Feasibility and acceptability of the smart pillbox and medication label with differentiated care to support person-centered tuberculosis care among ASCENT trial participants - A multicountry study.

Introduction: Digital adherence technologies (DATs) can offer alternative approaches to support tuberculosis treatment medication adherence. Evidence on their feasibility and acceptability in high TB burden settings is limited. We conducted a cross-sectional survey among adults with drug-sensitive tuberculosis (DS-TB), participating in pragmatic cluster-randomized trials for the Adherence Support Coalition to End TB project in Ethiopia (PACTR202008776694999), the Philippines, South Africa and Tanzania (ISRCTN 17706019). Methods: From each country we selected 10 health facilities implementing the DAT intervention (smart pillbox or medication labels, with differentiated care support), ensuring inclusion of urban/rural and public/private facilities. Adults on DS-TB regimen using a DAT were randomly selected from each facility. Feasibility of the DATs was assessed using a standardized tool. Acceptability was measured using a 5-point Likert-scale, using the Capability, Opportunity, Motivation, Behavior (COM-B) model. Mean scores of Likert-scale responses within each COM-B category were estimated, adjusted for facility-level clustering. Data were summarized by country and DAT type. Results: Participants using either the pillbox (n = 210) or labels (n = 169) were surveyed. Among pillbox users, phone ownership (79%), use of pillbox reminders (87%) and taking treatment without the pillbox (22%) varied by country. Among label users, phone ownership (81%), paying extra to use the labels (8%) and taking treatment without using labels (41%) varied by country. Poor network, problems with phone charging and access, not having the pillbox and forgetting to send text were reasons for not using DATs. Overall, people with TB had a favorable impression of both DATs, with mean composite scores between 4·21 to 4·42 across COM-B categories. Some disclosure concerns were reported. Conclusion: From client-perspective, pillboxes and medication labels with differentiated care support were feasible to implement and acceptable in variety of settings. However, implementation challenges related to network, phone access, stigma, additional costs to people with TB to use DATs need to be addressed.

Development of a women's empowerment index for Tanzania from the demographic and health surveys of 2004-05, 2010, and 2015-16.

BACKGROUND: Women's empowerment is a multidimensional construct which varies by context. These variations make it challenging to have a concrete definition that can be measured quantitatively. Having a standard composite measure of empowerment at the individual and country level would help to assess how countries are progressing in efforts to achieve gender equality (SDG 5), enable standardization across and within settings and guide the formulation of policies and interventions. The aim of this study was to develop a women's empowerment index for Tanzania and to assess its evolution across three demographic and health surveys from 2004 to 2016. RESULTS: Women's empowerment in Tanzania was categorized into six distinct domains namely; attitudes towards violence, decision making, social independence, age at critical life events, access to healthcare, and property ownership. The internal reliability of this six-domain model was shown to be acceptable by a Cronbach's α value of 0.658. The fit statistics of the root mean squared error of approximation (0.05), the comparative fit index (0.93), and the standardized root mean squared residual (0.04) indicated good internal validity. The structure of women's empowerment was observed to have remained relatively constant across three Tanzanian demographic and health surveys. CONCLUSIONS: The use of factor analysis in this research has shown that women's empowerment in Tanzania is a six-domain construct that has remained relatively constant over the past ten years. This could be a stepping stone to reducing ambiguity in conceptualizing and operationalizing empowerment and expanding its applications in empirical research to study different women related outcomes in Tanzania.

Clinical profiles of diabetic foot ulcer patients undergoing major limb amputation at a tertiary care center in North-eastern Tanzania.

BACKGROUND: Diabetic foot ulcers complications are the major cause of non-traumatic major limb amputation. We aimed at assessing the clinical profiles of diabetic foot ulcer patients undergoing major limb amputation in the Surgical Department at Kilimanjaro Christian Medical Centre (KCMC), a tertiary care hospital in North-eastern Tanzania. METHODS: A cross-sectional hospital-based study was conducted from September 2018 through March 2019. Demographic data were obtained from structured questionnaires. Diabetic foot ulcers were graded according to the Meggitt-Wagner classification system. Hemoglobin and random blood glucose levels data were retrieved from patients' files. RESULTS: A total of 60 patients were recruited in the study. More than half (31/60; 51.67%) were amputated. Thirty-five (58.33%) were males. Fifty-nine (98.33%) had type II diabetes. Nearly two-thirds (34/60; 56.67%) had duration of diabetes for more than 5 years. The mean age was 60.06 ± 11.33 years (range 30-87). The mean haemoglobin level was 10.20 ± 2.73 g/dl and 9.84 ± 2.69 g/dl among amputees. Nearly two thirds (42/60; 70.00%) had a haemoglobin level below 12 g/dl, with more than a half (23/42; 54.76%) undergoing major limb amputation. Two thirds (23/31; 74.19%) of all patients who underwent major limb amputation had mean hemoglobin level below 12 g/dl. The mean Random Blood Glucose (MRBG) was 13.18 ± 6.17 mmol/L and 14.16 ± 6.10 mmol/L for amputees. Almost two thirds of the study population i.e., 42/60(70.00%) had poor glycemic control with random blood glucose level above 10.0 mmol/L. More than half 23/42 (54.76%) of the patients with poor glycemic control underwent some form of major limb amputation; which is nearly two thirds (23/31; 74.19%) of the total amputees. Twenty-eight (46.67%) had Meggitt-Wagner classification grade 3, of which nearly two thirds (17:60.71%) underwent major limb amputation. CONCLUSION: In this study, the cohort of patients suffering from diabetic foot ulcers treated in a tertiary care center in north-eastern Tanzania, the likelihood of amputation significantly correlated with the initial grade of the Meggit-Wagner ulcer classification. High blood glucose levels and anaemia seem to be also important risk factors but correlation did not reveal statistical significance.

Long-Term Complications of Hypospadias Repair: A Ten-Year Experience from Northern Zone of Tanzania.

BACKGROUND: Hypospadias is one of the commonest congenital penile abnormalities in newborn males. The external urethral opening can be located anywhere from the glans penis along the ventral aspect of the shaft of the penis up to the scrotum or the perineum in extreme cases. The condition has a huge impact on the patient's psychological, emotional and sexual well-being. AIM: To determine the proportion of patients who develop long-term complications after hypospadias repair and its associated risk factors. METHODS: This was a hospital-based analytical cross-sectional study, conducted at KCMC Urology Institute from January 2009 to December 2018 and all children were followed up for 1-year post-operatively. A structural data sheet was used to collect information from patients' files. Study parameters include age, location of hypospadias, surgical technique, surgeon experience, chordee, suture size, materials to assess the association with long-term complications. RESULTS: A total of 254 patients were included in the study, the majority were aged more than 2 years (71.83%) with mean age at operation (SD) of 4.74 ± 2.99 years. Distal types were the most common type of hypospadias (125 patients; 50%), and 51 patients (20%) had severe chordee. Tubularized incised plate (TIP) repair was the most common technique (130 patients; 51.59%). The number of patients with long-term complications following hypospadias repair was 156 (61.60%) and urethrocutaneous fistula (UCF) accounted for 40.5%. The surgeon's experience, location of hypospadias, surgical technique and associated chordee were significant predictors of long-term complications of hypospadias repair. CONCLUSION: Tubularized incised plate urethroplasty is a safe and reliable method of hypospadias repair. Proximal hypospadias with severe chordee still remain a challenge.

HIV surveillance based on routine testing data from antenatal clinics in Malawi (2011-2018): measuring and adjusting for bias from imperfect testing coverage.

OBJECTIVE: The use of routinely collected data from prevention of mother-to-child transmission programs (ANC-RT) has been proposed to monitor HIV epidemic trends. This poses several challenges for surveillance, one of them being that women may opt-out of testing and/or test stock-outs may result in inconsistent service availability. In this study, we sought to empirically quantify the relationship between imperfect HIV testing coverage and HIV prevalence among pregnant women from ANC-RT data. DESIGN: We used reports from the ANC Register of all antenatal care (ANC) sites in Malawi (2011-2018), including 49 244 monthly observations, from 764 facilities, totaling 4 375 777 women. METHODS: Binomial logistic regression models with facility-level fixed effects and marginal standardization were used to assess the effect of testing coverage on HIV prevalence. RESULTS: Testing coverage increased from 78 to 98% over 2011-2018. We estimated that, had testing coverage been perfect, prevalence would have been 0.4% point lower (95% CI 0.3-0.5%) than the 7.9% observed prevalence, a relative overestimation of 6%. Bias in HIV prevalence was the highest in 2012, when testing coverage was lowest (72%), resulting in a relative overestimation of HIV prevalence of 15% (95% CI 12-17%). Overall, adjustments for imperfect testing coverage led to a subtler decline in HIV prevalence over 2011--2018. CONCLUSION: Malawi achieved high coverage of routine HIV testing in recent years. Nevertheless, imperfect testing coverage can lead to overestimation of HIV prevalence among pregnant women when coverage is suboptimal. ANC-RT data should be carefully evaluated for changes in testing coverage and completeness when used to monitor epidemic trends.

Delivering comprehensive HIV services across the HIV care continuum: a comparative analysis of survival and progress towards 90-90-90 in rural Malawi.

INTRODUCTION: Partners In Health and the Malawi Ministry of Health collaborate on comprehensive HIV services in Neno, Malawi, featuring community health workers, interventions addressing social determinants of health and health systems strengthening. We conducted an observational study to describe the HIV care continuum in Neno and to compare facility-level HIV outcomes against health facilities nationally. METHODS: We compared facility-level outcomes in Neno (n=13) with all other districts (n=682) from 2013 to 2015 using mixed-effects linear regression modelling. We selected four outcomes that are practically useful and roughly mapped on to the 90-90-90 targets: facility-based HIV screenings relative to population, new antiretroviral therapy (ART)enrolments relative to population, 1-year survival rates and per cent retained in care at 1 year. RESULTS: In 2013, the average number of HIV tests performed, as a per cent of the adult population, was 11.75%, while the average newly enrolled patients was 10.03%. Percent receiving testing increased by 4.23% over 3 years (P<0.001, 95% CI 2.98% to 5.49%), while percent enrolled did not change (P=0.28). These results did not differ between Neno and other districts (P=0.52), despite Neno having a higher proportion of expected patients enrolled. In 2013, the average ART 1-year survival was 80.41% nationally and 91.51% in Neno, which is 11.10% higher (P=0.002, 95% CI 4.13% to 18.07%). One-year survival declined by 1.75% from 2013 to 2015 (P<0.001, 95% CI -2.61% to -0.89%); this was similar in Neno (P=0.83). Facility-level 1-year retention was 85.43% nationally in 2013 (P<0.001, 95% CI 84.2% to 86.62%) and 12.07% higher at 97.50% in Neno (P=0.001, 95% CI 5.08% to19.05%). Retention declined by 2.92% (P<0.001, 95% CI -3.69% to -2.14%) between 2013 and 2015, both nationally and in Neno. CONCLUSION: The Neno HIV programme demonstrated significantly higher survival and retention rates compared with all other districts in Malawi. Incorporating community health workers, strengthening health systems and addressing social determinants of health within the HIV programme may help Malawi and other countries accelerate progress towards 90-90-90.

Impact and economic evaluation of a novel HIV service delivery model in rural Malawi.

OBJECTIVE: We performed an impact and cost-effectiveness analysis of a novel HIV service delivery model in a high prevalence, remote district of Malawi with a population of 143 800 people. DESIGN: A population-based retrospective analysis of 1-year survival rates among newly enrolled HIV-positive patients at 682 health facilities throughout Malawi, comparing facilities implementing the service delivery model (n = 13) and those implementing care-as-usual (n = 669). METHODS: Through district-level health surveillance data, we evaluated 1-year survival rates among HIV patients newly enrolled between July 2013 and June 2014 - representing 129 938 patients in care across 682 health facilities - using a multilevel modeling framework. The model, focused on social determinants of health, was implemented throughout Neno District at 13 facilities and compared with facilities in all other districts. Activity-based costing was used to annualize financial and economic costs from a societal perspective. Incremental cost-effectiveness ratios were expressed as quality-adjusted life-years gained. RESULTS: The national average 1-year survival rate for newly enrolled antiretroviral therapy clients was 78.9%: this rate was 87.9% in Neno District, compared with 78.8% across all other districts in Malawi (P < 0.001; 95% confidence interval: 0.079-0.104). The economic cost of receiving care in Neno district (n = 6541 patients) was $317/patient/year, compared with an estimated $219/patient in other districts. This translated to $906 per quality-adjusted life-year gained. CONCLUSION: Neno District's comprehensive model of care, featuring a strong focus on the community, is $98 more expensive per capita per annum but demonstrates superior 1-year survival rates, despite its remote location. Moreover, it should be considered cost-effective by traditional international standards.

Towards elimination of mother-to-child transmission of HIV: performance of different models of care for initiating lifelong antiretroviral therapy for pregnant women in Malawi (Option B+).

INTRODUCTION: Malawi introduced a new strategy to improve the effectiveness of prevention of mother-to-child HIV transmission (PMTCT), the Option B+ strategy. We aimed to (i) describe how Option B+ is provided in health facilities in the South East Zone in Malawi, identifying the diverse approaches to service organization (the "model of care") and (ii) explore associations between the "model of care" and health facility-level uptake and retention rates for pregnant women identified as HIV-positive at antenatal (ANC) clinics. METHODS: A health facility survey was conducted in all facilities providing PMTCT/antiretroviral therapy (ART) services in six of Malawi's 28 districts to describe and compare Option B+ service delivery models. Associations of identified models with program performance were explored using facility cohort reports. RESULTS: Among 141 health facilities, four "models of care" were identified: A) facilities where newly identified HIV-positive women are initiated and followed on ART at the ANC clinic until delivery; B) facilities where newly identified HIV-positive women receive only the first dose of ART at the ANC clinic, and are referred to the ART clinic for follow-up; C) facilities where newly identified HIV-positive women are referred from ANC to the ART clinic for initiation and follow-up of ART; and D) facilities serving as ART referral sites (not providing ANC). The proportion of women tested for HIV during ANC was highest in facilities applying Model A and lowest in facilities applying Model B. The highest retention rates were reported in Model C and D facilities and lowest in Model B facilities. In multivariable analyses, health facility factors independently associated with uptake of HIV testing and counselling (HTC) in ANC were number of women per HTC counsellor, HIV test kit availability, and the "model of care" applied; factors independently associated with ART retention were district location, patient volume and the "model of care" applied. CONCLUSIONS: A large variety exists in the way health facilities have integrated PMTCT Option B+ care into routine service delivery. This study showed that the "model of care" chosen is associated with uptake of HIV testing in ANC and retention in care on ART. Further patient-level research is needed to guide policy recommendations.

Effect of women's groups and volunteer peer counselling on rates of mortality, morbidity, and health behaviours in mothers and children in rural Malawi (MaiMwana): a factorial, cluster-randomised controlled trial.

BACKGROUND: Women's groups and health education by peer counsellors can improve the health of mothers and children. We assessed their effects on mortality and breastfeeding rates in rural Malawi. METHODS: We did a 2×2 factorial, cluster-randomised trial in 185,888 people in Mchinji district. 48 equal-sized clusters were randomly allocated to four groups with a computer-generated number sequence. 24 facilitators guided groups through a community action cycle to tackle maternal and child health problems. 72 trained volunteer peer counsellors made home visits at five timepoints during pregnancy and after birth to support breastfeeding and infant care. Primary outcomes for the women's group intervention were maternal, perinatal, neonatal, and infant mortality rates (MMR, PMR, NMR, and IMR, respectively); and for the peer counselling were IMR and exclusive breastfeeding (EBF) rates. Analysis was by intention to treat. The trial is registered as ISRCTN06477126. FINDINGS: We monitored outcomes of 26,262 births between 2005 and 2009. In a factorial model adjusted only for clustering and the volunteer peer counselling intervention, in women's group areas, for years 2 and 3, we noted non-significant decreases in NMR (odds ratio 0.93, 0.64-1.35) and MMR (0.54, 0.28-1.04). After adjustment for parity, socioeconomic quintile, and baseline measures, effects were larger for NMR (0.85, 0.59-1.22) and MMR (0.48, 0.26-0.91). Because of the interaction between the two interventions, a stratified analysis was done. For women's groups, in adjusted analyses, MMR fell by 74% (0.26, 0.10-0.70), and NMR by 41% (0.59, 0.40-0.86) in areas with no peer counsellors, but there was no effect in areas with counsellors (1.09, 0.40-2.98, and 1.38, 0.75-2.54). Factorial analysis for the peer counselling intervention for years 1-3 showed a fall in IMR of 18% (0.82, 0.67-1.00) and an improvement in EBF rates (2.42, 1.48-3.96). The results of the stratified, adjusted analysis showed a 36% reduction in IMR (0.64, 0.48-0.85) but no effect on EBF (1.18, 0.63-2.25) in areas without women's groups, and in areas with women's groups there was no effect on IMR (1.05, 0.82-1.36) and an increase in EBF (5.02, 2.67-9.44). The cost of women's groups was US$114 per year of life lost (YLL) averted and that of peer counsellors was $33 per YLL averted, using stratified data from single intervention comparisons. INTERPRETATION: Community mobilisation through women's groups and volunteer peer counsellor health education are methods to improve maternal and child health outcomes in poor rural populations in Africa. FUNDING: Saving Newborn Lives, UK Department for International Development, and Wellcome Trust.

A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality.

BACKGROUND: The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action. METHODS/DESIGN: This study uses a two-by-two factorial cluster-randomised controlled trial design to test the impact of two interventions. The impact of a community mobilisation intervention run through women's groups, on home care, health care-seeking behaviours and maternal and infant mortality, will be tested. The impact of a volunteer-led infant feeding and care support intervention, on rates of exclusive breastfeeding, uptake of HIV-prevention services and infant mortality, will also be tested. The women's group intervention will employ local female facilitators to guide women's groups through a four-phase cycle of problem identification and prioritisation, strategy identification, implementation and evaluation. Meetings will be held monthly at village level. The infant feeding intervention will select local volunteers to provide advice and support for breastfeeding, birth preparedness, newborn care and immunisation. They will visit pregnant and new mothers in their homes five times during and after pregnancy.The unit of intervention allocation will be clusters of rural villages of 2500-4000 population. 48 clusters have been defined and randomly allocated to either women's groups only, infant feeding support only, both interventions, or no intervention. Study villages are surrounded by 'buffer areas' of non-study villages to reduce contamination between intervention and control areas. Outcome indicators will be measured through a demographic surveillance system. Primary outcomes will be maternal, infant, neonatal and perinatal mortality for the women's group intervention, and exclusive breastfeeding rates and infant mortality for the infant feeding intervention.Structured interviews will be conducted with mothers one-month and six-months after birth to collect detailed quantitative data on care practices and health-care-seeking. Further qualitative, quantitative and economic data will be collected for process and economic evaluations. TRIAL REGISTRATION: ISRCTN06477126.