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Objectives\ud 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.\ud \ud Methods\ud 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.\ud \ud Results\ud 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).\ud \ud Conclusions\ud 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.

Background: Calculate the efficiency of the EmERGE Pathway of Care for medically stable people living with HIV managed at five European HIV clinics (Table 1). The Pathway allows for EmERGE participants to communicate virtually with their caregivers. Methods: EmERGE participants, followed up between 2016 and 2019, mainly used HIV outpatient services. Micro- costing studies were performed at each site. Unit and annual costs were calculated in national currencies and converted to US$ 2018 OECD purchasing parity prices (PPPs). Costs were linked to mean per patient year (MPPY) use of outpatient services. Data on use of services were collected retrospectively one year before and prospectively one year after the introduction of EmERGE. Annual costs of HIV outpatient services were combined with primary outcome measures (CD4 count, viral load) to assess efficiency. Out-of- pocket expenditure data were also collected. Results: Two thousand, two hundred and fifty-one participants recruited: 87% to 93% men, mean age at recruitment 41 to 47 years ; 70% to 84% had full-time employment, median 37.5 hours/week and monthly income $1580 ; 5% to 16% participants received social services support, median $318 to 1558/month. Median sick days three months before enrolment was zero days (IQR 0 to 1) ; 50% to 82% participants did not take days off to visit clinic and the return trip took a median 1.5 to 2.0 hours at a median cost $5 to 41. MPPY outpatient visits decreased in four sites from 9% to 31% and associated costs from 5% to 33% (Table 1) ; use and costs increased by 8% in one site. Cost of ARVs comprised 83% to 91% annual outpatient costs. Annual costs of use of HIV services was similar across four clinics, but one site, located in one of the least affluent countries, had higher ARV costs. Primary outcome measures of participants did not change substantially during the study. Conclusions: Implementation of the EmERGE Pathway was efficient in all sites. ARVs were the main cost drivers ; a country’s national socio- economic situation should be considered when setting ARV prices. Other structural changes also affect costs, as demonstrated in two clinics, where changes resulted in reductions and increases of annual costs respectively. Future efficiencies can be anticipated by the introduction of the Pathway for all people living with HIV or those with other chronic diseases as has been demonstrated during the Covid-19 pandemic.

Background: New digital approaches to clinical management of HIV have potential to manage capacity whilst maintaining excellent clinical outcomes. This study examined the feasibility and uptake of a digital care pathway for people living with medically stable HIV at five clinical sites in Europe. Materials and methods: The EmERGE platform (Figure 1) was codesigned, developed and integrated into the IT systems at the five sites. Participants were seen once a year by their clinician with interim results checked, encrypted and pushed through to an app on their mobile phone. A pre- post study design was used with clinical and questionnaire data collected including: viral load outcomes ; serious adverse events (SAEs) ; patient activation [PAM-13] ; adherence [M-MASRI] ; quality of life [EQ-5D-5L ; PROQOL-HIV] ; system usability score [SUS] and patient experience at baseline [M0], 12 [M12] and 24 months [M24]. Changes over time were estimated using mixed effects regression models. Results: The GDPR- compliant EmERGE platform was successfully integrated at all sites during 2017. Two thousand, two hundred and fifty-one participants (mean 23.1% of clinic cohorts) were enrolled and followed up for between 12 and 30 months each. Demographics were representative of clinic cohorts: 91% male (2048/2251) ; 71% MSM (1598/2251) ; 27.9% aged over 50 (629/2251) ; 20.4% (460/2251) non-national at site. Virological outcomes remained excellent (10/2251 with confirmed VL > 50 ; none lost to clinical follow- up) ; no SAEs related to the pathway were reported. Patients were highly activated, no clinically important change was observed in PAM-13 score ; adjusted average continuous PAM-13 score at M12 compared to M0 -0.95 (99% CI -2.10, 0.19). Median self-reported adherence was 100% at each time point. Health-related quality of life was generally good although pain/discomfort and anxiety/depression were common (up to 34% and 44% respectively at M12) on EQ-5D-5L. Stigma was the lowest scoring domain of PROQOL-HIV. The usability of the platform was excellent [SUS score 85 at M12 and M24] ; 94.6% would recommend EmERGE to a friend. Conclusions: This co-designed digital health supported pathway offers a secure, safe, feasible and acceptable option for routine care to people living with medically stable HIV: providing individuals with access to their data and other information whilst helping clinics to manage capacity.

