Digital health innovation can fail to move beyond prototype or pilot stages or achieve intended outcomes due to a lack of involvement and attunement to local context. This article shares the potential of place-based co-production to support the development, acceptability and usability of context-attuned, digital health service innovation for young people. To illustrate the approach, we report on a collaborative, interdisciplinary project involving a Zambian public health research partner based in Lusaka, Zambia, three European universities and a not-for-profit digital innovation partner. Our youth-led, co-production process involved 6 stages: recruitment of youth Co-design Leaders; role play-based care pathway co-design; app co-design; digital prototype development; stakeholder consultation; and digital pathway testing. We used a combination of qualitative social science research, community and arts-based, human-centred design and digital innovation methods. Young people traced the digital testing and sampling process from accessing self-testing and sampling kits to laboratory processing of results through to how results should be communicated. They were encouraged to evaluate how these processes would work in the context of their everyday lives. We systematically embedded this ideation work into a technically functional 'eHealth Yabwela' app and clinical or laboratory worker-facing web application which young people user tested. Our place-based focus encouraged elicitation of whole pathway, in situ, logistical feasibility alongside social and technical concerns, enabling us to engage with potential adoption and accessibility barriers during the design process. Youth-led co-production created the conditions for participants to lead discussions, voice requirements and hold the project team accountable. Young people recognised that advocacy, overcoming digital inequalities, and further co-production with healthcare workers already facilitating youth-friendly healthcare provision would be needed to integrate the pathway within local systems.

Broadening the access of HIV–preexposure prophylaxis (HIVPrEP) prevents HIV transmission. In Brighton, we partnership with The Terrence Higgins Trust to deliver a communitybased HIVPrEP service (PrEP2U). PrEP2U operates weekly, offering comprehensive STI/HIV testing, HIVPrEP monitoring and hepatitis A & B and human papilloma virus vaccinations. We aimed to explore whether PrEP2U is providing HIVPrEP to a different population compared with our clinic. Eightytwo individuals attended PrEP2U between August and December 2022, 66 (80%) identified as cismale, 5 (6%) cisfemale, 5 (6%) transfeminine, 2 (2%) transmasculine and 4 (5%) nonbinary. Thirtyone (38%) were nonUK born and 66 (80%) had not used HIVPrEP previously. PrEP2U attendees were significantly more likely to be cisfemale, transfeminine, nonbinary, nonUK born and had not used HIVPrEP previously compared with the sexual health clinic (table 1). Despite HIVPrEP being available for 2 years, PrEP2U is attracting a diverse group of people who have not used HIVPrEP previously. More work is needed to broaden and improve the access of HIVPrEP using community partners to reach neglected populations.

IntroductionWe have developed a community based, bi-weekly, drop-in HIV-PrEP clinic (PrEP2U) in partnership with a community organisation to improve the access to HIV-PrEP for seldom heard populations. We aimed to evaluate the service and explore the experience of PrEP2U users.MethodAn anonymous electronic survey was sent to patients via text message following their appointment at PrEP2U from August to December 2022. We collected data on demographics, previous HIV-PrEP use and how users had found out about PrEP2U and free text responses evaluating the service.ResultsOverall, 30/89 (34%) responded to our survey, 26 (87%) identified as cis-male, 1 (3%) cis female and 3 (10%) as trans/non-binary. Twenty-four (80%) described themselves as being gay/queer, 5 (17%) bisexual/pansexual and 1 (3%) as heterosexual. Twenty-six (87%) had not used HIV-PrEP previously. Respondents would recommend the clinic to friends (median of 5/5 (Interquartile range = 5–5) on a Likert scale where 5 is highly recommend) and would use the service again (5/5 (5–5), where 5 is definitely use again). Respondents found out about the service either online (9, 30%), via Terrence Higgins Trust communication (9, 30%) from friends (8, 27%) or from local sex on premises venues (3, 30%). Themes which emerged from the free-text responses from respondents included: confidentiality, accessibility, and the non-judgemental approach from the team which participants felt were important.DiscussionTo our knowledge, this is the first user evaluation of a community-based HIV-PrEP service in the UK. Despite HIV-PrEP being available for 2 years via the UK NHS programme, we are seeing a group of people who haven’t used HIV-PrEP previously. More work is needed to both broaden the access to HIV-PrEP using community partners to engage seldom reached populations, and to innovate to streamline person centred clinical pathways.

