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Community-led trials: Intervention co-design in a cluster randomised controlled trial

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Abstract

In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how prevention works at a system level, programmes have to be perceived as locally relevant and they must engage stakeholders who make them work. Locally, each participating community has to know the intervention is relevant to them; they have to want to do it. That happens much more easily if they design the programme themselves.
C O M M E N T A R Y Open Access
Community-led trials: Intervention co-design
in a cluster randomised controlled trial
Neil Andersson
1,2
From The Camino Verde Trial colloquium
Acapulco, Mexico. 17-21 June 2013
Abstract
In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial,
each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus
of activities to choose from, the trial randomised clusters to a participatory research protocol that began with
sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector
control.
Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more
meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used
the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated
with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they
want to do. Several discussion groups in each intervention community produced multiple plans for prevention,
recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose
longer term actions like garbage disposal and improving water supplies.
A big part of the skill set for community-led trials is being able to stand back and simply support communities in
what they want to do and how they want to do it, something that does not come naturally to many vector control
programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in
participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong
involvement of women in dengue control activities seems to have discouraged men in settings where activity in
public spaces or outside of the home would ordinarily be considered a male competence.
Community-led trials address the tension between one-size-fits-all programme interventions and local needs.
Whatever the conventional wisdom about how prevention works at a system level, programmes have to be
perceived as locally relevant and they must engage stakeholders who make them work. Locally, each participating
community has to know the intervention is relevant to them; they have to want to do it. That happens much more
easily if they design the programme themselves.
Article
The British Medical Journal published the multi-centred
Camino Verde cluster randomised controlled trial [1] as
the first report of a community mobilisation intervention
leading to serological evidence of reduced dengue virus
infection. Beyond dengue prevention, publication of the
Camino Verde trial in the BMJ showed that community-
led trials can be reported in high quality journals.
In conventional randomised controlled trials (RCTs), re-
searchers design the interventions. In the RCT world of
researcher hypotheses, concepts like fidelity and reprodu-
cibility have been interpreted to mean that all participants
all clusters in a cluster RCT must receive verifiably
the same intervention. In the Camino Verde trial, each
intervention community designed its own set of actions to
prevent dengue. Instead of a fixed prevention programme
or menu of activities to choose from, the trial randomised
Correspondence: andersson@ciet.org
1
Centro de Investigación de Enfermedades Tropicales (CIET), Universidad
Autónoma de Guerrero, Acapulco, Guerrero, Mexico
2
Department of Family Medicine, McGill University, Montreal, Canada
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
The Author(s) BMC Public Health 2017, 17(Suppl 1):397
DOI 10.1186/s12889-017-4288-6
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
clusters to a participatory research protocol that began
with sharing and discussing evidence, leading to local
authorship of the action plan for vector control. A similar
protocol, without the vector-specific references, might be
applicable to many health or social issues.
Evolution of RCT methods
Public health research has evolved beyond observational
studies, increasingly to includeRCTs.Theseexperiments
involve comparisons with people who do not receive the
intervention (controls), and rely on random allocation of
the intervention to generate convincing evidence of impact
or lack of impact. The consequence of randomisation is
that exposure to the intervention is independent of all
events and relationships that precede it it converts poten-
tial confounders and other covariates into random differ-
ences. This lifts the onerous and often futile burden of
proof of observational studies, where the researcher is
obliged to exclude potential confounders as possible expla-
nations of a presumed effect [2, 3].
In the three-quarters of a century since the first pub-
lished RCT in the 1930s [4], we have seen major develop-
ments of trial methods in several directions. The biggest
volume of health-related RCTs is undisputedly the clinical
trials sponsored by the pharmaceutical industry [5], essen-
tially to comply with legal requirements about proof of ef-
ficacy. There has also been a surge of the n-of-1 clinical
management trials used in personalised medicine [6, 7]
and most recently the emergence of pragmatic trials with
implications for large scale public health policy [810].
Pragmatic trials refocus RCT methodology such that
randomising and comparing with a control group are the
principal contributions of the trial; there is no longer any
double blinding or placebos that were almost synonymous
with efficacy trials [11]. The related surge in public policy
trials brought to light the advantage of clusters to reduce
contamination bias for educational and mobilisation inter-
ventions; where interventions work between people,in-
stead of trying to isolate people to avoid spill-over, it
makes sense to intervene at cluster level.
There have also been shifts in the definition of the
intervention in trials. Brown and others [12] defined
adaptive trials as having planned modification of charac-
teristics of the intervention based on information from
the accumulating data. Product development adaptive
trials, borrowed from business studies, now talk about
involving consumersin programme development at all
stages [13, 14]. Community-led trials, although with very
different origins in participatory research, benefit from
some of these technical developments in RCT methods.
