Natalie Leon

The impact of provider-initiated (opt-out) HIV testing and counseling of patients with sexually transmitted infection in Cape Town, South Africa: a controlled trial

BackgroundThe effectiveness of provider-initiated HIV testing and counseling (PITC) for patients with sexually transmitted infection (STI) in resource-constrained settings are of particular concern for high HIV prevalence countries like South Africa. This study evaluated whether the PITC approach increased HIV testing amongst patients with a new episode of sexually transmitted infection, as compared to standard voluntary counseling and testing (VCT) at the primary care level in South Africa, a high prevalence and low resource setting.MethodsThe design was a pragmatic cluster-controlled trial with seven intervention and 14 control clinics in Cape Town. Nurses in intervention clinics integrated PITC into standard HIV care with few additional resources, whilst lay counselors continued with the VCT approach in control clinics. Routine data were collected for a six-month period following the intervention in 2007, on new STI patients who were offered and who accepted HIV testing. The main outcome measure was the proportion of new STI patients tested for HIV, with secondary outcomes being the proportions who were offered and who declined the HIV test.ResultsA significantly higher proportion of new STI patients in the intervention group tested for HIV as compared to the control group with (56.4% intervention versus 42.6% control, p = 0.037). This increase was achieved despite a significantly higher proportion intervention group declining testing when offered (26.7% intervention versus 13.5% control, p = 0.0086). Patients were more likely to be offered HIV testing in intervention clinics, where providers offered the HIV test to 76.8% of new STI patients versus 50.9% in the control group (p = 0.0029). There was significantly less variation in the main outcomes across the intervention clinics, suggesting that the intervention also facilitated more consistent performance.ConclusionsPITC was successful in three ways: it increased the proportion of new STI patients tested for HIV; it increased the proportion of new STI patients offered HIV testing; and it delivered more consistent performance across clinics. Recommendations are made for increasing the impact and feasibility of PITC in high HIV prevalence and resource-constrained settings. These include more flexible use of clinical and lay staff, and combining PITC with VCT and other community-based approaches to HIV testing.Trial registrationControlled trial ISRCTN93692532

Improving treatment adherence for blood pressure lowering via mobile phone SMS-messages in South Africa: a qualitative evaluation of the SMS-text Adherence SuppoRt (StAR) trial.

BackgroundEffective use of proven treatments for high blood pressure, a preventable health risk, is challenging for many patients. Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment, though more research is needed on impact and patient perceptions of such support interventions, especially in low-resource settings.MethodAn individually-randomised controlled trial in a primary care clinic in Cape Town (2012–14), tested the effect of an adherence support intervention delivered via SMS-texts, on blood pressure control and adherence to medication, for hypertensive patients. (Trial registration: ClinicalTrials.gov NCT02019823). We report on a qualitative evaluation that explored the trial participants’ experiences and responses to the SMS-text messages, and identified barriers and facilitators to delivering adherence support via patients’ own mobile phones. Two focus groups and fifteen individual interviews were conducted. We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three researchers.ResultsMost participants were comfortable with the technology of using SMS-text messages. Messages were experienced as acceptable, relevant and useful to a broad range of participants. The SMS-content, the respectful tone and the delivery (timing of reminders and frequency) and the relational aspect of trial participation (feeling cared for) were all highly valued. A subgroup who benefitted the most, were those who had been struggling with adherence due to high levels of personal stress. The intervention appeared to coincide with their readiness for change, and provided practical and emotional support for improving adherence behaviour. Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility. Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours.ConclusionAdherence support for treatment of raised blood pressure, delivered via SMS-text message on the patient’s own phone, was found to be acceptable, relevant and helpful, even for those who already had their own reminder systems in place. Our findings begin to identify for whom and what core elements of the SMS-text message intervention appear to work best in a low-resource operational setting, issues that future research should explore in greater depth.