Making associations between sexually transmitted infections (STIs) and child sexual abuse can be controversial. To contribute to the paucity of research in this field, this service evaluation aims to (1) define the prevalence of STIs in children aged 0–13 years seen at a regional Children’s Sexual Assault Referral Centre, (2) determine whether sexual transmission is the most likely mode of transmission for diagnosed STIs, (3) identify factors affecting application of STI screening and (4) assess follow-up. Methods consisted of retrospective analysis of an anonymous database for all patients seen between 1 July 2016 and 1 July 2019. Of 241 children seen, 114/241 (47.3%) received STI screening and 10/114 (8.8%) tested positive (4.1% of children seen overall). No asymptomatic child was diagnosed with an STI. Sexual transmission was the most likely mode of transmission based on child disclosure and physical examination findings for 6/10 children diagnosed with an STI.

This study estimated the efficiency of implementing the EmERGE Pathway of Care for people living with medically stable HIV in Brighton, UK; an App enables individuals to communicate with caregivers via their smart-phone. Individual data on the use of HIV outpatient services were collected one-year pre- and post-implementation of EmERGE. Unit costs of HIV outpatient services were calculated and linked with mean use of services per patient year. Primary outcomes were CD4 count and viral load; patient activation and quality-of-life measures were secondary outcomes. 565 participants were followed up April 2017 - October 2018: 93% men, mean age at recruitment 47.0 years (95%CI:46.2-47.8). Outpatient visits decreased by 9% from 5.6 (95%CI:5.4-5.8) to 5.1 (95%CI:4.9-5.3). Face-to-face visits decreased and virtual visits increased. Annual costs decreased by 9% from £751 (95%CI: £722-£780) to £678 (95%CI: £653-£705). Including anti-retroviral drugs, total annual cost decreased from £7,343 (95%CI: £7,314-7,372) to £7,270 (95%CI: £7,245-7,297): ARVs costs comprised 90%. EmERGE was a cost-saving intervention, patients remained engaged and clinically stable. Annual costs were reduced, but ARVs continue to dominate costs. Extension of EmERGE to other people with chronic conditions, could produce greater efficiencies but these needs to be evaluated and monitored over time.

Background ‘PrEP-EmERGE’ is a co-designed digital health innovation that supports HIV-PrEP users via a novel digital-health pathway and mobile-health application. Method A cross sectional study using a mixed-methods approach evaluating the usability and acceptability of the PrEP-EmERGE app. Data were collected via an online survey sent to all active users in September-2021. Usability was assessed using a validated usability tool, (SUS). Acceptability was assessed using modified (PREMs). Thematic analysis was used to analyse all free-text responses. Results 81/133(61%) PrEP EmERGE participants completed an online evaluation. 78/81(96%) identified as cis-male, 74/81 (91%) identified as ‘white’. 69/81(85%) reported daily PrEP use, 7/81 (9%) reported using event-based dosing schedule, and 5/81 (6%) were switching between dosing schedules. Overall, the median SUS score was 78/100[IQR=70-92]. There were no differences in median SUS scores by PrEP dosing schedules (p=0.46) or months’ of experience of using the app (p=0.38). Overall, 73/81 (90%) would recommend the PrEP EmERGE app to a friend and 78/81 (96%) rated their satisfaction of the app as excellent, good or satisfactory. The free text responses generated three key themes: accessibility (of results); autonomy (taking responsibility for their [sexual] health) and functionality (including technical recommendations for app development and the digital health pathway). Conclusion Applications such as PrEP EmERGE may provide an important role to help facilitate the increasing number of patients accessing sexual health services for the provision of PrEP. Additionally, the PrEP EmERGE app appears to offer a highly acceptable and usable innovation which may an impact on sustaining PrEP use and optimising adherence.

