Institute for Global Health


The Centre for Clinical Research in Infection and Sexual Health - Research Projects

Study Short TitleFull TitleName of PIDatesStatus
BHIVA COVID-19 RegistryBritish HIV Association (BHIVA) COVID-19 RegistryCaroline SabinOctober 2020 - ongoingCurrent
Association of HIV with outcomes of COVID-19 hospitalization outcomesOutcomes of COVID-19-related hospitalization among people with HIV in the ISARIC World Health Organization (WHO) Clinical Characterization Protocol (UK)Caroline SabinMay 2020 - ongoingCurrent
UK community survey of COVID/HIVCommunity Survey of the experiences of COVID-19 on people living with HIV in the UKCaroline SabinJune 2020 - ongoingCurrent
SIREN (Sarscov2 Immunity & REinfection EvaluatioN)Impact of detectable anti-SARS-COV2 on the subsequent incidence of COVID-19 in healthcare workersAlejandro Arenas-PintoSeptember 2020 to September 2022Current
Analysing immune responses to vaccinationAnalysing humoral and cellular immune responses to vaccination during chronic infectionDimitra Peppa, Richard Gilson, Laura WatersOctober 2020 to October 2025Recruiting
UKACHUKACH Cohort for Acute Hepatitis C: A prospective, multicentre, observational, cohort study of Acute Hepatitis C in the United KingdomJohn Saunders Recruiting
ANTIMICROBIAL PROPHYLAXIS SURVEY (POPS) Understanding the Prevelance of Prophylaxis for STI use among sexual health clinic usersJohn Saunders Recruiting
ASSISTAssessing the impact of introducing online postal self-sampling for sexually transmitted infections into sexual health provision within the UK on health inequalities, access to care and clinical outcomes.Fiona Burns & Jo Gibbs2st January 2021 to 31st March 2024Recruiting
ChampionsCapturing Hepatitis C diagnoses Amongst MSM using Peer networks to Improve linkage to Services: Part 1 (Qualitative)Nina Vora Recruiting
DEVA Richard Gilson Recruiting
EAGLE Richard Gilson Recruiting
Jenner IITemporal analysis of host immune responses and mechanisms impairing control of viral replication of during the course of HIV-1 infectionDimitra Peppa Recruiting
LEGACYSARS-CoV-2 Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)Richard Gilson Recruiting
LAPTOPAn Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease – The Late Presenter Treatment Optimisation Study (LAPTOP)Robert Miller Recruiting
POPPY NEW WAVE A prospective, observational study to examine the efects of ageing on the clinical outcomes of people living with HIV in England and Ireland - Waves 4 and 5 POPPY 4 & 5 - 'Pharmacokinetic and Clinical Observations in People over Fifty Waves 4 and 5'Ian Williams Recruiting
POSITIVE VOICESPositive Voices: The national survey of people living with HIVRichard Gilson Recruiting
PREP DLM Urine drug level monitoring (DLM) to support HIV pre-exposure prophylaxis (PrEP) adherenceJohn Saunders Recruiting
RIO The RIO Trial: A randomised placebo controlled trial of ART plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) vs ART plus placebo in treated Primary HIV Infection on viral control off ARTSarah Pett Recruiting
SEQUENCE DIGITALSEQUENCE Digital - Sexual health equity through evidence-based online clinical care: Pre-Trial Qualitative StudiesJohn Saunders Recruiting
SEPACScreening and early detection to prevent anal cancer; development of a biomarker screening toolRichard GilsonApril 2019 to March 2022Recruiting
INTUITInteraction Design for Trusted Sharing of Personal Health Data to Live Well with HIVJo Gibbs Closed for recruitment
Chips+CHIPS+: Optimising the health of young people with HIV in their transition from paediatric to adult careAlistair Teague Closed for recruitment
POPPYThe POPPY (Pharmacokinetic and clinical Observations in PeoPle over fiftY) StudyCaroline Sabin Closed for recruitment
POPPY SleepPOPPY Sleep Substudy: study looking at the effects of being HIV positive and being on antiretroviral medication may have on sleeping and sleep patternCaroline Sabin Closed for recruitment