Provider-initiated testing and counselling for HIV: from debate to implementation

Recent statements by the new Minister of Health about ‘mass voluntary counselling and Testing (VCT) campaigns’, and references in the latest draft VCT policy to ‘provider-initiated VCT’, suggest that a policy space is opening up in South Africa for the expansion of HIV testing models beyond the current VCT approach. The existing VCT programme is showing some successes. For example, the Human Sciences Research Council (HSRC) has reported a dramatic increase in the number of 15 - 48-year-olds who report awareness of their HIV status, from 11.9 % in 2005 to 24.7% in 2008. Despite increased testing rates and willingness to test, most HIV-positive people do not know their status, do not consider themselves at risk and do not self-initiate testing, even with widespread awareness of and accessibility to VCT services. Barriers associated with VCT uptake include clients having to initiate testing themselves, lengthy pre- and post-test counselling, implementation barriers (organisational management, supervision, human resource and infrastructure limitations), and patient concerns about confidentiality. Possible strategies for expanding HIV testing include ‘provider-initiated HIV testing and counselling’ (PITC)6 – also referred to as ‘opt-out’ HIV testing or ‘routine offer of HIV testing’ – and broad-based testing approaches such as ‘mass VCT’ campaigns, mobile VCT services, community- and home-based HIV testing initiatives and self-testing.

Implementing a provider-initiated testing and counselling (PITC) intervention in Cape town, South Africa: a process evaluation using the normalisation process model.

BackgroundProvider-initiated HIV testing and counselling (PITC) increases HIV testing rates in most settings, but its effect on testing rates varies considerably. This paper reports the findings of a process evaluation of a controlled trial of PITC for people with sexually transmitted infections (STI) attending publicly funded clinics in a low-resource setting in South Africa, where the trial results were lower than anticipated compared to the standard Voluntary Counselling and Testing (VCT) approach.MethodThis longitudinal study used a variety of qualitative methods, including participant observation of project implementation processes, staff focus groups, patient interviews, and observation of clinical practice. Data were content analysed by identifying the main influences shaping the implementation process. The Normalisation Process Model (NPM) was used as a theoretical framework to analyse implementation processes and explain the trial outcomes.ResultsThe new PITC intervention became embedded in practice (normalised) during a two-year period (2006 to 2007). Factors that promoted the normalising include strong senior leadership, implementation support, appropriate accountability mechanisms, an intervention design that was responsive to service needs and congruent with professional practice, positive staff and patient perceptions, and a responsive organisational context. Nevertheless, nurses struggled to deploy the intervention efficiently, mainly because of poor sequencing and integration of HIV and STI tasks, a focus on HIV education, tension with a patient-centred communication style, and inadequate training on dealing with the operational challenges. This resulted in longer consultation times, which may account for the low test coverage outcome.ConclusionLeadership and implementation support, congruent intervention design, and a responsive organisational context strengthened implementation. Poor compatibility with nurse skills on the level of the clinical consultation may have contributed to limiting the size of the trial outcomes. A close fit between the PITC intervention design and clinical practices, as well as appropriate training, are needed to ensure sustainability of the programme. The use of a theory-driven analysis promotes transferability of the results, and the findings are therefore relevant to the implementation of HIV testing and to the design and evaluation of complex interventions in other settings.Trial registrationCurrent controlled trials ISRCTN93692532

The role of ‘hidden’ community volunteers in community-based health service delivery platforms: examples from sub-Saharan Africa

Community-based research on child survival in sub-Saharan Africa has focussed on the increased provision of curative health services by a formalised cadre of lay community health workers (CHWs), but we have identified a particular configuration, that deserves closer scrutiny. We identified a two-tiered CHW system, with the first tier being the lessor known or ‘hidden’ community/village level volunteers and the second tier being formal, paid CHWs, in Ethiopia, Mali, and Niger. Whilst the disease-focussed tasks of the formal CHW tier may be more amenable to classic epidemiological surveillance, we postulate that understanding the relationship between formalised CHWs and volunteer cadres, in terms of scope, location of practice and ratio to population, would be important for a comprehensive evaluation of child survival in these countries. We report on the findings from our joint qualitative and quantitative investigations, highlighting the need to recognise the ‘hidden’ contribution of volunteers. We need to better characterize the volunteers’ interaction with community-based and primary care services and to better understand ways to improve the volunteer systems with the right type of investments. This is particularly important for considering the models for scale-up of CHWs in sub-Saharan Africa.

