Prevalence and psychosocial factors associated with self-injurious thoughts among people living with HIV presenting for HIV testing in Mozambique.

Self-injurious thoughts have been associated with psychiatric morbidity and suicide. Little is known about psychosocial factors associated with self-injurious thoughts among people newly diagnosed with HIV in sub-Saharan Africa. This study examined whether food insufficiency, mental health symptoms, or social support were associated with recent self-injurious thoughts among people newly diagnosed with HIV in Mozambique. The sample included 2001 PLWH aged ≥ 18 newly diagnosed with HIV at 10 health clinics in Mozambique between April 2013 and June 2015. Data were collected at time of HIV diagnosis. Multivariable logistic regression modeled the association of social support, affective mental health symptom severity, somatic mental health symptom severity, and food insufficiency on recent self-injurious thoughts. Ten percent of respondents reported recent self-injurious thoughts, which was higher among women than men (11% vs 7%). In multivariable analyses, food insufficiency [adjusted odds ratio (aOR) 1.7 (95% CI 1.3, 2.2)], and low [aORvs no = 4.8, 95% CI 1.7, 13.4) and moderate/high affective symptom severity [aORvs no = 8.7, 95% CI 2.8, 27.6) were associated with greater odds of self-injurious thoughts. Interventions to address self-injurious thoughts should consider accompanying psychosocial stressors. Longitudinal research to examine mechanisms through which psychosocial stressors are associated with self-injurious thoughts is warranted.

Prevalence and psychosocial factors associated with self-injurious thoughts among people living with HIV presenting for HIV testing in Mozambique

Self-injurious thoughts have been associated with psychiatric morbidity and suicide. Little is known about psychosocial factors associated with self-injurious thoughts among people newly diagnosed with HIV in sub-Saharan Africa. This study examined whether food insufficiency, mental health symptoms, or social support were associated with recent self-injurious thoughts among people newly diagnosed with HIV in Mozambique. The sample included 2001 PLWH aged ≥ 18 newly diagnosed with HIV at 10 health clinics in Mozambique between April 2013 and June 2015. Data were collected at time of HIV diagnosis. Multivariable logistic regression modeled the association of social support, affective mental health symptom severity, somatic mental health symptom severity, and food insufficiency on recent self-injurious thoughts. Ten percent of respondents reported recent self-injurious thoughts, which was higher among women than men (11% vs 7%). In multivariable analyses, food insufficiency [adjusted odds ratio (aOR) 1.7 (95% CI 1.3, 2.2)], and low [aORvs no = 4.8, 95% CI 1.7, 13.4) and moderate/high affective symptom severity [aORvs no = 8.7, 95% CI 2.8, 27.6) were associated with greater odds of self-injurious thoughts. Interventions to address self-injurious thoughts should consider accompanying psychosocial stressors. Longitudinal research to examine mechanisms through which psychosocial stressors are associated with self-injurious thoughts is warranted.

Household Decision-Making and HIV Care Continuum Outcomes Among Women Living with HIV in Mozambique.

Gender inequality has been associated with HIV infection among women. Less is known about the relationship between gender inequality and HIV care continuum outcomes. This study assessed whether household decision-making power (DMP), one component of gender inequality, was associated with linkage to HIV care, antiretroviral therapy (ART) initiation, or retention in care among women living with HIV in Mozambique. The sample included 600 women ≥18 years of age newly diagnosed with HIV in Mozambique. Data were collected between April 2013 and June 2016. DMP was assessed with three questions about participation in decisions regarding: major household decisions, routine household decisions, and visits to family. Women who did not contribute to decision making in any domain were categorized as having low DMP. HIV care information was obtained from electronic medical records. Multivariable log-Poisson regression analyses were conducted to assess the relationship between DMP and HIV care continuum outcomes. Almost half (49%) of participants reported medium DMP, followed by high (39%) and low DMP (12%). In multivariable regression analyses, when compared with respondents with medium DMP, those with low DMP had a lower likelihood of retention in care 12 months after diagnosis [adjusted risk ratio (aRR) 0.69 (95% CI 0.49-0.98)]. There was no significant relationship between low DMP and linkage to HIV care or ART initiation. High DMP was not significantly associated with HIV outcomes assessed. Women who report low DMP may face barriers to long-term engagement in HIV care. Interventions to improve retention in care among women should consider the role of household decision making and gender inequality.

