Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: results of a multicentre, randomised controlled trial

OBJECTIVE: A multicentre, randomised non-inferiority trial compared the efficacy and safety of 14 days of ofloxacin and metronidazole (standard-of-care (SoC)) versus a single dose of intramuscular ceftriaxone followed by 5 days of azithromycin and metronidazole (intervention arm (IA)) in women with mild-to-moderate pelvic inflammatory disease (PID). METHODS: Women with a clinical diagnosis of PID presenting at sexual health services were randomised to the SoC or IA arms. Treating clinicians and participants were not blinded to treatment allocation but the clinician performing the assessment of primary outcome was blinded. The primary outcome was clinical cure defined as ≥70% reduction in the modified McCormack pain score at day 14-21 after starting treatment. Secondary outcomes included adherence, tolerability and microbiological cure. RESULTS: Of the randomised population 72/153 (47.1%) reached the primary end point in the SoC arm, compared with 68/160 (42.5%) in the IA (difference in cure 4.6% (95% CI -15.6% to 6.5%). Following exclusion of 86 women who were lost to follow-up, attended outside the day 14-21 follow-up period, or withdrew consent, 72/107 (67.3%) had clinical cure in the SoC arm compared with 68/120 (56.7%) in the IA, giving a difference in cure rate of 10.6% (95% CI -23.2% to 1.9%). We were unable to demonstrate non-inferiority of the IA compared with SoC arm. Women in the IA took more treatment doses compared with the SoC group (113/124 (91%) vs 75/117 (64%), p=0.0001), but were more likely to experience diarrhoea (61% vs 24%, p<0.0001). Of 288 samples available for analysis, Mycoplasma genitalium was identified in 10% (28/288), 58% (11/19) of which had baseline antimicrobial resistance-associated mutations. CONCLUSION: A short-course azithromycin-based regimen is likely to be less effective than the standard treatment with ofloxacin plus metronidazole. The high rate of baseline antimicrobial resistance supports resistance testing in those with M. genitalium infection to guide appropriate therapy. TRIAL REGISTRATION NUMBER: 2010-023254-36

Performance of a tool to identify different types of self-reported sexual risk among women attending a contraception and sexual health clinic: results of a cross-sectional survey

INTRODUCTION: A clinical prediction rule (CPR) using psychosocial questions was previously derived to target sexual healthcare in general practice by identifying women at risk of unintended pregnancy (UIP) and sexually transmitted infections (STIs). This psychosocial CPR may help target resources within contraception and sexual health (CASH) services. This study investigated how well it predicted recent self-reported risk of UIP and STI acquisition among women attending a CASH clinic. METHODS: Female patients aged 16-44 years attending a CASH clinic in South-East England were offered a questionnaire on arrival. This comprised psychosocial questions, and others addressing three sexual risks: (1) two or more male sexual partners in the last year (2+P), (2) risk of STI acquisition through most recent partner and (3) risk of UIP in the last 6 months. A CPR score was calculated for each participant and cross-tabulated against self-report of each sexual risk to estimate CPR sensitivity and specificity. RESULTS: The psychosocial questions predicting 2+P had sensitivity 83.2% (95% CI 79.3% to 86.5%) and specificity 56.1% (95% CI 51.3%-60.6%). Those predicting combined 2+P and/or risk of STI acquisition through most recent partner had a sensitivity of 89.1% (95% CI 85.7%-91.8%) and specificity of 43.7% (95% CI 39.0%-48.5%). Questions predicting risk of UIP in the last 6 months had a sensitivity of 82.5% (95% CI 78.6%-86.0%) and specificity of 48.3% (95% CI 43.4%-53.1%). CONCLUSIONS: The CPR demonstrated good sensitivity but low specificity, so may be suited to triaging or stratifying which interventions to offer CASH patients and by which mode (eg, online vs face-to-face). Further investigation of causal links between psychosocial factors and sexual risk is warranted to support development of psychosocial interventions for this patient group

The cost of care for people living with stable HIV in Croatia and the efficiency of EmERGE

Aim To estimate the cost-effectiveness of the EmERGE Pathway of Care for medically stable people living with HIV (PLHIV) at the University Hospital for Infectious Diseases (UHID), Zagreb. The Pathway includes a mobile application enabling individuals to communicate with their caregivers. Methods This study involving 293 participants collected data on the use of HIV outpatient services one year before and after EmERGE implementation. In departments sup - porting HIV outpatients, a micro-costing exercise was per - formed to calculate unit costs. These were combined with mean use of HIV services per patient year (MPPY) to esti - mate average annual costs. Primary outcomes were CD4 count, viral load, and secondary outcomes were patient activation, PAM13; and quality of life, PROQOL-HIV. Infor - mation on out-of-pocket expenditures was also collected. Results Outpatient visits decreased by 17%, from 4.0 (95% CI 3.8-4.3) to 3.3 MPPY (95% CI 3.1-3.5). Tests, including CD4 count, decreased, all contributing to a 33% reduction of annual costs: 7139 HRK (95% CI 6766-7528) to 4781 HRK (95% CI 4504-5072). Annual costs including anti-retroviral drugs (ARVs) decreased by 5%: 43 101 HRK (95% CI 42 728- 43,490) to 40 743 HRK (95% CI 40 466-41,034). ARVs remain the main cost driver in stable PLHIV. Primary and secondary outcomes did not change substantially between periods. Conclusion EmERGE Pathway was a cost-saving interven - tion associated with changes in management, and a reduc - tion in outpatient visits, tests, and costs. ARV costs domi - nated costs. Future efficiencies are possible if EmERGE is introduced to other PLHIV across the UHID and if ARV pric - es are reduced

