Lived experiences with pre-exposure prophylaxis uptake and adherence among transgender women in Thailand: a qualitative study.

BACKGROUND: Transgender women (TGW) are disproportionately affected by HIV, and HIV prevalence among TGW in Thailand has been increasing. Although oral daily pre-exposure prophylaxis (PrEP) is effective for HIV prevention, PrEP uptake and persistence among TGW have been low. This study aimed to provide a deeper understanding of TGW's experiences with PrEP uptake and adherence, and to identify major barriers to PrEP use to inform intervention adaptation. METHODS: We interviewed 20 young TGW (six non-PrEP users, eight adherent, six non-adherent) and 10 health care providers from two HIV clinics in Bangkok, Thailand, in 2022. We focused on understanding challenges to PrEP use in this population using an interview guide based on a theoretical model of behaviour change and thematic content analysis. RESULTS: Thematic analysis identified major barriers to and facilitators of PrEP uptake and adherence. Barriers to PrEP initiation included low self-perceived HIV risk, concern about potential side-effects, patient burdens such as frequent HIV testing for prescription refills and social stigma against PrEP. Barriers to adherence included side-effects, inconvenient access to health services (especially during COVID-19 lockdowns), forgetfulness resulting from busy schedules and low self-perceived HIV risk. TGW also reported health care providers' stigma against PrEP users deterred them from seeking further PrEP services. TGW identified major facilitators of PrEP initiation, including awareness about the benefits of PrEP, concern about risks of HIV and supportive social networks of PrEP users. As to PrEP regimens, most TGW participants reported a clear preference for long-lasting, injectable PrEP over daily oral PrEP. TGW and health care providers largely agreed on barriers and facilitators of PrEP use, but they differed in perceptions of HIV risk. CONCLUSIONS: The results highlighted challenges and opportunities to improve the delivery of PrEP, as well as other sexually transmissable infection and mental health services, especially among TGW. Thus, there is an urgent need for developing effective intervention programs that could raise PrEP awareness and knowledge, reduce PrEP stigma, and improve PrEP delivery systems among TGW in Thailand.

Long COVID and Hybrid Immunity among Children and Adolescents Post-Delta Variant Infection in Thailand.

This study aimed to assess long COVID, and describe immunogenicity against Omicron variants following BNT162b2 vaccination. A prospective cohort study was conducted among children (aged 5-11) and adolescents (aged 12-17) who had SARS-CoV-2 infection from July to December 2021 (Delta predominant period). Long COVID symptoms were assessed by questionnaires at 3 months after infection. Immunogenicity was evaluated by using a surrogate virus-neutralizing antibody test (sVNT) against the Omicron variant. We enrolled 97 children and 57 adolescents. At 3 months, 30 children (31%) and 34 adolescents (60%) reported at least one long COVID symptom, with respiratory symptoms prevailing (25% children and 32% adolescents). The median time from infection to vaccination was 3 months in adolescents and 7 months in children. At 1 month following vaccination, in children who received one-dose and two-dose BNT162b2 vaccines, the median (IQR) sVNT against Omicron was 86.2% inhibition (71.1-91.8) and 79.2% inhibition (61.5-88.9), respectively (p = 0.26). Among adolescents who received one-dose and two-dose BNT162b2 vaccines, the median (IQR) sVNT against Omicron was 64.4% inhibition (46.8-88.8) and 68.8% inhibition (65.0-91.2) (p = 0.64). Adolescents had a higher prevalence of long COVID than children. Immunogenicity against the Omicron variant after vaccination was high and did not vary between one or two doses of the vaccine in either children or adolescents.

Alcohol use, suicidality and virologic non-suppression among young adults with perinatally acquired HIV in Thailand: a cross-sectional study.