Participatory research in an epidemiological framework
Participatory research is an umbrella term that includes
partnered research, community-based participatory
research, action research, participatory action research,
participatory evaluation, community and patient engage-
ment [15]. It implies the systematic co-creation of new
knowledge in equitable partnerships with people affected
or those who will benefit from or act on it [16, 17]. Al-
though participatory research for some people implies
small scale, very local exercises, there is nothing in its
definition that excludes national and multi-national par-
ticipatory research operations [18].
Adding equitable stakeholder engagement to RCT in-
frastructure has several benefits [19]: cultural anchoring
shapes the scope and direction of research, making it
more meaningful to stakeholders; recruitment of com-
munity members to management roles builds capacity;
the dialogic approach leads to creative turbulence that,
when resolved, promotes positive and sustained out-
comes; success increases confidence over time, with im-
plications for other health issues; goals are often
sustained beyond funded time frames; and systemic
changes achieved from the engagement have wider
implications.
An early example of a community-led trial, Rebuilding
from Resilience [20],was a partnership of 12 Indigenous
womens shelters across Canada. This tested the impact
and cost implications of evidence-based community-led
initiatives to decrease domestic violence. The womens
shelter directors took the driving seat in their own re-
search. They viewed randomisation as the only fair way
to decide whose turn it was to receive the available re-
sources; each shelter director drew a number out of a
hat, indicating whether their shelter would join the first
wave or the second wave. In each community, a detailed
development and consultation process led to a baseline
study, using other gender violence questionnaires as ref-
erence. The results fuelled a series of discussions and
workshops on how to prevent gender violence. The
baseline for the second wave provided the unexposed
contrast for the follow-up study of the first wave, after 2
years of interventions.
Implementation and interpretation of community-led
trials
Camino Verde illustrates some issues in the design, im-
plementation and interpretation of community-led trials.
Replication of the intervention
Because Camino Verde randomised a participatory re-
search protocol, the conclusion of the trial should
strictly be that participatory research rather than spe-
cific vector control actions added value to existing
programmes attempting to reduce dengue virus infec-
tion. There is no problem about ensuring replication
[21] in other conditions, since each intervention cluster
The Author(s) BMC Public Health 2017, 17(Suppl 1):397 Page 6 of 173
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received the same evidence-based engagement protocol
to discuss and to mobilise for dengue prevention [22].
Ethics
The stringent ethical codes associated with RCTs, includ-
ing informed consent [23], play out differently in explana-
tory trials and community-led pragmatic trials, where
communities essentially choose what they want to do [24].
Issues of withholding interventions in control communi-
ties [25] can be settled by randomising the delay among
all eligible communities, as in a stepped wedge design. Re-
sidual problems include demonstrating respect for com-
munity autonomy when the locus of research shifts from
the individual to community level [26].
Intervention co-design
Intervention co-design is neither easy nor automatic,
and communities do not always come up quickly with
the most effective solutions. In Camino Verde, the ap-
proach to community-led design took 3 years to develop
prior to the main trial. Once the protocol was in place,
many residents started with the idea that government
should solve their dengue problem. Between the differ-
ent discussion groups in each intervention community
that led to multiple plans for prevention, most commu-
nities developed their compound intervention recognis-
ing different time lines; they chose some fast
turnarounds, like elimination of breeding sites, and lon-
ger term actions like garbage disposal and improving
water supplies.
Biases
Selection bias can be reduced by concealment of centra-
lised allocation of the intervention. As in most pragmatic
trials, blinding and placebos are impossible in
community-led trials, and biases can result from service
providers and communities knowing what the interven-
tions are. In a community-led trial a Hawthorne effect
(an impact because the group receiving the intervention
know they are receiving an intervention) is likely and is
part of the intervention benefit. Practical steps to ensure
knowledge of allocation of the intervention affects the
outcome measure as little as possible can include using
biological outcomes (such as serological evidence of
dengue infection in the Camino Verde trial) rather than
responses from officials. In interventions where partici-
pants choose what they do, it is possible that their
choice of intervention is influenced by what they read
[27]. In Camino Verde, communities chose the interven-
tion based on evidence of local vector habits and com-
munity discussions, so there was little risk of a
publication bias.
Trial implementation
In any trial, a rigid and well documented protocol helps
avoid undisclosed implementation flexibility [28]; this is
also true for community-led trials, when the interven-
tion is to share information and co-design solutions.
What individual intervention communities opted to do
in the Camino Verde trial was up to them, but the work
of the Camino Verde trial team adhered tightly to the
protocol. Mostly this involved training of facilitators and
handing over the evidence for discussion.
Analysis
In any cluster trial, a lot of analytic power is foregone
when cluster is the unit of randomisation and the unit of
intervention [29]. The Camino Verde main analysis per
protocol was the most conservative possible for a cluster
trial: a t-test treated each cluster as a unit and the out-
come rate as continuous variables in each cluster.
Strictly following protocol, as happened in the Camino
Verde analysis, avoids p-hacking [30] and hypothesizing
after the results are known (HARKing) [31]. This is es-
pecially important in community-led trials where local
initiatives can give rise to unexpected and interesting
ways of doing things. A Camino Verde example was the
reintroduction of larvivorous fish in some communities;
this generated interesting supplementary results [32] but
did not influence the trials principal analysis.
