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.

Differentiated service delivery for HIV treatment models in Thailand: A cross-sectional assessment of real-world implementation and uptake.

OBJECTIVES: First, to describe the antiretroviral therapy (ART) delivery models available in Thailand to understand differentiated service delivery for further service system optimization and expansion of best practices; second, to determine the client characteristics associated with model uptake. METHODS: Across-sectional assessment using secondary data was conducted to describe ART models implemented as routine services at four public hospitals in three major provinces with a high-HIV burden in Thailand. From April to October 2020, ART clients were screened consecutively according to the inclusion criteria: Thai, aged ≥18 years, and on ART for ≥6 months. HIV treatment models were categorised based on the service type, location, provider, and frequency. Logistic regression was used to identify the associated factors. RESULTS: Seven individual ART delivery models were identified: four were facility-based and three were out-of-facility. No group models were identified. Of 3,366 records of ART clients reviewed, 3,213 (95.5%) met the study criteria and received ART through the following models: conventional (32.6%), nurse-led clinical consultation (10.0%), fast-track refill (29.0%), after-hours clinic (10.6%), pharmacist-led pickup center (3.6%), key population-led community-based organisation (2.7%), and mailing (11.5%). Age, population, duration on ART, and viral load were associated with the uptake of certain alternative service models when compared to the conventional model. CONCLUSIONS: Among the variety of ART delivery approaches available in Thailand, facility-based models remain the most prevalent. Future work should investigate the role of client preference and choice in choosing service models and service utilisation patterns over time, and assess the acceptability and effectiveness of these models.

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.

Age-Specific Prevalence of Anal and Cervical Human Papillomavirus Infection and High-Grade Lesions in 11 177 Women by Human Immunodeficiency Virus Status: A Collaborative Pooled Analysis of 26 Studies.

BACKGROUND: Age-specific data on anal, and corresponding cervical, human papillomavirus (HPV) infection are needed to inform female anal cancer prevention. METHODS: We centrally reanalyzed individual-level data from 26 studies reporting HPV prevalence in paired anal and cervical samples by human immunodeficiency virus (HIV) status and age. For women with HIV (WWH) with anal high-grade squamous intraepithelial lesions or worse (HSIL+), we also investigated concurrent cervical cytopathology. RESULTS: In HIV-negative women, HPV16 prevalence decreased significantly with age, both at anus (4.3% at 15-24 years to 1.0% at ≥55 years; ptrend = 0.0026) and cervix (7.4% to 1.7%; ptrend < 0.0001). In WWH, HPV16 prevalence decreased with age at cervix (18.3% to 7.2%; ptrend = 0.0035) but not anus (11.5% to 13.9%; ptrend = 0.5412). Given anal HPV16 positivity, concurrent cervical HPV16 positivity also decreased with age, both in HIV-negative women (ptrend = 0.0005) and WWH (ptrend = 0.0166). Among 48 WWH with HPV16-positive anal HSIL+, 27 (56%) were cervical high-risk HPV-positive, including 8 with cervical HPV16, and 5 were cervical HSIL+. CONCLUSIONS: Age-specific shifts in HPV16 prevalence from cervix to anus suggest that HPV infections in the anus persist longer, or occur later in life, than in the cervix, particularly in WWH. This is an important consideration when assessing the utility of cervical screening results to stratify anal cancer risk.

Estradiol and Testosterone Concentrations Among Thai Transgender Women in a Transgender-Led, Integrated Gender-Affirming Care and Sexual Health Clinic: A Real-World Analysis.

