Pooled Pharyngeal, Rectal, and Urine Specimens for the Point-of-Care Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Lay Providers in Key Population-Led Health Services in Thailand.

Routine testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in people with heightened risk is lacking in Thailand. This study aimed to assess the performance of the Cepheid Xpert CT/NG assay, conducted by key population (KP) lay providers, for CT and NG detection on single-site and pooled specimens from the pharynx, rectum, and urine. Between August and October 2019, 188 men who have sex with men and 11 transgender women were enrolled. Participants collected urine specimens while trained KP lay providers obtained pharyngeal and rectal swabs. Compared to single-site testing with the Abbott RealTime CT/NG assay by medical technologists, the Xpert assay missed one pharyngeal NG infection out of 199 single-site specimens, giving a 93.3% sensitivity for pharyngeal NG and one missed pharyngeal NG infection out of fifty pooled specimens, giving an 88.9% sensitivity for pharyngeal NG. There was no discrepancy between the two assays for CT detection. The Cohen's Kappa coefficient of pooled specimen testing by the Xpert was 0.93 for NG and 1 for CT when compared to single-site testing by Abbott. Implementing pooled specimen testing by KP lay providers can be a cost-saving strategy to enhance the uptake of CT/NG services for populations facing increased risk.

Acceptability and retention of the key population-led HIV treatment service for men who have sex with men and transgender women living with HIV in Thailand.

INTRODUCTION: In Thailand, where the HIV epidemic is concentrated among key populations (KPs), particularly men who have sex with men (MSM) and transgender women (TGW), an HIV service delivery model tailored to KPs was piloted. This study evaluated the acceptability and retention of clients who accepted and declined the KP-led HIV treatment service. METHODS: A retrospective cohort study was conducted using secondary data from three community-based organizations (CBOs) and three hospitals in Thailand. KP lay providers were trained to lead HIV treatment service in which MSM and TGW living with HIV received counselling and a 3-month antiretroviral therapy (ART) supply at CBOs. Thai MSM and TGW who were at least 18 years, on ART for at least 6-12 months, without co-morbidities/co-infections, and virally suppressed were eligible and offered the service. Those who declined received ART via other service models offered by the hospitals and served as a comparison group. RESULTS: Of 220 clients screened between February 2019 and February 2020, 72% (159/220) were eligible of which 146 were MSM and 13 were TGW. Overall, 45% (72/159) accepted the KP-led service. Of those who declined, 98% (85/87) preferred to see the physician at the hospital. After 12 months of follow-up, among those accepted, 57% were in care at the CBO, 32% were referred back to and in care in other service models offered by the hospital, 10% were successfully transferred out to other hospital and 1% were lost to follow-up (LTFU); among those declined, 92% were in care in any service models offered by the hospital, 5% were successfully transferred out to other hospital, 2% were LTFU and 1% died (p-value<0.001). CONCLUSIONS: Despite moderate acceptability and retention in care at the CBO among the clients accepting the KP-led service, almost all clients were engaged in care overall. Multiple service models that meet the preferences and needs of KPs living with HIV should be available to optimize engagement in care.

Assessment of U=U understanding, PrEP awareness, HIV risk behaviours and factors associated with low HIV knowledge among users of Hornet, an online dating application for LGBTQ, in Thailand.