Patterns and Predictors of HIV Status Disclosure in the 12 Months After Diagnosis in Mozambique.

BACKGROUND: HIV disclosure benefits people living with HIV, their partners, and HIV programs. However, data on the prevalence of disclosure and associated correlates have come largely from patients already in HIV care, potentially overestimating disclosure rates and precluding examination of the impact of disclosure on HIV care outcomes. SETTING: We used data from an implementation study conducted in Maputo City and Inhambane Province, Mozambique. Adults were enrolled at HIV testing clinics after diagnosis and traced in the community 1 and 12 months later when they reported on disclosure and other outcomes. METHODS: We examined patterns of participants' disclosure to their social networks (N = 1573) and sexual partners (N = 1024) at both follow-up assessments and used relative risk regression to identify correlates of nondisclosure. RESULTS: Disclosure to one's social network and sexual partners was reported by 77.8% and 57.7% of participants, respectively, at 1 month and 92.9% and 72.4% of participants, respectively, at 12 months. At both time points, living in Inhambane Province, being single or not living with a partner, having high levels of anticipated stigma, and not initiating HIV treatment were associated with increased risks of nondisclosure to social networks. Nondisclosure to sexual partners at both follow-up assessments was associated with being women, living in Inhambane Province and in a household without other people living with HIV, and reporting that posttest counseling addressed disclosure. CONCLUSIONS: Although reported disclosure to social networks was high, disclosure to sexual partners was suboptimal. Effective and acceptable approaches to support partner disclosure, particularly for women, are needed.

Progress in Mozambique: Changes in the availability, use, and quality of emergency obstetric and newborn care between 2007 and 2012.

INTRODUCTION: Maternal mortality in Mozambique has not declined significantly in the last 10-15 years, plateauing around 480 maternal deaths per 100,000 live births. Good quality antenatal care and routine and emergency intrapartum care are critical to reducing preventable maternal and newborn deaths. MATERIALS AND METHODS: We compare the findings from two national cross-sectional facility-based assessments conducted in 2007 and 2012. Both were designed to measure the availability, use and quality of emergency obstetric and neonatal care. Indicators for monitoring emergency obstetric care were used as were descriptive statistics. RESULTS: The availability of facilities providing the full range of obstetric life-saving procedures (signal functions) decreased. However, an expansion in the provision of individual signal functions was highly visible in health centers and health posts, but in hospitals, performance was less satisfactory, with proportionally fewer hospitals providing assisted vaginal delivery, obstetric surgery and blood transfusions. All other key indicators showed signs of improvements: the institutional delivery rate, the cesarean delivery rate, met need for emergency obstetric care (EmOC), institutional stillbirth and early neonatal death rates, and cause-specific case fatality rates (CFRs). CFRs for most major obstetric complications declined between 17% and 69%. The contribution of direct causes to maternal deaths decreased while the proportion of indirect causes doubled during the five-year interval. CONCLUSIONS: The indicator of EmOC service availability, often used for planning and developing EmONC networks, requires close examination. The standard definition can mask programmatic weaknesses and thus, fails to inform decision makers of what to target. In this case, the decline in the use of assisted vaginal delivery explained much of the difference in this indicator between the two surveys, as did faltering hospital performance. Despite this backsliding, many signs of improvement were also observed in this 5-year period, but indicator levels continue below recommended thresholds. The quality of intrapartum care and the adverse consequences from infectious diseases during pregnancy point to priority areas for programmatic improvement.

