Good performance of syphilis rapid diagnostic test kits among young key populations in Thailand.

BACKGROUND: The prevalence of syphilis is increasing among adolescents and young adults (AYAs) globally. Use of syphilis rapid diagnostic treponemal tests (RDTs) may improve test coverage and same-day treatment. This study aims to determine sensitivity and specificity of two syphilis RDTs. METHODS: A cross-sectional study was conducted in men who have sex with men and transgender women aged 15-24 years attending a sexual health clinic in Bangkok. Syphilis RDTs used were Determine Syphilis TP and Bioline Syphilis 3.0, using whole blood from finger pricks and venipuncture. Treponemal pallidum electrochemiluminescence assay was used as standard reference. RESULTS: From February to July 2022, 200 AYAs with a mean age 21.1 (SD2.1) years were enrolled, including 50 (25.0%) living with HIV. Prevalence of syphilis was 10.5% (95%CI 6.6-15.6), which was higher among AYAs living with HIV (22.0%) compared with AYAs unaffected by HIV (6.7%). Sensitivities of Determine Syphilis TP and Bioline Syphilis 3.0 were 85.7% (95%CI 63.7-97.0) and 66.7% (95%CI 43.0-85.4), respectively. Specificity of both RDTs was 100% (95%CI 98.0-100.0). Performance of RDTs was similar for both specimens. CONCLUSIONS: Syphilis RDTs have high sensitivity and specificity in diagnosing syphilis. It should be considered for use in sexual health clinics with high syphilis prevalence to initiate treatment promptly.

Temporal trend of drug-resistant tuberculosis among Thai children during 2006-2021.

Background: The prevalence of drug-resistant tuberculosis (DR-TB) in adults has stabilized in the past decade. Our study aimed to describe the prevalence of DR-TB in Thai children between 2006 and 2021. Materials and methods: Children younger than 15 years old who had culture-confirmed Mycobacterium tuberculosis complex (MTB), positive PCR-MTB, or positive Xpert MTB/RIF were included in this cohort. Drug susceptibility testing (DST) was performed using phenotypic and/or genotypic methods. The prevalence of DR-TB was compared using the chi-square test. Results: Among 163 confirmed TB cases (44% as pulmonary TB, 27% as extrapulmonary TB, and 29% with both), the median age (IQR) was 12.2 (7.3-14.2) years. DST was performed in 139 cases (85%), revealing prevalences of all DR-TB, isoniazid-resistant TB (Hr-TB), and rifampicin monoresistant/multidrug-resistant TB (Rr/MDR-TB) of 21.6% (95% CI 14.7-28.4), 10.8% (95% CI 5.6-16.0%), and 2.9% (95% CI 0.1-5.7%), respectively. The DR-TB rates did not differ significantly between 2006-2013, 2014-2018, and 2019-2021 (p > 0.05). Two pre-extensively DR-TB (pre-XDR) cases with fluoroquinolone resistance were detected after 2014. Conclusion: The prevalence of DR-TB in Thai children was stable. However, one-tenth of DR-TB cases confirmed with DST were Hr-TB, which required adjustment of the treatment regimen. The pre-XDR cases should be closely monitored.

Pharmacokinetics and Safety of WHO-Recommended Dosage and Higher Dosage of Levofloxacin for Tuberculosis Treatment in Children: a Pilot Study.

OBJECTIVES: To evaluate the pharmacokinetic parameters of the 2020 World Health Organization (WHO)-recommended pediatric dosage of levofloxacin and the higher-than-WHO dosage. METHODS: Children aged 1-15 years with tuberculosis who received levofloxacin-based treatment for at least 7 days were enrolled. First, five children were enrolled to receive the WHO-recommended dosage (15-20 mg/kg/day), then an additional five children received a dosage higher than the WHO-recommended dosage (20-30 mg/kg/day). Blood samples were collected at predose and postdose 1, 2, 4, 6, 8, and 12 hours. A target of the ratio of the free area under the concentration-time curve to minimum inhibitory concentration (fAUC/MIC) was 100. RESULTS: The median (interquartile range) age was 9.6 (4.9-10.5) and 12.0 (10.1-12.3) years in the WHO dosage and higher-than-WHO dosage groups, respectively. The median (interquartile range) duration of antituberculosis treatment was 24 (8-24) weeks. The geometric mean (95% confidence interval) of fAUC/MIC was 60.4 (43.5-84.0) and 103.2 (70.1-151.8) in the WHO and higher-than-WHO dosage groups, respectively. There was no adverse event of QT prolongation or any other grade 3 or 4 adverse events. CONCLUSION: Levofloxacin at a higher dose of 20-30 mg/kg/day could achieve the fAUC/MIC target in children.