Mala Malini Hep B study Richard Gilson Ongoing
HIV Bioresource Fiona Burns Paused
Elite ControllersHIV elite controllers: Comprehensive assessment of host factors associated with HIV-1 elite controlDimitra Peppa Paused
B-SUREA prospective, Multi-Centre Study (B-Sure) to evaluate long-term durability of sustained virologic response in chronic hepatitis B participants with and without nucleos(t)ide therapy who have recieved and responsed to GSK3228836 in a previous treatmentRichard Gilson In follow up
DOLOMITEDOLOMITE NEAT ID Network Study: A multi- site observational study to define the safety and effectiveness of Dolutegravir use in HIV positive pregnant womenSherie Roedling In follow up
Eurosida 9EuroSIDA Cohort 9: Observational cohort study collecting clinical and demographic data for HIV-positive adults.Simon Edwards In follow up
Eurosida 10EuroSIDA Cohort X: Observational cohort study collecting clinical and demographic data for coinfected HIV/HCV positive adults.Simon Edwards In follow up
SAFETXTSafetxt: randomised controlled trial of safer sex intervention delivered through mobile phone messagingJohn Saunders In follow up
GSK EPI-HSV-006An epidemiologicaL study to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe.John Saunders In follow up
MAVMETMAVMET: a multicentre, 48 week randomised controlled factorial trial of adding Maraviroc and/or Metformin for hepatic steatosis in HIV-1-infected adults on combination antiretroviral therapySarah Pett Completed
PETRAMUnderstanding changes in treatment-related regional bone turnover using 18F-fluoride-PET/CT in HIV-1-infected men: PETRAM studySarah Pett Completed
SAFER (UCLH) Nina Vora Completed
PrEP IMPACT TrialPrEP IMPACT Trial: A pragmatic health technology assessment of PrEP and implementation.Richard Gilson Completed
POPPY LIVERHepatic steatosis in people living with HIV older than 50 years of age: The POPPY Hepatic Steatosis Sub-StudyAlejandro Arenas-Pinto Completed
ECLEAREarly administration of anti-latency reversing therapy and broadly neutralizing antibodies to limit the establishment of the HIV-1 reservoir during initiation of antiretroviral treatment - a randomized controlled trial (eCLEAR)Erica Pool Completed
FLAIRFLAIR: A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy and Safety of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected ART-Naive Adult ParticipantsSarah PettNov 2016 - currentCompleted 
BESTTBESTT WOMEN's STUDY: Bone Evaluation in HIV positive women who switch from Truvada/NNRTI to TriumeqLaura WatersMay 2016 – Apr2020Completed
VITAVITA: A randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosisRichard GilsonNov 2017 – Jun 2019Completed
TANGOA Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1-infected adults who are virologically supressed  Sarah PettApr 2018 - currentCompleted
BRIDGE-ITA randomised controlled trial to determine the effectiveness of bridging from emergency to regular contraception: The Bridge –it studyRichard Gilson Completed
DISCOVERGS-US-412-2055: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 InfectionRichard Gilson Completed
PRIME FSHPRIME Ovarian Biomarker Study: Biomarkers of ovarian ageing in postmenopausal women living with HIV - a prevalence studyRob Miller/Shema Tariq Completed
STARTStrategic Timing of AntiRetroviral Treatment (START): Randomized study to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3Ian Williams Completed
PROUDPRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay menRichard Gilson Completed
RiverRIVER - Research in Viral Eradication of HIV Reservoirs - a functional cure studySarah Pett Completed
H-ART 2 HEARTDeep Cardiovascular Phenotyping of People with HIV on Anti-Retroviral Therapy at risk of Heart DiseaseRichard Gilson Completed
GENAFRICAGenetic markers of kidney disease progression in people of African heritage in the UK CHIC cohortSarah Pett Completed
CIPHERCIPHER - study of cognitive function in HIV+ people.Lewis Haddow Completed