Ambiguity of indicators
Ambiguity of indicators and difficulty in defining the
measurement parameters are not avoided by randomisa-
tion and can cause problems in clinical, pragmatic and
community-led trials. With the further variability intro-
duced by different packages of solutions in each partici-
pating community, a reliable endpoint is helpful.
Camino Verde opted for a hard biological endpoint:
serological evidence of dengue virus infection.
Skills and infrastructure
Introduction of high level research methods and partici-
patory research into local programme development has
multiple advantages, including improving the
programme in question, but it requires a quantum shift
in skills and sensibilities. The key to almost any trial is
in the measurement skill. In community-led trials, add-
itional skills of promoting dialogue, often in an intercul-
tural context, are indispensable. An article by Morales-
Pérez and colleagues describes the training of Mexican
facilitators in the Camino Verde trial [33]. A big part of
the skill set is being able to stand back and simply sup-
port communities in what they want to do and how they
want to do it, something that does not come naturally to
many vector control programs.
The Author(s) BMC Public Health 2017, 17(Suppl 1):397 Page 7 of 173
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Unexpected negative outcomes
The turbulence implicit in any participatory research
process can in the short term introduce and exacerbate
local frictions. One example of this is the gender dy-
namic that seems to have resulted from the surge of
interest and involvement of women and children in the
Mexican arm of the Camino Verde trial [34]. Analysis
indicated interruptions of the results chain between
knowledge and preventive action in men exposed to the
intervention. It seems plausible that the strong involve-
ment of women in dengue control activities had a nega-
tive effect on the men in communities where activity in
public spaces or outside of the home would ordinarily
be considered a male competence.
The way forward
The Camino Verde trial is an interesting precedent for
community-led RCTs in public health, addressing the
well-known tension between programme interventions
and local needs. For logistical and administrative pur-
poses, public health programmes have objectives, actions
to reach those objectives, outputs, outcomes and im-
pacts. Unfortunately, that strong sense of system does
little to make programmes locally relevant or engaging
to stakeholders who must make them work. Locally,
each participating community has to know the interven-
tion is relevant to them; they have to want to do it. That
happens much more easily if they design the programme
themselves.
Public health practitioners are increasingly recognising
that stakeholder engagement and participation is crucial
for success. There is nothing new in this proposition, be-
ing a founding principle of the 1978 primary health care
concept at Alma Ata [35]. The decentralised nature of
engagement and participation has long been held to be
contradictory to any one-size-fits-all formulation.
Community-led RCTs provide informative answers to a
few very specific questions.
Where the objective of the exercise is very clear in
this case it was to control Aedes aegypti and there are
several options of how to achieve this, quite what com-
munities do should not matter so much as that they do
get involved.
Acknowledgements
I thank Anne Cockcroft for her input into drafts of the article.
Funding
The UBS Optimus Foundation provided funding for publication of this
manuscript.
Authorscontribution
NA conceived and wrote the article.
Competing interests
The author declares that he has no competing interests.
About this supplement
This article has been published as part of BMC Public Health Volume 17
Supplement 1, 2017: The Green Way to Aedes aegypti mosquito control:
aspects and implications of the Camino Verde trial in Mexico and Nicaragua.
The full contents of the supplement are available online at https://
bmcpublichealth.biomedcentral.com/articles/supplements/volume-17-
supplement-1
PublishersNote
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Published: 30 May 2017
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... Nine articles (22%) reported on more than one country. [22][23][24]28,29,[38][39][40]44 Original research predominated (n = 32; 78%). According to the objective as stated, nine (24.3%) studies evaluated efficacy/ effectiveness/cost-effectiveness exclusively; 10 (24.4%) assessed effectiveness combined with other CBI aspects, for example, processes, feasibility, and acceptability; six (16.2%) provided formative research results; and five (13.5%) described the intervention and reported on implementation outcomes. ...
... With few exceptions, 47,54,55 there was more than one article available per CBI ( Table 2). The CBIs assessed through multi-trial initiatives were of flexible design so they could be tailored to different implementation contexts, as seen with Camino Verde (the Green Way) [22][23][24][25][26][27][28][29][30][31][32] and the Ecobio-social CBIs from Asia 40-46 and Latin America. [33][34][35][36][37][38][39] Despite their similarities, these CBIs are differentiated by country in this study. ...
Article
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Randomized control trials have provided evidence that some community-based interventions (CBIs) work in vector-borne diseases (VBDs). Conversely, there is limited evidence on how well those CBIs succeed in producing specific outcomes in different contexts. To conduct a realist synthesis for knowledge translation on this topic, we examined the extent to which realist concepts (context, mechanisms, and outcomes) and their relationships are present in the existing literature on CBIs for VBDs. Articles on CBIs were identified from prior scoping reviews of health interventions for VBDs. Content of the articles was extracted verbatim if it referred either to realist concepts or CBI features. The number of articles and the average number of words extracted per category per CBI were quantified. Content of the articles was scrutinized to inductively gather qualitative evidence on the interactions between realist concepts. We reviewed 41 articles on 17 CBIs from 12 countries. The average number of words used for mechanisms was much lower than those used for outcomes and context (309,474, and 836, respectively). The average number of words used for mechanisms increased when a CBI was described in three or more articles. There were more extensive accounts on CBI features than on mechanisms. It was difficult to gather evidence on the interactions among realist concepts from the content of the articles. Scarce reporting on mechanisms in published articles limits conducting a realist synthesis of CBIs in VBDs. More transdisciplinary research that goes beyond the biomedical paradigm is needed to boost the development of intervention mechanisms in this field.
... The involvement of people who had experienced a stroke and a carer in the development stage and other stages of clinical trials is encouraged [18,19]. In particular, engagement of these key research partners in the planning, adaptation, and modification of the intervention was reliant on their early involvement in the project and facilitated a strong design for testing the program in a future clinical trial [20]. ...
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Movement-based mindfulness interventions (MBI) are complex, multi-component interventions for which the design process is rarely reported. For people with stroke, emerging evidence suggests benefits, but mainstream programs are generally unsuitable. We aimed to describe the processes involved and to conduct a formative evaluation of the development of a novel yoga-based MBI designed for survivors of stroke. We used the Medical Research Council complex interventions framework and principles of co-design. We purposefully approached health professionals and consumers to establish an advisory committee for developing the intervention. Members collaborated and iteratively reviewed the design and content of the program, formatted into a training manual. Four external yoga teachers independently reviewed the program. Formative evaluation included review of multiple data sources and documentation (e.g., formal meeting minutes, focus group discussions, researcher observations). The data were synthesized using inductive thematic analysis. Three broad themes emerged: (a) MBI content and terminology; (b) manual design and readability; and (c) barriers and enablers to deliver the intervention. Various perspectives and feedback on essential components guided finalizing the program. The design phase of a novel yoga-based MBI was strengthened by interdisciplinary, consumer contributions and peer review. The 12-week intervention is ready for testing among survivors of stroke.
... To develop technology-based strategies that are considerate of SDoH, the population of interest should be involved in every phase of the development and design process to ensure that the intervention meets the needs and fits the context of the population [79,85]. Capturing the behavioral and technology use patterns within the youth's social, built, and political environments provides an avenue for increasing the engagement, satisfaction, and cultural appropriateness of the intervention [85,86]. However, few studies have engaged youth in the design and development of technology-based interventions [82,87,88]. ...
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Purpose of Review This review highlights obesity-related disparities among Latino children and adolescents, discusses the social determinants of health (SDoH) that drive disparities, and presents case studies of strategies for reducing disparities and promoting health equity. Recent Findings Recommended strategies for reducing obesity-related disparities include the use of culturally grounded programming, multi-sector collaborations, and technology. We present two exemplar studies that demonstrate that integrating cultural values and enhancing the overall cultural fit of prevention programs can increase engagement among high-risk Latino families. We also examine the use of multi-sector collaborations to build community capacity and address key SDoH that impact health behaviors and outcomes. Our last example study demonstrates the utility of technology for engaging youth and extending the reach of prevention strategies in vulnerable communities. Summary To address growing obesity-related disparities, there is an urgent need to develop and test these strategies among high-risk, vulnerable populations like Latino children and adolescents.
... This was measured by the response to the statement: I will never be open to include my patients' cultural beliefs and practices in the health decisionmaking process. It corresponded to the Intention to Change intermediate outcome of the CASCADA model of planned behavior, [28] which has been successfully used to explore dengue prevention behavior [29]. We assessed the students' intended behavior instead of actual practice or action, which would have required follow-up of clinical practice over several years. ...
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Background Cultural safety, whereby health professionals respect and promote the cultural identity of patients, could reduce intercultural tensions that hinder patient access to effective health services in Colombia. Game jams are participatory events to create educational games, a potentially engaging learning environment for Millennial medical students. We set out to determine whether medical student participation in a game jam on cultural safety is more effective than more conventional education in changing self-reported intended patient-oriented behavior and confidence in transcultural skills. Methods We conducted a parallel-group, two-arm randomized controlled trial with 1:1 allocation. Colombian medical students and medical interns at University of La Sabana participated in the trial. The intervention was a game jam to create an educational game on cultural safety, and the reference was a standard lesson plus an interactive workshop on cultural safety. Both sessions lasted eight hours. Stratified randomization allocated the participants to the intervention and control groups, with masked allocation until commencement. Results 531 students completed the baseline survey, 347 completed the survey immediately after the intervention, and 336 completed the survey after 6 months. After the intervention, game jam participants did not have better intentions of culturally safe behaviour than did participants in the reference group (difference in means: 0.08 95% CI − 0.05 to 0.23); both groups had an improvement in this outcome. Multivariate analysis adjusted by clusters confirmed that game jam learning was associated with higher transcultural self-efficacy immediately after the intervention (wt OR 2.03 cl adj 95% CI 1.25–3.30). Conclusions Game jam learning improved cultural safety intentions of Colombian medical students to a similar degree as did a carefully designed lecture and interactive workshop. The game jam was also associated with positive change in participant transcultural self-efficacy. We encourage further research to explore the impact of cultural safety training on patient-related outcomes. Our experience could inform initiatives to introduce cultural safety training in other multicultural settings. Trial registration Registered on ISRCTN registry on July 18th 2019. Registration number: ISRCTN14261595 .
... This is especially true in the public healthcare sector, where researchers and policy makers have been highlighting the opportunity for a reorientation of the systems towards collaborative processes in designing, organizing, and delivering public services [12,[14][15][16][17][18][19][20]. Co-production is an approach that allows one to explore needs and habits and to build individual behaviors that can result in good health and wellbeing [20,21]. Service users can provide a fundamental contribution in designing, providing, and managing public services and/or in reaching their outcomes. ...
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Co-production is an approach to designing, delivering, and evaluating public services through strict collaboration among professionals and the people using services with an equal and reciprocal relationship. Health promotion initiatives that include education services rarely use the co-production approach. Nevertheless, the value of co-production is widely recognized, although it is considered a normative good, and scarce and mixed evidence is available in literature. The purpose of this paper is to provide evidence supporting the hypothesis that a co-production approach, applied to an intervention for preventing obesity, can be effective and efficient. To this end, an evaluation of the processes, outputs meant as intermediate results, and behavioral and economic outcomes of a public health-promotion initiative co-produced and co-delivered with adolescents (beFood) was conducted. Mixed methods were used, including field-observations, two self-reported questionnaires, and an opportunity–cost analysis that compared beFood to traditional approaches of public health promotion. The co-production model was successfully implemented and appears to be effective—more than 5000 adolescents were reached by only 49 co-producer adolescents, who reported behavioral changes (e.g., eating better and practicing more physical activity). The cost analysis showed that the co-production approach was also efficient, producing relevant savings and potentially making available more than 3000 h of professionals’ time. This research can support a re-thinking of public institutions’ organization, public initiatives’ design, and public servants’ role.
... The Camino Verde trial methods and findings are described in detail elsewhere [22,23,24]. The trial took place in 90 clusters (of about 140 households each) in coastal regions of Guerrero state, Mexico, and in 60 clusters in Managua, Nicaragua, randomly allocated to intervention or control groups. ...
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Background Dengue vector entomological indices are widely used to monitor vector density and disease control activities. But the value of these indices as predictors of dengue infection is not established. We used data from the impact assessment of a trial of community mobilization for dengue prevention (Camino Verde) to examine the associations between vector indices and evidence of dengue infection and their value for predicting dengue infection levels. In 150 clusters in Mexico and Nicaragua, two entomological surveys, three months apart, allowed calculation of the mean Container Index, Breteau index, Pupae per Household Index, and Pupae per Container Index across the two surveys. We measured recent dengue virus infection in children, indicated by a doubling of dengue antibodies in paired saliva samples over the three-month period. We examined the associations between each of the vector indices and evidence of dengue infection at household level and at cluster level, accounting for trial intervention status. To examine the predictive value for dengue infection, we constructed receiver operating characteristic (ROC) curves at household and cluster level, considering the four vector indices as continuous variables, and calculated the positive and negative likelihood ratios for different levels of the indices. None of the vector indices was associated with recent dengue infection at household level. The Breteau Index was associated with recent infection at cluster level (Odds ratio 1.36, 95% confidence interval 1.14–1.61). The ROC curve confirmed the weak predictive value for dengue infection of the Breteau Index at cluster level. Other indices showed no predictive value. Conventional vector indices were not useful in predicting dengue infection in Mexico and Nicaragua. The findings are compatible with the idea of sources of infection outside the household which were tackled by community action in the Camino Verde trial.
... Most of the findings obtained in these studies face validity, reliability and generalizability limitations because almost all were conducted using qualitative methodologies or quasi-experimental designs with convenience sampling of a target population. Only four studies in which schools were involved as a part of the community-based intervention followed a CRCT design, which is more reliable for carrying out and evaluating the outcomes of a community intervention [70]. Nonetheless, we cannot disregard these findings because they can be helpful in qualitative analyses and defining new hypotheses for dengue education in students and the rest of community that could be tested under aCRCT in subsequent investigations. ...
