Adjuvanted and unadjuvanted monovalent influenza A(H1N1)pdm09 vaccines were both effective in preventing LCI. Overall, the vaccines were also effective against influenza-related hospitalization. For both outcomes adjuvanted vaccines were more effective in children than in adults.

Background Severe mental illness (SMI) presents a major burden to societies worldwide. Low- and middle-income countries (LMICs) often do not have sufficient financial resources and qualified staff to provide extensive specialised services for outpatients with SMI. Our research therefore aims to explore and test low-cost interventions that use existing resources in routine patient-clinician meetings, families and communities. Methods In Bosnia-Herzegovina, Colombia and Uganda, three psychosocial interventions will be tested, i.e. making patient-clinician meetings therapeutically effective through DIALOG+, family involvement in multi-family group meetings, and support for patients in befriending schemes with volunteers. All interventions will be provided to patients with SMI, delivered over a six-month period and evaluated with assessments at baseline and after six and 12 months. We will conduct nine trials including non-controlled trials, non-randomised controlled trials and randomised controlled trials (RCTs). Core outcome criteria will be used across all studies. However, details of study delivery and additional outcome criteria vary to accommodate local contexts, interests and priorities. The studies will be analysed separately, but with the option to compare and combine findings. Discussion The approach provides the opportunity to learn from commonalities and differences in the results and experiences across the three resource-oriented approaches and the three countries. If successfully implemented the studies can lead to more extensive research and are expected to inform health policies and clinical practice of community care for patients with SMI in the three participating countries and other LMICs. Trial registration All RCTs were registered prospectively and non-randomised trials retrospectively within the ISRCTN Registry. DIALOG+ in Uganda: ISRCTN25146122 (Date of Registration: 20/11/2018, prospective); DIALOG+ in Colombia: ISRCTN83333181 (Date of Registration: 20/11/2018, prospective); DIALOG+ in Bosnia-Herzegovina: ISRCTN13347129 (Date of Registration: 20/11/2018, prospective); Volunteer Support in Uganda: ISRCTN86689958 (Date of Registration: 04/03/2019, retrospective); Volunteer Support in Colombia: ISRCTN72241383 (Date of Registration: 04/03/2019, retrospective);Volunteer Support in Bosnia-Herzegovina: ISRCTN51290984 (Date of Registration: 20/11/2018, prospective); Family Involvement in Uganda: ISRCTN78948497 (Date of Registration: 04/03/2019, retrospective); Family Involvement in Colombia: ISRCTN11440755 (Date of Registration: 04/03/2019, retrospective); Family Involvement in Bosnia-Herzegovina: ISRCTN13347355 (Date of Registration: 20/11/2018, ...

Background DIALOG+ is a resource-oriented and evidence-based intervention to improve quality of life and reduce mental distress. While it has been extensively studied in mental health care, there is little evidence for how to use it in primary care settings for patients with chronic physical conditions. Considering that DIALOG+ is used in existing routine patient-clinician meetings and is very low cost, it may have the potential to help large numbers of patients with chronic physical conditions, mental distress and poor quality of life who are treated in primary care. This is particularly relevant in low- and middle-income countries (LMICs) where resources for specialised services for such patients are scarce or non-existent. Methods An exploratory non-controlled trial will be conducted to primarily assess the feasibility and acceptability and, secondarily, outcomes of delivering DIALOG+ to patients with chronic physical conditions and poor quality of life in primary care settings in Bosnia and Herzegovina, Colombia and Uganda. Thirty patients in each country will receive DIALOG+ up to three times in monthly meetings over a 3-month period. Feasibility will be assessed by determining the extent to which the intervention is implemented as planned. Experiences will be captured in interviews and focus groups with care providers and participants to understand acceptability. Quality of life, symptoms of anxiety and depression, objective social situation and health status will be assessed at baseline and again after the three-session intervention. Discussion This study will inform our understanding of the extent to which DIALOG+ may be used in the routine care of patients with chronic physical conditions in different primary care settings. The findings of this exploratory trial can inform the design of future full randomised controlled trials of DIALOG+ in primary care settings in LMICs. Trial registration All studies were registered prospectively (on 02/12/2020 for Uganda and Bosnia and Herzegovina, and 01/12/2020 for Colombia) within the ISRCTN Registry. ISRCTN17003451 (Bosnia and Herzegovina), ISRCTN14018729 (Colombia) and ISRCTN50335796 (Uganda). Protocol version and date: v2.0; 28/07/2020 (Bosnia and Herzegovina), v0.3 02/08/2020 (Colombia) and v1.0, 05/11/2020 (Uganda).

Aims Social isolation in people living with schizophrenia is associated with poor quality of life and increased symptom severity. Volunteer befriending interventions are a potential strategy for addressing social isolation, but evidence of their effectiveness is limited, particularly in low- and middle-income countries. We assessed the experiences of volunteer befriending and tested its effectiveness for improving the quality of life of patients with schizophrenia in Bosnia and Herzegovina. Methods Between March 2018 and July 2020, we conducted a parallel-group, randomised controlled trial in adults with schizophrenia and poor quality of life at an outpatient clinic in Sarajevo. Patients were randomised to either the intervention, in which they were matched with a volunteer befriender with whom they met fortnightly over the 6-month intervention period, or treatment as usual. The primary outcome was quality of life measured on the Manchester Short Assessment and secondary outcomes were psychiatric symptoms and objective social outcomes. Outcome measurement was conducted by blinded researchers at 6- and 12-months. Results In total, 65 patients were randomised into the intervention (n = 33) and control arms (n = 32) and 55 (85%) completed follow-up assessments at 6 months. Patients in the intervention showed a significantly more favourable quality of life at 6 months (primary outcome; mean difference: 0.7, 95% CI [0.3–1.1], p = 0.003) and 12 months (mean difference: 1.7, 95% CI [1.1–2.3], p < 0.001). They also had significantly lower symptom levels at both follow-ups, and a significantly more favourable objective social situation after 12 months. Participants reported largely positive experiences. Conclusion The exploratory trial conducted at one site found sustained improvements in quality of life and reductions in psychiatric symptoms. This suggests that volunteer befriending may be a feasible and effective treatment for patients with schizophrenia in resource-limited contexts, such as Bosnia and Herzegovina.