RESUMO
BACKGROUND: Small incentives could improve engagement in HIV care. We evaluated the short-term and longer-term effects of financial incentives for visit attendance on viral suppression among adults initiating antiretroviral therapy (ART) in Tanzania. METHODS: In a type 1 hybrid effectiveness-implementation study, we randomised (1:1) 32 primary care HIV clinics in four Tanzanian regions to usual care (control group) or the intervention (usual care plus ≤6 monthly incentives [22â500 Tanzanian Shillings, about US$10, each], conditional on visit attendance). Adults (aged ≥18 years) initiating ART (<30 days) who owned a mobile phone and had no plans to transfer to another facility were eligible. The primary outcome was retention on ART with viral suppression (<1000 copies per mL) at 12 months. Secondary outcomes included retention on ART with viral suppression at 6 months and viral suppression at 6 months and 12 months using a lower threshold (<50 copies per mL). Intent-to-treat analysis and a cluster-based permutation test were used to evaluate the effect of financial incentives on outcomes. This trial is registered with ClinicalTrials.gov, NCT04201353, and is completed. FINDINGS: Between May 28, 2021, and March 8, 2022, 1990 participants (805 male and 1185 female) were enrolled in the study. 1059 participants were assigned to the intervention group and 931 participants were assigned to the control group. Overall, 1536 (88%) participants at 6 months and 1575 (83%) at 12 months were on ART with viral suppression. At 12 months, 6 months after the intervention ended, 866 (85%) participants in the intervention group compared with 709 (81%) in the control group had viral loads less than 1000 copies per mL (adjusted risk difference [aRD] 4·4 percentage points, 95% CI -1·4 to 10·1, permutation test p=0·35). At 6 months, 858 participants (90%) in the intervention group were on ART with viral loads less than 1000 copies per mL compared with 678 (86%) in the control group (aRD 5·1 percentage points, 95% CI 1·1 to 9·1, permutation test p=0·06). Effects were larger at 6 months and 12 months with the lower threshold for viral suppression, and there was significant effect heterogeneity by region. Adverse events included 106 deaths (56 in the control group and 50 in the intervention group), none related to study participation. INTERPRETATION: Short-term incentives for visit attendance had modest, short term benefits on viral suppression and did not harm retention or viral suppression after discontinuation. These findings suggest the need to understand subgroups who would most benefit from incentives to support HIV care. FUNDING: National Institute of Mental Health. TRANSLATION: For the Swahili translation of the abstract see Supplementary Materials section.
RESUMO
INTRODUCTION: Adverse sexual and reproductive health (SRH) outcomes, such as unplanned pregnancies and HIV infection, disproportionately affect adolescent girls and young women (AGYW; aged 15-24 years) in east Africa. Increasing uptake of preventive SRH services via innovative, youth-centred interventions is imperative to addressing disparities in SRH outcomes. METHODS AND ANALYSIS: From 2018 to 2019, we used human-centred design to co-develop a theoretically driven HIV and pregnancy prevention intervention for AGYW at private drug shops called Accredited Drug Dispensing Outlets (ADDOs) in Tanzania. The result, Malkia Klabu (Queen Club), was a customer loyalty programme designed to strengthen ADDOs' role as SRH providers while encouraging uptake of critical SRH prevention products among AGYW. Malkia Klabu members had access to free contraceptives and oral HIV self-test (HIVST) kits and earned punches on a loyalty card for other shop purchases; punches were redeemable for small prizes. Our pilot among 40 shops showed that intervention ADDOs had higher AGYW patronage and distributed more HIVST kits and contraceptives to AGYW relative to business-as-usual (ie, client purchasing) comparison shops. We will conduct a cluster-randomised controlled trial (c-RCT) among 120-140 ADDOs in 40 health catchment areas in Shinyanga and Mwanza Regions (Lake Zone), Tanzania. ADDO shop recruitment includes a 1-month run-in with a tablet-based electronic inventory management system for tracking shop transactions, followed by enrolment, randomisation and a 24-month trial period. Our c-RCT evaluating the human-centred design-derived intervention will assess population impact on the primary outcomes of HIV diagnoses and antenatal care registrations, measured with routine health facility data. We will also assess secondary outcomes focusing on mechanisms of action, evaluate programme exposure and AGYW behaviour change in interviews with AGYW, and assess shop-level implementation strategies and fidelity. ETHICS AND DISSEMINATION: Ethical approval was granted from both the University of California, San Francisco and the Tanzanian National Institute for Medical Research. Study progress and final outcomes will be posted annually to the National Clinical Trials website; study dissemination will occur at conferences, peer-reviewed manuscripts and local convenings of stakeholders. TRIAL REGISTRATION NUMBER: NCT05357144.
