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Inclusive Implementation Of Long-Acting HIV Treatment And Prevention

Project Leads: Professor Chloe Orkin, Dr Sara Paparini


With early antiretroviral therapy (ART), people with HIV can achieve a normal life expectancy and do not pass the virus on to others. Pre-exposure prophylaxis (PrEP) can stop people from getting the virus. Taking daily treatment or PrEP requires daily good decision-making, which some find hard to manage. This can have serious clinical outcomes.

New longer-acting injectable treatments and PrEP have been developed and many more are in development. These innovations can free people from the burden of taking tablets. However,  SHARE researchers have shown that they are not being equitably offered to women, racially minoritised people and older adults in studies or in clinics. This needs to change and it can be changed by intentional study design.  The SHARE-led ILANA study is cited as an example of an inclusive study design in the World Health Organisation toolkit on improving inclusion into clinical trials.

Barts Health NHS Trust delivers care to around 6,000 people living
with HIV


To help bridge these inequities SHARE is improving access to clinical research for the full diversity of people living with, and affected by, HIV in the UK. Our activities for this research theme include:

  • Conducting clinical trials of long-acting treatments and PrEP
  • Delivering implementation science studies on barriers and facilitators to using long-acting compounds
  • Delivering trials on long-term remission and potential cures.
  • Facilitating inclusion of under-represented groups, such as pregnant and breast-feeding women, in clinical trials.


Orkin C, Arasteh K, Górgolas Hernández-Mora M, Pokrovsky V, Overton ET, Girard PM, Oka S, Walmsley S, Bettacchi C, Brinson C, Philibert P, Lombaard J, St Clair M, Crauwels H, Ford SL, Patel P, Chounta V, D’Amico R, Vanveggel S, Dorey D, Cutrell A, Griffith S, Margolis DA, Williams PE, Parys W, Smith KY, Spreen WR. Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection. N Engl J Med. 2020 Mar 19;382(12):1124-1135. doi: 10.1056/NEJMoa1909512. Epub 2020 Mar 4. PMID: 32130806

Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir- containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0. PMID: 32504574

Orkin C, Squires KE, Molina JM, Sax PE, Wong WW, Sussmann O, Kaplan R, Lupinacci L, Rodgers A, Xu X, Lin G, Kumar S, Sklar P, Nguyen BY, Hanna GJ, Hwang C, Martin EA; DRIVE-AHEAD Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Clin Infect Dis.2019 Feb 1;68(4):535-544. doi: 10.1093/cid/ciy540. PMID: 30184165; PMCID: PMC6355823

Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6. PMID: 28993180

Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2. PMID: 28259777
Orkin C, Molina JM, Lombaard J, DeJesus E, Rodgers A, Kumar S, Martin E, Hanna G, Hwang C. Once-daily Doravirine in Human Immunodeficiency Virus Type 1-Infected, Antiretroviral-naive Adults: An Integrated Efficacy Analysis. Clin Infect Dis. 2020 Mar 17;70(7):1344-1352. doi: 10.1093/cid/ciz424. Erratum in: Clin Infect Dis. 2020 Jan 2;70(2):360. PMID: 31121015
Orkin C, Eron JJ, Rockstroh J, Podzamczer D, Esser S, Vandekerckhove L, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Opsomer M; AMBER study group. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve HIV-1 patients. AIDS. 2020 Apr 1;34(5):707-718. doi: 10.1097/QAD.0000000000002463. PMID: 31833849

Apea VJ, Wan YI, Dhairyawan R, Puthucheary ZA, Pearse RM, Orkin CM, Prowle JR. Ethnicity and outcomes in patients hospitalised with COVID-19 infection in East London: an observational cohort study. BMJ Open. 2021 Jan 17;11(1):e042140. doi: 10.1136/bmjopen-2020-042140. PMID: 33455936; PMCID: PMC7813387

Cevik M, Haque SA, Manne-Goehler J, Kuppalli K, Sax PE, Majumder MS, Orkin C. Gender disparities in coronavirus disease 2019 clinical trial leadership. Clin Microbiol Infect. 2021 Jan 5:S1198-743X(20)30785-0. doi: 10.1016/j.cmi.2020.12.025. Epub ahead of print. PMID: 33418021; PMCID: PMC7785275

Parry S, Bundle N, Ullah S, Foster GR, Ahmad K, Tong CYW, Balasegaram S, Orkin C. Implementing routine blood-borne virus testing for HCV, HBV and HIV at a London Emergency Department – uncovering the iceberg? Epidemiol Infect. 2018 Jun;146(8):1026-1035. doi: 10.1017/S0950268818000870. Epub 2018 Apr 17. PMID: 29661260

Get in touch

If you’d like more information about research theme one, please contact the project leads:

Professor Chloe Orkin
Email c.m.orkin@qmul.ac.uk

Dr Sara Paparini
Email s.paparini@qmul.ac.uk