BACKGROUND: Over 50% of HIV infections in Thailand annually occur among men who have sex with men (MSM) and transgender women who use online applications to meet their sexual partners. We conducted a cross-sectional study assessing undetectable=untransmittable (U=U) understanding, pre-exposure prophylaxis (PrEP) awareness, sexual behaviours and factors associated with HIV knowledge among users of Hornet in Thailand. METHODS: From November 2019 to January 2020, a survey was conducted using convenience sampling on Hornet in Thailand. HIV literacy was assessed via 22 questions, and multivariable linear regression was performed. RESULTS: 960 responses were assessed; median age was 34 years, the majority were MSM (80.4%), Thai (83.8%), had at least bachelor's degree (74.9%). Regarding the risk profiles, 39.1% reported inconsistent condom use, 15.0% used amphetamine-type stimulants, 56.9% had not taken PrEP in the last six months and 20.5% never had an HIV test. Only 22.8% thought that U=U was completely accurate. Lower HIV knowledge was associated with being from Africa (ß -8.13, 95% CI -14.39 to -1.87), age of 25 years or younger (ß -2.6, 95% CI -4.37 to -0.82), education less than bachelor's degree (ß -2.58, 95% CI -3.98 to -1.19), having more than one sexual partners (ß -2.41, 95% CI -4.13 to -0.69), paying three or more people to have intercourse (ß -2.5, 95% CI -4.26 to -0.74), not knowing one's HIV status (ß -3.56, 95% CI -5.45 to -1.68) and not answering about previous PrEP use (ß -4.11, 95% CI -7.86 to -0.36). Higher HIV knowledge was associated with being from Europe (ß 2.54, 95% CI 0.46 to 4.61), the Americas (ß 3.37, 95% CI 0.44 to 6.30) and previous PrEP use (ß 2.37, 95% CI 0.94 to 3.81). CONCLUSION: Among Hornet users in Thailand, the U=U message was unclear, and PrEP use was suboptimal. Large HIV knowledge gaps and high-risk behaviours were concerning. Educational campaigns in online spaces are needed to promote awareness and HIV prevention strategies.

Acute HIV-1 infection viremia associate with rebound upon treatment interruption.

BACKGROUND: Analytic treatment interruption (ATI) studies evaluate strategies to potentially induce remission in people living with HIV-1 but are often limited in sample size. We combined data from four studies that tested three interventions (vorinostat/hydroxychloroquine/maraviroc before ATI, Ad26/MVA vaccination before ATI, and VRC01 antibody infusion during ATI). METHODS: The statistical validity of combining data from these participants was evaluated. Eleven variables, including HIV-1 viral load at diagnosis, Fiebig stage, and CD4+ T cell count were evaluated using pairwise correlations, statistical tests, and Cox survival models. FINDINGS: Participants had homogeneous demographic and clinical characteristics. Because an antiviral effect was seen in participants who received VRC01 infusion post-ATI, these participants were excluded from the analysis, permitting a pooled analysis of 53 participants. Time to viral rebound was significantly associated with variables measured at the beginning of infection: pre-antiretroviral therapy (ART) viral load (HR = 1.34, p = 0.022), time to viral suppression post-ART initiation (HR = 1.07, p < 0.001), and area under the viral load curve (HR = 1.34, p = 0.026). CONCLUSIONS: We show that higher viral loads in acute HIV-1 infection were associated with faster viral rebound, demonstrating that the initial stage of HIV-1 infection before ART initiation has a strong impact on viral rebound post-ATI years later. FUNDING: This work was supported by a cooperative agreement between the Henry M. Jackson Foundation for the Advancement of Military Medicine and the US Department of the Army (W81XWH-18-2-0040). This research was funded, in part, by the US National Institute of Allergy and Infectious Diseases (AAI20052001) and the I4C Martin Delaney Collaboratory (5UM1AI126603-05).

High Proportion of Blood-Borne and Sexually Transmitted Infections Among People Deprived of Liberty in a Central Male Prison in Thailand: A Cross-Sectional Study 2018-2019.