Assuntos
Infecções por HIV , Humanos , Tanzânia , Feminino , Adolescente , Adulto Jovem , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Gravidez , Saúde da Mulher , Ensaios Clínicos Controlados Aleatórios como Assunto , ComércioRESUMO
OBJECTIVE: Depression and anxiety are prevalent among people with HIV (PWH), hindering retention in care. Though economic interventions can improve care engagement and mental health in the general population, this remains understudied among PWH. This study assessed whether financial incentives improve mental health among adult antiretroviral therapy (ART) initiates in Lake Zone, Tanzania. DESIGN: Two-arm randomized controlled trial. METHODS: From 2021 to 2023, 32 clinics were randomized to offer patients monthly financial incentives (22 500âTSH/US$ 10) for ≤six months (conditional on visit attendance) or standard-of-care (SoC) services. We assessed changes in depression (PHQ-2 scores) and anxiety (GAD-2 scores) symptoms at baseline, six, and 12âmonths. Difference-in-differences effects were used to estimate changes over time by arm using inverse probability of censoring sample weights (IPCW). RESULTS: Participants ( n â=â1990) were 57.3% female; median age was 35.0. Baseline prevalences of depression and anxiety symptoms were 66.2% and 60.4%, respectively, and endline prevalences were 7.8% and 7.6% in the intervention and SoC arms, respectively, with no differences by arm. Using IPCW, the differences in the prevalence of depression and anxiety symptoms in the intervention arm compared to the SoC arm were 2.5 percentage points [95% confidence interval (CI): -3.0, 8.0) and 2.3 percentage points (95% CI: -3.2, 7.9) respectively after six months, and 5.5 percentage points (95% CI: -0.20, 10.8) and 3.8 percentage points (95% CI: -1.5, 9.2) respectively after 12âmonths. CONCLUSION: Both study arms experienced substantial reductions in poor mental health, primarily within the first six months of care. Financial incentives provided in this study did not significantly augment these downward trends but may improve engagement in care, indirectly improving mental health.
Assuntos
Ansiedade , Depressão , Infecções por HIV , Motivação , Humanos , Tanzânia/epidemiologia , Feminino , Masculino , Adulto , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Infecções por HIV/economia , Depressão/epidemiologia , Ansiedade/epidemiologia , Saúde Mental , Pessoa de Meia-Idade , Adulto JovemRESUMO
BACKGROUND: Economic incentives can improve clinical outcomes among in-care people living with HIV (PLHIV), but evidence is limited for their effectiveness among out-of-care PLHIV or those at risk of disengagement. We propose a type 1 hybrid effectiveness-implementation study to advance global knowledge about the use of economic incentives to strengthen the continuity of HIV care and accelerate global goals for HIV epidemic control. METHODS: The Rudi Kundini, Pamoja Kundini study will evaluate two implementation models of an economic incentive strategy for supporting two groups of PLHIV in Tanzania. Phase 1 of the study consists of a two-arm, cluster randomized trial across 32 health facilities to assess the effectiveness of a home visit plus one-time economic incentive on the proportion of out-of-care PLHIV with viral load suppression (< 1000 copies/ml) 6 months after enrollment (n = 640). Phase 2 is an individual 1:1 randomized controlled trial designed to determine the effectiveness of a short-term counseling and economic incentive program offered to in-care PLHIV who are predicted through machine learning to be at risk of disengaging from care on the outcome of viral load suppression at 12 months (n = 692). The program includes up to three incentives conditional upon visit attendance coupled with adapted counselling sessions for this population of PLHIV. Consistent with a hybrid effectiveness-implementation study design, phase 3 is a mixed methods evaluation to explore barriers and facilitators to strategy implementation in phases 1 and 2. Results will be used to guide optimization and scale-up of the incentive strategies, if effective, to the larger population of Tanzanian PLHIV who struggle with continuity of HIV care. DISCUSSION: Innovative strategies that recognize the dynamic process of lifelong retention in HIV care are urgently needed. Strategies such as conditional economic incentives are a simple and effective method for improving many health outcomes, including those on the HIV continuum. If coupled with other supportive services such as home visits (phase 1) or with tailored counselling (phase 2), economic incentives have the potential to strengthen engagement among the subpopulation of PLHIV who struggle with retention in care and could help to close the gap towards reaching global "95-95-95" goals for ending the AIDS epidemic. TRIAL REGISTRATION: Phase 1: ClinicalTrials.gov, NCT05248100 , registered 2/21/2022. Phase 2: ClinicalTrials.gov, NCT05373095 , registered 5/13/2022.