AMBERAMBER - randomised, double-blind study to evaluate efficacy and safety of DRV/cobicistat/FTC/TAF vs. DRV/cobicistat fixed dose combination plus Truvada®Laura Waters Completed
EMERALDEMERALD: randomized, active-controlled, open-label study to evaluate the efficacy and safety of switching to a D/C/F/TAF once-daily single-tablet regimen versus continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with FTC/TDFLaura Waters Completed
FLU STUDYInfluenza acquisition in Health Care Workers who work on a dedicated influenza cohort wardRichard Gilson Completed
STOP HCV-1STOP HCV-1: Stratified Treatment OPtimisation for HCV-1: An open-label randomised controlled trial (RCT) testing biomarker-stratified short-course first-line and re-treatment direct-acting antiviral (DAA) oral treatment regimens to cure mild chronic Hepatitis C (HCV) disease.Richard Gilson Completed
PARTNERPARTNER 2.0: A study in HIV sero-different partnerships to estimate the rate of transmission of HIV and to investigate factors associated with condom useRichard Gilson Completed
PIBIKA Phase IV Randomised, Open-Label Pilot Study to Evaluate Switching from Protease-Inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in Integrase Inhibitor-naïve, virologically suppressed HIV-1 infected adults harbouring drug resistance mutationsLaura Waters Completed
ICOSInternational SARS-CoV-2 Infection Observational StudyRichard Gilson27th May 2020 - (ongoing)Completed
GS-1489GS-US-380-1489: A phase 3, randomised, Double Blind Study to Evaluate the Safety and Efficacy of GS9883/FTC/TAF vs. Triumeq in HIV-1 Infected, Antiretroviral Treatment Naïve AdultsLaura Waters Completed
GS-1490GS-US-380-1490: A Phase 3, Randomised, Double Blind Study of the Safety and Efficacy of a Fixed Dose combination of GS9883/FTC/TAF vs. DOL/FTC/TAF in HIV-1 infected, Antiretroviral Treatment- Naïve AdultsLaura Waters Completed
Merck 021MK-1439A-021: Double-Blind, Randomised Trial of Safety and Efficacy of FDC of TDF/3TC/doravirine (MK1439A) Once Daily vs Atripla® in Treatment Naïve HIV-positivesIan Williams Completed
Merck 024MK-1439A-024: randomised study evaluating immediate vs deferred switch to  FDC of TDF/3TC/doravirine in patients stable and suppressed on a PI/r+2NRTIIan Williams Completed
Merck 018A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA™ or EPZICOM™/KIVEXA™, in Treatment-Naïve HIV-1Infected Subjects.Ian Williams Completed
SALSAA Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressedSarah Pett Completed
HIPVACHIPvac: Randomised controlled trial of Imiquimod cream vs. podophyllotoxin in combination with quadrivalent HPV or control vaccination in the treatment and prevention of recurrence of anogenital warts.Richard GilsonFeb 2014 - currentCompleted
SYPHILIS TRANSCRIPTOMICSSyphilis Transcriptomics: Proof of concept study that aims to utilise next generation sequencing and transcriptomic approaches to understand infection with Treponema pallidumPatrick FrenchOct 2017 - currentCompleted
HPV SAMPLINGHPV Sampling Study: A study to evaluate the performance of human papillomavirus (HPV) DNA detection in residual specimens taken for Chlamydia trachomatis/Neisseria gonorrhoea nucleic acid amplification testing in men who have sex with men (MSM)Diarmuid NugentJan 2018 - currentCompleted
PRIMEPRIME: Quantitative and qualitative study that will exploring the impact of the menopause on HIV-positive women's health and wellbeingShema TariqJan 2016 – Oct 2017Completed
UK HDRDUK HIV Drug Resistance DatabaseDavid Dunn2001 – currentCompleted
GS-1823GS-US-292/1823: A Phase 3b, Randomised, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of ABC/3TC plus a Third Antiretroviral Agent to the E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult SubjectsLaura WatersSep 2016 – May 2018Completed
GS-1826GS-US-292-1826: A Phase 3b, Randomised, Open-Label Study to Evaluate Switching from a TDF Containing Regimen to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 60 YearsLaura WatersAug 2016 – Mar 2018Completed