Data are lacking or outdated on burden of HIV, viral hepatitis infection, and sexually transmitted infections such as syphilis among people deprived of liberty in the Asia-Pacific region. We aimed to evaluate the proportion of viral hepatitis B (HBV), hepatitis C (HCV), HIV, and syphilis infections, and factors associated with HCV, HBV, and HIV infection in a central male prison. A cross-sectional study was performed among 1,028 people deprived of liberty from a central male prison in Bangkok, Thailand. People deprived of liberty were screened for HIV, HBV, HCV, and syphilis infections during 2018-2019. HBV and HCV were defined as positive hepatitis B surface antigen and positive anti-HCV antibody, respectively. Proportions (95% confidence interval [CI]) of infections were calculated based on the binomial distribution. HBV proportion was reported for different age groups. Risk factors associated with HCV infections were evaluated by logistic regression model. The median age was 38 (interquartile range, 32-50) years, and 6.9% reported use of injection drugs. The proportion of HIV, HBV, anti-HCV, HCV RNA, and syphilis was 2.9% (95% CI, 1.9-4.1), 6.4% (5-8.1), 5.9% (4.6-7.6), 4.2% (3-5.6), and 4.8% (3.5-6.3), respectively. One (0.1%), 7 (0.6%), and 2 (3%) were co-infected with HIV/HBV, HIV/HCV, and HDV/HBV, respectively. HBV proportion differed across age groups: 3.7% in <30 years, 7% in 31-40 years, 9.7% in 41-50 years, and 5.5% in >50 years. Factors associated with HCV infection were older age, lower education level, previous incarceration, and injection drug use. In multivariable models, older age was associated with HBV infection, and men having sex with men was associated with HIV infection. The proportion of blood-borne infections was higher among males than among the general population. HBV vaccination, routine HCV screening, and treatment with pan-genotypic direct-acting antivirals with minimal specialist requirements should be implemented in Thai prisons.

Prevalence and the associated factors of hepatitis B and hepatitis C viral infections among HIV-positive individuals in same-day antiretroviral therapy initiation program in Bangkok, Thailand.

BACKGROUND: Viral hepatitis is highly prevalent among people with HIV (PWH) and can lead to chronic liver complications. Thailand started universal hepatitis B vaccination at birth in 1992 and achieved over 95% coverage in 1999. We explored the prevalence of hepatitis B and C viral infections and the associated factors among PWH from same-day antiretroviral therapy (SDART) service at the Thai Red Cross Anonymous Clinic, Bangkok, Thailand. METHODS: We collected baseline characteristics from PWH enrolled in the SDART service between July 2017 and November 2019. Multivariable logistic regression was performed to determine factors associated with positive hepatitis B surface antigen (HBsAg) and hepatitis C antibody (anti-HCV). RESULTS: A total of 4011 newly diagnosed PWH who had HBsAg or anti-HCV results at baseline: 2941 men who have sex with men (MSM; 73.3%), 851 heterosexuals (21.2%), 215 transgender women (TGW; 5.4%), and 4 transgender men (0.1%). Median age was 27 years. Overall seroprevalence of HBsAg and anti-HCV were 6.0 and 4.1%, respectively. Subgroup prevalence were 6.2 and 4.7% among MSM, 4.6 and 2.4% among heterosexuals, and 9.3 and 3.7% among TGW, respectively. Factors associated with HBsAg positivity were being MSM, TGW, born before 1992, CD4 count < 200 cells/mm3, and alanine aminotransferase ≥ 62.5 U/L. Factors associated with anti-HCV positivity were being MSM, age > 30 years, alanine aminotransferase ≥ 62.5 U/L, creatinine clearance < 60 ml/min, and syphilis infection. CONCLUSIONS: Around 5-10% of newly diagnosed PWH in Bangkok had hepatitis B viral infection after 25 years of universal vaccination. Anti-HCV positivity was found in 4-5% of PWH who were MSM and TGW. As World Health Organization and Thailand national guidelines already support routine screening of hepatitis B and C viral infections in PWH and populations at increased risk of HIV including MSM and TGW, healthcare providers should reinforce this strategy and provide linkage to appropriate prevention and treatment interventions. Catch-up hepatitis B vaccination should be made available under national health coverage.

Anti-HIV antibody development up to 1 year after antiretroviral therapy initiation in acute HIV infection.