INTRODUCTION: Young adults with perinatally acquired HIV (YA-PHIV) are facing transitions to adult life. This study assessed health risk behaviours (including substance use), mental health, quality of life (QOL) and HIV treatment outcomes of Thai YA-PHIV. METHODS: A cross-sectional study was conducted in Thai YA-PHIV aged 18-25 years who were enrolled in a prospective cohort study at five tertiary paediatric HIV care centres in Thailand. Study data were obtained through face-to-face interviews from November 2020 to July 2021. Assessments were performed for alcohol use (Alcohol Use Disorders Identification Test; AUDIT), smoking (Fagerstrom Test for Nicotine Dependence), drug/substance use (Drug Abuse Screening Test; DAST-10), depression (Patient Health Questionnaire for Adolescents; PHQ-A), anxiety (Generalized Anxiety Disorder; GAD-7) and QOL (World Health Organization QOL Brief-Thai). HIV treatment outcomes were extracted from the National AIDS Program database. RESULTS: Of 355 YA-PHIV, 163 (46%) were males: their median age was 21.7 (interquartile range, IQR 20.2-23.5) years. There were 203 YA-PHIV (58%) who reported ever having sex; 141 (40%) were sexually active in the past 6 months, of whom 86 (61%) reported 100% condom use. Overall, 49 (14%) met the criteria for harmful alcohol use; 28 (7.9%) were alcohol dependent. Sixty (17%) were current smokers and 37 (11%) used drugs/substances. The frequency of moderate up to severe symptoms for depression was 18% and for anxiety was 9.7%. Their overall QOL was good in 180 (51%), moderate in 168 (47%) and poor in five (1.4%). There were 49 YA-PHIV (14%) with CD4 <200 cells/mm3 and 85 (24%) with virologic non-suppression (HIV-RNA >200 copies/ml). On multivariate analyses, the highest education at the primary to high school or vocational school levels (adjusted odds ratio [aOR] 2.02, 95% CI 1.40-3.95, p 0.04), harmful alcohol use (aOR 2.48, 95% CI 1.24-4.99, p 0.01), alcohol dependence (aOR 3.54, 95% CI 1.51-8.31, p <0.01) and lifetime suicidal attempt (aOR 2.66, 95% CI 1.11-6.35, p 0.03) were associated with non-suppression. CONCLUSIONS: Regular screening for alcohol use and mental health, including suicidality, would be useful to identify YA-PHIV who need more intensive psychosocial support or referral services to ensure they can achieve and maintain a high QOL into adult life.

Social Network Strategy to Promote HIV Testing and Linkage to HIV Services among Young men who Have sex with men and Transgender Women in Thailand.

Background: Social network strategies (SNS) assumes that people in the same social share similar HIV risk. Methods: This study evaluated SNS to promote HIV testing of young men who have sex with men (YMSM) and transgender women (YTGW) aged 15-24 years. "Recruiters" referred their 'network members' (NMs) to clinic. NMs were provided HIV testing. Proportions of first-time HIV testers and number of NMs were analyzed. Results: Between April 2021 to March 2022, 83 recruiters referred 202 NMs. Median age of NMs was 19 years (IQR 17-20), 62% were YMSM. One-hundred-and-twenty-four NMs (61%) were first-time HIV testers. YTGW recruited more NMs per recruiter (5.4 vs 1.4, p = 0.002). HIV prevalence was 3.0% (95% CI 1.1-6.4). Thirty-one-point-three percent of NMs at HIV risk initiated oral HIV preexposure prophylaxis. Conclusions: SNS is a good strategy to reach adolescents at risk of HIV infection. More than half of NMs were first-time HIV testers.

Immunogenicity of BNT162b2 Vaccination against SARS-CoV-2 Omicron Variant and Attitudes toward a COVID-19 Booster Dose among Healthy Thai Adolescents.

Despite the BNT162b2 vaccination coverage, rapid transmission of Omicron SARS-CoV-2 has occurred, which is suspected to be due to the immune escape of the variant or waning vaccine efficacy of multiple BNT162b2 vaccination doses. Our study aims to compare immunogenicity against Omicron prior to and post a booster dose of BNT162b2 in healthy adolescents, and to evaluate their attitudes toward booster dose vaccination. A cross sectional study was conducted among healthy adolescents aged 12-17 who received two doses of BNT162b2 more than 5 months ago. Participants and their guardians performed self-reported questionnaires regarding reasons for receiving the booster. A 30 ug booster dose of BNT162b2 was offered. Immunogenicity was evaluated by a surrogate virus neutralization test (sVNT) against the Omicron variant, and anti-spike-receptor-binding-domain IgG (anti-S-RBD IgG) taken pre-booster and 14-days post-booster. From March to April 2022, 120 healthy Thai adolescents with a median age of 15 years (IQR 14-16) were enrolled. sVNT against Omicron pre- and post-booster had 11.9 (95%CI 0-23.9) and 94.3 (90.6-97.4) % inhibition. Geometric means (GMs) of anti-S-RBD IgG increased from 837 (728, 953) to 3041 (2893, 3229) BAU/mL. Major reasons to receive the booster vaccination were perceived as vaccine efficacy, reduced risk of spreading infection to family, and safe resumption of social activities. A booster dose of BNT162b2 elicits high immunogenicity against the Omicron variant. Motivation for receiving booster doses is to reduce risk of infection.

