El realismo mágico como discurso poscolonial

This chapter outlines the main objective of each of the three research papers presented in this thesis and explains how the research papers in Chapters 5-7 fit together. While most of the methods used are presented in detail in each paper, an overview of the methods is provided, with additional details available in appendices.

4.1 Research objectives

The specific objectives of the research presented in this thesis are:

1. To determine differences in patient characteristics and levels of adherence between patients

obtaining AL in public health facilities and ADDOs, and to examine factors associated with adherence in both of these settings (Chapter 6).

2. To evaluate the effect on dispenser knowledge and patient adherence of text message reminders targeted at ADDO dispensers concerning advice to provide when dispensing AL (Chapter 5).

3. To compare the validity of assessing patient adherence with self-reported data compared to smart blister packs (Chapter 7).

In this thesis, the second research objective is addressed first (Chapter 5), with Chapter 6 addressing the first research objective. This order was necessary, as the research paper on the text message intervention in ADDOs was published first, and the subsequent research papers reference its description of methods.

4.2 Overview of study design

The research was composed of three related studies, a cluster-randomised trial (CRT) of a text message intervention, an observational study in public health facilities, and a comparison of methods to

assess adherence. The first two studies relied on adherence measured by self-report and pill count, but in order to assess the validity of this approach, a third study using smart blister packs—a customised electronic monitoring device—was nested within the other two studies.

A CRT was chosen to evaluate the text message intervention. In CRTs, as in other randomised controlled trials, the random allocation of the intervention ensures (theoretically) that known and unknown factors that might affect the outcome are evenly distributed, allowing differences in outcome between control and intervention arms to be attributed to the intervention. In order to minimise

contamination between dispensers working in the same or nearby shops, the intervention was delivered at the cluster (ADDO) level. The observational study in public health facilities was conducted in order to address whether or not adherence to AL obtained in ADDOs was lower than in public health facilities. These studies were conducted in parallel, with teams simultaneously working at ADDOs and public health facilities in each district of Mtwara.

Mtwara region was selected as the research site, as this was one of three focus regions for the IMPACT2 umbrella project, along with Mwanza and Mbeya. Mtwara was selected for this adherence study for several reasons. Both Mtwara and Mbeya had established ADDOs, but Mwanza did not, and DLDB could not officially supply ACTs. In Mbeya, the low prevalence of malaria might have resulted in slow patient enrolment compared to Mtwara region, where transmission is moderately high. Finally, an IHI office is located in Mtwara and could help with field logistics.

ADDO census. Preliminary data collection for the CRT began in May 2012 with a census and brief

survey of all ADDOs in Mtwara. The primary purpose of the census was to build a sampling frame for the CRT and collect data to guide the sampling process in order to minimise contamination between control and intervention ADDOs. Selection and randomisation of ADDOs, as well as selection of public health facilities for the observational study, are described further in Chapters 5 and 6.

Text message intervention. The text message intervention is described in Chapter 5. Briefly,

dispensers at selected ADDOs were visited prior to beginning the intervention to invite participation. Messages were scheduled in advance and sent automatically Monday – Friday of the first four weeks, and Monday, Wednesday, Friday of the next 10 weeks. Content of text messages was based on ACT dispensing instructions. Each of the seven content messages was paired with a unique quote to

encourage reading or a question based on the content of a previous message. Respondents that replied correctly (at their own expense) were compensated with extra airtime.

Enrolment of outlets. From September – November 2012, both control and intervention ADDOs

and selected public health facilities were visited and asked to participate in the research. Dispensers were provided with smart blister packs of AL (discussed in Chapter 7) and asked to register all patients that obtained any drug for fever or malaria at the outlet on a study form (Appendix 1a-b). The intention was to register 12 patients obtaining ACTs in one week per outlet, but it took 2-3 weeks to recruit this number in some outlets.

Patient and dispenser interviews. Registered patients obtaining AL were visited at home on day

4 for a structured interview covering when and how each dose of AL was taken (Appendix 1c) and collection of blood samples and blister packs. Determination of patient adherence is described in Chapters 5-7. Interviews of ADDO dispensers were conducted from mid-October – November 2012, following completion of patient interviews in a given district. Dispensers were asked about their knowledge of advice to provide patients when dispensing AL using open-ended questions. Responses were recorded verbatim and evaluated against a pre-specified description of correct responses.

Key informant interviews (KIIs). Key informant interviews were conducted in each district with

the DMO and, when available, the District Pharmacist, the District Nursing Officer, and / or the Malaria Focal Person. Data were collected on ADDO roll out, training, supervision, inspection, and community sensitization, as well as availability of ACTs and RDTs in health facilities, and other malaria control and

research activities. The data are not presented separately in this thesis but inform the interpretation of the studies described in the research papers.

Socioeconomic indices. To determine socioeconomic status, data were collected from patients

on ownership of household possessions, housing characteristics, and access to utilities, based on standard Demographic and Health Survey variables (http://www.measuredhs.com). Socioeconomic indices were calculated using principal component analysis, with the factor scores from the first principal component used as weights [1]. Scores were divided into quintiles, and the proportions of patients in each quintile were presented in tables.

Registration of CRT and ethical approvals. The CRT was registered with Current Controlled Trials,

ISRCTN83765567. Both the CRT and the observational study were submitted together for ethical approval to LSHTM and IHI. An amendment was also submitted to LSHTM when it was decided to test patients with RDTs at the interview, in addition to collecting blood smears and filter papers (this amendment was included in the original protocol submitted to IHI). Approval letters are included in Appendix 2.

When enrolling outlets to participate in the study, a consent form with a standard introduction to the research was read and signed by a dispenser at each outlet (Appendix 1a). Informed consent was also collected from patients and dispensers prior to interview.

References

1. Vyas S, Kumaranayake L: Constructing socio-economic status indices: how to use principal