Purpose: Feminizing hormone therapy (FHT) is used by many transgender women as a pharmacological method to mitigate gender dysphoria. However, information on hormone concentrations among those who use FHT is lacking. We aimed to determine the proportion of Thai transgender women who were using FHT who had hormone concentrations within target ranges in a real-world clinic setting. Methods: Transgender women who attended Tangerine Clinic in Bangkok, Thailand, reported current use of FHT at clinic entry, and tested for both blood estradiol (E2) and total testosterone (TT) concentrations were included in the analysis. Hormone target concentrations were defined as 100-200 pg/mL for E2 and <50 ng/dL for TT. Results: Of 1534 transgender women included, 2.5% had undergone orchiectomy, and 524 (34.2%) had any hormones within target concentrations. Median (interquartile range) E2 and TT concentrations at baseline were 29 (14.3-45.3) pg/mL and 298.5 (22-646) ng/dL, respectively. Among those who had any hormones within target concentrations, 28 (1.8%), 11 (0.7%), and 485 (31.6%) had both hormones, only E2, and only TT within target concentrations, respectively. Among 1010 (65.8%) transgender women who had neither hormone within target concentrations, 989 (64.5%) and 21 (1.4%) had suboptimal and supraphysiological E2 concentrations, respectively. Among those who came to at least one follow-up visit (n=302), 165 (54.6%) transgender women managed to achieve or maintain either hormone within target concentrations. Conclusion: One-third of Thai transgender women who were using FHT had any hormones within target concentrations at baseline in this real-world setting study. Most transgender women who had neither hormone within target concentrations had suboptimal rather than supraphysiological E2 concentrations. More than half managed to achieve or maintain at least one hormone concentration within target concentrations at follow-up visits, suggesting a positive effect from attending a trans-led, integrated gender-affirming care and sexual health service.

Key population-led community-based same-day antiretroviral therapy (CB-SDART) initiation hub in Bangkok, Thailand: a protocol for a hybrid type 3 implementation trial.

BACKGROUND: Same-day antiretroviral therapy (SDART) initiation, in which people living with HIV (PLHIV) who are antiretroviral therapy (ART)-naïve, willing, and clinically eligible start ART on the same day of HIV diagnosis, has been implemented in several healthcare facilities in Thailand since 2017. This evidence-based practice has demonstrated increased ART uptake, virologic suppression, and retention in care. However, linkage to care gaps exist in community-based organizations (CBOs) in Bangkok whereby as much as 20% of key populations (KP), mainly men who have sex with men and transgender women, living with HIV were lost to follow-up pre-ART initiation. To increase access to and uptake of ART among these populations, this study proposes that trained KP lay providers should lead community-based ART (CB-SDART) initiation service. This protocol describes the combined use of the Proctor's implementation outcome framework and the Consolidated Framework for Implementation Research to guide and evaluate the CB-SDART implementation. METHODS: This study follows the hybrid design type 3: it is an implementation trial that secondarily assesses service and client outcomes by comparative interrupted time series analysis. Five strategies have been formulated to meet three implementation outcomes (i.e., feasibility, fidelity, and sustainability): (1) developing stakeholder relationships by engaging the CBO leaderships, (2) training and educating KP lay providers, (3) adapting and tailoring SDART to CBO-specific context, (4) using evaluative and iterative strategies to assess adherence to standard operating procedures, and (5) developing stakeholder relationships by engaging external stakeholders. Teleconsultation with physicians and ART home delivery will be integrated as another ART initiation option for clients and allow service provision during the COVID-19 pandemic. A mixed-method assessment will be conducted on key stakeholders and PLHIV diagnosed at two implementing CBOs, Rainbow Sky Association of Thailand and Service Workers in Group Foundation, in Bangkok, Thailand. DISCUSSION: This implementation research may be the first to provide robust data at the implementation, service, and client levels to inform how to successfully task-shift SDART initiation service to trained KP lay providers and facilitate the expansion of CB-SDART in the future. TRIAL REGISTRATION: This trial was registered with the Thai Clinical Trial Registry as TCTR20210709004 on July 9, 2021.

Long-acting preexposure prophylaxis in low- and middle-income countries: key considerations for implementation.

PURPOSE OF REVIEW: HIV preexposure prophylaxis (PrEP) is a key tool in ending the HIV epidemic. Long-acting cabotegravir (LA- CAB) phase II/III studies revealed promising efficacy in preventing HIV acquisition. Here, we discuss key considerations for implementing LA-CAB in low- and middle-income countries (LMIC). RECENT FINDINGS: PrEP roll out in LMIC is still far from ideal, and contextual factors within LMIC vary widely. Implementation science studies are urgently needed to optimize the implementation of LA-CAB in different settings, consider effective service delivery models, and ensure program sustainability. Preferences and concerns regarding LA-CAB among potential users are unknown but likely specific to local context. Demedicalized and simplified PrEP service delivery increases uptake, and ways to safely and effectively do the same for LA- CAB need to be explored. Although ideally LA-CAB should be an additional choice of HIV prevention method, its cost will be the major determinant in deciding its position as a first line choice or restricted second-line option. SUMMARY: LA-CAB has the potential to enhance PrEP uptake. However, several implementation challenges need to be explored and addressed to ensure it can be accessed and utilized in different settings by those who need it the most.