Article
Dengue virus is the main arboviral disease transmitted by Aedes mosquitoes and affects mainly school-aged children and teens. Many methods have been developed for dengue control, including health education strategies for elementary and high school students. The objective of this study is to provide an update on the status of health education on dengue in schools and provide new perspectives on health behavior research in order to reduce the proliferation of mosquitoes and spread of arboviral diseases among school-aged children and other community members. A systematic review about health educational initiatives was carried out. This research discusses the effectiveness of these strategies in educating students about dengue disease and mosquito control and how the school is relevant for community-based participation in research on dengue education. The study found that employing ludic strategies and directly involving children in mosquito control in their households have been the most attractive and effective strategies for dengue education in children and teens. However, the sustainability of protective behaviors has been poorly evaluated, and new approaches for health behavior research are needed. Inasmuch as, schools are important places for gathering community members, and students can serve as an essential link between educative interventions and the community.
... Studies have shown that involvement of individuals in creating solutions to their challenges leads to better ownership and uptake of the interventions [37,38]. Evidently, these results are indicative that cocreated interventions, especially between landlords and tenants may be easily adopted. ...
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Background: Sharing of sanitation is commonly being practiced in low income areas in Sub Saharan Africa. However, the Joint Monitoring Program (JMP) categorizes shared sanitation as a limited sanitation service. These shared facilities are often the only option available for most of the residents in low income settlements, and improving their management is key to reducing open defecation and risk of disease. This study sought to investigate barriers and opportunities for improved management of shared sanitation in low income settlements of Kisumu in Kenya. Methods: Thirty-nine In-depth interviews and 11 focus group discussions were held with residents, who mainly included tenants and landlords. Analysis followed a thematic approach to define the problem, specify the target behaviour and define what needs to change. Results: Pit latrines were commonly shared among landlords and tenants. Shared sanitation facilities were unclean due to poor use and lack of cleaning. Participants identified behavioural challenges such as poor use of the shared toilets, and social challenges such as lack of cooperation in cleaning. These results led to identification of opportunities for improvement such as instituting clear cleaning plans, communication among users, and problem solving mechanisms between landlords and tenants. These approaches could form the basis for designing intervention strategies for improving the management of shared sanitation. Conclusion: The results highlight the need to focus on social aspects for improvement of shared sanitation management in low income settlements. Through a social approach, shared sanitation facilities can be managed appropriately to afford the millions of low income dwellers an opportunity to access sanitation. This study provides further evidence on approaches for improved management of shared sanitation facilities in line with the JMP’s recommendation for high quality shared facilities.
Article
Background Adolescents (10-19 years) are a big segment of the Nigerian population, and they face serious risks to their health and well-being. Maternal mortality is very high in Nigeria, and rates of pregnancy and maternal deaths are high among female adolescents. Rates of HIV infection are rising among adolescents, gender violence and sexual abuse are common, and knowledge about sexual and reproductive health risks is low. Adolescent sexual and reproductive health (ASRH) indicators are worse in the north of the country. Objective In Bauchi State, northern Nigeria, the project will document the nature and extent of ASRH outcomes and risks, discuss the findings and codesign solutions with local stakeholders, and measure the short-term impact of the discussions and proposed solutions. Methods The participatory research project is a sequential mixed-methods codesign of a pragmatic cluster randomized controlled trial. Focus groups of local stakeholders (female and male adolescents, parents, traditional and religious leaders, service providers, and planners) will identify local priority ASRH concerns. The same stakeholder groups will map their knowledge of factors causing these concerns using the fuzzy cognitive mapping (FCM) technique. Findings from the maps and a scoping review will inform the contextualization of survey instruments to collect information about ASRH from female and male adolescents and parents in households and from local service providers. The survey will take place in 60 Bauchi communities. Adolescents will cocreate materials to share the findings from the maps and survey. In 30 communities, randomly allocated, the project will engage adolescents and other stakeholders in households, communities, and services to discuss the evidence and to design and implement culturally acceptable actions to improve ASRH. A follow-up survey in communities with and without the intervention will measure the short-term impact of these discussions and actions. We will also evaluate the intervention process and use narrative techniques to assess its impact qualitatively. Results Focus groups to explore ASRH concerns of stakeholders began in October 2021. Baseline data collection in the household survey is expected to take place in mid-2022. The study was approved by the Bauchi State Health Research Ethics Committee, approval number NREC/03/11/19B/2021/03 (March 1, 2021), and by the Faculty of Medicine and Health Sciences Institutional Review Board McGill University (September 13, 2021). Conclusions Evidence about factors related to ASRH outcomes in Nigeria and implementation and testing of a dialogic intervention to improve these outcomes will fill a gap in the literature. The project will document and test the effectiveness of a participatory approach to ASRH intervention research. Trial Registration ISRCTN Registry ISRCTN18295275; https://www.isrctn.com/ISRCTN18295275 International Registered Report Identifier (IRRID) DERR1-10.2196/36060
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Introduction Optimal immunisation programme service delivery and childhood vaccine coverage remains an ongoing challenge in South Africa. Previous health systems approaches have made recommendations on how to address identified barriers but detailed local implementation studies are lacking. This study aimed to improve immunisation service delivery in children under 24 months in Khayelitsha, Western Cape Province using an adaptive, co-design approach to assess and improve childhood immunisation service delivery at the clinic level. Methods A rapid, adaptive approach to identification of barriers and assessment of current childhood immunisation service delivery was developed with three clinics in Khayelitsha, Western Cape Province. This informed a short co-design process with key stakeholders and service providers to develop local interventions targeted at high priority barriers. Interventions were implemented for 4–6 months and evaluated using theory-based evaluation tools. Clinic service delivery, satisfaction and changes to clinic processes and parent engagement and knowledge were measured. Results Interventions developed included weekly community immunisation education radio sessions, daily clinic health talks, immunisation education and promotion materials and service provider and parent quality checklists. Evaluation post-intervention showed improvement in parents’/guardians’ knowledge about immunisation, parent engagement and service provider commitment to improvement in service quality. Radio sessions and immunisation education and communication materials were deemed most useful by parents and providers. Conclusion Immunisation service delivery can be strengthened using an adaptive, clinic-led assessment process which can effectively identify barriers, inform co-designed interventions and be evaluated over a short period. This approach provides a framework to guide future local participatory action research to more effectively improve childhood immunisation service delivery and other child health services in under-resourced settings.