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.

Sexually transmitted infections incidence in young Thai men who have sex with men and transgender women using HIV pre-exposure prophylaxis.

BACKGROUND: Sexually transmitted infections are a major public health issue worldwide. HIV pre-exposure prophylaxis (PrEP) use among youth may be associated with increased incidence of sexually transmitted infections (STIs). OBJECTIVES: To measure the prevalence and incidence of STIs among young men who have sex with men (YMSM) and young transgender women (YTGW) using PrEP. METHODS: A prospective cohort of 15- to 19-year-old YMSM and YTGW with HIV risk defined as inconsistent condom use and/or multiple sex partners were enrolled. Participants were provided daily oral tenofovir disoproxil fumarate/emtricitabine. STI screening was done at baseline and month 6 for syphilis, urine, and anal swab nucleic acid amplification testing for C. trachomatis (CT) and N. gonorrheaoe (NG). RESULTS: From March 2018 to June 2019, 200 adolescents (147 MSM and 53 TGW) with a median (IQR) age of 18 years (17-19) were enrolled. STI prevalence was 22.5% (95% CI 16.7-28.3). STI incidence was 25.2 per 100 person-years (95% CI 14.7, 40.3). Factors associated with STI incidence were self-reported >2 sex partners in the past month (unadjusted rate ratio [uRR] 4.6, 95% CI 1.0, 20.6), and moderate PrEP adherence (uRR 7.3, 95% CI 1.6, 32.6). CONCLUSIONS: STI incidence in YMSM and YTGW PrEP users was high at approximately one in five. Regular screening and treatment of STIs should be implemented in youth HIV prevention packages.

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.

No increased acute kidney injury rate through giving an intravenous colistin loading dose in pediatric patients.

OBJECTIVES: A colistin loading dose is required to achieve adequate drug exposure for the treatment of multidrug-resistant Gram-negative bacteria. However, data on acute kidney injury (AKI) rates associated with this approach in children have been unavailable. The aim of this study was to examine AKI rates in children who were prescribed a colistin loading dose. METHODS: A retrospective study was conducted in patients aged 1 month to 18 years who had received intravenous colistin for ≥48 h. Loading dose (LD) was defined as colistin methanesulfonate at 4-5 mg of colistin base activity/kg/dose. AKI was defined according to KDIGO serum creatinine (SCr) criteria - SCr ≥ 1.5 times the baseline, measured 3-7 days after colistin initiation. Augmented renal clearance (ARC) was defined as an estimated glomerular filtration rate (eGFR) >150 mL/min/1.73 m2. The rates of AKI were compared between children receiving or not receiving an LD, and between different eGFR groups. RESULTS: In total, 181 children were enrolled. The mean age was 4.3 years (95% confidence interval [CI], 3.6-4.9 years). Ninety-five of the subjects (52.5%) were male. There were 157 children with a baseline eGFR of ≥ 80 mL/min/1.73 m2. The overall AKI rate within the first week in this group was 20.4% (95% CI, 14.4-27.6%): LD, 16.1% vs no LD, 23.2% (p = 0.29). Subgroup analysis, excluding patients with ARC, showed a lower AKI rate of 12.8% (95% CI, 6.8-21.3%): LD, 9.7% vs no LD, 14.3% (p = 0.53). CONCLUSIONS: AKI rate was not different among children who received an intravenous colistin loading dose. This approach should be implemented to ensure the necessary drug exposure required for good treatment outcomes.

Acceptance and outcome of interventions in a meropenem de-escalation antimicrobial stewardship program in pediatrics.