Early initiation of antiretroviral therapy (ART) in acute HIV infection (AHI) is effective at limiting seeding of the HIV viral reservoir, but little is known about how the resultant decreased antigen load affects long-term Ab development after ART. We report here that Env-specific plasma antibody (Ab) levels and Ab-dependent cellular cytotoxicity (ADCC) increased during the first 24 weeks of ART and correlated with Ab levels persisting after 48 weeks of ART. Participants treated in AHI stage 1 had lower Env-specific Ab levels and ADCC activity on ART than did those treated later. Importantly, participants who initiated ART after peak viremia in AHI developed elevated cross-clade ADCC responses that were detectable 1 year after ART initiation, even though clinically undetectable viremia was reached by 24 weeks. These data suggest that there is more germinal center (GC) activity in the later stages of AHI and that Ab development continues in the absence of detectable viremia during the first year of suppressive ART. The development of therapeutic interventions that can enhance earlier development of GCs in AHI and Abs after ART initiation could provide important protection against the viral reservoir that is seeded in individuals treated early in the disease.

Same-day antiretroviral therapy initiation hub model at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand: an observational cohort study.

INTRODUCTION: WHO has recommended rapid antiretroviral therapy (ART) initiation, including same-day ART (SDART). However, data on the feasibility in real-world settings are limited. We implemented a cohort study at a stand-alone HIV testing centre to examine its applicability and effectiveness. METHODS: Data were collected from the Thai Red Cross Anonymous Clinic in Bangkok, Thailand, between July 2017 and July 2018 from clients who were ART-naïve and could return for follow-up visits. Baseline laboratory tests and chest X-ray were performed according to national guidelines, and clinical eligibility was determined based on physical examination and chest X-ray findings. Primary outcomes were retention in care and viral load suppression at 3, 6 and 12 months. RESULTS: During the study period, 2427 people tested HIV positive. Of these, 2107 (2207/2427, 86.8%) met logistical criteria, and 1904 (1904/2427, 78.5%) agreed to SDART. One thousand seven hundred and twenty-nine (1729/2427, 71.2%) were placed on ART, with 1257 received same-day initiation and 1576 initiated ART within 7 days; 1198 clients were successfully referred to free, sustained ART sites. Retention among eligible clients who accepted SDART service at months 3, 6 and 12 was 79.8%, 75.2% and 75.3%, respectively. CONCLUSIONS: Same-day ART initiation hub model at a stand-alone HIV testing centre in an urban setting in Bangkok, Thailand, is highly feasible and has a potential for scaling up. CLINICAL TRIAL NUMBER: NCT04032028.

Evaluation of the integration of telehealth into the same-day antiretroviral therapy initiation service in Bangkok, Thailand in response to COVID-19: a mixed-method analysis of real-world data.

INTRODUCTION: Same-day antiretroviral therapy (SDART) initiation has been implemented at the Thai Red Cross Anonymous Clinic (TRCAC) in Bangkok, Thailand, since 2017. HIV-positive, antiretroviral therapy (ART)-naïve clients who are willing and clinically eligible start ART on the day of HIV diagnosis. In response to the first wave of the coronavirus disease 2019 (COVID-19) outbreak in March 2020, telehealth follow-up was established to comply with COVID-19 preventive measures and allow service continuation. Here, we evaluate its implementation. METHODS: Pre-COVID-19 (until February 2020) clients who initiated SDART received a 2-week ART supply and returned to the clinic for evaluation before being referred to long-term ART maintenance facilities. If no adverse events (AEs) occurred, another 8-week ART supply was provided while referral was arranged. During the first wave of COVID-19 (March-May 2020), clients received a 4-week ART supply and the option of conducting follow-up consultation and physical examination via video call. Clients with severe AEs were required to return to TRCAC; those without received another 6-week ART supply by courier to bridge transition to long-term facilities. This adaptation continued post-first wave (May-August 2020). Routine service data were analysed using data from March to August 2019 for the pre-COVID-19 period. Interviews and thematic analysis were conducted to understand experiences of clients and providers, and gain feedback for service improvement. RESULTS: Of 922, 183 and 321 eligible clients from the three periods, SDART reach [89.9%, 96.2% and 92.2% (p = 0.018)] and ART initiation rates [88.1%, 90.9% and 94.9% (p<0.001)] were high. ART uptake, time to ART initiation and rates of follow-up completion improved over time. After the integration, 35.3% received the telehealth follow-up. The rates of successful referral to a long-term facility (91.8% vs. 95.3%, p = 0.535) and retention in care at months 3 (97.5% vs. 98.0%, p = 0.963) and 6 (94.1% vs. 98.4%, p = 0.148) were comparable for those receiving in-person and telehealth follow-up. Six clients and nine providers were interviewed; six themes on service experience and feedback were identified. CONCLUSIONS: Telehealth follow-up with ART delivery for SDART clients is a feasible option to differentiate ART initiation services at TRCAC, which led to its incorporation into routine service.

