Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa.

BACKGROUND: Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process. METHOD: We describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development. RESULTS: We used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808 ). CONCLUSION: The complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.

Tsogolo la Thanzi: A Longitudinal Study of Young Adults Living in Malawi's HIV Epidemic.

Tsogolo la Thanzi (TLT) was designed to study how young adults navigate sexual relationships and childbearing during a generalized HIV epidemic. TLT began in 2009 with a population-representative sample of 1,505 women and 574 men between the ages of 15 and 25 living in Balaka, southern Malawi, where regional adult HIV prevalence then stood at 15 percent. The first phase (2009-11) included a series of eight interviews, spaced four months apart. During this time, women's romantic and sexual partners enrolled in the study on an ongoing basis. A refresher sample of 315 women was added in 2012. Seventy-eight percent of respondents were re-interviewed in the second phase of TLT (2015), which consisted of follow-up interviews approximately 3.5 years after the previous interview (ages 21-31). At each wave, detailed information about fertility intentions and behaviors, relationships, sexual behavior, health, and a range of sociodemographic and economic traits was gathered by means of face-to-face surveys. Biomarkers for HIV and pregnancy were also collected. Distinguishing features include: a population-representative sample, closely spaced data collection, dyadic data on couples over time, and an experimental approach to HIV testing and counseling. Data are available through restricted data-user agreements managed by Data Sharing for Demographic Research (DSDR) at the University of Michigan.

Assessing stakeholder perceptions of the acceptability and feasibility of national scale-up for a dual HIV/syphilis rapid diagnostic test in Malawi.

OBJECTIVES: The WHO recommends pregnant women receive both HIV and syphilis testing at their first antenatal care visit, as untreated maternal infections can lead to severe, adverse pregnancy outcomes. One strategy for increasing testing for both HIV and syphilis is the use of point-of-care (rapid) diagnostic tests that are simple, proven effective and inexpensive. In Malawi, pregnant women routinely receive HIV testing, but only 10% are tested for syphilis at their first antenatal care visit. This evaluation explores stakeholder perceptions of a novel, dual HIV/syphilis rapid diagnostic test and potential barriers to national scale-up of the dual test in Malawi. METHODS: During June and July 2015, we conducted 15 semistructured interviews with 25 healthcare workers, laboratorians, Ministry of Health leaders and partner agency representatives working in prevention of mother-to-child transmission in Malawi. We asked stakeholders about the importance of a dual rapid diagnostic test, concerns using and procuring the dual test and recommendations for national expansion. RESULTS: Stakeholders viewed the test favourably, citing the importance of a dual rapid test in preventing missed opportunities for syphilis diagnosis and treatment, improving infant outcomes and increasing syphilis testing coverage. Primary technical concerns were about the additional procedural steps needed to perform the test, the possibility that testers may not adhere to required waiting times before interpreting results and difficulty reading and interpreting test results. Stakeholders thought national scale-up would require demonstration of cost-savings, uniform coordination, revisions to testing guidelines and algorithms, training of testers and a reliable supply chain. CONCLUSIONS: Stakeholders largely support implementation of a dual HIV/syphilis rapid diagnostic test as a feasible alternative to current antenatal testing. Scale-up will require addressing perceived barriers; negotiating changes to existing algorithms and guidelines; and Ministry of Health approval and funding to support training of staff and procurement of supplies.

HIV treatment optimism and its predictors among young adults in southern Malawi.