The epidemiological impact and cost-effectiveness of key population-led PrEP delivery to prevent HIV among men who have sex with men in Thailand: A modelling study.

Background: Although key populations (KPs), such as men-who-have-sex-with-men (MSM) are disproportionately affected by HIV, many prevention and treatment services are not easily accessible for KP members. To address the needs of KPs, Thailand established pre-exposure prophylaxis (PrEP) service delivery together with and led by KP members. This study determines the epidemiological impact and cost-effectiveness of key population-led (KP-led) PrEP. Methods: We calibrated a compartmental deterministic HIV transmission model to the HIV epidemic among Thai MSM. Besides KP-led PrEP, we included other Thai service delivery models of PrEP (fee-based PrEP, the government PrEP program).Data on consistent PrEP use (5 years daily use, 95% effectiveness for preventing HIV) came from Thai PrEP delivery models. For the period 2015-2032, we ranged the number of PrEP starters (40,000-120,000), effectiveness of PrEP (45%-95%), and proportion of consistent users (10%-50%). The analysis started in 2015 when PrEP was introduced. A cost-effectiveness ratio of <160,000 Baht per quality-adjusted life year (QALY) over 40 years was cost-effective. Findings: Without PrEP, 53,800 (interquartile range 48,700-59,700) new HIV infections are expected in 2015-2032. KP-led PrEP was found to have the strongest epidemiological impact of all delivery models averting 58% of infections compared to without PrEP. The epidemiological impact depends on the number of PrEP starters and proportion of consistent use. Although all PrEP service delivery models are cost-effective, KP-led PrEP is most cost-effective with incremental cost-effectiveness ratios of 28,000-37,300 Thai Baht per QALY. Interpretation: Our model projects KP-led PrEP having the greatest epidemiological impact and being the most cost-effective service delivery model of PrEP in Thailand. Funding: This study was supported by the US Agency for International Development and U.S. President's Emergency Plan for AIDS Relief through the Linkages Across the Continuum of HIV Services for Key Populations cooperative agreement (AID-OAA-A-14- 0045) managed by FHI 360.

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.

Acceptability and satisfaction towards self-collection for chlamydia and gonorrhoea testing among transgender women in Tangerine Clinic, Thailand: shifting towards the new normal.

INTRODUCTION: Provider-collected swabs are an unappealing procedure for many transgender women and may have led to suboptimal rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing. Self-collection for CT/NG testing is recommended for men who have sex with men. However, the information on acceptability and clinical performance to support a recommendation for transgender women is lacking. We aimed to determine the acceptability and satisfaction towards self-collection for CT/NG testing among Thai transgender women. METHODS: Thai transgender women who attended Tangerine Clinic (a transgender-led, integrated, gender-affirming care and sexual health services clinic in Bangkok, Thailand) between May and July 2020 and had condomless sexual intercourse within the past six months were offered to collect urine and perform self-swabs of pharyngeal, rectal, and if applicable, neovaginal compartments for pooled nucleic acid amplification testing for CT/NG infections. Participants received a diagram, video and oral instructions about how to perform self-collection procedure. Those who accepted self-collection were also offered to receive provider collection to evaluate the performance between the two methods. Self-administered questionnaires were used to assess satisfaction. RESULTS: Among 216 transgender women enrolled, 142 (65.7%) accepted self-collection. All who accepted had pharyngeal, rectal and urine samples collected. Of 31 transgender women who had undergone genital surgery, 28 (90.3%) accepted neovaginal self-swab. The acceptance rate increased from 46.2% in May to 84.5% in July 2020. One participant had an invalid result. All transgender women who accepted self-collection could perform it without assistance, and 82.8% were highly satisfied with the method. None reported dissatisfaction. Due to the COVID-19 pandemic, provider collection services were discontinued early, and only eight transgender women were able to perform both methods for performance evaluation. The performance agreement was 100%. CONCLUSIONS: Thai transgender women had high acceptability and satisfaction towards self-collection for CT/NG testing. The performance was promising compared to provider collection. Our results support the implementation of self-collection to the sexually transmitted infection services, particularly during the COVID-19 pandemic where physical distancing is the new normal. A larger study is warranted to determine the performance of self-collection for CT/NG testing in each anatomical compartment and confirm the performance between self-collection and provider collection.