Progress in Mozambique: Changes in the availability, use, and quality of emergency obstetric and newborn care between 2007 and 2012

Maternal mortality in Mozambique has not declined significantly in the last 10-15 years, plateauing around 480 maternal deaths per 100,000 live births. Good quality antenatal care and routine and emergency intrapartum care are critical to reducing preventable maternal and newborn deaths. Materials and methods: We compare the findings from two national cross-sectional facility-based assessments conducted in 2007 and 2012. Both were designed to measure the availability, use and quality of emergency obstetric and neonatal care. Indicators for monitoring emergency obstetric care were used as were descriptive statistics. Results: The availability of facilities providing the full range of obstetric life-saving procedures (signal functions) decreased. However, an expansion in the provision of individual signal functions was highly visible in health centers and health posts, but in hospitals, performance was less satisfactory, with proportionally fewer hospitals providing assisted vaginal delivery, obstetric surgery and blood transfusions. All other key indicators showed signs of improvements: the institutional delivery rate, the cesarean delivery rate, met need for emergency obstetric care (EmOC), institutional stillbirth and early neonatal death rates, and cause-specific case fatality rates (CFRs). CFRs for most major obstetric complications declined between 17% and 69%. The contribution of direct causes to maternal deaths decreased while the proportion of indirect causes doubled during the five-year interval. Conclusions: The indicator of EmOC service availability, often used for planning and developing EmONC networks, requires close examination. The standard definition can mask programmatic weaknesses and thus, fails to inform decision makers of what to target. In this case, the decline in the use of assisted vaginal delivery explained much of the difference in this indicator between the two surveys, as did faltering hospital performance. Despite this backsliding, many signs of improvement were also observed in this 5-year period, but indicator levels continue below recommended thresholds. The quality of intrapartum care and the adverse consequences from infectious diseases during pregnancy point to priority areas for programmatic improvement.

A combination intervention strategy to improve linkage to and retention in HIV care following diagnosis in Mozambique: A cluster-randomized study.

BACKGROUND: Concerning gaps in the HIV care continuum compromise individual and population health. We evaluated a combination intervention strategy (CIS) targeting prevalent barriers to timely linkage and sustained retention in HIV care in Mozambique. METHODS AND FINDINGS: In this cluster-randomized trial, 10 primary health facilities in the city of Maputo and Inhambane Province were randomly assigned to provide the CIS or the standard of care (SOC). The CIS included point-of-care CD4 testing at the time of diagnosis, accelerated ART initiation, and short message service (SMS) health messages and appointment reminders. A pre-post intervention 2-sample design was nested within the CIS arm to assess the effectiveness of CIS+, an enhanced version of the CIS that additionally included conditional non-cash financial incentives for linkage and retention. The primary outcome was a combined outcome of linkage to care within 1 month and retention at 12 months after diagnosis. From April 22, 2013, to June 30, 2015, we enrolled 2,004 out of 5,327 adults ≥18 years of age diagnosed with HIV in the voluntary counseling and testing clinics of participating health facilities: 744 (37%) in the CIS group, 493 (25%) in the CIS+ group, and 767 (38%) in the SOC group. Fifty-seven percent of the CIS group achieved the primary outcome versus 35% in the SOC group (relative risk [RR]CIS vs SOC = 1.58, 95% CI 1.05-2.39). Eighty-nine percent of the CIS group linked to care on the day of diagnosis versus 16% of the SOC group (RRCIS vs SOC = 9.13, 95% CI 1.65-50.40). There was no significant benefit of adding financial incentives to the CIS in terms of the combined outcome (55% of the CIS+ group achieved the primary outcome, RRCIS+ vs CIS = 0.96, 95% CI 0.81-1.16). Key limitations include the use of existing medical records to assess outcomes, the inability to isolate the effect of each component of the CIS, non-concurrent enrollment of the CIS+ group, and exclusion of many patients newly diagnosed with HIV. CONCLUSIONS: The CIS showed promise for making much needed gains in the HIV care continuum in our study, particularly in the critical first step of timely linkage to care following diagnosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT01930084.

Advanced Human Immunodeficiency Virus Disease at Diagnosis in Mozambique and Swaziland.