Ability of Alere™ HIV Combo to diagnose acute HIV infection is based mainly on HIV-1 p24 antigen detection.

BACKGROUND: Alere™ HIV Combo is the only rapid and sensitive point-of-care 4th generation (antigen/antibody) HIV test newly available in Thailand which is advantageous of differentiating between positivity of antigen or antibody or both, especially in acute HIV infection (AHI). AHI in this study was defined by positive machine-based 4th generation test with measurable HIV-RNA but negative 3rd generation (IgM/IgG antibody only) tests. OBJECTIVE: To evaluate the performance characteristics of Alere™ HIV Combo. METHODS: Fifty stored plasma samples of subjects diagnosed with AHI were used to evaluate Alere™ HIV Combo. RESULTS: Of the 50 AHI samples, Alere™ HIV Combo was positive in 37 (74%): 5 with antibody positive only (R1), 26 with p24 antigen positive only (R2), and 6 with both p24 antigen and antibody positive (R3). Mean sample/cut-off (S/ CO) ratios from machine-based 4th generation test of R1, R2 and R3 were 21.55, 148.38 and 72.97 respectively as compared to 7.57 for the 13 non-reactive (NR) samples. The corresponding median log10 HIV-RNA of NR, R1, R2 and R3 were 5.59, 5.86, 7.00 and 6.61 copies/mL respectively. R2 and R3 had significantly higher S/CO and HIV-RNA than NR and R1. Alere™ HIV Combo detected mainly p24 antigen in AHI as seen in 32/50 (64%) subjects and could detect 11/50 (22%) antibody in AHI samples which were missed by the two 3rd generation HIV tests used in our testing algorithm. CONCLUSIONS: Alere™ HIV Combo is the ideal screening test in a setting with high AHI where machine-based 4th generation test is not available.

Uptake of oral fluid-based HIV self-testing among men who have sex with men and transgender women in Thailand.

BACKGROUND: Suboptimal uptake of HIV testing remains a primary bottleneck to HIV prevention and treatment for men who have sex with men (MSM) and transgender women (TGW) in Thailand. The World Health Organization has recommended HIV self-testing (HIVST) as an additional strategic HIV service. However, HIVST has not been fully endorsed and implemented in many countries in Southeast Asia. The aim of this study was to assess the uptake of oral fluid-based HIVST in MSM and TGW populations in Thailand. METHODS: During 2017 and 2018, we conducted a cross-sectional study using convenience sampling to enroll 2,524 participants from three major urban areas. Participants were recruited during outreach and online activities and were offered unassisted or assisted HIVST, or referral to HIV testing services. A descriptive analysis was performed for summarizing data. RESULTS: A total of 2,502 participants (1,422 MSM and 1,082 TGW) were included in the analysis with about one-third (36.1%) of them being first-time testers. Among all participants enrolled in the study, a total of 2,486 participants (99.3%) selected HIVST versus referral to HIV testing services. Of those who selected HIVST, 2,095 (84.3%) opted for assisted HIVST while the rest opted for unassisted HIVST: 1,148 of 1,411 MSM (81.4%) and 947 of 1,075 TGW (88.1%) selected assisted HIVST. While no serious adverse events were reported during the study, we found that among 179 participants who needed a confirmatory test and were referred to HIV testing services, 108 (60.3.4%) accessed these later services. CONCLUSIONS: This study demonstrated a high uptake of oral fluid-based HIVST among MSM and TGW populations in Thailand and that HIVST could be scaled up through the national epidemic control program. However, a better understanding of HIV testing-seeking behavior and innovative follow-up solutions are needed to improve and monitor linkages to services for people who undertake HIVST.