Purpose: To assess the potential effectiveness of a co-designed reduced visit pathway of care for individuals living with stable HIV in terms of empowerment (which encapsulates patient confidence, skills and knowledge to self-manage health and care). Methods: People living with stable HIV across five diverse clinical sites in Europe were invited to take part in the EmERGE study - whereby individuals are seen once, instead of twice, a year by their clinician - with their interim visit supported via an mHealth platform. We report here on preliminary data on the primary outcome, empowerment, measured by PAM-13 (Patient Activation Measure-13) at baseline (M0) and 12 months (M12). Results: PAM-13 was available on 2112/2251 (93.8%) of participants at M0 and 1026/1439 (72.3%) at M12. The overall proportion of participants at low activation Levels (L) 1&2 was 12.4% (261/2112) at baseline, ranging from 10.5% in Antwerp to 13.5% in Zagreb. At M12, the overall proportion was 14.1% (145/1026), ranging from 9.0% in Zagreb to 17.1% in Barcelona. Change in activation from L1&2 at baseline to L3&4 at M12 was achieved by 63/101 (62.4%) L1&2 baseline participants whilst 93/891 (10.4%) of baseline participants at L3&4 had dropped to L1&2 by M12 ; 836/992 (84.3%) did not switch between L1&2 and L3&4. The distribution of participants across each of the four levels of PAM-13 was similar across sites at baseline with≥86% of participants with the highest levels of activation. At four out of five sites, the proportion at L3&4 is currently lower at M12 than at M0. Conclusions: The majority of participants had a high level of empowerment at baseline. Over 60% of respondents in the lowest categories of PAM-13 (L1&2) at baseline shifted to L3&4 in M12. The proportion of participants at low activation levels was similar between sites. Follow-up continues until October 2019.

In the era of well-treated HIV, attention is turning towards how successful ageing can be achieved for all. Integral to this success is personal well-being which can be influenced by perceptions of ones’ ageing. Purpose: To describe perceptions of ageing among individuals living with stable HIV engaged with remote healthcare delivered via a novel smartphone application (‘app’). Method: All EmERGE participants were eligible for this ageing sub-study. Two questions drawn from the US Health and Retirement Study assessed: 1) satisfaction with ageing, rated on a Likert scale (strongly disagree to strongly agree), 2) ‘What age do you feel?’. Lastly, participant opinion on inclusion of information on ageing issues within the ‘app’ was sought. Results: 944 individuals participated across five European study sites. Mean age was 44.6 (SD=9.9), with 32.6% aged>50. 91.5% were male and 79.4% were Caucasian. 99% responded to the statement ‘So far I am satisfied with the way that I am ageing?’ with the majority either somewhat or strongly in agreement (68.8%) and 14.7% either somewhat or strongly disagreed, as shown in table 1. Satisfaction did not vary by age, except for greater dissatisfaction in over 60s. The overall mean age felt (n=916) was 39.4 (SD=10.8), with mean difference from actual age of 5.2 years. 10.4% felt their age, with most (69.5%) feeling younger (by a median of 7 years, IQR 4–11) and 20.2% feeling older (by 3 years, IQR 1–7). The proportion feeling younger increased with increasing age group (p