BACKGROUND: Early diagnosis of human immunodeficiency virus (HIV) is a prerequisite to maximizing individual and societal benefits of antiretroviral therapy. METHODS: Adults ≥18 years of age testing HIV positive at 10 health facilities in Mozambique and Swaziland received point-of-care CD4+ cell count testing immediately after diagnosis. We examined median CD4+ cell count at diagnosis, the proportion diagnosed with advanced HIV disease (CD4+ cell count ≤350 cells/µL) and severe immunosuppression (CD4+ cell count ≤100 cells/µL), and determinants of the latter 2 measures. RESULTS: Among 2333 participants, the median CD4+ cell count at diagnosis was 313 cells/µL (interquartile range, 164-484), more than half (56.5%) had CD4+ ≤350 cells/µL, and 13.9% had CD4+ ≤100 cells/µL. The adjusted relative risk (aRR) of both advanced HIV disease and severe immunosuppression at diagnosis was higher in men versus women (advanced disease aRR = 1.31; 95% confidence interval [CI] = 1.16-1.48; severe immunosuppression aRR = 1.54, 95% CI = 1.17-2.02) and among those who sought HIV testing because they felt ill (advanced disease aRR = 1.30, 95% CI = 1.08-1.55; severe immunosuppression aRR = 2.10, 95% CI = 1.35-2.26). Age 18-24 versus 25-39 was associated with a lower risk of both outcomes (advanced disease aRR = 0.70, 95% CI = 0.59-0.84; severe immunosuppression aRR = 0.62, 95% CI = 0.41-0.95). CONCLUSIONS: More than 10 years into the global scale up of comprehensive HIV services, the majority of adults diagnosed with HIV at health facilities in 2 high-prevalence countries presented with advanced disease and 1 in 7 had severe immunosuppression. Innovative strategies for early identification of HIV-positive individuals are urgently needed.

Informing efforts to reach UNAIDS' 90-90-90 targets: a comparison of characteristics of people diagnosed with HIV in health facilities to the general population of people living with HIV in Mozambique.

Global targets aim to increase the number of people living with HIV (PLWH) who know their status. Using data from Mozambican facility-based HIV testing and counseling (HTC) and a population-based survey, we compared characteristics of PLWH diagnosed in HTC to the general population of PLWH to identify subgroups that are missing from the health system and may be undiagnosed. Male and female PLWH aged 50+ (PPR = 0.47, p = .0001) and with higher HIV knowledge (PPR = 0.52, p = .004) were underrepresented in HTC. A higher proportion of patients diagnosed in health facilities were aged 25-39 (PPR = 1.23, p = .02). Female PLWH with lower economic (PPR = 0.70, p = .04) and educational status (PPR = 0.86, p = .02) and male PLWH aged 18-24 (PPR = 0.47, p = .03) were underrepresented in HTC. Comparing HTC data to population-based data can inform efforts to increase HIV diagnoses and to ensure that all PLWH know their status.

Feasibility and Acceptability of Health Communication Interventions Within a Combination Intervention Strategy for Improving Linkage and Retention in HIV Care in Mozambique.

BACKGROUND: Challenges to ensuring timely linkage to and retention in HIV care are well documented. Combination intervention strategies can be effective in improving the HIV care continuum. Data on feasibility and acceptability of intervention types within intervention packages are limited. METHODS: The Engage4Health study assessed the effectiveness of a combination intervention strategy to increase linkage and retention among adults newly diagnosed with HIV in Mozambique. The study included 2 health communication interventions-modified delivery of pre-antiretroviral therapy (pre-ART) counseling sessions and SMS reminders-and 3 structural interventions-point-of-care CD4 testing after diagnosis, accelerated ART initiation, and noncash financial incentives. We used a process evaluation framework to assess dose delivered-extent each intervention was delivered as planned-and dose received-participant acceptability-of health communication versus structural interventions in the effectiveness study to understand associated benefits and challenges. Data sources included study records, participant interviews, and clinical data. RESULTS: For dose delivered of health communication interventions, 98% of eligible clients received pre-ART counseling and 90% of participants received at least one SMS reminder. For structural interventions, 74% of clients received CD4 testing and 53% of eligible participants initiated ART within 1 month. Challenges for structural interventions included facility-level barriers, staffing limitations, and machine malfunctions. For dose received, participants reported pre-ART counseling and CD4 testing as the most useful interventions for linkage and financial incentives as the least useful for linkage and retention. DISCUSSION: Findings demonstrate that health communication interventions can be feasibly and acceptably integrated with structural interventions to create combination intervention strategies.

Causes of death among women aged 17-49 years between 2007 and 2010 in Maputo, Mozambique.

OBJECTIVES: To describe causes of death among young women and estimate the role of HIV/AIDS as a cause in Maputo City, based on the civil death register. METHODS: Death data of 17-49 year-old women were abstracted from January 2007-March 2010 from the civil death register in Maputo City, registering overall about 15 000 deaths per-year. Causes of death in the register were either based on physicians' diagnoses on death certificates or determined by asking questions to deceased relatives. Causes of death were written in Portuguese; we translated them into English and classified them into 106 codes using ICD-9; these codes were then categorized into 10 groups. Estimated populations from the 2007 census were used to calculate annual mortality rates. An earlier study was used to compare deaths in 2001. FINDINGS: A total of 9640 deaths (6510 for residents of Maputo City) were registered and 77% had a specified cause of death reported. HIV-deaths represented 36% of all deaths and 40% among 25-39 year-olds. The death rate did not increase linearly by age, as there was a peak among women aged 30-34 years. The overall annual death rate was 6.7 deaths per 1000 population, with a notable decline by year. Death rates for HIV slightly declined by year. HIV-deaths explained most of the peak in death rate among 30-34-year-olds. The share of HIV-deaths among all deaths increased from 18% in 2001 to 35% in 2007-2010. Sixty-eight percent of all and 92% of HIV-related deaths occurred in hospital, with no increase over time. CONCLUSIONS: Routine death register was useful to study death rates, distribution of deaths, and change over time in the urban setting of Maputo during late 2000s. Over time, the death rate among 17-49 years old women seemed to have declined, but the relative contribution of HIV increased.

Determinants of nutritional status in children under five living in a rural area of Mozambique: a population survey / Determinantes del estado nutricional en niños menores de cinco años que viven en una zona rural de Mozambique: una encuesta de población

Background: Malnutrition in sub-Saharan Africa contributes to high rates of childhood morbidity and mortality. Little information is available regarding moderate malnutrition prevalence in children under five in rural areas. Methods: To assess nutritional status and the prevalence of malnutrition in children from Ibo Island, Mozambique, a nutritional population survey in children under 5 years was carried out. A structured questionnaire was administered from April 2009 to February 2010. Anthropometric measurements were recorded as z-scores and child nutritional status derived from the World Health Organization Child Growth Standards (WHO) reference population. Results: 3313 people on Ibo were identified and interviewed and nutritional assessment was carried out in the 526 children under five. Most children had been fully vaccinated (90.5%), breastfed (100%), and some were also bottle fed (22.0%). The mean duration of the different feeding regimes were 20.3±4.47 months for breastfeeding, 2.5±0.8 months for exclusive breastfeeding and 3.2±4.0 months for bottle feeding. The mean number of daily meals across the child age range was 2.3±0.5. More stunted children had been exclusively breastfed than mixed fed (p=0.058). Severe stunting was more likely in children in the ≤11 (26.3%) and 12-23 (21.2%) month age groups (p=0.007). 13.5% of severely stunted children had not been fully vaccinated (p=0.014), 72.7% ate unassisted (p=0.013) and 64.8% had their own dish to eat from (p=0.001) compared to the non-stunted group. More children from the 46-60 month age group (27.7%) were underweight compared to the other groups (p=0.047). Conclusions: moderate and severe malnutrition, especially stunting, in children under five in a rural setting in Mozambique are still prevalent. Strategies to tackle this problem are required (AU)