Healthcare workers’ perceptions and experience on using mHealth technologies to deliver primary healthcare services: qualitative evidence synthesis

This is the protocol for a review and there is no abstract. The objectives are as follows: The review has the following two objectives. To identify, appraise and synthesise qualitative research evidence on healthcare workers’ perceptions and experiences regarding their use of mHealth technologies to provide and support the delivery of primary healthcare services. To identify hypotheses, for subsequent consideration and assessment in effectiveness reviews, about why some technologies are more effective than others.

Pathways to multidrug-resistant tuberculosis diagnosis and treatment initiation: a qualitative comparison of patients’ experiences in the era of rapid molecular diagnostic tests

BackgroundAlthough new molecular diagnostic tests such as GenoType MTBDRplus and Xpert® MTB/RIF have reduced multidrug-resistant tuberculosis (MDR-TB) treatment initiation times, patients’ experiences of diagnosis and treatment initiation are not known. This study aimed to explore and compare MDR-TB patients’ experiences of their diagnostic and treatment initiation pathway in GenoType MTBDRplus and Xpert® MTB/RIF-based diagnostic algorithms.MethodsThe study was undertaken in Cape Town, South Africa where primary health-care services provided free TB diagnosis and treatment. A smear, culture and GenoType MTBDRplus diagnostic algorithm was used in 2010, with Xpert® MTB/RIF phased in from 2011–2013. Participants diagnosed in each algorithm at four facilities were purposively sampled, stratifying by age, gender and MDR-TB risk profiles. We conducted in-depth qualitative interviews using a semi-structured interview guide. Through constant comparative analysis we induced common and divergent themes related to symptom recognition, health-care access, testing for MDR-TB and treatment initiation within and between groups. Data were triangulated with clinical information and health visit data from a structured questionnaire.ResultsWe identified both enablers and barriers to early MDR-TB diagnosis and treatment. Half the patients had previously been treated for TB; most recognised recurring symptoms and reported early health-seeking. Those who attributed symptoms to other causes delayed health-seeking. Perceptions of poor public sector services were prevalent and may have contributed both to deferred health-seeking and to patient’s use of the private sector, contributing to delays. However, once on treatment, most patients expressed satisfaction with public sector care. Two patients in the Xpert® MTB/RIF-based algorithm exemplified its potential to reduce delays, commencing MDR-TB treatment within a week of their first health contact. However, most patients in both algorithms experienced substantial delays. Avoidable health system delays resulted from providers not testing for TB at initial health contact, non-adherence to testing algorithms, results not being available and failure to promptly recall patients with positive results.ConclusionWhilst the introduction of rapid tests such as Xpert® MTB/RIF can expedite MDR-TB diagnosis and treatment initiation, the full benefits are unlikely to be realised without reducing delays in health-seeking and addressing the structural barriers present in the health-care system.

Self-management of medical abortion : a qualitative evidence synthesis.

