Point-of-Care (PoC) STIs
To strengthen STI services as part of the KPLHS model, IHRI launched a study in August 2019 to integrate Point-of-Care (POC) testing for chlamydia and gonorrhea into HIV services at four CBOs in Bangkok, Chonburi, and Chiang Mai. The study aims to enroll 2,100 MSM and TGW, including those who are living with HIV or without HIV regardless of PrEP status. This study has further strengthened the capacity of trained key population lay providers in providing STI screening and management, as well as their research capacities. To reduce the gap between diagnosis and treatment of STIs in CBOs, the prescription of oral drugs for chlamydia at CBOs was initiated. For any participants who have abnormal testing on STIs, we aim to refer them to treatment within the next day after knowing their status, in order to decrease the transferal of diseases to their partners or others. In addition, one of the key barriers to enrollment in this study was needing to show one’s private parts to CBO staff, which was against Thai culture. . This privacy issue was addressed by allowing self-collection in the study.
The study started with a validation study in RSAT and SWING Bangkok (first 200 participants) to assess the performance of the pooling strategy (three compartments from 1 participant) for STI testing and to ensure the ability of machines and analyzers. The Standard of Care (SoC) for this experiment was laboratory-based with separate testing of three compartments by using Abbott RealTime assay. Then, we compared with trained key population (KP) lay providers who performed separate and pooled samples by Cepheid GeneXpert at community-based organization (CBO). The pooled sample in this experiment was prepared using fresh urine, pharyngeal specimen and rectal specimen collected from each participant. Pooled sampling can reduce costs by eliminating the need for testing of three separate compartments, while avoiding missed infections by selecting only one compartment for screening. The validation part of the study was completed in October 2019 and the analysis showed that chlamydia and gonorrhea and HIV viral load testing by KP lay providers using the GeneXpert assay in CBOs was feasible, and performance of the assay was excellent when compared with SoC. Currently, the study is ongoing with plans to continue enrolling participants until the end of this year.
Hiransuthikul A, Janamnuaysook R, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. High burden of chlamydia and gonorrhoea in pharyngeal, rectal and urethral sites among Thai transgender women: implications for anatomical site selection for the screening of STI. Sex Transm Infect 2019.
Hiransuthikul A, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. Correlations of chlamydia and gonorrhoea among pharyngeal, rectal and urethral sites among Thai men who have sex with men: multicentre community-led test and treat cohort in Thailand. BMJ open 2019; 9(6): e028162.
Hiransuthikul A, Pattanachaiwit S, Teeratakulpisarn N, Chamnan P, Pathipvanich P, Thongpaen S, Pengnonyang S, Trachunthong D, Nonenoy S, Lertpiriyasuwat C, Phanuphak P, Phanuphak N. High subsequent and recurrent sexually transmitted infection prevalence among newly diagnosed HIV-positive Thai men who have sex with men and transgender women in the Test and Treat cohort. Int J STD AIDS 2019; 30(2): 140-6.
Bacterial sexually transmitted infections (STI) are a major public health concern globally, affecting over 357 million people every year. Neisseria gonorrhoeae (NG), the etiological agent of gonorrhoea, is estimated to have caused 78 million infections in 2012. The Western Pacific and African regions have the highest incidence of gonococcal infections worldwide, with 89 and 50 cases per 100,000 population respectively. Over the past few years, concerns have been raised over the spread of gonococcal antimicrobial resistance (AMR). Identifying new treatment options for multi-drug resistant gonorrhoea is a key element of the WHO global action plan to control the spread and impact of gonococcal AMR, sponsored by the Global Antibiotic Research and Development Partnership (GARDP).
Zoliflodacin is a new promising option to address the risk posed by the threat of drug-resistant gonorrhoea. The purpose of this phase III multi-center, randomized, open-label, non-inferiority trial is to confirm the efficacy and safety outcomes observed in the phase II trial and to generate the necessary evidence to support a marketing authorization application in the USA, the European Union (EU), South Africa and Thailand.
IHRI has been preparing to initiate, in August 2020, a phase III multi-center study to evaluate the efficacy and safety of zoliflodacin, a promising single-dose oral medication, to treat gonococcal infection. The study will be conducted in the United States of America, the European Union, South Africa and Thailand.
FIND is a global non-profit organization that bridges innovative diagnostic testings to facilitate access into the targeted countries, especially low- and middle-income countries. FIND acts as the middleman to determine how to coordinate between the technology development company and selected high disease burden countries to reduce those countries’ assessment periods when diagnostic testings are launched. Thailand is a destination for Neisseria gonorrhoea (NG) point-of-care (POC) diagnostic tests in Asia due to the high burden of NG and gonorrhea resistance. IHRI cooperates with FIND to gather the information from the selected key STI stakeholders in Thailand who understand the national context on NG/STI treatment and testing by using an interview guide provided by FIND. In addition, to supplement the interviews, an online survey tool developed by FIND is extended to the additional stakeholders to input the different perspectives on these testings. The gathered information would be beneficial for the country when the affordable and reliable NG POC diagnostic tests are available in Thailand.
Bexsero Vaccine study
The global burden of morbidity and mortality resulting from infections with Neisseria gonorrhoeae (N. gonorrhoeae) is a pressing global public health problem. With an estimated 80 million new infections worldwide and >580,000 diagnosed cases annually in the United States (US), gonococcal infections significantly impact both short and long-term reproductive health and contribute to increasing Human Immunodeficiency Virus (HIV) transmission. This pervasive pathogen impacts sexual and reproductive health, reduces quality of life, and imposes a substantial strain on the budgets of both communities and national health systems globally.
To date, N. gonorrhoeae has developed resistance to all antibiotics used for routine therapy by a wide variety of bacterial antimicrobial resistance mechanisms. The continued emergence of multidrug resistant (MDR) and most recently, extensively drug-resistant (XDR) strains has driven governments and health institutions to increase investment in biomedical countermeasures to mitigate the threat.
Despite decades of vaccine research, no vaccines against gonorrhea have been successful in preventing human disease. However, novel approaches to vaccine development for Neisseria meningitidis serogroup B have shown evidence of protection against N. gonorrhoeae. Specifically, the use of outer membrane vesicle (OMV) vaccines to serogroup B meningococcal strains has been associated with reduced rates of incident gonococcal infection in ecologic studies.
Bexsero, the GSK vaccine against serogroup B N. meningitidis (rMenB+OMV NZ) is an OMV vaccine that contains protein antigens commonly expressed on the surface of both meningococcus and gonococcus, inducing bactericidal antibodies that mediate killing of the majority of epidemiologically relevant serogroup B N. meningitidis strains; therefore, it may also have the potential to prevent gonorrhea infection.
This study aims to evaluate the efficacy of the U.S. FDA licensed vaccine rMenB+OMV NZ (Bexsero) in preventing N. gonorrhoeae infection through a randomized controlled trial (RCT) in participants disproportionately impacted by gonococcal infection relative to the general population (defined below). Participants will be randomized in a 1:1 ratio to receive two IM doses (0, 2 months) of Bexsero vaccine or placebo. This study will be conducted in early 2021 – a Phase II randomized, observer-blind, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection.