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Background Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes. Methods StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals. Results The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (− 0.08% (− 0.31 to 0.16) (IFCC − 0.82 mmol/mol (− 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was − 0.71% (− 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful. Conclusions Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes. Trial registration Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.

Background The SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention is a pragmatic randomised controlled trial, testing the effectiveness of brief text messaging for improving clinical outcomes and medication adherence. The intervention did not impact glycaemic control. We conducted a pre-and post-trial process evaluation alongside the StAR2D study in Malawi and South Africa, exploring the experiences and perceptions of patient participants, to better understand potential underlying reasons for the trial outcomes. Methods We employed a qualitative research design, including conducting semi structured in-depth interviews and focus groups at both trial sites. Purposive sampling was used to ensure representation of a wide range of patients with type 2 diabetes with regards to age, gender, ethnicity, language, and duration of diabetes. We interviewed the same participants at baseline and at the end of the trial. We used within-case and across-case thematic analysis to identify key themes. Results Brief messages delivered by text were acceptable and useful for addressing informational and support needs for participants. Some participants reported behaviour changes because of the text reminders and advice on a healthy lifestyle. Both participating in the trial and the messages were experienced as a source of support, caring, and motivation. Participants’ ability to act on the messages was limited. A common theme was frustration over the lack of ability to effectively control one’s blood glucose level. They reported a range of routinised, partial diabetes care adherence behaviours, shaped by complex and interacting individual, social, and health service factors. Participant responses and intervention impact were similar across sites, despite differences in health services. Conclusion This process evaluation provided context and insight into the factors influencing participants’ engagement with the text messaging intervention. The complex context in which patients take their diabetes medication, may explain in part, why brief text messaging may have been insufficient to bring about changes in health outcomes. The scale of need for self-management and health service support, suggests that health system strengthening, and other forms of self-management support should accompany digital communication interventions. (Current Controlled Trials ISRCTN70768808, registered 03/08/2015.)

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 (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.

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.\ud \ud 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.\ud \ud 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.\ud \ud 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.\ud \ud 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.\ud \ud Trial Registration: ISRCTN Registry ISRCTN70768808; http://www.isrctn.com/ISRCTN70768808 (Archived by WebCite at http://www.webcitation.org/786316Zqk)\ud \ud International Registered Report Identifier (IRRID): DERR1-10.2196/12377

UNSTRUCTURED Background: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicines regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making 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, and linked technologies such as SMS-text messaging have shown promise in delivering low-cost interventions efficiently. However, evidence that these interventions will work when carried out at a larger scale, and of the extent to which they will improve health outcomes when added to usual care is limited. Methods: We will carry out a randomised clinical trial in two contrasting settings in sub-Saharan Africa, Cape Town in South Africa and Lilongwe in Malawi, to provide information about the impact of sending brief automated messages via SMS text-messaging. The messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We will allocate patients using a randomly-generated assignment plan to receive either intervention messages, or an active control. We will follow up people for twelve months measuring important risk factors for poor health outcomes and complications in diabetes so we can estimate potential health benefits, including HbA1c as a marker for long-term blood glucose control and blood pressure control, We will record the costs of doing this, and estimate cost-effectiveness. We will also capture collection of medication and assess the reception of the intervention by participants and health care workers. Discussion: The knowledge gained will have wide application 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 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: ISRCTN70768808 (Registered on 3 August 2015)

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.

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.

OBJECTIVES: The World Health Organization 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 semi-structured 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.

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. Keywords: Option B+; lifelong HIV treatment; counselling; same-day initiation; prevention of mother-to-child transmission of HIV; qualitative. (Published: 15 June 2016) Citation: Katirayi L et al. Journal of the International AIDS Society 2016, 19 :20919 http://www.jiasociety.org/index.php/jias/article/view/20919 | http://dx.doi.org/10.7448/IAS.19.1.20919

This study measures HIV treatment optimism and its predictors in a representative sample of young adults in southern Malawi. In 2010, 1,275 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 four-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 non-linear 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 non-primary 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.