Abstract Medical abortion is a method of pregnancy termination that by its nature enables more active involvement of women in the process of managing, and sometimes even administering the medications for, their abortions. This qualitative evidence synthesis reviewed the global evidence on experiences with, preferences for, and concerns about greater self-management of medical abortion with lesser health professional involvement. We focused on qualitative research from multiple perspectives on women’s experiences of self-management of first trimester medical abortion (< 12 weeks gestation). We included research from both legal and legally-restricted contexts whether medical abortion was accessed through formal or informal systems. A review team of four identified 36 studies meeting inclusion criteria, extracted data from these studies, and synthesized review findings. Review findings were organized under the following themes: general perceptions of self-management, preparation for self-management, logistical considerations, issues of choice and control, and meaning and experience. The synthesis highlights that the qualitative evidence base is still small, but that the available evidence points to the overall acceptability of self-administration of medical abortion. We highlight particular considerations when offering self-management options, and identify key areas for future research. Further qualitative research is needed to strengthen this important evidence base. Résume L’avortement médicamenteux est une méthode d’interruption de grossesse qui, par sa nature, permet une participation plus active des femmes à la gestion, et parfois même l’administration des médicaments pour leur propre avortement. Cette synthèse de données qualitatives a examiné les données mondiales sur les expériences, les préférences et les préoccupations relatives à une autogestion croissante de l’avortement médicamenteux, avec une moindre participation des professionnels de santé. Nous nous sommes concentrés sur la recherche qualitative, depuis de multiples perspectives, sur la manière dont les femmes ont vécu l’autogestion d’un avortement médicamenteux du premier trimestre (< 12 semaines) de gestation. Nous avons inclus la recherche portant sur des environnements légaux et juridiquement restrictifs, que l’avortement médicamenteux ait été obtenu par des systèmes formels ou informels. Une équipe de quatre personnes a sélectionné 36 études réunissant les critères d’inclusion, en a extrait des données et rédigé un projet de synthèse. Les résultats ont été organisés d’après les thèmes suivants : perceptions générales de l’autogestion, préparation à l’autogestion, considérations logistiques, questions de choix et contrôle, et signification et expérience. La synthèse montre que la base de données qualitative est encore mince, mais que ces informations indiquent une acceptabilité globale de l’auto-administration. Nous soulignons des points particuliers à prendre en compte lors de l’application des options d’autogestion, et nous identifions des domaines clés pour de futures recherches. Il faut poursuivre les recherches qualitatives pour étoffer cette base de données importante. Resumen El aborto con medicamentos es un método de interrupción del embarazo que por su naturaleza permite una participación más activa de las mujeres en el proceso de manejar, y en algunos casos incluso administrar los medicamentos, para su aborto. Esta síntesis de evidencia cualitativa revisó la evidencia mundial de experiencias, preferencias e inquietudes relacionadas con mayor automanejo del aborto con medicamentos y menos participación de profesionales de la salud. Nos enfocamos en investigaciones cualitativas, desde múltiples puntos de vista sobre las experiencias de las mujeres con el automanejo del aborto con medicamentos en el primer trimestre de embarazos (< 12 semanas) de gestación. Incluimos investigaciones de contextos donde es legal y donde es restringido por la ley, ya sea que los servicios de aborto con medicamentos hayan sido accedidos por medio de sistemas formales o informales. Un equipo de revisión integrado por cuatro personas identificó 36 estudios que reunían los criterios de inclusión, extrajó datos de estos estudios y redactó los hallazgos de la revisión sintetizada. Los hallazgos fueron organizados bajo las siguientes temáticas: percepciones generales del automanejo, preparación para el automanejo, consideraciones logísticas, asuntos de elección y control, y significado y experiencia. La síntesis destaca que la base de evidencia cualitativa aún es pequeña, pero que la evidencia existente indica la aceptación general de la autoadministración. Destacamos asuntos específicos que deben ser considerados al aplicar las opciones de automanejo, e identificamos áreas clave para futuras investigaciones. Se necesitan más investigaciones cualitativas para fortalecer esta importante base de evidencia.