Assuntos
Infecções por HIV , Motivação , Humanos , Tanzânia/epidemiologia , Ciência de Dados , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Infecções por HIV/terapia , Continuidade da Assistência ao Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Ensaios Clínicos Fase II como AssuntoRESUMO
Mental illness is prevalent among people living with HIV (PLHIV) and hinders engagement in HIV care. While financial incentives are effective at improving mental health and retention in care, the specific effect of such incentives on the mental health of PLHIV lacks quantifiable evidence. We evaluated the impact of a three-arm randomized controlled trial of a financial incentive program on the mental health of adult antiretroviral therapy (ART) initiates in Tanzania. Participants were randomized 1:1:1 into one of two cash incentive (combined; provided monthly conditional on clinic attendance) or the control arm. We measured the prevalence of emotional distress, depression, and anxiety via a difference-in-differences model which quantifies changes in the outcomes by arm over time. Baseline prevalence of emotional distress, depression, and anxiety among the 530 participants (346 intervention, 184 control) was 23.8%, 26.6%, and 19.8%, respectively. The prevalence of these outcomes decreased substantially over the study period; additional benefit of the cash incentives was not detected. In conclusion, poor mental health was common although the prevalence declined rapidly during the first six months on ART. The cash incentives did not increase these improvements, however they may have indirect benefit by motivating early linkage to and retention in care.Clinical Trial Number: NCT03341556.
Assuntos
Infecções por HIV , Motivação , Adulto , Humanos , Tanzânia/epidemiologia , Saúde Mental , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Infecções por HIV/psicologia , Ansiedade/epidemiologiaRESUMO
BACKGROUND: Concerns about the interconnected relationship between HIV and mental health were heightened during the COVID-19 pandemic. This study assessed whether there were temporal changes in the mental health status of people living with HIV presenting for care in Shinyanga region, Tanzania. Specifically, we compared the prevalence of depression and anxiety before and during COVID-19, with the goal of describing the changing needs, if any, to person-centered HIV services. METHODS: We analyzed baseline data from two randomized controlled trials of adults initiating ART in Shinyanga region, Tanzania between April-December 2018 (pre-COVID-19 period, n = 530) and May 2021-March 2022 (COVID-19 period, n = 542), respectively. We compared three mental health indicators that were similarly measured in both surveys: loss of interest in things, hopelessness about the future, and uncontrolled worrying. We also examined depression and anxiety which were measured using the Hopkins Symptom Checklist-25 in the pre-COVID-19 period and the Patient Health Questionnaire-4 in the COVID-19 period, respectively, and classified as binary indicators per each scale's threshold. We estimated prevalence differences (PD) in adverse mental health status before and during the COVID-19 pandemic, using stabilized inverse probability of treatment weighting to adjust for underlying differences in the two study populations. RESULTS: We found significant temporal increases in the prevalence of feeling 'a lot' and 'extreme' loss of interest in things ['a lot' PD: 38, CI 34,41; 'extreme' PD: 9, CI 8,12)], hopelessness about the future [' a lot' PD: 46, CI 43,49; 'extreme' PD: 4, CI 3,6], and uncontrolled worrying [' a lot' PD: 34, CI 31,37; 'extreme' PD: 2, CI 0,4] during the COVID-19 pandemic. We also found substantially higher prevalence of depression [PD: 38, CI 34,42] and anxiety [PD: 41, CI 37,45]. CONCLUSIONS: After applying a quasi-experimental weighting approach, the prevalence of depression and anxiety symptoms among those starting ART during COVID-19 was much higher than before the pandemic. Although depression and anxiety were measured using different, validated scales, the concurrent increases in similarly measured mental health indicators lends confidence to these findings and warrants further research to assess the possible influence of COVID-19 on mental health among adults living with HIV. Trial Registration NCT03351556, registered November 24, 2017; NCT04201353, registered December 17, 2019.
