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A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme.

ABSTRACT: The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard" the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the results from this model are presented [1].Data were collected from a random subsample of 725 women (7.7% of the trial population) using structured interviews, coital diaries, in-depth interviews, counting returned gel applicators, focus group discussions, and ethnography. The core of the model was a customised, semi-structured in-depth interview. There were two levels of triangulation: first, discrepancies between data from the questionnaires, diaries, in-depth interviews and applicator returns were identified, discussed with participants and, to a large extent, resolved; second, results from individual participants were related to more general data emerging from the focus group discussions and ethnography. A democratic and equitable collaboration between clinical trialists and qualitative social scientists facilitated the success of the model, as did the preparatory studies preceding the trial. The process revealed some of the underlying assumptions and routinised practices in "clinical trial culture" that are potentially detrimental to the collection of accurate data, as well as some of the shortcomings of large qualitative studies, and pointed to some potential solutions.The integration of qualitative social science and the use of mixed methods and triangulation in clinical trials are feasible, and can reveal (and resolve) inaccuracies in data on adherence and sensitive behaviours, as well as illuminating aspects of "trial culture" that may also affect data accuracy.

SUBMITTER: Pool R

PROVIDER: S-EPMC2908129 | biostudies-other | 2010 Jul

REPOSITORIES: biostudies-other

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A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme.

Pool Robert R Montgomery Catherine M CM Morar Neetha S NS Mweemba Oliver O Ssali Agnes A Gafos Mitzy M Lees Shelley S Stadler Jonathan J Crook Angela A Nunn Andrew A Hayes Richard R McCormack Sheena S

PloS one 20100721 7

<h4>Background</h4>The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard" the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the ...[more]

PMID: 20657778

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Project description:BackgroundThere is a need for valid approaches to measure sexual interactions to assess the impact of behavioural interventions and to predict the impact of behaviour changes. Different methods of asking about sexual behaviour often yield conflicting answers and men often report higher levels of heterosexual activity than women. To better understand self-reported sexual behaviour data and how best to collect it, we analyzed data collected as part of a larger project (ST IMPACTS) on the social and behavioural impact of introducing community-level HIV self-testing (HIVST) with counseling (semi-supervised with pre- and generic post-test counseling provided on delivery or collection of test kits) in an urban Malawian setting.MethodsInformation on sexual behaviour was collected from HIV self-testers over a three-month period. Three different methods were used: retrospective face-to-face interviews (FTFI); audio computer assisted self-interviews (ACASI) and a prospective coital diary. Both retrospective instruments were used before and after the three-month study period. Frequency and cross-tabulation, as well as scatterplots, were used for exploratory analyses. Chi-square tests were used to test for differences in proportions. Spearman's correlation coefficient was used to explore associations between both continuous and ordinal variables and Wilcoxon's paired sample and Mann-Whitney test was used to test for differences in such variables or between variables.ResultsThere was reasonable agreement between the two retrospective methods although both yielded inconsistent answers e.g. with lower reported numbers of life-time sexual partners at the end than at the beginning of the study period. The diary method elicited higher reported levels of sex with multiple partners than both retrospective instruments which may be due to inadequate recall. Over the study period 37.4% of men and 19.7% of women reported multiple sexual partners using the diary. There was no clear relationship between reported sexual behaviour and HIV status (prevalence 9.6%).ConclusionsDiaries may therefore have higher validity for sensitive behaviour reporting and thus be the preferred method in similar African contexts in measuring sexual behaviours.

Project description:Mixed methods are commonly used in health services research; however, data are not often integrated to explore complementarity of findings. A triangulation protocol is one approach to integrating such data. A retrospective triangulation protocol was carried out on mixed methods data collected as part of a process evaluation of a trial. The multi-country randomised controlled trial found that a web-based training in communication skills (including use of a patient booklet) and the use of a C-reactive protein (CRP) point-of-care test decreased antibiotic prescribing by general practitioners (GPs) for acute cough. The process evaluation investigated GPs' and patients' experiences of taking part in the trial.Three analysts independently compared findings across four data sets: qualitative data collected view semi-structured interviews with (1) 62 patients and (2) 66 GPs and quantitative data collected via questionnaires with (3) 2886 patients and (4) 346 GPs. Pairwise comparisons were made between data sets and were categorised as agreement, partial agreement, dissonance or silence.Three instances of dissonance occurred in 39 independent findings. GPs and patients reported different views on the use of a CRP test. GPs felt that the test was useful in convincing patients to accept a no-antibiotic decision, but patient data suggested that this was unnecessary if a full explanation was given. Whilst qualitative data indicated all patients were generally satisfied with their consultation, quantitative data indicated highest levels of satisfaction for those receiving a detailed explanation from their GP with a booklet giving advice on self-care. Both qualitative and quantitative data sets indicated higher patient enablement for those in the communication groups who had received a booklet.Use of CRP tests does not appear to engage patients or influence illness perceptions and its effect is more centred on changing clinician behaviour. Communication skills and the patient booklet were relevant and useful for all patients and associated with increased patient satisfaction. A triangulation protocol to integrate qualitative and quantitative data can reveal findings that need further interpretation and also highlight areas of dissonance that lead to a deeper insight than separate analyses.