DOR-DOL Efficacy of doravirine + dolutegravir dual therapy in the context of antiretroviral therapy switchLaura Waters Upcoming
WEIGHT GAIN STUDY Alejandro Arenas-Pinto Upcoming
TREP-AB (SYPHILIS RCT)Oral and Neuro-Penetrative Alternative Antibiotics for Patients with SyphilisRichard Gilson Upcoming
TRANSBICEfficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH)Laura Waters Upcoming
TINIESSmall Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis BStuart FlanaganSeptember 2022Upcoming
STI AbbottDevelopment & Evaluation of CT/NG Rapid TestsRichard GilsonSeptember 2022Upcoming
SPOTFIREPOC test evaluationRichard GilsonSeptember 2022Upcoming
SHINESinecatechins in High grade Intraepithelial Neoplasia EradicationRichard GilsonApril-2023Upcoming
SHIELDSecuring best health outcomes for people living with HIV through optimal engagement with care: Learning from Disruptive changeLaura Waters Upcoming
SEPAC patient experiences Emmi Suonpera Upcoming
SAFE ONE (BV Study)Phase I study of a BV treatmentRichard Gilson Upcoming
REFINE-BREgimen optimisation: Feasibility of sImplifying NucleotidE therapy in HIV/HBV coinfectionStuart Flanagan Upcoming
PRIME DisabilityThe PRIME Disability StudyShema Tariq Upcoming
PrEPaRePre-exposure prophylaxis use in people newly diagnosed with HIVRichard Gilson Upcoming
PrEP Quality of LifePrEP Quality of LifeJohn Saunders Upcoming
OXFORD GC studyEcology of oral Neisseria species in men who have sex with men: implications for Neisseria gonorrhoeae transmission and the emergence of antimicrobial resistanceRichard Gilson Upcoming
OTAC (INSIGHT)An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19Alejandro Arenas-Pinto Upcoming
MOSAICCohort study in human Monkeypox virus diseaseAlejandro Arenas-Pinto Upcoming
MISTRALGut microbiome correlates of serious AIDS and non-AIDS eventsSarah PettSeptember 2022Upcoming
META-DSwitch from stable cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir to TDF/3TC/doravirine in people living with HIV: Impact on lipids, body composition, insulin sensitivity, neuroendocrine function and inflammation markersAlejandro Arenas-Pinto Upcoming
HIS-UKEvaluating the Home-based Intervention Strategy (HIS-UK) to reduce new Chlamydia infection among young men aged 16-25 years by promoting correct and consistent condom use: What is the cost effectiveness of two different delivery models (face-to-face and digital delivery)?Richard Gilson Upcoming
GSK HSV REC-003A study on the reactogenicity, safety, immune response, and efficacy of a vaccine against HSV-2 in healthy participants aged 18-40 years or in participants aged 18-60 years with recurrent HSV-2 genital herpesJohn Saunders Upcoming
Gonorrhoea vaccine study (phase 3)A Phase III, randomised, observer blind, placebo-controlled study to assess the efficacy of meningococcal combined ABCWY vaccine in preventing gonococcal infection in adolescents and adults 16 to 50 years of age.Richard Gilson Upcoming
Gonorrhoea vaccine study (phase 1)A Phase I/II, observer-blind, randomised, placebo controlled multi-country study to assess safety and efficacy of GSK NgG candidate vaccine when administered to healthy adults 18 to 50 years of ageRichard Gilson Upcoming
EBI-HIVTBCShema Tariq Upcoming
CASCADEManagement of the current HIV epidemic in Europe: Important insights from HIV seroconverter cohortsKholoud Porter Upcoming
B-WELLMulti-Centre, Randomised, Partial-Blind Parallel Study to Assess the Efficacy and Safety of Treatment with GSK3228836 in Participants with Chronic Hepatitis B Virus on stable nucleos(t)ide treatment, or naïve patients not currently on nucleos(t)ide therapyRichard Gilson Upcoming
MgenFeasibility of culture of Mycoplasma genitalium (MGen) from clinical specimensJohn Saunders Upcoming
B-togetherA Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment with GSK3228836 followed by Pegylated Interferon Alpha 2a in Participants with Chronic Hepatitis B Virus (B-Together)Richard Gilson Upcoming