Retention in event-driven PrEP among young Thai men who have sex with men at risk of HIV acquisition.

Background: Daily pre-exposure prophylaxis (PrEP) regimen of tenofovir/emtricitabine (TDF/FTC) tablet is the standard of care for HIV prevention in Thailand. Event-driven PrEP (ED-PrEP), taking two loading pills 2-24 h prior to sex and two doses afterward, is considered an alternative regimen. This pilot study aimed to describe accuracy of and retention in ED-PrEP use among Thai young men who have sex with men (YMSM).Methods: A cohort of YMSM aged 15-19 years at risk of HIV infection, defined as reporting irregular condom use or having an HIV-positive sexual partner, was enrolled. All participants were provided oral TDF/FTC, condoms, and the "Raincoat" mobile application, which reminds users when to administer ED-PrEP. Participants attended clinic visits at Months 1, 3, and 6 and followed up by phone at Months 2, 4, and 5. Proper use of ED-PrEP was reported in person-months.Results: From August 2020 to July 2021, 36 YMSM with a median age of 18.7 (IQR, 17.5-19.4) years were enrolled. Thirty-two participants (88.9%, 95% CI: 73.9-96.9%) were retained at 6 months. No HIV incidence occurred during this study period. Of 197 person-months of follow-up, 69 (35%) involved sexual activity. In this group, 61% used ED-PrEP correctly. "Unplanned sexual activity" was the most commonly cited reason for incorrect use.Conclusions: YMSM who have infrequent sex had very high retention in ED-PrEP. However, about one-third of the sexually active period, ED-PrEP was not used correctly due to not taking the loading dose, suggesting that this regimen may not be suitable for unanticipated sexual activity.

A Mobile Phone App to Support Adherence to Daily HIV Pre-exposure Prophylaxis Engagement Among Young Men Who Have Sex With Men and Transgender Women Aged 15 to 19 Years in Thailand: Pilot Randomized Controlled Trial.

BACKGROUND: Widespread smartphone use provides opportunities for mobile health HIV prevention strategies among at-risk populations. OBJECTIVE: This study aims to investigate engagement in a theory-based (information-motivation-behavioral skills model) mobile phone app developed to support HIV pre-exposure prophylaxis (PrEP) adherence among Thai young men who have sex with men (YMSM) and young transgender women (YTGW) in Bangkok, Thailand. METHODS: A randomized controlled trial was conducted among HIV-negative YMSM and YTGW aged 15-19 years initiating daily oral PrEP. Participants were randomized to receive either youth-friendly PrEP services (YFS) for 6 months, including monthly contact with site staff (clinic visits or telephone follow-up) and staff consultation access, or YFS plus use of a PrEP adherence support app (YFS+APP). The target population focus group discussion findings and the information-motivation-behavioral skills model informed app development. App features were based on the 3Rs-risk assessment of self-HIV acquisition risk, reminders to take PrEP, and rewards as redeemable points. Dried blood spots quantifying of tenofovir diphosphate were collected at months 3 and 6 to assess PrEP adherence. Tenofovir diphosphate ≥350-699 fmol/punch was classified as fair adherence and ≥700 fmol/punch as good adherence. Data analysis on app use paradata and exit interviews were conducted on the YFS+APP arm after 6 months of follow-up. RESULTS: Between March 2018 and June 2019, 200 participants with a median age of 18 (IQR 17-19) years were enrolled. Overall, 74% (148/200) were YMSM; 87% (87/100) of participants who received YFS+APP logged in to the app and performed weekly HIV acquisition risk assessments (log-in and risk assessment [LRA]). The median duration between the first and last log-in was 3.5 (IQR 1.6-5.6) months, with a median frequency of 6 LRAs (IQR 2-10). Moreover, 22% (22/100) of the participants in the YFS+APP arm were frequent users (LRA≥10) during the 6-month follow-up period. YMSM were 9.3 (95% CI 1.2-74.3) times more likely to be frequent app users than YTGW (P=.04). Frequent app users had higher proportions (12%-16%) of PrEP adherence at both months 3 and 6 compared with infrequent users (LRA<10) and the YFS arm, although this did not reach statistical significance. Of the 100 participants in the YFS+APP arm, 23 (23%) were interviewed. The risk assessment function is perceived as the most useful app feature. Further aesthetic adaptations and a more comprehensive rewards system were suggested by the interviewees. CONCLUSIONS: Higher rates of PrEP adherence among frequent app users were observed; however, this was not statistically significant. A short app use duration of 3 months suggests that they may be useful in establishing habits in taking daily PrEP, but not long-term adherence. Further studies on the specific mechanisms of mobile phone apps that influence health behaviors are needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT03778892; https://clinicaltrials.gov/ct2/show/NCT03778892.