Uptake of Primary Care Services and HIV and Syphilis Infection among Transgender Women attending the Tangerine Community Health Clinic, Bangkok, Thailand, 2016 - 2019.

INTRODUCTION: Transgender women (TGW) need a specific package of primary care services usually not available in the publicly funded healthcare system. In addition, little is known about HIV and syphilis prevalence and incidence in clinic-based samples of TGW. Here we evaluate the uptake of a transgender-specific package of primary care services by TGW in Bangkok, Thailand and assess HIV and syphilis prevalence and incidence among them. METHODS: Open cohort study of TGW attending services at the Tangerine Community Health Clinic from 2016 to 2019. Cross-sectional and longitudinal analysis of routinely collected clinic data was performed to study trends in the number of clients, clinic visits and HIV and syphilis prevalence and incidence. RESULTS: During the study period, 2947 TGW clients made a total of 5227 visits to Tangerine. The number of clients significantly increased from 446 in 2016 to 1050 in 2019 (p < 0.001) and the number of visits from 616 to 2198 during the same period (p < 0.001). Prevalence of HIV at first visit was 10.8% and of syphilis 9.8%. HIV incidence was 1.03 per 100 person years (PY) and of syphilis 2.06 per 100 PY of follow-up. From 2016 to 2019, significant decreases occurred in the annual prevalence of HIV from 14.6% to 9.9% (p < 0.01). The annual prevalence of syphilis significantly increased from 6.6% in 2016 to 14.6% in 2018, and then decreased to 7.3% in 2019 (p < 0.001). The annual HIV incidence decreased during 2016 to 2019, from 1.68 to 1.28 per 100 PY, but this reduction was not statistically significant. The annual incidence of treponemal test seroconversion significantly increased from zero in 2016 to 4.55 per 100 PY in 2019 (p < 0.001). CONCLUSIONS: The increasing uptake of a transgender-specific package of services, including co-located gender affirmative hormone therapy, suggests this may be an effective model in engaging and retaining TGW in primary care. The decrease in HIV prevalence and low HIV incidence across calendar years point at a possible reduction of HIV acquisition among the TGW population served by Tangerine. The increasing prevalence of syphilis suggests ongoing high-risk sexual behaviour and underscores the need for screening and treatment for this infection at the time of delivery of HIV services.

Client and provider preferences for HIV care: Implications for implementing differentiated service delivery in Thailand.

INTRODUCTION: Differentiated service delivery (DSD) for antiretroviral therapy (ART) maintenance embodies the client-centred approach to tailor services to support people living with HIV in adhering to treatment and achieving viral suppression. We aimed to assess the preferences for HIV care and attitudes towards DSD for ART maintenance among ART clients and providers at healthcare facilities in Thailand. METHODS: A cross-sectional study using self-administered questionnaires was conducted in September-November 2018 at five healthcare facilities in four high HIV burden provinces in Thailand. Eligible participants who were ART clients aged ≥18 years and ART providers were recruited by consecutive sampling. Descriptive statistics were used to summarize demographic characteristics, preferences for HIV services and expectations and concerns towards DSD for ART maintenance. RESULTS: Five hundred clients and 52 providers completed the questionnaires. Their median ages (interquartile range; IQR) were 38.6 (29.8 to 45.5) and 37.3 (27.3 to 45.1); 48.5% and 78.9% were females, 16.8% and 1.9% were men who have sex with men, and 2.4% and 7.7% were transgender women, respectively. Most clients and providers agreed that ART maintenance tasks, including ART refill, viral load testing, HIV/sexually transmitted infection monitoring, and psychosocial support should be provided at ART clinics (85.2% to 90.8% vs. 76.9% to 84.6%), by physicians (77.0% to 94.6% vs. 71.2% to 100.0%), every three months (26.7% to 40.8% vs. 17.3% to 55.8%) or six months (33.0% to 56.7% vs. 28.9% to 80.8%). Clients agreed that DSD would encourage their autonomy (84.9%) and empower responsibility for their health (87.7%). Some clients and providers disagreed that DSD would lead to poor ART retention (54.0% vs. 40.4%), increased loss to follow-up (52.5% vs. 42.3%), and delayed detection of treatment failure (48.3% vs. 44.2%), whereas 31.4% to 50.0% of providers were unsure about these expectations and concerns. CONCLUSIONS: Physician-led, facility-based clinical consultation visit spacing in combination with multi-month ART refill was identified as one promising DSD model in Thailand. However, low preference for decentralization and task shifting may prove challenging to implement other models, especially since many providers were unsure about DSD benefits. This calls for local implementation studies to prove feasibility and governmental and social support to legitimize and normalize DSD in order to gain acceptance among clients and providers.