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.

Evaluation of a pre-exposure prophylaxis programme for men who have sex with men and transgender women in Thailand: learning through the HIV prevention cascade lens.

INTRODUCTION: Men who have sex with men (MSM) and transgender women (TGW) are two key populations (KPs) in Thailand at high risk for HIV. Uptake and scale-up of pre-exposure prophylaxis (PrEP) among them has been slow. We used data from Princess PrEP, Thailand's largest KP-led PrEP programme, to operationalize PrEP service cascades. We identified gaps and pointed out where additional data are needed to inform a larger HIV prevention cascade. METHODS: Numbers of people tested for HIV, tested HIV negative, eligible for PrEP (defined as any of the following in the past three months: condomless sex with partners of unknown/uncertain HIV status or antiretroviral treatment or viral load status, multiple partners, engaging in sex work, sexually transmitted infections, injecting drugs, using amphetamine-type stimulants, or repeated use of post-exposure prophylaxis), offered PrEP and accepted PrEP during January to November 2019 were retrieved from Princess PrEP database to inform PrEP service cascades for MSM and TGW. Reasons for not accepting PrEP were documented. RESULTS: Of 6287 MSM who received HIV testing in Princess PrEP, 92.3% were HIV negative and 70.2% of them were eligible for PrEP. PrEP was offered to 94.7% of those eligible and 48.0% of those offered accepted it. Among 900 TGW who had HIV testing, 95.3% tested HIV negative and 64.8% of them met PrEP eligibility criteria. Of these, 95.0% were offered PrEP and 43.9% of them accepted it. Among MSM and TGW who met PrEP eligibility criteria, no or low-HIV-risk perception was the most common reason provided (46.7% of 2007 MSM and 41.9% of 296 TGW) for not accepting PrEP. CONCLUSIONS: PrEP service cascades from the Princess PrEP programme identified no or low-risk perception as key barrier to PrEP acceptance among MSM and TGW who met PrEP eligibility criteria. More implementation research studies are needed to explore PrEP motivation and access in larger communities outside of clinical services. This is to identify gaps and strategies to address them within motivation, access and effective use domains of the HIV prevention cascade.

Cervical determinants of anal HPV infection and high-grade anal lesions in women: a collaborative pooled analysis.

BACKGROUND: Cervical cancer screening might contribute to the prevention of anal cancer in women. We aimed to investigate if routine cervical cancer screening results-namely high-risk human papillomavirus (HPV) infection and cytohistopathology-predict anal HPV16 infection, anal high-grade squamous intraepithelial lesions (HSIL) and, hence, anal cancer. METHODS: We did a systematic review of MEDLINE, Embase, and the Cochrane library for studies of cervical determinants of anal HPV and HSIL published up to Aug 31, 2018. We centrally reanalysed individual-level data from 13 427 women with paired cervical and anal samples from 36 studies. We compared anal high-risk HPV prevalence by HIV status, cervical high-risk HPV, cervical cytohistopathology, age, and their combinations, using prevalence ratios (PR) and 95% CIs. Among 3255 women with anal cytohistopathology results, PRs were similarly calculated for all anal HSIL and HPV16-positive anal HSIL. FINDINGS: Cervical and anal HPV infections were highly correlated. In HIV-negative women, anal HPV16 prevalence was 41% (447/1097) in cervical HPV16-positive versus 2% (214/8663) in cervical HPV16-negative women (PR 16·5, 95% CI 14·2-19·2, p<0·0001); these values were 46% (125/273) versus 11% (272/2588) in HIV-positive women (4·4, 3·7-5·3, p<0·0001). Anal HPV16 was also associated with cervical cytohistopathology, with a prevalence of 44% [101/228] for cervical cancer in HIV-negative women (PR vs normal cytology 14·1, 11·1-17·9, p<0·0001). Anal HSIL was associated with cervical high-risk HPV, both in HIV-negative women (from 2% [11/527] in cervical high-risk HPV-negative women up to 24% [33/138] in cervical HPV16-positive women; PR 12·9, 95% CI 6·7-24·8, p<0·0001) and HIV-positive women (from 8% [84/1094] to 17% [31/186]; 2·3, 1·6-3·4, p<0·0001). Anal HSIL was also associated with cervical cytohistopathology, both in HIV-negative women (from 1% [5/498] in normal cytology up to 22% [59/273] in cervical HSIL; PR 23·1, 9·4-57·0, p<0·0001) and HIV-positive women (from 7% [105/1421] to 25% [25/101]; 3·6, 2·5-5·3, p<0·0001). Prevalence of HPV16-positive anal HSIL was 23-25% in cervical HPV16-positive women older than 45 years (5/20 in HIV-negative women, 12/52 in HIV-positive women). INTERPRETATION: HPV-based cervical cancer screening programmes might help to stratify anal cancer risk, irrespective of HIV status. For targeted secondary anal cancer prevention in high-risk groups, HIV-negative women with cervical HPV16, especially those older than 45 years, have a similar anal cancer risk profile to that of HIV-positive women. FUNDING: International Agency for Research on Cancer.