Preference and ability to perform blood-versus oral-fluid-based HIV self-testing in adolescents and young adults in Bangkok.

Introduction: Adolescents and young adults (AYA) have limited access to HIV screening tests despite the risk of acquiring HIV infection. This study aims to understand AYA preferences and their ability to perform HIV self-tests (HIVST).Methods: A cross-sectional study looked at AYA preferences when offered a choice between blood-based (INSTI®) and oral fluid-based (OraQuick®) HIVST. Adolescents and young adult participants between 18 and 24 years-old who report inconsistent condom use or had a history of sexually transmitted diseases were enrolled. Participants were offered a choice between blood-based and/or oral fluid-based HIVSTs with explanations of the differences between two types. Then, written and short video instructions according to the chosen type were given before participants performed a test. The study seeks to understand test preference, ability to perform and interpret test results.Results: From March to April 2021, 87 AYA were enrolled with a median age of 20 years (interquartile range (IQR) 18-22). Of the participants, 54 (62.1%) were men who have sex with men (MSM), 25 (28.7%) were cisgender men or women and 8 (9.2%) were transgender women (TGW). There were 37 (42.5%) first-time HIV testers and 32 (36.8%) HIV PrEP users. There were 57 participants (65.6%, 95% CI 54.6%-75.4%) that preferred blood-based HIVSTs. Reasons for preferring blood-based testing were the rapid results (77.2%) and higher accuracy (66.7%). The ability to perform and interpret HIVST results were 89.5% and 98% among INSTI users and 93.3% and 100.0% among OraQuick® users. None was HIV-positive. Moreover, 13.8% of the participants initiated same-day pre-exposure prophylaxis (PrEP).Conclusions: Thai AYA preferred blood-based over oral fluid-based HIVSTs. Most AYAs were able to perform the HIVSTs and interpret results. Supervision and post-test counselling of HIVSTs should be implemented to ensure AYA gain benefits from HIVSTs.

Diagnostic Accuracy of Loop-Mediated Isothermal Amplification (TB-LAMP) for Tuberculosis in Children.

BACKGROUND: Diagnosing tuberculosis (TB) in children is challenging due to its paucibacillary nature. Loop-mediated isothermal amplification (TB-LAMP) is a simple, rapid, and specific point-of-care molecular diagnostic test. However, evaluation of its performance remains limited in children. This study aimed to evaluate the diagnostic performance of Eiken TB-LAMP among children with presumed tuberculosis disease. METHODS: Pulmonary and extrapulmonary specimens were collected from children under 18 years with presumed TB. Each specimen was tested by using TB-LAMP, acid-fast bacilli (AFB) smear microscopy, and one of the two molecular assays (polymerase chain reaction [PCR] or Xpert MTB/RIF). Sensitivity and specificity were estimated compared to mycobacterial culture as reference standard. RESULTS: From January 2020 to January 2021, 75 participants with presumed TB were enrolled with median age of 7 years (IQR 2-12). Seventeen specimens from 16 (21.3%) children had bacteriologically confirmed TB: 10 pulmonary and 7 extrapulmonary specimens. Overall sensitivity and specificity of TB-LAMP was 76.5% (95% CI 50.1%-93.2%) and 100% (95% CI 94.3%-100%), respectively. It had significantly higher sensitivity than AFB (52.9%, 95% CI 27.8%-77.0%) and similar to other molecular assays; PCR 82.4% (95% CI 56.6%-96.2%), Xpert MTB/RIF 70.0% (95% CI 34.8%-93.3%). Sensitivity of TB-LAMP for pulmonary, lymph node tissue, and extrapulmonary fluid was 80% (95% CI 44.4%-97.5%), 100% (95% CI 39.8-100), and 33.3% (95% CI 0.8-90.6), respectively. TB-LAMP detected all smear-positive (N = 9) and 50% of smear-negative (N = 8) specimens. CONCLUSIONS: TB-LAMP had higher sensitivity than AFB microscopy and accuracy similar to other molecular assays in both pulmonary and extrapulmonary specimens. These findings support using TB-LAMP as a point-of-care test in children.

Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study.

BACKGROUND: HIV disproportionately affects young Thai men who have sex with men (YMSM). Recent studies report a high incidence and prevalence of HIV among Thai YMSM. The Thai national guidelines have recommended pre-exposure prophylaxis (PrEP) since 2014 for key populations; free PrEP has been piloted since 2019. Smartphone-based mobile health (mHealth) interventions provide an optimal platform for innovative PrEP adherence interventions for Thai YMSM. OBJECTIVE: This study aims to adapt the P3 (Prepared, Protected, emPowered) app, developed with YMSM and transwomen in the United States to improve PrEP adherence and persistence for YMSM in Thailand. The app aims to provide daily adherence support and addresses gaps in staff available for large-scale PrEP rollout needed to see population-level effects of HIV prevention. METHODS: We conducted focus group discussions (FGDs) with YMSM and key informant interviews (KIIs) with PrEP care providers in Bangkok, Thailand, to investigate PrEP adherence facilitators and barriers, preferences for functions and features in mHealth apps among YMSM, and how to best adapt the P3 app to the Thai context. We conducted four FGDs with 4-8 participants per group and 15 KIIs. RESULTS: For FGDs, 23 YMSM participated with a mean age of 20 years (range 18-21), 96% (22/23) enrolled in full-time education, and all owned smartphones. The mean age of KII participants was 40 (range 26-60) years; most were state health service providers, with the majority being counselors (6/15, 40%) and physicians (6/15, 40%). Overall, the facilitators and barriers for PrEP adherence identified were similar to those of MSM and YMSM globally including the United States. Key themes included general recommendations for improving mHealth apps in Thailand, such as presenting reliable information in an appealing format, minimizing privacy risks, and addressing connectivity challenges. Additional themes focused on P3 Thailand adaptations and were related to cultural and stylistic preferences, engagement strategies, and recommendations for new functions. To develop the adapted app, P3 Thailand, these findings were balanced with resource limitations resulting in the prioritization of minor modifications: changes in app esthetics (color scheme, iconography, and imagery) and changes in the presentation of information in two of the app's features. FGDs identified similar PrEP adherence facilitators and barriers to those already addressed within the app. CONCLUSIONS: The core elements of the P3 app address major PrEP facilitators and barriers for Thai YMSM; however, changes to the app features, including stylistic presentation, were needed to appropriately customize the app to the Thai context. Given the similarities of facilitators and barriers for PrEP adherence globally, adapting existing PrEP mHealth solutions based on input from end users and key informants provides a promising approach. However, partnerships with local app designers and developers can improve the adaptation process and final product. TRIAL REGISTRATION: ClinicalTrials.gov NCT04413708; http://clinicaltrials.gov/ct2/show/NCT04413708.

Acceptability of blood-based HIV self-testing among adolescents aged 15-19 years at risk of HIV acquisition in Bangkok.

INTRODUCTION: Young men who have sex with men (YMSM) and young transgender women (YTGW) in Thailand are at high HIV risk. HIV self-tests (HIVSTs) are rapidly administrable and prompt linkage to HIV treatment or prevention services. This study assesses the acceptability and feasibility of blood-based HIVST use in adolescents. METHODS: A cross-sectional study was conducted among YMSM and YTGW aged 15-19 years with HIV acquisition risk. Participants completed questionnaires on the HIVST and then administered INSTI® independently, an HIVST immunoassay detecting gp41 and gp36 antibodies from finger-stick blood. Confirmatory HIV antibody tests were performed. RESULTS: Between July and September 2020, 90 adolescents were enrolled. Mean (SD) age was 17.6 (1.1) years. Half (N = 45) were YMSM. Forty-six (51%) were first-time HIV testers, and 32 (36%) had "ever used" HIV pre-exposure prophylaxis (PrEP). Two (2.2%, 95% CI: 0.0-5.3) tested positive, 21 (23.4%) invalid, and 67 (74.4%) negative. Invalidity causes included 17 (81%) insufficient blood, 3 (14%) buffer spillage, and 1 (5%) procedural missteps; all had negative HIV antibody tests. HIV self-test acceptability was 87.8% (95% CI: 81.0-94.5). Most (79%) preferred HIVST performance in hospital rather than at home. CONCLUSIONS: HIVSTs are acceptable in HIV at-risk adolescents. Blood-based HIVSTs should be positioned as rapid point-of-care tests with real-time linkage to HIV services.