Demedicalisation of HIV interventions to end HIV in the Asia-Pacific.

Despite the challenges to the HIV response in the Asia-Pacific, a demedicalisation of HIV intervention has been demonstrated to be an important strategy to maximise the uptake of HIV prevention tools among key populations in this region. Demedicalisation of HIV interventions translates medical discourse and shifts the paradigm from a disease-focused to a people-centred approach. It also recognises real-life experiences of key populations in the HIV response by empowering them to voice their needs and be at the forefront of the epidemic control. We further categorise a demedicalisation approach into three frameworks: (1) the demystification of clinical or medical concerns; (2) the destigmatisation of people living with HIV; and (3) the decentralisation of healthcare services. This article reviewed the demedicalisation framework by looking at the HIV intervention examples from countries in the Asia-Pacific, which included: (1) a study on drug-drug interaction between pre-exposure prophylaxis and feminising hormone treatment for transgender women; (2) the roles of key population-led health services; and (3) certification of key population lay providers.

Factors Associated With and Characteristic of HIV/Tuberculosis Co-Infection: A Retrospective Analysis of SECOND-LINE Clinical Trial Participants.

BACKGROUND: Tuberculosis (TB) is a common infection in people living with HIV. However, the risk factors for HIV/TB co-infection in second-line HIV therapy are poorly understood. We aimed to determine the incidence and risk factors for TB co-infection in SECOND-LINE, an international randomized clinical trial of second-line HIV therapy. METHODS: We did a cohort analysis of TB cases in SECOND-LINE. TB cases included any clinical or laboratory-confirmed diagnoses and/or commencement of treatment for TB after randomization. Baseline factors associated with TB were analyzed using Cox regression stratified by site. RESULTS: TB cases occurred at sites in Argentina, India, Malaysia, Nigeria, South Africa, and Thailand, in a cohort of 355 of the 541 SECOND-LINE participants. Overall, 20 cases of TB occurred, an incidence rate of 3.4 per 100 person-years (95% CI: 2.1 to 5.1). Increased TB risk was associated with a low CD4+-cell count (≤200 cells/µL), high viral load (>200 copies/mL), low platelet count (<150 ×109/L), and low total serum cholesterol (≤4.5 mmol/L) at baseline. An increased risk of death was associated with TB, adjusted for CD4, platelets, and cholesterol. A low CD4+-cell count was significantly associated with incident TB, mortality, other AIDS diagnoses, and virologic failure. DISCUSSION: The risk of TB remains elevated in PLHIV in the setting of second-line HIV therapy in TB endemic regions. TB was associated with a greater risk of death. Finding that low CD4+ T-cell count was significantly associated with poor outcomes in this population supports the value of CD4+ monitoring in HIV clinical management.

CD4/CD8 Ratio Recovery of Children and Adolescents Living With HIV With Virological Suppression: A Prospective Cohort Study.