This study measures HIV treatment optimism and its predictors in a representative sample of young adults in southern Malawi. In 2010, 1275 women and 470 men between the ages of 16 and 26 were asked about their exposure to people on antiretroviral therapy (ART), sexual risk behavior, HIV status, and beliefs about ART. We used confirmatory factor analysis to develop a 4-item scale of the belief that HIV is a less serious health threat due to ART (reduced-severity optimism) and used a single measure to capture belief in the reduced infectivity of HIV due to ART (reduced-susceptibility optimism). Overall, respondents reported low levels of HIV treatment optimism. Being female and using ART were the largest predictors of both types of treatment optimism. We found a nonlinear relationship between exposure to people on ART and reduced-severity optimism. People who knew someone on ART but did not discuss it with them had lower levels of reduced-severity optimism than people who did not know anyone on ART and people who regularly discussed treatment with someone on ART. In multivariate regression models, HIV treatment optimism was positively associated with all measures of sexual risk behavior among men, but negatively associated with unprotected sex with a nonprimary partner among women. Our findings suggest that the spread of ART in Malawi has not led to widespread HIV treatment optimism. This may reflect the relatively recent spread of ART, the generalized nature of the HIV epidemic, or the fact that access to ART is complicated by structural limitations that delay treatment and limited availability of second-line medicines.

EXTending availability of self-management structured EducatioN programmes for people with type 2 Diabetes in low-to-middle income countries (EXTEND)-a feasibility study in Mozambique and Malawi.

BACKGROUND: Globally, there are estimated 425 million people with type 2 diabetes (T2D) with 80% from low-middle income countries (LMIC). Diabetes self-management education (DSME) programmes are a vital and core component of the treatment pathway for T2D. Despite LMIC being disproportionally affected by T2D, there are no DSME available that meet international diabetes federation criterion. METHODS: The aims were to test the feasibility of delivering a proven effective and cost-effective approach used in a UK population in two urban settings in Malawi and Mozambique by; (1) developing a culturally, contextually and linguistically adapted DSME, the EXTending availability of self-management structured EducatioN programmes for people with type 2 Diabetes in low-to-middle income countries (EXTEND) programme; (2) using a mixed-method approach to evaluate the delivery of training and the EXTEND programme to patients with T2D. RESULTS: Twelve healthcare professionals were trained. Ninety-eight participants received the DSME. Retention was high (100% in Mozambique and 94% in Malawi). At 6 months HbA1c (-0.9%), cholesterol (-0.3 mmol/L), blood pressure (-5.9 mm Hg systolic and -6.1 mm Hg diastolic) improved in addition to indicators of well-being (problem areas in diabetes and self-efficacy in diabetes). CONCLUSION: It is feasible to deliver and evaluate the effectiveness of a culturally, contextually and linguistically adapted EXTEND programme in two LMIC. The DSME was acceptable with positive biomedical and psychological outcomes but requires formal testing with cost-effectiveness. Challenges exist in scaling up such an approach in health systems that do not have resources to address the challenge of diabetes.

Mobile Messaging Support Versus Usual Care for People With Type 2 Diabetes on Glycemic Control: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicine regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making the best use of medicine in low- and middle-income settings are scarce. Mobile phones are widely available in these settings, including among people with diabetes; linked technologies, such as short message service (SMS) text messaging, have shown promise in delivering low-cost interventions efficiently. However, evidence showing that these interventions will work when carried out at a larger scale and measuring the extent to which they will improve health outcomes when added to usual care is limited. OBJECTIVE: The objective of this trial is to test the effectiveness of sending brief, automated SMS text messages for improving health outcomes and medication adherence in patients with type 2 diabetes compared to an active control. METHODS: We will carry out a randomized trial recruiting from clinics in two contrasting settings in sub-Saharan Africa: Cape Town, South Africa, and Lilongwe, Malawi. Intervention messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We allocated patients, using randomization with a minimization algorithm, to receive either three to four intervention messages per week or non-health-related messages every 6 weeks. We will follow up with participants for 12 months, measuring important risk factors for poor health outcomes and complications in diabetes. This will enable us to estimate potential health benefits, including the primary outcome of hemoglobin A1c (HbA1c) levels as a marker for long-term blood glucose control and a secondary outcome of blood pressure control. We will record the costs of performing these activities and estimate cost-effectiveness. We will also use process evaluation to capture the collection of medication and assess the reception of the intervention by participants and health care workers. RESULTS: Recruitment to the trial began in September 2016 and follow-up of participants was completed in October 2018. Data collection from electronic health records and other routinely collected sources is continuing. The database lock is anticipated in June 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from this study will have wide applications and advance the evidence base for effectiveness of mobile phone-based, brief text messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness and acceptability that will further inform policy development and decision making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied. TRIAL REGISTRATION: ISRCTN Registry ISRCTN70768808; http://www.isrctn.com/ISRCTN70768808 (Archived by WebCite at http://www.webcitation.org/786316Zqk). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12377.