BACKGROUND: Prospective audit and feedback is a method that allows the antimicrobial stewardship program (ASP) team to interact with attending physicians to tailor antibiotic therapy, including de-escalation, as appropriate. This study aimed to evaluate the acceptance and outcomes of ASP de-escalation recommendations in children who received meropenem. METHODS: A prospective cohort study was conducted in children aged 1 month to 18 years who received meropenem in a tertiary-care teaching hospital. The ASP team gave recommendation between 72 and 120 h after initiating meropenem therapy. Acceptance of de-escalation recommendations among primary physicians was evaluated within 24 h of recommendation. Outcomes included clinical success rate on the 7th day and incidence rate of acquisition of carbapenem-resistant gram-negative bacteria (CR-GNB) within 30 days. RESULTS: From March to December 2019, 217 children with a median (interquartile range) age of 2.1 (0.6, 9.5) years received meropenem. The ASP team gave recommendations in 127 (58.5%) of cases for continuation of meropenem therapy and 90 (41.5%) of cases for de-escalation. The overall acceptance of ASP de-escalation recommendations was 57.8% (95%CI: 46.9-68.1%). Clinical success rates were 85.2% in the accepted group compared to 77.5% in the rejected group (P = 0.06). The incidence rate of acquisition of CR-GNB within 30 days after treatment was 5.8% in the accepted group and 15.8% in the rejected group (P = 0.03). CONCLUSIONS: About half of the recommendations to de-escalate meropenem prescriptions were accepted through the ASP intervention. Carbapenem-resistant gram-negative bacteria acquisitions was less likely in the de-escalation group. A robust de-escalation strategy 72 h following carbapenem initiation should be encouraged to combat multidrug-resistant organisms.

Effects of vitamin D and calcium supplementation on bone mineral density among Thai youth using daily HIV pre-exposure prophylaxis.

INTRODUCTION: Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) is used for HIV pre-exposure prophylaxis (PrEP). TDF may affect bone mineral density (BMD), particularly in youth who are at a stage of peak bone mass accrual. The objective of this study was to evaluate the effect of vitamin D and calcium supplementation on BMD among Thai youth receiving daily oral PrEP. METHODS: This open-label randomized trial was conducted in male youth aged between 15 and 24 years. Participants were randomized to Arm A who received once-daily TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200 mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only. PrEP users were defined as taking at least two tablets/week (tenofovir-diphosphate level of >350 fmol/punch). Adherence to vitamin D/calcium supplementation was defined as self-reported adherence of >50%. Lumbar spine (L2-L4) BMD (LSBMD) was evaluated by dual-energy X-ray absorptiometry scan zero and six months after PrEP initiation. RESULTS: From March 2019 to March 2020, 100 youth were enrolled. Baseline characteristics between the two arms were similar. Median (IQR) age was 18 (17 to 20) years. At entry, median (IQR) LSBMD z-score was -0.8 (-1.5 to -0.3), 17% had low LSBMD (Z-score < -2). The median amount of calcium intake from nutritional three-day recall was 167 (IQR 94 to 272) mg/day, 39% of participants had vitamin D deficiency, defined as 25(OH)D levels <20 IU/mL. At six months, 79 participants were evaluated. Of these, 42 (52%) were PrEP takers and 25 of 38 (66%) of arm A participants had good adherence to vitamin D/calcium supplementation. Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03). There were significantly higher increases in LSBMD among youth with vitamin D deficiency who were supplemented; arm A + 0.05 (0 to 0.05) compared to arm B + 0.03 (-0.1 to 0.03), p = 0.04. CONCLUSIONS: Increases in LSBMD over six months among youth using PrEP who received vitamin D/calcium supplementation was greater than those not supplemented. Long-term follow-up should be considered to explore long-term outcomes.

Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial.