"I have the strength to get through this using my past experiences with HIV": findings from a mixed-method survey of health outcomes, service accessibility, and psychosocial wellbeing among people living with HIV during the Covid-19 pandemic

We examined the impact of Covid-19 restrictions on the wellbeing and access to care among people living with HIV (PLWH) in the UK. A cross-sectional anonymous online survey was circulated to PLWH attending care at three HIV services in Sussex. The questionnaire covered key themes: socio-demographic characteristics; changes in physical and mental health; accessibility of essential health services and information; and socio-economic concerns. Free-text qualitative responses were examined through framework analysis. Quantitative data from 653 respondents were available, with a subset of 385 free-text qualitative responses. In terms of mental health, 501 (77.6%) respondents reported feeling more anxious; 464 (71.8%) reported feeling more depressed than usual; and 128 (19.8%) reported having suicidal thoughts since the start of the pandemic. Respondents worried about running out of HIV medicine (n = 264, 40.7%); accessing HIV services (n = 246, 38.0%) as well as other health services (n = 408, 63.0%). Widespread resilience was also noted: 537 (83.3%) of respondents felt that living with HIV had equipped them with the strength to adapt to the Covid-19 pandemic. Findings highlight important gaps between the multifaceted needs of PLWH. Multisectoral collaborations and investments are needed to adequately support PLWH and to build resilience to future shocks within HIV services

Emerge mhealth platform: implementation and technical evaluation of a digital supported pathway of care for medically stable HIV

In this article, we described a new mobile-Health (mHealth) supported clinical pathway of care for people living with medically stable HIV in terms of platform acceptability, usability and technical feasibility. The EmERGE mHealth platform was codesigned with clinicians and the com-munity, developed using Scrum agile methodology, integrated with hospital information systems and validated in a large prospective cohort study of 2251 participants. The evaluation of this new paradigm of care was conducted using a tailored Health Technology Assessment: the Model for Assessment of Telemedicine Applications. Usability and acceptability were assessed through the System Usability Score and a Patient Reported Experience Measure. The EmERGE platform was successfully deployed across diverse care settings in five European countries and used by 2251 patients and more than 20 clinicians for up to 30 months. Results from the formal evaluation demon-strated that the EmERGE platform is feasible and acceptable, with a high level of usability (median System Usability Score (SUS) 85.0%) and very positive patient-reported experiences (94.2% would recommend to a friend). The EmERGE platform is a secure and General Data Protection Regulation (GDPR)-compliant system with a complete set of functionalities that could be easily adapted to other clinical conditions, clinical sites and health systems thanks to its modular technical architec-ture

Validation study of mHealth technology in HIV to improve empowerment and healthcare utilisation: research and innovation to generate evidence for personalised care (EmERGE)

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Measuring quality of life among people living with HIV:A systematic review of reviews

Abstract Aim A systematic review of reviews was conducted to identify and appraise brief measures of health-related quality of life (HRQoL) that have been used in peer-reviewed research with people living with HIV. Methods The review was conducted in two stages: 1) search of electronic databases to identify systematic reviews of tools used to measure HRQoL in adults living with HIV, published since the year 2000; 2) selection of HRQol scales from those identified in the reviews. Inclusion criteria included scales that could be self-administered in 10 min or less, covering at least 3 domains of quality of life (physical function, social/role function and mental/emotional function). For generic scales, inclusion criteria included the availability of normative data while for HIV-specific scales, patient input into the development of the scale was required. Results Ten reviews met the inclusion criteria. Nine generic scales met the inclusion criteria: the EuroQol five dimensions questionnaire (EQ-5D); Health Utilities Index; McGill Quality of Life questionnaire; Medical Outcomes Study (MOS) Short Form (SF)-12; SF-36; World Health Organisation Quality of Life (WHOQOL- BREF), Questions of Life Satisfaction (FLZM) and SF-20. Available psychometric data supported the EQ-5D and SF-36. Seven HIV-specific scales met the inclusion criteria: the AIDS Clinical Trials Group (ACTG)-21; HIV-QL-31; MOS-HIV; Multidimensional Quality of Life Questionnaire for Persons with HIV/AIDS (MQOL-HIV), PROQOL-HIV, Symptom Quality of Life Adherence (HIV-SQUAD) and the WHOQOL-HIV BREF. Of the HIV -specific measures, the MOS-HIV was considered to have the most well-established psychometric properties, however limitations identified in the reviews included insufficient input from people living with HIV in the development of the scale, cross-cultural relevance and continued applicability. Two relatively new measures, the WHOQOL-HIV BREF and PROQOL-HIV, were considered to have promising psychometric properties and may have more relevance to people living with HIV. Conclusion The findings highlight the need for further validation of HRQoL measures in people living with HIV. The choice of one measure over another is likely to be influenced by the purpose of the quality of life assessment and the domains of HRQoL that are most relevant to the specific research or clinical question