Assuntos
COVID-19 , Infecções por HIV , Adulto , Humanos , Ansiedade/epidemiologia , COVID-19/epidemiologia , Depressão/epidemiologia , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Pandemias , Prevalência , Tanzânia/epidemiologiaRESUMO
Background: Research has demonstrated the importance of understanding risk factors for mental health and wellbeing. Less research has focused on protective factors that protect mental health and promote wellbeing in diverse contexts. Estimating structural paths from risk protective factors to psychopathology and wellbeing can inform prioritization of targeted investment in adolescent health programs that seek to modify factors that are most closely associated with mental wellbeing. Study objective: The purpose of this study was to examine risk factors (e.g. emotional neglect, emotional abuse, physical neglect, stigma) and protective factors (e.g. community relationships, self-esteem, and autonomy) among adolescent orphans, protective associations with depression, anxiety and externalizing behaviors and promotive associations with hope, happiness, and health. Methods: The analytic sample was collected between January and March of 2019 and included 350 adolescent orphans ages 10-15 from three districts in Tanzania. Participants completed survey interviews, 75-90â min in length, that measured risk and protective factors, psychological symptoms, and mental wellbeing measures. Results: Results of the fitted structural equation model indicated that structural paths from protective factors to psychopathology (ß = -0.53, p = 0.015) and mental wellbeing (ß = 0.72, p = 0.014) outcomes were significant. Structural paths from risk factors to psychopathology (ß = -0.34, p = 0.108) and mental wellbeing (ß = -0.24, p = 0.405) were not significant. Conclusion: In a sample of vulnerable youth, protective factors (e.g. community relationships, self-esteem, and autonomy) were significantly associated with reduced depression, anxiety and externalizing behaviors and increased hope, happiness, and health in a structural equation model that included risk factors (emotional neglect, emotional abuse, physical neglect). Results suggest that strong community relationships, self-esteem and autonomy may be important modifiable factors to target in intervention programs aimed at supporting adolescent mental wellbeing.
RESUMO
BACKGROUND: Utu is a Kiswahili term with a long history of cultural significance in Tanzania. It conveys a value system of shared, collective humanity. While variants of Utu have been studied in other contexts, a measure of Utu that captures this important collective asset has not been developed in Tanzania. The aims of this study were to (1) examine dimensional constructs that represent Utu, (2) validate a measurement scale of Utu for use with adolescents, (3) examine differences between orphan and non-orphan adolescents in self-reported Utu and, (4) examine structural paths between adverse life experiences, coping strategies, Utu, and resilience. METHODS: This study collected survey data from adolescents from three districts in peri-urban Tanzania in two samples: 189 orphan adolescents ages 10-17 in May 2020 and 333 non-orphan adolescents ages 10-14 in August 2020. Confirmatory factor analysis was used to validate the hypothesized factor structure of the developed Utu measure. Structural equation models were used to examine path associations with adverse life experiences, coping and resilience. RESULTS: The five dimensional constructs comprising the Utu measure included Resource Sharing, Group Solidarity, Respect and Dignity, Collectivity, and Compassion. Confirmatory factor analysis of the Utu measure demonstrated excellent fit (CFI = 0.98; TLI = 0.97; SRMR = 0.024; RMSEA = 0.046) and internal consistency (α = 0.94) among adolescents in this study. Positive, significant associations were found between Utu and coping (ß = 0.29, p < 0.001) and Utu and intra/interpersonal and collective resilience (ß = 0.13, p < 0.014). Utu was not significantly associated with adverse life experiences, age or gender. CONCLUSIONS: A five-dimensional measurement scale for Utu was validated in a sample of orphan and non-orphan adolescents in Tanzania. Utu is a collective asset associated with higher levels of reported resilience in both orphan and non-orphan adolescent populations in Tanzania. Promoting Utu may be an effective universal public health prevention approach. Implications for adolescent programming are discussed.