BACKGROUND: There are limited data on immune restoration of young adults living with virologically suppressed human immunodeficiency virus (HIV). We investigated recovery rates of CD4/CD8 ratio among Thai children and adolescents after they initiated combination antiretroviral therapy (cART). METHODS: Children and adolescents who started cART at age of ≥ 5 years were eligible in this study if they achieved HIV RNA < 50 copies/mL and had a CD4/CD8 ratio < 0.8 at the time of virological suppression. Normalization of CD4/CD8 ratio was defined as 2 consecutive values ≥ 1. Using group-based trajectory analysis, low- and high-recovery groups were identified in terms of CD4/CD8 ratio recovery. RESULTS: One hundred thirty-eight children and adolescents (101 perinatally infected and 37 behaviorally infected) with median age of 10.6 years at cART treatment initiation were included. After 559 person-years of follow-up (PYFU), overall incidence rate of CD4/CD8 ratio normalization was 4.1 (95% confidence interval, 2.7-6.2) per 100 PYFU. The probabilities of normalization at 2, 5, and 10 years after HIV suppression were 5.2%, 22.6%, and 35.6%, respectively. The low-recovery group had lower median pre-cART CD4 count (146 vs 304 cells/µL, P = .01), pre-cART CD4/CD8 ratio (0.15 vs 0.23, P = .03) and at first viral suppression (0.38 vs 0.65, P = .0001), compared to the high-recovery group. CONCLUSIONS: Less than half of children and adolescents living with HIV on cART with viral suppression had CD4/CD8 ratio normalization. Those with older age at cART initiation, lower pre-cART CD4 count, or CD4/CD8 ratio had slower ratio recovery. Long-term prognoses such as ongoing immune activation and clinical outcomes among children and adolescents on suppressive cART without CD4/CD8 ratio normalization need to be further investigated.

Drug-drug Interactions Among Thai Transgender Women Living with Human Immunodeficiency Undergoing Feminizing Hormone Therapy and Antiretroviral Therapy: The iFACT Study.

BACKGROUND: Drug-drug interactions between feminizing hormone therapy (FHT) and antiretroviral therapy (ART) are a major concern among transgender women (TGW), which may lead to suboptimal ART adherence and inappropriate FHT dosage. To evaluate potential drug-drug interactions between FHT and ART, we performed intensive measurements of the pharmacokinetic (PK) parameters of blood tenofovir (TFV), efavirenz (EFV), and estradiol (E2). METHODS: Twenty TGW with newly diagnosed human immunodeficiency virus (HIV) infection were enrolled. FHT (E2 valerate 2 mg/d and cyproterone acetate 25 mg/d) was prescribed at baseline until week 5 and restarted at week 8. ART (TFV disoproxil fumarate/emtricitabine/EFV at 300/200/600 mg) was initiated at week 3. The E2 PK parameters were measured intensively at weeks 3 (without ART) and 5 (with ART), and TFV and EFV PK parameters were measured intensively at weeks 5 (with FHT) and 8 (without FHT). RESULTS: The median (interquartile range) age and body mass index were 25.5 (22.5-31.0) years and 20.6 (19.3-23.1) kg/m2, respectively. The differences in geometric mean ratios between weeks 3 and 5 were as follows for E2 area under the curve, maximum concentration, and concentration at 24 hours (C24), respectively: 0.72 (90% confidence interval, .64-.81; P < .001), 0.81 (.72-.92; P = .006), and 0.64 (.50-.83; P = .004). The differences in geometric mean ratios between weeks 5 and 8 were as follows for TFV AUC, TFV C24, and EFV C24: 0.86 (90% confidence interval, .80-.93; P = .002), 0.83 (.75-.93; P = .006), and 0.91 (.85-.97; P = .02). CONCLUSIONS: Among HIV-positive TGW, E2 PK parameters were significantly lower in the presence of TFV disoproxil fumarate/emtricitabine/EFV, and some TFV and EFV PK parameters were lower in the presence of FHT. Further studies should determine whether these reductions are clinically significant and whether they occur with other FHT or ART regimens.