INTRODUCTION: Strategies are needed to curb the increasing HIV incidence in young men who have sex with men (YMSM) and transgender women (YTGW) worldwide. We assessed the impact of youth-friendly services (YFS) and a mobile phone application (app) on adherence to pre-exposure prophylaxis (PrEP) in YMSM and YTGW in Thailand. METHODS: A randomized control trial was conducted in YMSM and YTGW aged 15 to 19 years. Participants were provided daily oral tenofovir disoproxil fumerate/emtricitabine (TDF/FTC), condoms and randomized to receive either YFS or YFS plus a PrEP app (YFS + APP), whose features included self-assessment of HIV acquisition risk, point rewards and reminders for PrEP and clinic appointments. Clinic visits occurred at zero, one, three and six months and telephone contact at two, four and five months. HIV testing was performed at every clinic visit. PrEP adherence was evaluated with intracellular tenofovir diphosphate (TFV-DP) concentrations in dried blood spot (DBS) samples at months 3 and 6. The primary endpoint assessed was "PrEP adherence" defined as TFV-DP DBS concentrations ≥700 fmol/punch (equivalent to ≥4 doses of TDF/week). RESULTS: Between March 2018 and June 2019, 489 adolescents were screened at three centres in Bangkok. Twenty-seven (6%) adolescents tested positive for HIV and 200 (41%) adolescents participated in the study. Of these, 147 were YMSM (74%) and 53 YTGW (26%). At baseline, median age was 18 years (IQR 17 to 19), 66% reported inconsistent condom use in the past month. Sexually transmitted infection prevalence was 23%. Retention at six months was 73%. In the YFS + APP arm, median app use duration was three months (IQR 1 to 5). PrEP adherence at month 3 was 51% in YFS and 54% in YFS + APP (p-value 0.64) and at month 6 was 44% in YFS and 49% in YFS + APP (p-value 0.54). No HIV seroconversions occurred during 75 person years of follow-up. CONCLUSIONS: Youth-friendly PrEP services enabled good adherence among half of adolescent PrEP users. However, the mobile phone application tested did not provide additional PrEP adherence benefit in this randomized trial. Adolescent risk behaviours are dynamic and require adaptive programmes that focus on "prevention-effective adherence."

Workshop on use of intravenous immunoglobulin in hand, foot and mouth disease in Southeast Asia.

The South East Asia Infectious Disease Clinical Research Network convened subject matter experts at a workshop to make consensus recommendations for study design of a clinical trial for use of intravenous immunoglobulin (IVIg) in severe hand, foot and mouth disease (HFMD). HFMD is a highly contagious emerging infection among children in the region, a small proportion of whom develop neurologic and cardiopulmonary complications with high case-fatality rates. The use of IVIg for treatment of severe disease is widespread and a part of local, national, and international guidelines, but no clinical evidence warrants the use of this drug, which is expensive and has potentially serious side effects. During a 2-day workshop in March 2014, a group of HFMD experts reviewed the current evidence related to use of IVIg in HFMD and discussed potential study design, feasibility, inclusion and exclusion criteria, sample size, primary and secondary endpoints, and subsidiary studies for a randomized, placebo-controlled trial.

Acceptability of pre-exposure prophylaxis among men who have sex with men and transgender women in Northern Thailand.

BACKGROUND: Northern Thailand has a high burden HIV epidemic among MSM and TG. Oral pre-exposure prophylaxis (PrEP) with tenofovir-emtricitabine has demonstrated efficacy in preventing HIV among MSM and TG in Chiang Mai, Thailand. Determinants of PrEP acceptability are needed to gauge the potential uptake of this prevention strategy. METHODS: From January to February 2012, 238 MSM and TG participants, who self-reported as HIV-uninfected or of unknown status, completed a self-administered survey on hand-held computers. Participants were recruited by venue-day-time sampling and asked to rate their likelihood of using oral PrEP for HIV prevention with an efficacy of 50%. PrEP acceptability was defined as being "very likely" to use PrEP. Odds ratios and 95% CIs were calculated to identify correlates of acceptability. RESULTS: 131 MSM and 107 TG responded, with mean ages of 23.7 and 21.8, respectively. 24% of MSM engaged primarily in receptive anal sex vs. 74% of TG. 21% of MSM and 44% of TG reported regular medication use. Prior awareness of PrEP was high at 66% among both MSM and TG respondents. 41% of MSM and 37% of TG were "very likely" to use PrEP. Among MSM, factors associated with PrEP acceptability included a prior history of STIs (AOR 4.6; 95%CIs 1.7-12.6), previous HIV testing (AOR 2.4 95%CIs 1.1-5.3), regularly planned sex (AOR 2.8 95%CIs 1.1-7.2), and infrequent sex (AOR 2.9 95%CIs 1.3-6.3). Among TG, factors associated with acceptability included prior awareness of PrEP (AOR 3.3; 95%CIs 1.2-9.0) and having private insurance (AOR 5.0; 95%CIs 1.3-19.0). CONCLUSION: MSM and TG in Northern Thailand are distinct groups in terms of sexual behaviors, patterns of medication use, and correlates of PrEP acceptability. Efforts to maximize PrEP uptake should include expanded HIV testing services and the provision of financial subsidies to reduce the cost of PrEP.