"My wife's mistrust. That's the saddest part of being a diabetic": A qualitative study of sexual well-being in men with Type 2 diabetes in sub-Saharan Africa.

INTRODUCTION: Sexual dysfunction is a common complication for men with diabetes, yet little is known about the lived experiences of sexual difficulties within the context of diabetes, particularly in low-and-middle-income countries. This study explores how men with type 2 diabetes in three sub-Saharan African settings (Cape Town and Johannesburg, South Africa; Lilongwe, Malawi) perceive and experience sexual functioning and sexual well-being, and the biopsychosocial contexts in which these occur and are shaped. METHODS: We used a qualitative research design, including individual interviews (n = 15) and focus group discussions (n = 4). Forty-seven men were included in the study. We used an inductive thematic analysis approach to develop our findings. A biopsychosocial conceptual model on the relationship between chronic illness and sexuality informed the interpretation of findings. RESULTS: Men across the study settings identified sexual difficulties as a central concern of living with diabetes. These difficulties went beyond biomedical issues of erectile dysfunction, comprising complex psychological and relational effects. Low self-esteem, related to a sense of loss of masculinity and reduced sexual and emotional intimacy in partner relationships were common experiences. Specific negative relational effects included suspicion of infidelity, mutual mistrust, general unhappiness, and fear of losing support from partners. These effects may impact on men's ability to cope with their diabetes. Further stressors were a lack of information about the reasons for their sexual difficulties, perceived lack of support from healthcare providers and an inability to communicate with partners about sexual difficulties. CONCLUSION: More in-depth research is needed to better understand sexual functioning and well-being within the context of diabetes, and its potential impact on diabetes self-management. Holistic and patient-centered care should include raising awareness of sexual problems as a potential complication of diabetes amongst patients, their partners and care providers, and incorporating sexual well-being as part of routine clinical care.

Experiences of type 2 diabetes in sub-Saharan Africa: a scoping review.

BACKGROUND: The prevalence of diabetes in Sub-Saharan Africa (SSA) is growing rapidly. Qualitative research on experiences of type 2 diabetes in SSA is emerging, but no qualitative synthesis has been attempted. This scoping review aims to redress this lack of synthesis and to extract policy-relevant suggestions from the literature. METHODS: Scoping review methodology was employed. Eleven online databases were searched (CINAHLplus, Cochrane Library, EBESCOhost, GALE Group, MEDLINE, Pro-Quest, Pscyhinfo, Pubmed, SCOPUS, Web of Science, WorldCat), using terms designed to identify qualitative studies of experiences of diabetes in SSA. Findings from records identified in the search were analysed inductively in NVivo 10 in three stages, to produce an analytical synthesis of studies of diabetes experiences in SSA. RESULTS: Searches were conducted in 2017 and identified 2743 records, which were reduced to 21 after screening. The earliest identified record was published in 2003 and there was a clustering of records published between 2014 and 2016. The 21 records were based in eight SSA countries: Cameroon, Ethiopia, Ghana, Senegal, South Africa, Tanzania, Uganda, and Zimbabwe. A majority of the studies were conducted in Ghana (5) and South Africa (5), limiting the generalisability of our findings.The analytical synthesis produced five themes: identifying type 2 diabetes (how participants conceptualise and position their illnesses); hybridity of diabetes care (how multiple forms of care are often blended and/or pursued concurrently); impediments, improvisation and diabetes management (describing challenges faced, how these are responded to and management via diet and physical activity); sources of support (who supports participants and how); and diabetes and HIV/AIDs (the ways in which the two conditions are sometimes confused and how stigma is often experienced). CONCLUSIONS: The experiences of people with type 2 diabetes in SSA are under-researched across the region, pointing to a gap in knowledge. Interpreting our analytical synthesis, we suggest three priority areas for policy makers and implementers. Firstly, uncertainties relating to access to diabetes treatment need to be reduced. Secondly, more needs to be done to acknowledge and alleviate the economic struggles that those with diabetes face. Finally, high-quality information and education would improve recognition and management of the condition.