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Background Recent literature on community intervention research stresses system change as a condition for durable impact. This involves highly participatory social processes leading to behavioural change. Methods Before launching the intervention in the Nicaraguan arm of Camino Verde, a cluster-randomised controlled trial to show that pesticide-free community mobilisation adds effectiveness to conventional dengue controls, we held structured discussions with leaders of intervention communities on costs of dengue illness and dengue control measures taken by both government and households. These discussions were the first step in an effort at Socialising Evidence for Participatory Action (SEPA), a community mobilisation method used successfully in other contexts. Theoretical grounding came from community psychology and behavioural economics. Results The leaders expressed surprise at how large and unexpected an economic burden dengue places on households. They also acknowledged that large investments of household and government resources to combat dengue have not had the expected results. Many were not ready to see community preventive measures as a substitute for chemical controls but all the leaders approved the formation of “brigades” to promote chemical-free household control efforts in their own communities. Conclusions Discussions centred on household budget decisions provide a good entry point for researchers to engage with communities, especially when the evidence showed that current expenditures were providing a poor return. People became motivated not only to search for ways to reduce their costs but also to question the current response to the problem in question. This in turn helped create conditions favourable to community mobilisation for change. Trial registration ISRCTN27581154.
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Background Community mobilisation for prevention requires engagement with and buy in from those communities. In the Mexico state of Guerrero, unprecedented social violence related to the narcotics trade has eroded most community structures. A recent randomised controlled trial in 90 coastal communities achieved sufficient mobilisation to reduce conventional vector density indicators, self-reported dengue illness and serologically proved dengue virus infection. Methods The Camino Verde intervention was a participatory research protocol promoting local discussion of baseline evidence and co-design of vector control solutions. Training of facilitators emphasised community authorship rather than trying to convince communities to do specific activities. Several discussion groups in each intervention community generated a loose and evolving prevention plan. Facilitators trained brigadistas, the first wave of whom received a small monthly stipend. Increasing numbers of volunteers joined the effort without pay. All communities opted to work with schoolchildren and for house-to-house visits by brigadístas. Children joined the neighbourhood vector control movements where security conditions permitted. After 6 months, a peer evaluation involved brigadista visits between intervention communities to review and to share progress. Discussion Although most communities had no active social institutions at the outset, local action planning using survey data provided a starting point for community authorship. Well-known in their own communities, brigadistas faced little security risk compared with the facilitators who visited the communities, or with governmental programmes. We believe the training focus on evidence-based dialogue and a plural community ownership through multiple design groups were key to success under challenging security conditions. Trial registration ISRCTN27581154.
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Background A modified theory of planned behaviour (acronym CASCADA) proposes that Conscious knowledge precedes a change in Attitude, which in turn precedes positive deviations from negative Subjective norms, intention to Change, perception of Agency to change, Discussion of possible action, and Action itself. We used this as a results chain to investigate gender-specific behaviour dynamics in chemical-free dengue prevention. Methods Secondary analysis of the Mexican arm of a cluster randomised controlled trial used household survey data on intermediate outcomes of dengue prevention behaviour. We used a matrix of odds ratios between outcomes, transformed to a symmetrical range (−1, 1), to compute fuzzy transitive closure of the results chain for control and intervention clusters, then for male and female respondents separately in each group. Transitive closure of a map computes the influence of each factor on each other factor, taking account of all influences in the system. Cumulative net influence was the sum of influences across the results chain. Results Responses of 5042 women and 1143 men in 45 intervention clusters contrasted with those of 5025 women and 1179 men in 45 control clusters. Control clusters showed a distal block (negative influence) in the results chain with a cumulative net influence of 0.88; intervention clusters showed no such block and a cumulative net influence of 1.92. Female control respondents, like the overall control picture, showed a distal block, whereas female intervention responses showed no such blocks (cumulative net influence 0.78 and 1.73 respectively). Male control respondents showed weak distal blocks. Male intervention responses showed several new negative influences and a reduction of cumulative net influence (1.38 in control and 1.11 in intervention clusters). Conclusions The overall influence of the intervention across the results chain fits with the trial findings, but is different for women and men. Among women, the intervention overcame blocks and increased the cumulative net influence of knowledge on action. Among men, the intervention did not reinforce prevention behaviour. This might be related to emphasis, during the intervention, on women’s participation and empowerment. The fuzzy transitive closure of the CASCADA map usefully highlights the differences between gender-specific results chains. Trial registration ISRCTN27581154.