Assuntos
Resiliência Psicológica , Humanos , Adolescente , Psicometria , Reprodutibilidade dos Testes , Adaptação Psicológica , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: Determine the feasibility, acceptability, and preliminary effectiveness of financial incentives to motivate re-engagement in HIV care in Shinyanga, Tanzania. METHODS: Out-of-care people living with HIV (PLHIV) were identified from medical records in four clinics and home-based care providers (HBCs) from April 13, 2018 to March 3, 2020. Shinyanga Region residents, ≥18 years, who were disengaged from care were randomized 1:1 to a financial incentive (â¼$10 USD) or the standard of care (SOC), stratified by site, and followed for 180 days. Primary outcomes were feasibility (located PLHIV who agreed to discuss the study), acceptability (enrollment among eligibles), and re-engagement in care (clinic visit within 90 days). RESULTS: HBCs located 469/1,309 (35.8%) out-of-care PLHIV. Of these, 215 (45.8%) were preliminarily determined to be disengaged from care, 201 (93.5%) agreed to discuss the study, and 157 eligible (100%) enrolled. Within 90 days, 71 (85.5%) PLHIV in the incentive arm re-engaged in care vs. 58 (78.4%) in the SOC (Adjusted Risk Difference [ARD] = 0.08, 95% CI: -0.03, 0.19, p = 0.09). A higher proportion of incentivized PLHIV completed an additional (unincentivized) visit between 90-180 days (79.5% vs. 71.6%, ARD = 0.10, 95% CI: -0.03, 0.24, p = 0.13) and remained in care at 180 days (57.8% vs. 51.4%, ARD = 0.07, 95% CI: -0.09, 0.22, p = 0.40). CONCLUSIONS: Short-term financial incentives are feasible, acceptable, and have the potential to encourage re-engagement in care, warranting further study of this approach.
Assuntos
Infecções por HIV , Motivação , Humanos , Projetos Piloto , Infecções por HIV/tratamento farmacológico , TanzâniaRESUMO
Background: Economic incentives can improve clinical outcomes among in-care people living with HIV (PLHIV), but evidence is limited for their effectiveness among out-of-care PLHIV or those at-risk of disengagement. We propose a type 1 hybrid effectiveness-implementation study to advance global knowledge about the use of economic incentives to strengthen the continuity of HIV care and accelerate global goals for HIV epidemic control. Methods: The Rudi Kundini, Pamoja Kundini study will evaluate two implementation models of an economic incentive strategy for supporting two groups of PLHIV in Tanzania. Phase 1 of the study consists of a two-arm, cluster randomized trial across 32 health facilities to assess the effectiveness of a home visit plus one-time economic incentive on the proportion of out-of-care PLHIV with viral load suppression (<1000 copies/ml) 6 months after enrollment (n = 640). Phase 2 is an individual 1:1 randomized controlled trial designed to determine the effectiveness of a short-term counseling and economic incentive program offered to in-care PLHIV who are predicted through machine learning to be at-risk of disengaging from care on the outcome of viral load suppression at 12 months (n = 692). The program includes up to three incentives conditional upon visit attendance coupled with adapted counselling sessions for this population of PLHIV. Consistent with a hybrid effectiveness-implementation study design, phase 3 is a mixed methods evaluation to explore barriers and facilitators to strategy implementation in phases 1 and 2. Results will be used to guide optimization and scale-up of the incentive strategies, if effective, to the larger population of Tanzanian PLHIV who struggle with continuity of HIV care. Discussion: Innovative strategies that recognize the dynamic process of lifelong retention in HIV care are urgently needed. Strategies such as conditional economic incentives are a simple and effective method for improving many health outcomes, including those on the HIV continuum. If coupled with other supportive services such as home visits (phase 1) or with tailored counselling (phase 2), economic incentives have the potential to strengthen engagement among the subpopulation of PLHIV who struggle with retention in care and could help to close the gap towards reaching global '95-95-95' goals for ending the AIDS epidemic.Phase 1: Clinicaltrials.gov, NCT05248100, registered 2/21/2022 https://clinicaltrials.gov/ct2/show/NCT05248100Phase 2: Clinicaltrials.gov, NCT05373095, registered 5/13/2022 https://clinicaltrials.gov/ct2/show/NCT05373095.