Fundamentos: La desnutrición en el África subsahariana contribuye a las elevadas tasas de morbilidad y mortalidad infantil, disponiéndose de poca información sobre la prevalencia moderada de la malnutrición en niños menores de cinco años de las zonas rurales. Métodos: se realizó una encuesta nutricional de población en niños menores de 5 años, para evaluar el estado nutricional y la prevalencia de malnutrición en los niños de Ibo Island, Mozambique. Se administró un cuestionario estructurado de abril de 2009 a febrero de 2010. Las medidas antropométricas se registraron como puntuaciones z y el estado nutricional de los niños se obtuvo de acuerdo a las referencias de la Organización Mundial de la Salud (OMS) para el Crecimiento Infantil. Resultados: 3313 personas en Ibo fueron identificadas y entrevistadas. Se realizó una evaluación nutricional en los 526 niños menores de cinco años. La mayoría de los niños habían sido totalmente vacunados (90,5%), amamantados (100,0%) y algunos también alimentados con biberón (22,0%). La duración media de los diferentes regímenes de alimentación fue de 20,3±4,47 meses para la lactancia materna, 2,5±0,8 meses para la lactancia materna exclusiva y 3,2±4,0 meses para la alimentación con biberón. El número medio de comidas diarias en el rango de edad de los niños fue de 2,3±0,5. Los niños más atrofiados habían sido alimentados exclusivamente con leche materna que los alimentados con leche materna (p = 0,058). El retraso en el crecimiento fue más probable en los niños en los grupos ≤ 11 (26,3%) y 12-23 (21,2%) meses (p = 0,007). El 13,5% de los niños gravemente atrofiados no habían sido vacunados totalmente (p=0,014), el 72,7% no asistió (p=0,013) y el 64,8% tenía su propio plato para comer (p=0,001) en comparación con el grupo no atrofiado. Más niños del grupo de edad de 46-60 meses (27,7%) tenían peso inferior al de los otros grupos (p = 0,047). Conclusiones: la malnutrición moderada y severa, especialmente el retraso en el crecimiento, en niños menores de cinco años en un entorno rural en Mozambique siguen siendo frecuentes. Se requieren estrategias para abordar este problema (AU)

Is selective prenatal iron prophylaxis better than routine prophylaxis: final results of a trial (PROFEG) in Maputo, Mozambique.

OBJECTIVE: To compare routine versus selective (ie, screening and treatment for anaemia) prenatal iron prophylaxis in a malaria-endemic and HIV-prevalent setting, an extended analysis including previously missing data. DESIGN: A pragmatic randomised controlled clinical trial. SETTING: 2 health centres in Maputo, Mozambique. PARTICIPANTS: Pregnant women (≥18 years old; non-high-risk pregnancy) were randomly allocated to routine iron (n=2184) and selective iron (n=2142) groups. INTERVENTIONS: In the routine group, women received 60 mg ferrous sulfate plus 400 µg folic acid daily. In the selective group, women received 1 mg of folic acid daily and haemoglobin (Hb) screening at each visit; with low Hb (cut-off 9 g/dL) treatment (120 mg+800 µg of folic acid daily) for a month. PRIMARY OUTCOMES: preterm birth, low birth weight; secondary outcomes: self-reported malaria, labour complications, caesarean section, perinatal death, woman's death. Nurses collected pregnancy data. Birth data were abstracted from hospital records for 52% of women and traced using various methods and linked with probabilistic matching for 24%. Women's deaths were collected from death registers. RESULTS: Birth data were available for 3301 (76%) of the women. Outcomes were similar in the two groups: preterm births (27.1% in the selective vs 25.3% in the routine group), low birthweight infants (11.0% vs 11.7%), perinatal deaths (2.4% vs 2.4%) and caesarean sections (4.0% vs 4.5%). Women's deaths during pregnancy or <42 days postpartum were more common in the selective group (0.8% among the two best matched women) than in the routine group (0.4%). Extra deaths could not be explained by the cause of death, Hb level or HIV status at recruitment. CONCLUSIONS: Birth outcomes were similar in the two iron groups. There might have been more women's deaths in the selective iron group, but it is unclear whether this was due to the intervention, other factors or chance finding. TRIAL REGISTRATION NUMBER: NCT00488579.

Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique.

OBJECTIVE: Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique. DESIGN: A pragmatic randomized controlled trial. SETTING: Two health centres (1° de Maio and Machava) in Maputo, Mozambique. SUBJECTS: Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 µg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid). RESULTS: The level of adherence was 79% for having two or more visits, 53% for adequate prenatal care and 67% for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other. CONCLUSIONS: The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.

A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success.

The effects of prophylactic iron during pregnancy on maternal and child health in developing settings with endemic malaria and high prevalence of HIV remain unclear. This paper describes the rationale, implementation and success of a pragmatic randomised controlled trial comparing routine iron supplementation vs. screening and treatment for anaemia during pregnancy. The setting was two health centres in Maputo, Mozambique. Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited. The main outcomes are preterm delivery and low birthweight. The women were randomly assigned to one of two iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 µg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid. The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages. Collection of delivery data was challenging and data on about 40% of births is missing. These are currently being traced through different hospitals and health centres. The compliance of the study personnel and the women with regard to regular measurement of haemoglobin and intake of the iron and folic acid tablets was high and similar in both trial arms. Taking into account the various constraints encountered, the stages of the present trial prior to delivery were carried out well.

A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study.

BACKGROUND: Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum. METHODS/DESIGN: We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions-including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care-as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted. DISCUSSION: Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real-life" service delivery system in a SSA country severely impacted by HIV. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01930084.

A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study

Background: Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum. Methods/Design: We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions­including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care­as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted. Discussion: Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real-life" service delivery system in a SSA country severely impacted by HIV

Comparison of routine prenatal iron prophylaxis and screening and treatment for anaemia: pregnancy results and preliminary birth results from a pragmatic randomised controlled trial (PROFEG) in Maputo, Mozambique.

OBJECTIVE: To present the pregnancy results and interim birth results of a pragmatic randomised controlled trial comparing routine iron prophylaxis with screening and treatment for anaemia during pregnancy in a setting of endemic malaria and HIV. DESIGN: A pragmatic randomised controlled trial. SETTING: Two health centres (1° de Maio and Machava) in Maputo, Mozambique, a setting of endemic malaria and high prevalence of HIV. PARTICIPANTS: Pregnant women (≥18-year-olds; non-high-risk pregnancy, n=4326) attending prenatal care consultation at the two health centres were recruited to the trial. INTERVENTIONS: The women were randomly allocated to either Routine iron (n=2184; 60 mg ferrous sulfate plus 400 µg of folic acid daily throughout pregnancy) or Selective iron (n=2142; screening and treatment for anaemia and daily intake of 1 mg of folic acid). OUTCOME MEASURES: The primary outcomes were preterm delivery (delivery <37 weeks of gestation) and low birth weight (<2500 g). The secondary outcomes were symptoms suggestive of malaria and self-reported malaria during pregnancy; birth length; caesarean section; maternal and child health status after delivery. RESULTS: The number of follow-up visits was similar in the two groups. Between the first and fifth visits, the two groups were similar regarding the occurrence of fever, headache, cold/chills, nausea/vomiting and body aches. There was a suggestion of increased incidence of self-reported malaria during pregnancy (OR 1.37, 95% CI 0.98 to1.92) in the Routine iron group. Birth data were available for 1109 (51%) in the Routine iron group and for 1149 (54%) in the Selective iron group. The birth outcomes were relatively similar in the two groups. However, there was a suggestion (statistically non-significant) of poorer outcomes in the Routine iron group with regard to long hospital stay after birth (relative risk (RR) 1.43, 95% CI 0.97 to 1.26; risk difference (RD) 0.02, 95% CI -0.00 to 0.03) and unavailability of delivery data (RR 1.06, 95% CI 1.00 to 1.13; RD 0.03, 95% CI -0.01 to 0.07). CONCLUSIONS: These interim results suggest that routine iron prophylaxis during pregnancy did not confer advantage over screening and treatment for anaemia regarding maternal and child health. Complete data on birth outcomes are being collected for firmer conclusions. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, number NCT00488579 (June 2007). The first women were randomised to the trial proper April 2007-March 2008. The pilot was November 2006-March 2008. The 3-month lag was due to technical difficulties in completing trial registration.