The Association of Gender, Age, Efavirenz Use, and Hypovitaminosis D Among HIV-Infected Adults Living in the Tropics.

Vitamin D, which is important for calcium homeostasis and bone metabolism, has several noncalcemic actions. Low vitamin D levels have been observed in HIV-infected patients from high latitudes, with consequently reduced bone mineral density (BMD), but data from the tropics are scarce. We aimed to determine the prevalence of and risk factors for hypovitaminosis D among HIV-infected patients in the tropics. This was a cross-sectional study to determine serum 25-hydroxyvitamin D [25(OH)D] levels in HIV-infected patients who attended our HIV clinic in Bangkok, Thailand from July 2010 to June 2011. Hypovitaminosis D was defined as vitamin D insufficiency and deficiency [25(OH)D 20-30 ng/ml and <20 ng/ml, respectively]. Hypovitaminosis D prevalence was calculated and risk factors were determined using multivariate logistic regression. A total of 673 HIV-infected adults were included. The median age was 41 years and 47% were females. The median body mass index (BMI) was 21.9 kg/m(2) and 93% were using antiretroviral therapy (ART), with a median (IQR) duration of 8.9 (5.0-10.4) years. Thirty-one percent were using efavirenz (EFV). The prevalence of vitamin D insufficiency and deficiency was 40.6% and 29.9%, respectively. In multivariate analysis, female gender [odds ratio: OR (95% confidence interval: 95% CI) 1.7 (1.2-2.3), p = 0.005], age >37 years [OR (95% CI) 1.6 (1.1-2.4), p = 0.01], and EFV use [OR (95% CI) 2.0 (1.3-3.2), p = 0.004] were independent predictors of hypovitaminosis D. Even in tropical areas where the sun is abundant, hypovitaminosis D is highly prevalent. Thus, treatment of low vitamin D in HIV-infected patients at high risk should not be ignored to prevent reductions in BMD and other hypovitaminosis D-related comorbidities.

Cervical and anal HPV infection: cytological and histological abnormalities in HIV-infected women in Thailand.