Researching Complex Interventions in Health : The State of the Art

Table of contentsKEYNOTE PRESENTATIONSK1 Researching complex interventions: the need for robust approachesPeter CraigK2 Complex intervention studies: an important step in developing knowledge for practiceIngalill Rahm-HallbergK3 Public and patient involvement in research: what, why and how?Nicky BrittenK4 Mixed methods in health service research – where do we go from here?Gunilla BorglinSPEAKER PRESENTATIONSS1 Exploring complexity in systematic reviews of complex interventionsGabriele Meyer, Sascha Köpke, Jane Noyes, Jackie ChandlerS2 Can complex health interventions be optimised before moving to a definitive RCT? Strategies and methods currently in useSara LevatiS3 A systematic approach to develop theory based implementation interventionsAnne SalesS4 Pilot studies and feasibility studies for complex interventions: an introductionLehana Thabane, Lora GiangregorioS5 What can be done to pilot complex interventions?Nancy Feeley, Sylvie CossetteS6 Using feasibility and pilot trials to test alternative methodologies and methodological procedures prior to full scale trialsRod TaylorS7 A mixed methods feasibility study in practiceJacqueline Hill, David A Richards, Willem KuykenS8 Non-standard experimental designs and preference designsLouise von EssenS9 Evaluation gone wild: using natural experimental approaches to evaluate complex interventionsAndrew WilliamsS10 The stepped wedge cluster randomised trial: an opportunity to increase the quality of evaluations of service delivery and public policy interventionsKarla Hemming, Richard Lilford, Alan Girling, Monica TaljaardS11 Adaptive designs in confirmatory clinical trials: opportunities in investigating complex interventionsMunyaradzi DimairoS12 Processes, contexts and outcomes in complex interventions, and the implications for evaluationMark PetticrewS13 Processes, contexts and outcomes in complex interventions, and the implications for evaluationJanis Baird, Graham MooreS14 Qualitative evaluation alongside RCTs: what to consider to get relevant and valuable resultsWillem Odendaal, Salla Atkins, Elizabeth Lutge, Natalie Leon, Simon LewinS15 Using economic evaluations to understand the value of complex interventions: when maximising health status is not sufficientKatherine PayneS16 How to arrive at an implementation planTheo van AchterbergS17 Modelling process and outcomes in complex interventionsWalter SermeusS18 Systems modelling for improving health careMartin Pitt, Thomas Monks

Niger's child survival success, contributing factors and challenges to sustainability: a retrospective analysis

Background Household surveys undertaken in Niger since 1998 have revealed steady declines in under-5 mortality which have placed the country ‘on track’ to reach the fourth Millennium Development goal (MDG). This paper explores Niger’s mortality and health coverage data for children under-5 years of age up to 2012 to describe trends in high impact interventions and the resulting impact on childhood deaths averted. The sustainability of these trends are also considered. Methods and Findings Estimates of child mortality using the 2012 Demographic and Health Survey were developed and maternal and child health coverage indicators were calculated over four time periods. Child survival policies and programmes were documented through a review of documents and key informant interviews. The Lives Saved Tool (LiST) was used to estimate the number of child lives saved and identify which interventions had the largest impact on deaths averted. The national mortality rate in children under-5 decreased from 286 child deaths per 1000 live births (95% confidence interval 177 to 394) in the period 1989–1990 to 128 child deaths per 1000 live births in the period 2011–2012 (101 to 155), corresponding to an annual rate of decline of 3.6%, with significant declines taking place after 1998. Improvements in the coverage of maternal and child health interventions between 2006 and 2012 include one and four or more antenatal visits, maternal Fansidar and tetanus toxoid vaccination, measles and DPT3 vaccinations, early and exclusive breastfeeding, oral rehydration salts (ORS) and proportion of children sleeping under an insecticide-treated bed net (ITN). Approximately 26,000 deaths of children under-5 were averted in 2012 due to decreases in stunting rates (27%), increases in ORS (14%), the Hib vaccine (14%), and breastfeeding (11%). Increases in wasting and decreases in vitamin A supplementation negated some of those gains. Care seeking at the community level was responsible for an estimated 7,800 additional deaths averted in 2012. A major policy change occurred in 2006 enabling free health care provision for women and children, and in 2008 the establishment of a community health worker programme. Conclusion Increases in access and coverage of care for mothers and children have averted a considerable number of childhood deaths. The 2006 free health care policy and health post expansion were paramount in reducing barriers to care. However the sustainability of this policy and health service provision is precarious in light of persistently high fertility rates, unpredictable GDP growth, a high dependence on donor support and increasing pressures on government funding.