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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

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.

Disclosure of HIV status to family members could improve communication, relationship, and cohesion. We evaluated the impact of a family-centered program designed to increase the readiness/willingness of parents to disclose HIV status to their children. People living with HIV (PLWH) with children ≥8 years were surveyed regarding HIV knowledge, family relationship, attitudes, willingness/readiness to disclose, and they were then invited to participate in group education and family camps. Of 367 PLWH surveyed, 0.8% had disclosed, 14.7% had not yet disclosed but were willing/ready to disclose, 50.4% were willing but not ready, and 33.2% did not wish to disclose. The educational sessions and camps led to significant improvements of HIV knowledge and disclosure techniques, and readiness/willingness to disclose. Given the benefits of group education and family camps in supporting PLWH to improve their communication with their families and disclose their HIV status, these supporting activities should be included in HIV programs.

Background: 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 center using initiation hub model to examine its applicability and effectiveness. Methods: We collected data from the Thai Red Cross Anonymous Clinic in Bangkok, Thailand, from clients who were ART-naive and could return for follow-up visits (logistical criteria). Baseline laboratory tests and chest x-ray were performed according to national guidelines, and clinical eligibility was determined based only on physical examination and chest x-ray finding. Acceptability and care linkage were assessed, as well as viral load (VL) suppression and retention in care three, six, and 12 months after ART initiation. Historical data from clients at the same venue between February 2015 to June 2017 were used to compare ART initiation after HIV diagnosis and VL suppression with SDART clients by using Cox proportional-hazards model. Findings: Between July 2017 and July 2018, 2,427 people tested HIV-positive at the clinic, and 2,107 met logistical criteria. Of these, 1,904 (90·4%) agreed to SDART. 1,624 (85·3%) were placed on ART, and 77·4% (1,251/1,624) received same-day initiation. 92·8% (1,198/1,291) were successfully referred to sustained ART sites. Retention at month three, six, and 12 was 93·3% (1,211/1,289), 89·0% (757/851), and 92·1% (70/76), respectively. When compared to historical data, the hazard ratios to ART initiation after HIV diagnosis and viral load suppression among SDART clients were 3·6 (95%CI:3·4-3·8;p

Limited data are available on circumcision prevalence and acceptability among Thai men to prevent human immunodeficiency virus. Of 408 high-risk heterosexual men, 12.3% were circumcised. 14.2% and 24.9% expressed willingness to be circumcised before and after circumcision education, respectively. Neonatal circumcision acceptability was relatively high. One participant underwent circumcision at 3-month follow-up.

The objective of this study was to characterize HIV-serodiscordant heterosexual couples and to evaluate acceptance for HIV testing and HIV prevalence in nonindex partners. We conducted a cross-sectional study with quantitative and qualitative components. Two cohorts of 1767 HIV-positive people were screened to identify heterosexual HIV-serodiscordant couples. HIV-positive partners (index) were administered a questionnaire; CD4, viral load (VL), and antiretroviral therapy (ART) history were gathered from clinical records. HIV-negative/unknown status partners (nonindex) were invited for a similar questionnaire and HIV testing. In-depth interviews with three HIV-serodiscordant couples were conducted. Two hundred and ninety-seven index partners agreed to enroll in this study. The median duration of the relationship was 10 years, and 81% were sexually active. All but two index partners were on ART, and 98% had VL1000 copies/mL. Only 111 (37%) nonindex partners came for HIV testing, and all of them tested HIV-negative. In addition, only 41% of nonindex partners had HIV testing in the last one year. The main reasons for the nonindex partners not to come for HIV testing were "no interest" (n = 117, 63%) and "nondisclosure of HIV status" (n = 46, 25%). The latter was substantiated and explained by the qualitative outcome of this study, suggesting relation to stigma against HIV-positive people. Our results support the WHO recommendation for starting ART for treatment and prevention in HIV-serodiscordant couples at any CD4 count. Furthermore, we recommend the dissemination of data showing that no HIV transmission in heterosexual couples through sex practice has been observed provided VL is suppressed. This could be a powerful tool for effective fight against stigma and self-stigma in people living with HIV.

This study assessed the attitudes toward, and interest in, the test-and-treat strategy, comprising regular HIV testing and immediate antiretroviral treatment (ART) among men who have sex with men (MSM) in Bangkok, Thailand. A total of 363 participants completed the questionnaires before and after learning about their HIV status. Previous HIV testing reported by 69.8% and 34.7% tested at least annually. Before pretest counseling, 83.2% expressed interest in regular HIV testing and 78.8% in immediate ART. MSM who tested HIV-positive at enrollment were less likely than those who tested HIV-negative to have been tested for HIV before (45.7% vs. 60.8%, p < 0.0001). Among MSM who tested HIV-positive (n = 69, 15.9%), the median level of willingness to take ART immediately increased significantly after learning about their positive results (90 vs.100%, p < 0.0001). Interest in regular HIV testing remained high among HIV-negative MSM after becoming aware of their status (70.9% before vs. 71.9% after, p = 0.55). MSM participants have a strong desire and willingness to start ART immediately upon receiving an HIV-positive test result; it is important to provide the necessary information on the health benefits of early ART and education to the community to maintain their health and prevent HIV transmission.