Health diplomacy and the adaptation of global health interventions to local needs in sub-Saharan Africa and Thailand: evaluating findings from Project Accept (HPTN 043).

BACKGROUND: Study-based global health interventions, especially those that are conducted on an international or multi-site basis, frequently require site-specific adaptations in order to (1) respond to socio-cultural differences in risk determinants, (2) to make interventions more relevant to target population needs, and (3) in recognition of 'global health diplomacy' issues. We report on the adaptations development, approval and implementation process from the Project Accept voluntary counseling and testing, community mobilization and post-test support services intervention. METHODS: We reviewed all relevant documentation collected during the study intervention period (e.g. monthly progress reports; bi-annual steering committee presentations) and conducted a series of semi-structured interviews with project directors and between 12 and 23 field staff at each study site in South Africa, Zimbabwe, Thailand and Tanzania during 2009. Respondents were asked to describe (1) the adaptations development and approval process and (2) the most successful site-specific adaptations from the perspective of facilitating intervention implementation. RESULTS: Across sites, proposed adaptations were identified by field staff and submitted to project directors for review on a formally planned basis. The cross-site intervention sub-committee then ensured fidelity to the study protocol before approval. Successfully-implemented adaptations included: intervention delivery adaptations (e.g. development of tailored counseling messages for immigrant labour groups in South Africa) political, environmental and infrastructural adaptations (e.g. use of local community centers as VCT venues in Zimbabwe); religious adaptations (e.g. dividing clients by gender in Muslim areas of Tanzania); economic adaptations (e.g. co-provision of income generating skills classes in Zimbabwe); epidemiological adaptations (e.g. provision of 'youth-friendly' services in South Africa, Zimbabwe and Tanzania), and social adaptations (e.g. modification of terminology to local dialects in Thailand: and adjustment of service delivery schedules to suit seasonal and daily work schedules across sites). CONCLUSIONS: Adaptation selection, development and approval during multi-site global health research studies should be a planned process that maintains fidelity to the study protocol. The successful implementation of appropriate site-specific adaptations may have important implications for intervention implementation, from both a service uptake and a global health diplomacy perspective.

NIMH Project Accept (HPTN 043) HIV/AIDS community mobilization (CM) to promote mobile HIV voluntary counseling and testing (MVCT) in rural communities in Northern Thailand: modifications by experience.

Project Accept is a RCT designed to test the efficacy of community mobilization (CM), mobile voluntary counseling and testing (MVCT), and post-test support services (PTSS) in reducing HIV incidence in three African countries and Thailand. The intervention started in rural areas, northern Thailand in January 2006. CM initially included door-to-door visits during the daytime, small group discussions and joining organized meetings and followed by MVCT. In February 2007, CM strategy using HIV/AIDS "edutainment" (education and entertainment) during evening hours was introduced. After edutainment was initiated, the number of participants increased substantially. VCT uptake increased from 18 to 28 persons/day on average (t test; t = 7.87 P < 0.0001). Edutainment especially motivated younger people, as the median age of VCT clients decreased from 38 to 35 years old (median test; z = 6.74, P < 0.0001). Providing free MVCT in community settings along with edutainment during evening hours increased VCT uptake and was particularly attractive to younger adults.

Community-based intervention to increase HIV testing and case detection in people aged 16-32 years in Tanzania, Zimbabwe, and Thailand (NIMH Project Accept, HPTN 043): a randomised study.