Dietary change, noncommunicable disease and local knowledge: results of a small-scale study of the views of older Malawians.

Interviews were conducted with a small group of Malawians over the age of 60 in rural Karonga district and in Area 25 of the capital, Lilongwe. We asked their views on the changes in diet that had taken place over their lifetimes and also on the causes of 'noncommunicable' diseases, such as Type 2 diabetes and hypertension in their communities. Their answers generally confirmed research showing that dietary diversity is decreasing in Malawi, but many of our interviewees also recalled that hunger was more frequently experienced in the past. Our interviews revealed that though the essential rural diet based on either maize or cassava appears superficially largely unchanged, there have been significant changes in the varieties of crops grown, methods of production and food processing. Many of our interviewees were concerned that the application of chemical fertiliser and pesticides was harming their health.

HIV-positive pregnant and postpartum women's perspectives about Option B+ in Malawi: a qualitative study.

INTRODUCTION: The implementation of lifelong antiretroviral treatment (ART) for all pregnant women (Option B+) in Malawi has resulted in a significant increase in the number of HIV-positive pregnant women initiating treatment. However, research has highlighted the challenge of retaining newly initiated women in care. This study explores barriers and facilitators that affect a woman's decision to initiate and to adhere to Option B+. METHODS: A total of 39 in-depth interviews and 16 focus group discussions were conducted. Eligible women were ≥18 years old, living with HIV and either pregnant and receiving antenatal care from a study site or had delivered a child within the last 18 months, breastfed their child and received services at one of the study sites. Eligible women were identified by healthcare workers (HCWs) in the antenatal clinic and ART unit. Focus groups were also conducted with HCWs employed in these departments. Qualitative data were analyzed using Maxqda version 10 (VERBI Software, Berlin, Germany). RESULTS: The general perception towards the drug regimen used in Option B+ was positive; women reported fewer side effects and acknowledged the positive benefits of ART. Women felt hopeful about prolonging their life and having an HIV-uninfected baby, yet grappled with the fact that ART is a lifelong commitment. Women and HCWs discussed challenges with the counselling services for prevention of mother-to-child HIV transmission under the new Option B+ guidelines, and many women struggled with initiating ART on the same day as learning their HIV status. Women wanted to discuss their circumstances with their husbands first, receive a CD4 count and obtain an HIV test at another facility to confirm their HIV status. HCWs expressed concern that women might just agree to take the drugs to please them. HCWs also discussed concerns around loss to follow-up and drug resistance. CONCLUSIONS: Although Option B+ has significantly increased the number of women initiating ART, there are still challenges that need to be addressed to strengthen initiation, adherence and retention in care. Strategies to strengthen the counselling services upon diagnosis need to be developed to improve same-day initiation of ART and long-term adherence.

Brief Report: Health-Seeking Behavior and Symptoms Associated With Early HIV Infection: Results From a Population-Based Cohort in Southern Malawi.

HIV transmission is most likely to occur during the first few months after infection, yet few cases are identified during this period. Using a population-based cohort of young Malawian women, we identify the distinct symptomology and health-seeking behavior marking early HIV infection by comparing it with periods of seronegativity and chronic infection. During early HIV infection, women are more likely to report malaria-like symptoms and visit clinics for malaria care. In malaria-endemic contexts, where acute HIV symptoms are commonly mistaken for malaria, early diagnostic HIV testing and counseling should be integrated into health care settings where people commonly seek treatment for malaria.