Viral acute respiratory infections among infants visited in a rural hospital of southern Mozambique.

OBJECTIVES: To determine the epidemiology and clinical presentation of virus-associated acute respiratory infections (ARI) in Mozambican infants. METHODS: A systematic selection of nasopharyngeal aspirates (n = 333), collected from infants younger than 12 months who visited Manhiça District Hospital (southern Mozambique) with ARI during a 12 months respiratory syncitial virus surveillance, were tested for other common respiratory viruses. Four different polymerase chain reactions were used to diagnose rhinovirus (RV), influenza (Flu; A and B), adenovirus (ADV), human metapneumovirus (hMPV), parainfluenza (PIV; 1, 2, 3 and 4AB) and enterovirus (EV). RESULTS: At least one study virus was identified in more than half of the samples tested (185/333). Overall, 231 viruses were detected among 185 infants, listed in the order of prevalence: RV (26%), Flu (15%), ADV (14%), hMPV (7%), PIV (5%) and EV (3%). Acute respiratory infections (ARI) cases and viral episodes were seasonal and concentrate during the warm and the rainy season. Clinical features were similar among all study children regardless of the detection of virus, with the exception of ear discharge, which was more frequent among viral cases [6% (11/183) vs. 1% (2/144); P = 0.034]. Children with multiple viral infections had higher odds of severity such as nasal flaring and indrawing (OR = 2.7, P = 0.028 and OR = 3.8, P = 0.007, respectively) and higher odds of hospitalisation (OR = 4.42, P = 0.001, adjusted by age and sex). CONCLUSIONS: Viral ARI are frequent among infants visited in MHD. Strategies to prevent mild respiratory infections, and specially their complications, might alleviate health systems of source-limited settings.

Antimicrobial Susceptibility and Mechanisms of Resistance in Shigella and Salmonella Isolates from Children under Five Years of Age with Diarrhea in Rural Mozambique

The antimicrobial susceptibility and mechanisms of resistance of 109 Shigella and 40 Salmonella isolates from children with diarrhea in southern Mozambique were assessed. The susceptibility to seven antimicrobial agents was tested by disk diffusion, and mechanisms of resistance were searched by PCR or colorimetric method. A high proportion of Shigella isolates were resistant to chloramphenicol (Chl) (52%), ampicillin (Amp) (56%), tetracycline (Tet) (66%), and trimethoprim-sulfamethoxazole (Sxt) (84%). Sixty-five percent of the isolates were multidrug resistant. Shigella flexneri isolates were more resistant than those of Shigella sonnei to Amp (66% versus 0.0%, P < 0.001) and Chl (61% versus 0.0%, P < 0.001), whereas S. sonnei isolates presented higher resistance to Tet than S. flexneri isolates (93% versus 64%, P = 0.02). Resistance among Salmonella isolates was as follows: Tet and Chl, 15% each; Sxt, 18%; and Amp, 25%. Only 3% of Salmonella isolates were resistant to nalidixic acid (Nal), and none to ciprofloxacin or ceftriaxone (Cro). Among Salmonella isolates, multiresistance was found in 23%. Among Shigella isolates, antibiotic resistance was related mainly to the presence of oxa-1-like beta-lactamases for Amp, dfrA1 genes for Sxt, tetB genes for Tet, and Chl acetyltransferase (CAT) activity for Chl. Among Salmonella isolates, resistance was conferred by tem-like beta-lactamases for Amp, floR genes and CAT activity for Chl, tetA genes for Tet, and dfrA1 genes for Sxt. Our data show that Shigella isolates are resistant mostly to the most available, inexpensive antibiotics by various molecular mechanisms but remain susceptible to ciprofloxacin, Cro, and Nal, which is the first line for empirical treatment of shigellosis in the country