OBJECTIVES:Despite successful treatment, people living with HIV experience persisting and burdensome multidimensional problems. We aimed to assess the validity, reliability and responsiveness of Positive Outcomes, a patient-reported outcome measure for use in clinical practice.METHODS:In all, 1392 outpatients in five European countries self-completed Positive Outcomes, PAM-13 (patient empowerment), PROQOL-HIV (quality of life) and FRAIL (frailty) at baseline and 12 months. Analysis assessed: (a) validity (structural, convergent and divergent, discriminant); (b) reliability (internal consistency, test-retest); and (c) responsiveness.RESULTS:An interpretable four-factor structure was identified: 'emotional wellbeing', 'interpersonal and sexual wellbeing', 'socioeconomic wellbeing' and 'physical wellbeing'. Moderate to strong convergent validity was found for three subscales of Positive Outcomes and PROQOL (ρ = -0.481 to -0.618, all p < 0.001). Divergent validity was found for total scores with weak ρ (-0.295, p < 0.001). Discriminant validity was confirmed with worse Positive Outcomes score associated with increasing odds of worse FRAIL group (4.81-fold, p < 0.001) and PAM-13 level (2.28-fold, p < 0.001). Internal consistency for total Positive Outcomes and its factors exceeded the conservative α threshold of 0.6. Test-retest reliability was established: those with stable PAM-13 and FRAIL scores also reported median Positive Outcomes change of 0. Improved PROQOL-HIV score baseline to 12 months was associated with improved Positive Outcomes score (r = -0.44, p < 0.001).CONCLUSIONS:Positive Outcomes face and content validity was previously established, and the remaining validity, reliability and responsiveness properties are now demonstrated. The items within the brief 22-item tool are designed to be actionable by health and social care professionals to facilitate the goal of person-centred care.

We aimed to calculate the efficiency of the EmERGE Pathway of Care in five European HIV clinics, developed and implemented for medically stable people living with HIV. Participants were followed up for 1 year before and after implementation of EmERGE, between April 2016 and October 2019. Micro-costing studies were performed in the outpatient services of the clinics. Unit costs for outpatient services were calculated in national currencies and converted to US2018 OECD purchasing parity prices to enable between clinic comparisons in terms of outcomes and costs. Unit costs were linked to the mean use of services for medically stable people living with HIV, before and after implementation of EmERGE. Primary outcome measures were CD4 count and viral load; secondary outcomes were patient activation (PAM13) and quality of life (PROQOL-HIV). Out-of-pocket expenditure data were collected. There were 2251 participants: 87–93

OBJECTIVE:Calculate the efficiency of the EmERGE Pathway of Care for medically stable people living with HIV at the Hospital Clínic-IDIBAPS, Barcelona, Spain.METHODS:546 study participants were followed between 1st July 2016 and 30th October 2019 across three HIV outpatient clinics, but the virtual clinic was closed during the second year. Unit costs were calculated, linked to mean use outpatient services per patient year, one-year before and after the implementation of EmERGE. Costs were combined with primary and secondary outcomes.RESULTS:Annual costs across HIV-outpatient services increased by 8%: €1073 (95%CI €999-€1157) to €1158 (95%CI €1084-€1238). Annual cost of ARVs was €7,557; total annual costs increased by 1% from €8430 (95%CI €8356-8514) to €8515 (95%CI €8441-8595). Annual cost for 433 participants managed in face-to-face (F2F) clinics decreased by 5% from €958 (95%CI 905-1018) to €904 (95%CI 863-945); participants transferred from virtual to F2F outpatient clinics (V2F) increased their annual cost by a factor of 2.2, from €115 (95%CI 94-139) to €251 (95%CI 219-290). No substantive changes were observed in primary and secondary outcomes.CONCLUSION:EmERGE Pathway is an efficient and acceptable intervention. Increases in costs were caused by internal structural changes. The cost reduction observed in F2F clinics were off-set by the transfer of participants from the virtual to the F2F clinics due to the closure of the virtual clinic during the second year of the Study. Greater efficiencies are likely to be achieved by extending the use of the Pathway to other PLHIV.

