Implementing Long-Acting Novel Antiretrovirals

NCT05294159 | Completed

• 1 other identifier: IMP 218081
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 6

Brief Summary

This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK.

Conditions

Human Immunodeficiency Viruses

Keywords

HIV-1; Long-acting antivirals; Implementation science

Outcome Measures

Primary Outcomes (1)

• Proportion of participants that agree or completely agree (average score of 4 or higher) on the Feasibility of Intervention Measure (FIM) (a validated method)

  To evaluate feasibility of CAB and RPV LA administration at clinics in England and community based settings by patients

  12 months

Secondary Outcomes (13)

• Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) on the FIM and via qualitative interviews

  At Day 0, 4 Months and 12 Months

• Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) Acceptability of Intervention Measure (AIM) (a validated method)

  At Day 0, 4 Months and 12 Months

• Proportion of community site representatives that agree or completely agree (average score of 4 or higher) score of on the FIM and AIM with in-depth qualitative interviews with community site representative

  At 8 months and 12 months

• Proportion of injections occurring within target window from target date (± 7 days of target date)

  12 months

• Proportion of injections occurring after target window with/without use of oral ART

  12 months

Other Outcomes (5)

• Incidence of CAB and RPV LA related ADRs (adverse drug reactions) and all SAEs

  12 months

• Proportion of participants who do not progress to injections/discontinuation during oral lead in

  12 months

• Proportion of participants who discontinue CAB and RPV LA, for all cause, virological reasons or tolerability

  12 months

Study Arms (2)

Clinic-based PLH on CAB+RPV LA

All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites.

Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)

Community-based PLH on CAB+RPV LA

All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites.

Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)

Interventions

The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM) OTHER

The Feasibility and Acceptability of Intervention Measure (FIM and AIM) are used to evaluate the feasibilit and acceptability of our implementation strategies. The FIM and AIM is a validated implementation outcome measure where higher scores indicate greater feasibility and acceptability

Clinic-based PLH on CAB+RPV LA; Community-based PLH on CAB+RPV LA

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

108 stable, virally suppressed PWH. To achieve representation of underrepresented groups in HIV studies, a cap will be set on recruitment of men at 50%, white participants at 50% and age under 50y at 70%.

You may qualify if:

• ≥ 18 years of age
• Documented HIV-1 infection
• Virologically suppressed (HIV-1 RNA \<50 copies/ml) on a stable antiretroviral regimen
• No hepatitis B
• In accordance with EU license and NICE guidance

You may not qualify if:

• Based on contraindication for CAB LA, RPV LA, in accordance with EU license and NICE guidance
• Prior virologic failure on substances of NNRTI or INI class
• Resistance mutations to any substance of the NNRTI or INI class
• Prior exposure to CAB + RPV LA

Sponsors & Collaborators

• Queen Mary University of London: lead
• Chelsea and Westminster NHS Foundation Trust: collaborator
• Barts & The London NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator

Study Sites (6)

Brighton and Sussex University Hospitals NHS Trust

Brighton, BN2 1DH, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Blizard Institute

London, E1 2AT, United Kingdom

Location

Royal Free Hospital NHS

London, NW3 2QG, United Kingdom

Location

Guys' and St Thomas' NHS Trust

London, SE1 7EH, United Kingdom

Location

Chelsea & Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Related Publications (5)

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 RESULT

• 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 RESULT

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 RESULT

• 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 DERIVED

• Farooq HZ, Apea V, Kasadha B, Ullah S, Hilton-Smith G, Haley A, Scherzer J, Hand J, Paparini S, Phillips R, Orkin CM. Study protocol: the ILANA study - exploring optimal implementation strategies for long-acting antiretroviral therapy to ensure equity in clinical care and policy for women, racially minoritised people and older people living with HIV in the UK - a qualitative multiphase longitudinal study design. BMJ Open. 2023 Jul 9;13(7):e070666. doi: 10.1136/bmjopen-2022-070666.

  PMID: 37423623 DERIVED

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

• Chloe Orkin

  QMUL

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 24, 2022
• Study Start: July 18, 2022
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

GB (6)