To evaluate the safety and efficacy of four different regimens of didanosine (ddI) + stavudine (d4T) in HIV-infected Thais. Prospective, open-label, randomized study. Patients were randomized to four regimens of high and low doses of ddI and d4T or to ddI alone. D4T was added to the ddI-alone arm after week 24. The duration of study was 48 weeks. Seventy-eight patients were randomized (mean CD4 cell count, 255 x 10(6)/l; mean plasma HIV-1 RNA; 4.3 log10 copies/ml). In the intent-to-treat analysis, 78% of patients in the pooled combination arms and 20% of the patients in the ddI alone arm (to which d4T was added after 24 weeks) showed plasma HIV-1 RNA < 500 copies/ml at week 24 (P < 0.001), and 59% versus 53% at week 48, respectively. In addition, the proportion of patients with < 50 HIV-1 RNA copies/ml was 13% versus 7% at week 24 (P = 0.5) and 17% versus 20% at week 48 respectively. At week 24, median CD4 cell count increases from baseline were 101 x 10(6)/l in the pooled combination versus 76 x 10(6)/l in the ddI alone arm (P = 0.78). Logistic regression modeling suggested a correlation between receiving high dose ddI and achieving HIV-1 RNA < 500 copies/ml at week 48 (P = 0.07). The d4T/ddI combination was superior to ddI alone in producing HIV-1 viral suppression. At week 48, > 60% of patients treated with this combination reached HIV-1 RNA levels < 500 copies/ml. Receiving high dose ddI but not d4T may correlate with a better viral suppression

HIV-infected patients may have frequent atopy caused by an imbalance of Th1 and Th2 cytokines. The objective of the present study was to investigate whether IL-2 given in addition to antiretrovirals (ARV) would result in lower IgE levels and less allergic symptoms. Patients naive to IL-2 (n=28) began IL-2 plus ARV and were followed for 12 months. IgE, eosinophil and CD4 counts, HIV RNA, symptom scoring, PFT and skin prick test (SPT) were performed. It was found that the baseline median CD4 and IgE were 386.5 cells/mm3 and 63.5 IU/ml, respectively. Four patients had allergic rhinitis (AR) and 61% had a positive SPT to at least 1 antigen. At month 12, patients had higher CD4 counts (p0.001) compared to the baseline; however, there were no differences in IgE levels, allergic symptom scores or HIV RNA. The eosinophil count was higher after IL-2 administration. It was concluded that IL-2 plus ARV resulted in higher CD4 counts but had no effect on atopy.

The long running debate about clinical trial sponsors’ responsibility for providing treatment to patients after a trial has ended does not seem likely to end soon. In September 2003 the World Medical Association postponed its decision about whether or not the Declaration of Helsinki should be revised to reflect concerns that the US government and the pharmaceutical industry have expressed about post-trial treatment. Paragraph 30 of the Declaration of Helsinki currently states: “At the conclusion of the study every patient entered into the study should be assured of access to the best proven prophylactic diagnostic and therapeutic methods identified by the study”. The proposed revision to paragraph 30 would introduce two main changes: that the physician should make every effort to see that patients receive treatment once it has been approved by appropriate authorities and that the physician is required to explicitly tell patients if they are unlikely to continue receiving treatment from sponsors after they leave the study. The ethical concerns over the undertaking of clinical trials in developing countries especially with respect to the standard of treatment that should be provided to trial participants have resulted in little research in countries where interventions are needed most. The initiation of preventative HIV vaccine trials has been delayed by debate about the provision of antiretrovirals to participants. (excerpt)

Rationale Th1/Th2 imbalance may cause frequent atopy and allergic diseases in HIV infection. We hypothesize that IL-2 + ARV results in lower IgE and less allergic symptoms compared to ARV alone. Methods ARV-treated pts (n=58) naive to IL-2 randomized to either IL-2 + ARV (arm 1, n=28) or ARV (arm 2, n=30) were recruited and followed for 12 mo. Primary outcome was median IgE level. Secondary outcomes were % pts with AR, RAD, AD, symptom scores, eosinophils (Eo). Clinical, lab q 4 mo with yearly PFT, IHST. Results Baseline data were matched for age (37.6 yrs), gender (58%F), CD4+ (406 cells), VL (1.7 log), Eo (200 cells), IgE (60.5 IU/ml). Four (14%) and 7 (23%) pts in arm 1 and 2 had AR. Two (7%) in arm 2 had AD. No pts had RAD. Ten and 13% of arm 1 and 2 pts had high IgE (>100 IU/L) at baseline. Arm 1 pts received a median of three IL-2 cycles in 12 mo. At mo 12, arm 1 pts had higher CD4 (p 0.001). No differences in IgE, symptoms, Eos were seen between 2 arms. No effect of IL-2 on IgE was seen in subgroups with high IgE, positive IHST or AR at baseline. Conclusion When given in addition to ARV, IL-2 resulted in higher CD4; however, it did not have an effect on IgE levels, Eos, allergy symptoms. Successful ARV treatment, high baseline CD4+, low incidence of allergic diseases and low baseline IgE likely contributed to the lack of effect by IL-2.