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We discuss two ethical issues raised by Camino Verde, a 2011–2012 cluster-randomised controlled trial in Mexico and Nicaragua, that reduced dengue risk though community mobilisation. The issues arise from the approach adopted by the intervention, one called Socialisation of Evidence for Participatory Action. Community volunteer teams informed householders of evidence about dengue, its costs and the life-cycle of Aedes aegypti mosquitoes, while showing them the mosquito larvae in their own water receptacles, without prescribing solutions. Each community responded in an informed manner but on its own terms. The approach involves partnerships with communities, presenting evidence in a way that brings conflicting views and interests to the surface and encourages communities themselves to deal with the resulting tensions. One such tension is that between individual and community rights. This tension can be resolved creatively in concrete day-to-day circumstances provided those seeking to persuade their neighbours to join in efforts to benefit community health do so in an atmosphere of dialogue and with respect for personal autonomy. A second tension arises between researchers’ responsibilities for ethical conduct of research and community autonomy in the conduct of an intervention. An ethic of respect for individual and community autonomy must infuse community intervention research from its inception, because as researchers succeed in fostering community self-determination their direct influence in ethical matters diminishes. Trial registration: ISRCTN 27581154
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Background In the Mexican state of Guerrero, some households place fish in water storage containers to prevent the development of mosquito larvae. Studies have shown that larvivorous fish reduce larva count in household water containers, but there is a lack of evidence about whether the use of fish is associated with a reduction in dengue virus infection. We used data from the follow up survey of the Camino Verde cluster randomised controlled trial of community mobilisation to reduce dengue risk to study this association. Methods The survey in 2012, among 90 clusters in the three coastal regions of Guerrero State, included a questionnaire to 10,864 households about socio-demographic factors and self-reported cases of dengue illness in the previous year. Paired saliva samples provided serological evidence of recent dengue infection among 4856 children aged 3–9 years. An entomological survey in the same households looked for larvae and pupae of Aedes aegypti and recorded presence of fish and temephos in water containers. We examined associations with the two outcomes of recent dengue infection and reported dengue illness in bivariate analysis and then multivariate analysis using generalized linear mixed modelling. Results Some 17% (1730/10,111) of households had fish in their water containers. The presence of fish was associated with lower levels of recent dengue virus infection in children aged 3–9 years (OR 0.64; 95% CI 0.45–0.91), as was living in a rural area (OR 0.57; 95% CI 0.45–0.71), and being aged 3–5 years (OR 0.65; 95% CI 0.51–0.83). Factors associated with lower likelihood of self-reported dengue illness were: the presence of fish (OR 0.79; 95% CI 0.64–0.97), and living in a rural area (OR 0.74; 95% CI 0.65–0.84). Factors associated with higher likelihood of self-reported dengue illness were: higher education level of the household head (OR 1.28; 95% CI 1.07–1.52), living in a household with five people or less (OR 1.33; 95% CI 1.16–1.52) and household use of insecticide anti-mosquito products (OR 1.68; 95% CI 1.47–1.92). Conclusions Our study suggests that fish in water containers may reduce the risk of dengue virus infection and dengue illness. This could be a useful part of interventions to control the Aedes aegypti vector.
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The data includes measures collected for the two experiments reported in “False-Positive Psychology” [1] where listening to a randomly assigned song made people feel younger (Study 1) or actually be younger (Study 2). These data are useful because they illustrate inflations of false positive rates due to flexibility in data collection, analysis, and reporting of results. Data are useful for educational purposes.
Article
Clinical Trials Series: Comparative Effectiveness Studies and Patient Care Clinical trials of interventions in common practice can be built into the workflow of an electronic medical record. The authors review four such trials and highlight the strengths and weaknesses of this approach to gathering information.
Article
Over the past 70 years, randomized, controlled trials (RCTs) have reshaped medical knowledge and practice. Popularized by mid-20th-century clinical researchers and statisticians aiming to reduce bias and enhance the accuracy of clinical experimentation, RCTs have often functioned well in that role. Yet the past seven decades also bear witness to many limitations of this new "gold standard." The scientific and political history of RCTs offers lessons regarding the complexity of medicine and disease and the economic and political forces that shape the production and circulation of medical knowledge. The Rise of RCTs Physicians and medical researchers have attempted for millennia . . .