Project description:BackgroundMobile phone text messaging has been shown to improve adherence to antiretroviral therapy and to improve communication between patients and health care workers. It is unclear which strategies are most appropriate for scaling up text messaging programmes. We sought to investigate acceptability and readiness for ownership (community members designing, sending and receiving text messages) of a text message programme among a community of clients living with human immunodeficiency virus (HIV) in Yaoundé, Cameroon and to develop a framework for implementation.MethodsWe used the mixed-methods sequential exploratory design. In the qualitative strand we conducted 7 focus group discussions (57 participants) to elicit themes related to acceptability and readiness. In the quantitative strand we explored the generalizability of these themes in a survey of 420 clients. Qualitative and quantitative data were merged to generate meta-inferences.ResultsBoth qualitative and quantitative strands showed high levels of acceptability and readiness despite low rates of participation in other community-led projects. In the qualitative strand, compared to the quantitative strand, more potential service users were willing to pay for a text messaging service, preferred participation of health personnel in managing the project and preferred that the project be based in the hospital rather than in the community. Some of the limitations identified to implementing a community-owned project were lack of management skills in the community, financial, technical and literacy challenges. Participants who were willing to pay were more likely to find the project acceptable and expressed positive feelings about community readiness to own a text messaging project.ConclusionCommunity ownership of a text messaging programme is acceptable to the community of clients at the Yaoundé Central Hospital. Our framework for implementation includes components for community members who take on roles as services users (demonstrating clear benefits, allowing a trial period and ensuring high levels of confidentiality) or service providers (training in project management and securing sustainable funding). Such a project can be evaluated using participation rate, clinical outcomes, satisfaction with the service, cost and feedback from users.

Project description:INTRODUCTION:University undergraduate students are within the population at highest risk for acquiring sexually transmitted infections, unplanned pregnancy, and other negative health outcomes. Despite the availability of sexual health services at university health centres, many students delay or avoid seeking care. In this study, we describe how the Behaviour Change Wheel was used as a systematic approach to design an intervention to improve sexual health service use among university undergraduate students. METHODS:This paper describes the intervention development phase of a three-phased, sequential explanatory mixed methods study. Phases one and two included a quantitative and qualitative study that aimed to better understand students' use of sexual health services. In phase three, we followed the Behaviour Change Wheel to integrate the quantitative and qualitative findings and conduct stakeholder consultation meetings to select intervention strategies, including intervention functions and behaviour change techniques. RESULTS:Key linkages between opportunity and motivation were found to influence students' access of sexual health services. Stakeholders identified six intervention functions (education, environmental restructuring, enablement, modelling, persuasion, and incentivization) and 15 behaviour change techniques (information about health consequences, information about social and environmental consequences, feedback on behaviour, feedback on outcomes of behaviour, prompts/cues, self-monitoring of behaviour, adding objects to the environment, goal setting, problem solving, action planning, restructuring the social environment, restructuring the physical environment, demonstration of the behaviour, social support, credible source) as relevant to include in a toolbox of intervention strategies to improve sexual health service use. CONCLUSIONS:This study details the use of the Behaviour Change Wheel to develop an intervention aimed at improving university students' use of sexual health services. The Behaviour Change Wheel provided a comprehensive framework for integrating multiple sources of data to inform the selection of intervention strategies. Stakeholders can use these strategies to design and implement sexual health service interventions that are feasible within the context of their health centre. Future research is needed to test the effectiveness of the strategies at changing university students' sexual health behaviour.

Project description:OBJECTIVES:To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence. DESIGN:Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial. SETTING:Research clinic in Kigali, Rwanda. PARTICIPANTS:Rwandan women with high sexual risk. INTERVENTIONS:Women diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17?each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet. OUTCOME MEASURES:Adherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131). RESULTS:Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users?and 13/16 GynLP users used ?80% of required doses (Fisher's exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients. CONCLUSIONS:High-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes. TRIAL REGISTRATION NUMBER:NCT02459665.

Project description:Although intimate partner sexual aggression has been shown to be associated with adverse mental health outcomes, there is scant information about sexual aggression in Chinese intimate relationships in general and about its mental health impact in particular. This article aimed to investigate sexual aggression in Chinese intimate relationships, including the use of force or threat of force and non-physical coercive tactics in unwanted sex.The quantitative and qualitative data used in this paper were drawn from a prospective cohort study conducted in Hong Kong between September 2010 and September 2012. A total of 745 Chinese women aged 18 or older who had been in an intimate relationship in the preceding 12 months were recruited from sites in all districts of Hong Kong. Multiple logistic regression analysis, ordinary linear regression, and t-tests were used in quantitative analysis. Directed content analysis was used to analyze the transcripts of 59 women who revealed experiences of intimate partner sexual aggression in individual in-depth interviews.Of the 745 Chinese women in the study, 348 (46.7%) had experienced intimate partner physical violence in the past year, and 179 (24%) had experienced intimate partner physical violence and sexual aggression in the past year. Intimate partner sexual aggression significantly predicted PTSD and depressive symptoms after controlling for intimate partner physical violence. Among the 179 women reporting intimate partner physical violence and sexual coercion in the past year, 75 indicated that their partners used force or threat of force to make them have sex, and 104 of them reported that they gave in to sex because of non-physical coercive tactics used by their partners. Qualitative data revealed a variety of non-physical coercive tactics with different degrees of subtlety used to coerce women into unwanted sex with their partners. Chinese women experiencing physically forced sex had significantly more depressive symptoms and PTSD symptoms.Our findings indicate that sexual aggression in Chinese intimate relationships has specific mental health consequences over and above those associated with physical violence. Assessment of partner violence in Chinese relationships should include screening for sexual aggression in order to provide appropriate interventions.ClinicalTrials gov NCT01206192.

Dataset Information

A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme.

Publications

A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme.

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