BACKGROUND: Women infected with human immunodeficiency virus (HIV) have higher rates of persistent infection with high-risk human papillomavirus (hr-HPV) and cervical and anal dysplasia. We describe the epidemiology of hr-HPV, and cervical and anal intra-epithelial abnormalities in HIV-infected women in Thailand. METHODS: HIV-infected women aged 18-49 years, either HAART-naïve or -experienced, were enrolled in Bangkok, Thailand. A demographic and sexual-risk behaviour questionnaire was administered and a pelvic examination with colposcopy was performed on every woman. Cervical and anal samples were tested for cytology and HPV genotyping. RESULTS: A total of 256 women were enrolled with a median [interquartile range (IQR)] age of 35 (32-40) years. Ninety (35.2%) had detectable cervical hr-HPV. Being post-menopausal was associated with increased risk for cervical hr-HPV, while years since HIV diagnosis and plasma HIV RNA <40 copies/mL were significantly associated with decreased risk in multivariable regression analyses. Abnormal cervical cytology was detected in 6.3%. Cervical biopsies that were taken from 99 women (39.3%) owing to abnormalities seen during colposcopy showed cervical intra-epithelial neoplasia (CIN) in 22.6%. The sensitivity of cervical cytology to detect CIN2+ was 10.0%. Among 102 women enrolled in the anal substudy, 18.8% had anal HPV infection and 11.1% had anal hr-HPV. Two women had abnormal anal cytology. CONCLUSION: We found cervical and anal hr-HPV in 35.2% and 11.1% of Thai HIV-infected women, respectively. Moreover, the observed poor agreement between cervical cytology and histology results could indicate current cervical cancer screening programs for HIV-infected women might not be optimal for the detection of pre-neoplastic lesions.

Advanced liver fibrosis by transient elastography, fibrosis 4, and alanine aminotransferase/platelet ratio index among Asian hepatitis C with and without human immunodeficiency virus infection: role of vitamin D levels.

BACKGROUND AND AIM: Vitamin D insufficiency plays an important role in liver fibrosis in hepatitis C virus (HCV)-infected patients. We assessed liver fibrosis by transient elastography and 25 hydroxy vitamin D [25(OH)D] status in HCV-infected patients, with (HIV/HCV) or without HIV co-infection (HCV) from Thailand. METHODS: Fibrosis stage was defined as mild (< 7.1 kPa); moderate (7.2-9.4 kPa); severe (9.5-14 kPa), and cirrhosis (> 14 kPa). Hypovitaminosis D was defined as 25(OH)D < 30 ng/mL. Logistic regression analyses were used to assess predictors for significant fibrosis. Serum 25(OH) D levels, HCV genotypes (GT), interleukin-28B (IL28B) and HCV-RNA were assessed. RESULTS: A total of 331 HCV and 130 HIV/HCV patients were enrolled (70% male, 35% people who inject drugs [PWIDs]). HCV GT distribution was as follows: GT3 47%, GT1 34%, GT6 17%. IL-28B CC genotype (rs12979860) were found in 88% of HIV/HCV and 85% of HCV. In HCV, liver fibrosis was mild in 56.5%; moderate in 18.4%; severe in 12.4%; and cirrhosis in 12.7%. In HIV/HCV, these figures were 30.6%, 27.8%, 17.6%, and 24.1%, respectively. Patients with significant fibrosis were more often male, older, with HIV infection, hypovitaminosis D, and less likely to be infected with GT6. Factors associated with significant fibrosis by multivariate analysis were HIV infection (adjusted odd ratio [95% confidential interval]: 2.67, 1.20-5.93), P = 0.016, Fib-4 score > 1.45 (6.30, 2.70-14.74), P < 0.001, and hypovitaminosis D (2.48, 1.09-5.67), P = 0.031. GT 6 was less likely to have advanced liver fibrosis (0.17, 0.05-0.65), P = 0.01. CONCLUSIONS: HIV infection, Fib-4 score > 1.45, and hypovitaminosis D are strong and independent predictors for the presence of advanced fibrosis in our HCV-infected patients. These data highlight the urgent need of HCV treatment and vitamin D supplement in resource-limited settings.

Ergotism in Thailand caused by increased access to antiretroviral drugs: a global warning.

Ergotism is a toxic condition resulting from overexposure to the ergot compounds produced by various fungi of the genus Claviceps. Traditionally, such exposure was due to ingestion of infected grains, but long-term or excessive use of medications containing ergot derivatives or drug-drug interactions between these medications can result in ergotism. Ergotamine, typically used to treat migraine, has less than 5% bioavailability due to extensive first-pass metabolism by cytochrome P450 3A4 (CYP3A4). Concurrent intake of ergotamine and strong CYP3A4 inhibitors, such as the HIV protease inhibitors (PIs), can lead to clinical ergotism. A total of 13 cases of clinical ergotism in HIV-infected patients has been published since 1997 (most recently reviewed by Frohlich et al).