BACKGROUND: In developing countries, most people infected with HIV do not know their infection status. We aimed to assess whether HIV testing could be increased by combination of community mobilisation, mobile community-based voluntary counselling and testing (VCT), and support after testing. METHODS: Project Accept is underway in ten communities in Tanzania, eight in Zimbabwe, and 14 in Thailand. Communities at each site were paired according to similar demographic and environmental characteristics, and one community from each pair was randomly assigned to receive standard clinic-based VCT (SVCT), and the other community was assigned to receive community-based VCT (CBVCT) plus access to SVCT. Randomisation and assignment of communities to intervention groups was done by the statistics centre by computer; no one was masked to treatment assignment because the interventions were community based. Intervention was provided for about 3 years (2006-09). The primary endpoint of HIV incidence is pending completion of assessments after the intervention. In this interim analysis, we examined the secondary endpoint of uptake in HIV testing, differences in characteristics of clients receiving their first HIV test, and repeat testing. Analyses were limited to clients aged 16-32 years. This study is registered with ClinicalTrials.gov, number NCT00203749. FINDINGS: The proportion of clients receiving their first HIV test during the study was higher in CBVCT communities than in SVCT communities in Tanzania (2341 [37%] of 6250 vs 579 [9%] of 6733), Zimbabwe (5437 [51%] of 10,700 vs 602 [5%] of 12,150), and Thailand (7802 [69%] of 11,290 vs 2319 [23%] 10,033). The mean difference in the proportion of clients receiving HIV testing between CBVCT and SVCT communities was 40·2% (95% CI 15·8-64·7; p=0·019) across three community pairs (one per country). HIV prevalence was higher in SVCT communities than in CBVCT communities, but CBVCT detected almost four times more HIV cases than did SVCT across the three study sites (952 vs 264; p=0·003). Repeat HIV testing in CBVCT communities increased in all sites to reach 28% of all those testing for HIV by the end of the intervention period. INTERPRETATION: CBVCT should be considered as a viable intervention to increase detection of HIV infection, especially in regions with restricted access to clinic-based VCT and support services after testing. FUNDING: US National Institute of Mental Health, HIV Prevention Trials Network (via US National Institute of Allergy and Infectious Diseases), and US National Institutes of Health.

Reliability and validity of Thai versions of the MOS-HIV and SF-12 quality of life questionnaires in people living with HIV/AIDS.

BACKGROUND/AIM: As Thai people living with HIV/AIDS gain increasing access to antiretroviral (ARV) therapy, it is important to evaluate the impact this has not only on clinical outcomes, but also on patients' functional status and well-being. In this study, we translated, culturally adapted and tested the reliability and validity of two widely-used health-related quality of life questionnaires - the MOS-HIV Health Survey and the SF-12 - in people living with HIV/AIDS in Northern Thailand. METHODS: Questionnaires were administered to 100 patients at community hospital outpatient ARV clinics in northern Thailand. Reliability was estimated using Cronbach's alpha, while evidence for validity was tested using known-groups comparison based on CD4 group, symptom distress score, bed days and days of reduced activity in the past three months. RESULTS: Patients' median age was 36, with 58% female, 58% working as laborers, and 60% completing at least primary education. Median CD4 count was 218 cells/mm3. There were no missing data. For the MOS-HIV and SF-12, mean physical summary scores were 53.1 and 49.0 respectively; mean mental summary scores were 53.4 and 45.6, respectively. Internal consistency coefficients were >0.7 for all but one scale, the PF scale (0.67). As hypothesized, scores were slightly to moderately correlated with CD4 count, symptom score, number of days in bed or with reduced activity. Correlations were higher with physical health scores than with mental health scales. The MOS-HIV discriminated clinical known groups slightly better than the SF-12. CONCLUSION: Both the MOS-HIV and the shorter SF-12 were successfully adapted for people with HIV/AIDS in Northern Thailand, and showed encouraging evidence for reliability and validity. These patient reported questionnaires could be valuable tools in evaluating therapeutic interventions and other innovations in health and social services, and to estimate health needs and population disability related to HIV.

Awareness about antiretroviral treatment, intentions to use condoms, and decisions to have an HIV test among rural Northern Lowland Thai and ethnic minority young adults.

Young adults aged 18 to 32 years were randomly selected from a household probability sample participating in Project Accept in the remote areas of Chiang Mai province in northern Thailand in 2005. Among 2989 respondents, 44.4% had never heard of antiretroviral treatment (ART). Lack of awareness of ART was independently associated with having had no formal education compared with some formal education and being an ethnic minority compared with being Thai. In all, 57% of the respondents who had ever heard of ART stated that if ART were easily available in their communities it would affect their intentions to be tested for HIV, whereas only 36% stated that this would affect their intentions to use condoms. Younger participants were less likely to intend to get an HIV test as compared with older individuals, and ethnic minorities were less likely to report that they would get an HIV test compared with Thai lowlanders. Single individuals and people who lived separately from their spouses were more likely to have the intention to use condoms if ART were available.