Integrated malaria prevention in rural communities in Uganda: a qualitative feasibility study for a randomised controlled trial

Abstract Background A randomised controlled trial (RCT) on integrated malaria prevention, which advocates the use of several malaria prevention methods holistically, has been proposed. However, before conducting an RCT, it is recommended that a feasibility study is carried out to provide information to support the main study, particularly for such a complex intervention. Therefore, a feasibility study for an RCT on integrated malaria prevention in Uganda was conducted. Methods The qualitative study carried out in Wakiso District employed focus group discussions (FGDs) and key informant interviews (KIIs) to explore community willingness to participate in the RCT as well as assess stakeholder perspectives on the future study. The participants of the FGDs were community members, while the key informants were selected from malaria stakeholders including Ministry of Health officials, health practitioners, local leaders, district health team members, and community health workers (CHWs). Thematic analysis was employed with the support of NVivo. Results A total of 12 FGDs and 19 KIIs were conducted. Five main themes emerged from the study: malaria prevention practices related to integrated malaria prevention; preferred malaria prevention methods in the integrated approach; potential challenges of integrated malaria prevention; perspectives on the proposed RCT; and sustainability of integrated malaria prevention. Despite a few methods being employed holistically in the community, insecticide-treated nets were the most widely used and preferred method for malaria prevention mainly because they were provided free by the government. The main challenges in the integrated approach were the high cost of some methods such as house screening, and concerns about the potential side effects of insecticide-based methods such as indoor residual spraying. Participants expressed high willingness to participate in the RCT to promote the use of multiple methods in their households and community. Involvement of CHWs during implementation was proposed as a sustainability strategy for the RCT interventions. Conclusion There was high willingness to participate in the proposed RCT on integrated malaria prevention. However, high cost and perceived negative health effects from some methods were identified as potential challenges. The type of methods to be included as well as sustainability mechanisms needs to be considered during the design of the RCT.

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Feasibility study of an integrated stroke self-management programme: a cluster-randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2015-008900 ◽

2016 ◽

Vol 6 (1) ◽

pp. e008900 ◽

Cited By ~ 18

Author(s):

Fiona Jones ◽

Heather Gage ◽

Avril Drummond ◽

Ajay Bhalla ◽

Robert Grant ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Feasibility Study ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Management Programme ◽

Self Management ◽

Cluster Randomised ◽

Randomised Controlled

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Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽

10.1136/bmjopen-2017-019142 ◽

2018 ◽

Vol 8 (1) ◽

pp. e019142 ◽

Cited By ~ 7

Author(s):

Kate Jolly ◽

Jenny Ingram ◽

Joanne Clarke ◽

Debbie Johnson ◽

Heather Trickey ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Infant Feeding ◽

Feasibility Study ◽

Breast Feeding ◽

Controlled Trial ◽

Feasibility Trial ◽

Study Results ◽

Service Staff ◽

Before And After ◽

Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

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126 A Student Pilot for A Feasibility Study of the Theoretical 3S Trial (SPFT3S): GP and Ethics Committee Members Questionnaire

Age and Ageing ◽

10.1093/ageing/afab030.87 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

pp. i12-i42

Author(s):

L Brown ◽

R Foster ◽

M Dodd ◽

T McCormack

Keyword(s):

Feasibility Study ◽

Controlled Trial ◽

Negative Attitude ◽

Population Group ◽

Ethics Committee ◽

Willingness To Participate ◽

Double Blind ◽

North East ◽

The North ◽

Randomised Controlled

Abstract Introduction Emerging research suggests that statin use for primary prevention in people without diabetes aged 75 and older has no benefit. This study aims to determine the feasibility of the theoretical Stop Statin Study (3S), a double-blind randomised controlled trial carried out in general practice, which would test this hypothesis. 50% of trial patients would stop taking statins for 5 years in an event driven study. The questionnaires aim to identify the attitudes of general practitioners (GPs) and ethics committee members (ECMs) regarding stopping statins for 5 years in patients aged 75 and older without diabetes or history of cardiovascular disease and their willingness to allow patients to participate in the 3S study. Method Questionnaires comprised of 6 questions were designed. 4 students distributed the questionnaire and it was completed by 19 GPs based at 8 practices in the North-East of England. 31 ECMs (12 expert and 19 lay) responded by email. Results 95% of GPs who completed the survey would agree to their patients participating in the theoretical study with 47% of GPs indicating that their willingness to participate in the study is patient dependent. 95% of GPs would also consider stopping statins in this population group if sufficient research had been carried out or if the guidelines were changed. 42% of GPs have a negative attitude to prescribing statins in this population group. All the ECMs would approve the study, citing over-prescribing and polypharmacy as their reason. Conclusions The majority of GPs will participate in the theoretical 3S study, if their patients are willing to participate. There is already a negative perception amongst GPs towards the use of statins in elderly people without disease. The 3S study appears to be feasible from the GP and ethics perspective but would require a larger feasibility study.

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