Mobile technology platforms represent a method of streamlining long-term HIV care, yet they may fail to address broader health issues such as agerelated conditions. Purpose: To estimate the prevalence of frailty and falls among stable individuals with HIV engaged with remote healthcare, delivered via a novel smartphone application. Method: Cross-sectional, questionnaire-based sub-study of EmERGE participants. Frailty was assessed using the FRAIL scale, a five-item selfreport screening tool. Present criteria were summed (range 0–5) and catergorized: 0=robust, 1–2=pre-frail, ≥3 frail. Falls and their frequency were assessed and dichotomised to faller/non-faller and single/recurrent falls. Results: 944 individuals participated across five European study sites. Mean age was 44.6 years (SD 9.9), with 33% aged>50. 92% were male, 79% were of Caucasian ethnicity. Full frailty data were available for 891/944 (94%). Three quarters were robust (74%, 663/891) ; 25% (219/891) pre-frail ; and 9 frail (1%). Of the frailty criteria, fatigue was most frequently reported (13%) followed by unintentional weight loss (12%), problems with walking (6%) and stairs (5%). Only 2 participants reported>4 comorbidities. Demographic data were available for 6/9 frail individuals: 83.3% were aged>50 ; all were male. 120/940 (13%) participants had fallen in the last year. Fallers experienced a median of 2 falls (IQR 1–3), with 59% (68/116) falling recurrently (≥2falls). Fallers were on average 3.1 years older than non-fallers (95% CI 1.2–5.1), with a greater proportion aged>50 (44% vs 31%, p=0.005). Falls were more common in frail (5 vs 1%) and pre-frail individuals (43 vs 22%). Conclusion: Ageing issues were relatively uncommon in this cohort. Frailty was rare, with pre-frailty seen in 25%. Falls occurred and often recurred, and were related to frailty status and older age. Opportunities to explore ageing concerns with patients should be retained within mHealth delivered care and comprehensive geriatric assessment considered if identified.

Purpose: To assess the feasibility, usability & acceptability of a co-designed mHealth supported pathway of care for individuals living with stable HIV. Methods: Following a detailed background assessment, a co-design process was facilitated with community and clinicians at five diverse clinical sites across Europe, informing the development of the platform (Figure 1) within a reduced visit pathway of care. Individuals living with stable HIV (based on WHO criteria) are seen annually by their clinician with interim bloods drawn (6 & 18 months) ; results checked, encrypted and pushed securely to their mobile device alongside medication, appointment and other information. Data are reported on uptake, usability (System Usability Scale (SUS)) and experience over the first year. Results: The platform was successfully co-designed, developed and integrated into hospital ICT systems at the five sites ; GDPR compliance was ensured. 2251 participants enrolled in the study: uptake varied by site (10%-37% of respective cohorts). Reasons for non-participation included: clinician engagement (change to practice ; lack of virtual tariff ; perceptions of digitalising clinical work) ; patient choice (change to current pathway ; no smart phone ; confidentiality) ; technical aspects & research questionnaires also contributed. Of the 1439 individuals with 12 month data available to May 2019: 1222/1316(92.7%) were male ; median age 44 (range 20–75) ; 1077/1288(83.6%) MSM ; and 271/1318(20.6%) non-national at site. Viral load was undetectable at 12 months in 1229/1241(99%) ; no SAEs related to the pathway were reported. Usability rating was excellent: median SUS score 85/100 (IQR 70–95) & patient reported experience positive: 82.9% rated their experience as good/excellent ; 94.2% would recommend to a friend. Conclusions: The EmERGE pathway is a feasible and acceptable option in the menu of care for individuals living with stable HIV. Uptake has varied by site and learning gives insights into factors affecting roll out of such options. To date usability and reported experience is very good.reduced visit pathway of care.

The EmERGE project (http://www.emergeproject.eu/) will develop a mHealth platform to enable self-management of HIV in patients with stable disease. The platform will build upon and integrate the existing mHealth solutions operated by pioneering healthcare providers in the UK and Spain and apply a rigorous co-design approach to ensure patient and clinician input to the solution. The platform will provide users with web based (clinicians) and mobile device applications (patients) which interface securely with relevant medical data and facilitate remote access to key healthcare providers. EATG, the leading European HIV patient organisation, will provide a direct and deep interaction with representative patients and clinicians from 5 EU countries. The platform and interfaces will be validated in a large study of 3900 patients using a tailored Health Technology Assessment process: the Model for Assessment of Telemedicine applications, specifically developed for the assessment of mHealth solutions including translatability as a key factor.