OBJECTIVE:We aimed to evaluate the usability and acceptability of a co-designed mobile health (mHealth) application (PrEP-EmERGE) within a digital health pathway to support HIV pre-exposure prophylaxis (PrEP).METHODS:This was a cross-sectional study to evaluate the usability and acceptability of the PrEP-EmERGE app. Data were collected via an online survey sent to all PrEP EmERGE users in September 2021. Usability was assessed with a validated usability tool, the System Usability Scale (SUS). Acceptability was assessed using modified patient-reported experience measures (PREMs). Quantitative data were analysed using descriptive and/or inferential statistics and qualitative data (free text responses) using thematic analysis.RESULTS:In total, 81/133 (61%) active PrEP EmERGE users completed the online survey, which was available directly from their PrEP EmERGE app: 78/81 (96%) identified as cis-male, 74/81 (91%) reported their ethnicity as 'white', 69/81 (85%) reported daily PrEP use, 7/81 (9%) reported using an event-based dosing schedule, and 5/81 (6%) were switching between dosing schedules. Overall, the median SUS score was 78/100 (interquartile range: 70-92). There were no differences in median SUS scores by PrEP dosing schedules (p = 0.78) or months of experience of using the app (p = 0.31). Overall, 73/81 (90%) would recommend the PrEP EmERGE app to a friend and 78/81 (96%) rated their satisfaction of the app as excellent, good or satisfactory. The free text responses generated three key themes: accessibility (for results and information); autonomy [taking responsibility for their (sexual) health] and functionality (including technical recommendations for app development and the digital health pathway).CONCLUSIONS:Innovative, co-designed digital health pathways, such as PrEP EmERGE can help sexual health services to manage increasing numbers of people accessing PrEP - ensuring that they retain access for those who need to be seen face-to-face. We report high levels of acceptability and usability during the first 4 months of this novel pathway.

Abstract Background: The aim of this study was to calculate the cost-effectiveness of the EmERGE Pathway of Care for medically stable people living with HIV in the Hospital Capuchos, Centro Hospitalar Universitário de Lisboa Central (HC-CHLC). The app enables individuals to receive HIV treatment information and communicate with caregivers. Methods: This before-and-after study collected the use of services data 1 year before implementation and after implementation of EmERGE from November 1, 2016, to October 30, 2019. Departmental unit costs were calculated and linked to mean use of outpatient services per patient-year (MPPY). Annual costs per patient-year were combined with primary (CD4 count; viral load) and secondary outcomes (PAM-13; PROQOL-HIV). Results: Five hundred eighty-six EmERGE participants used HIV outpatient services. Annual outpatient visits decreased by 35% from 3.1 MPPY (95% confidence interval [CI]: 3.0–3.3) to 2.0 (95% CI: 1.9–2.1) as did annual costs per patient-year from €301 (95% CI: €288–€316) to €193 (95% CI: €182–€204). Laboratory tests and costs increased by 2%, and radiology investigations decreased by 40% as did costs. Overall annual cost for HIV outpatient services decreased by 5% from €2093 (95% CI: €2071–€2112) to €1984 (95% CI: €1968–€2001); annual outpatient costs decreased from €12,069 (95% CI: €12,047–€12,088) to €11,960 (95% CI: €11,944–€11,977), with 83% of annual cost because of antiretroviral therapy (ART). Primary and secondary outcome measures did not differ substantially between periods. Conclusions: The EmERGE Pathway produced cost savings after implementation—extended to all people living with HIV additional savings are likely to be produced, which can be used to address other needs. Antiretroviral drugs (ARVs) were the main cost drivers and more expensive in Portugal compared with ARV costs in the other EmERGE sites.

To evaluate frailty, falls and perceptions of ageing among clinically stable individuals with HIV, engaged with remote healthcare delivered via a novel smartphone application.

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.

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-por ting 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.