. Lancet HIV. 2023 Jul;10(7):e472-e481. doi: 10.1016/S2352-3018(23)00080-2. Epub 2023 Jun 1.

  PMID: 37271160 BACKGROUND

• GOV.UK [Internet]. [cited 2026 Apr 14]. HIV testing, PrEP, new HIV diagnoses and care outcomes for people accessing HIV services: 2025 report. Available from: https://www.gov.uk/government/statistics/hiv-annual-data-tables/hiv-testing-prep-new-hiv-diagnoses-and-care-outcomes-for-people-accessing-hiv-services-2025-report

  BACKGROUND

• 3. Noori T. Unpublished data. European AIDS Clinical Society. 2025 Oct 16.

  BACKGROUND

• Orkin C, Hayes R, Haviland J, Wong YL, Ring K, Apea V, Kasadha B, Clarke E, Byrne R, Fox J, Barber TJ, Clarke A, Paparini S. Perspectives of People With HIV 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. Clin Infect Dis. 2025 Jun 4;80(5):1103-1113. doi: 10.1093/cid/ciae523.

  PMID: 39465685 BACKGROUND

• 1. Elias A. et al. Female participants are under-represented in real-world studies of Cabotegravir + Rilpivirine. In. 2023.

  BACKGROUND

Study Officials

• Chloe Orkin

  Queen Mary University of London

  STUDY CHAIR

Central Study Contacts

Nishat Halim

CONTACT

020 7377 7457; n.halim@qmul.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infection and Inequities

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-04