Background: High risk settings for transmission of HIV and sexually transmitted infections (STI) offer an opportunity for screening of difficult to reach risk groups. Methods: Free, anonymous counselling and testing for HIV, syphilis, Chlamydia and hepatitis B/C were offered to visitors in two selected gay venues in Antwerp, by a multidisciplinary team. Participants completed an anonymous questionnaire. The STI-test results were communicated by cell phone using standardised text messages. Results: In total, 137 MSM were tested. Facilitators of risky sexual behaviour (alcohol and drug use) were reported by 34 and 21%, respectively. Four men (3%) were newly diagnosed with HIV; 25 men (18%) had an active, transmittable STI. Infected MSM were significantly less often registered with a fixed general practitioner (GP). Conclusions: Outreach testing in gay venues is a suitable method to detect MSM at risk for HIV/STI. Although the outreach approach is very labour intensive, it shows a high yield of new STI-diagnoses that are not detected in the regular health system.

SETTING: Twenty-seven health centres in Addis Ababa, Ethiopia. OBJECTIVE: To assess the uptake of human immunodeficiency virus (HIV) testing among tuberculosis (TB) suspects in Addis Ababa, and to determine reasons for non-acceptance of the test. DESIGN: From February to March 2009, new TB suspects identified in 27 health centres in Addis Ababa were offered HIV testing. Patients were interviewed by trained nurses using a pretested questionnaire. RESULT: Of the 506 TB suspects, 59% were tested for HIV and accepted the test result. Individuals with knowledge about HIV counselling and testing procedures were 2.5 times more likely to be tested than individuals with poor knowledge. TB suspects who had previously been tested for HIV were twice as likely to accept HIV testing and to receive the result of the test (OR = 2.0, 95%CI 1.4-2.9). Government employees (OR = 2.8, 95%CI 1.2-6.3) and merchants (OR = 2.7, 95%CI 1.2-5.7) were more likely to be tested for HIV as compared to jobless individuals. CONCLUSION: The TB control programme in Ethiopia should increase its educational efforts among all TB suspects, but especially among jobless individuals, to increase the uptake of HIV testing.

The definitive version is available at www3.interscience.wiley.com, The administration of isoniazid (INH) has been proposed, evaluated and implemented to prevent tuberculosis (TB) disease among patients who are infected with the human immunodeficiency virus (HIV). This strategy has been developed in communities where TB is highly endemic and at a time when antiretroviral (ARV) treatment was not, or was rarely available. Although INH prevention programmes were somewhat pushed to the background due to the worldwide advocacy for ARV drugs, prevention of TB remains of paramount importance. The dual HIV-TB infection poses problems, not only for the individual and his/her clinician but also for the programme manager. We review various aspects of TB preventive treatment in countries with a high prevalence of HIV-TB co-infection and limited resources but with increasing access to ARV treatment.

(Central African Journal of Medicine: 2002 48 (7-8): 94-95)

Zimbabwe and Zambia.To determine the genetic diversity of Mycobacterium tuberculosis strains isolated from tuberculosis (TB) patients in Zimbabwe and Zambia.M. tuberculosis isolates cultured from TB patients presenting at referral hospitals in Zimbabwe and health care clinics in Zambia were characterised by IS6110 genotyping and/or spoligotyping using internationally standardised methods. Genotypic data were compared to those from Cape Town and the SpolDB3.0 database.A predominant group of strains could be identified among 116/246 (47.2%) Zimbabwean isolates by their characteristic IS6110-banding pattern and unique spoligotype signature, where spacers 21-24, 27-30 and 33-36 were deleted. Comparison with strains from Cape Town showed that they were closely related to a family of strains present in 2.3% of Cape Town patients. Comparison of the spoligotypes with those obtained from 114 isolates from Zambia showed that 74 (65%) of these isolates had the same spoligotype signature. Spoligotypes in the SpolDB3.0 database showed that this group of strains was rarely isolated in other parts of the world, but was commonly isolated in Southern Africa.A predominant group of strains infecting approximately half of the patients in the study are major contributors to the TB epidemic in this region. We have designated this group of strains the Southern Africa 1 (SAF1) family.