RESUMO
Machine learning methods for health care delivery optimization have the potential to improve retention in HIV care, a critical target of global efforts to end the epidemic. However, these methods have not been widely applied to medical record data in low- and middle-income countries. We used an ensemble decision tree approach to predict risk of disengagement from HIV care (missing an appointment by ≥28 days) in Tanzania. Our approach used routine electronic medical records (EMR) from the time of antiretroviral therapy (ART) initiation through 24 months of follow-up for 178 adults (63% female). We compared prediction accuracy when using EMR-based predictors alone and in combination with sociodemographic survey data collected by a research study. Models that included only EMR-based indicators and incorporated changes across past clinical visits achieved a mean accuracy of 75.2% for predicting risk of disengagement in the next 6 months, with a mean sensitivity of 54.7% for targeting the 30% highest-risk individuals. Additionally including survey-based predictors only modestly improved model performance. The most important variables for prediction were time-varying EMR indicators including changes in treatment status, body weight, and WHO clinical stage. Machine learning methods applied to existing EMR data in resource-constrained settings can predict individuals' future risk of disengagement from HIV care, potentially enabling better targeting and efficiency of interventions to promote retention in care.
RESUMO
BACKGROUND: The transition from childhood to adolescence is a uniquely sensitive period for social and emotional learning in the trajectory of human development. This transition is characterized by rapid physical growth, sexual maturation, cognitive and behavioral changes and dynamic changes in social relationships. This pivotal transition provides a window of opportunity for social emotional learning that can shape early adolescent identity formation and gender norms, beliefs and behaviors. The objective of this study is to evaluate the potential of a social emotional learning intervention for very young adolescents (VYAs) to improve social emotional mindsets and skills. METHODS: Discover Learning is a social emotional learning intervention designed for VYAs (10-11 years of age) to support development of social emotional mindsets and skills from four primary schools in Dar es Salaam, Tanzania. The intervention delivered three different packages of learning experiences to three arms of the study. 528 VYAs were randomized to each of the three study arms (A-Content learning, B-Content learning and reflection, and C-Content learning, reflection and experiential practice). A quantitative survey was administered to all participants before and after the intervention to capture changes in social emotional mindsets and skills. A discrete choice experiment measured changes in gender norms, beliefs and behaviors. RESULTS: 528 VYAs were included in the analysis. Participants in all three arms of the study demonstrated significant improvements in social emotional mindsets and skills outcomes (generosity, curiosity, growth mindset, persistence, purpose and teamwork). However, Group C (who received experiential social learning opportunities in small, mixed-gender groups and a parent and community learning components demonstrated larger treatment effects on key outcomes in comparison to Groups A and B. Results indicate Group C participants had greater change in gender equity outcomes (OR = 1.69, p = <0.001) compared to Group A (OR = 1.30, p = <0.001) and Group B (OR = 1.23, p = 0.004). CONCLUSION: These findings provide evidence that social emotional learning interventions targeting VYAs can improve social emotional mindsets and skills and gender equity outcomes. The findings indicate the importance of experiential learning activities in mixed-gender groups during the unique developmental window of early adolescence. The study also provides support for the inclusion of parental/caregiver and community engagement in programs designed for VYAs. TRIAL REGISTRATION: Retrospectively registered on July 7th, 2020. NCT0445807.
Assuntos
Aprendizado Social , Criança , Cognição , Emoções , Equidade de Gênero , Humanos , TanzâniaRESUMO
INTRODUCTION: Conditional economic incentives are shown to promote medication adherence across a range of health conditions and settings; however, any long-term harms or benefits from these time-limited interventions remain largely unevaluated. We assessed 2-3 years outcomes from a 6-month incentive programme in Tanzania that originally improved short-term retention in HIV care and medication possession. METHODS: We traced former participants in a 2013-2016 trial, which randomised 800 food-insecure adults starting HIV treatment at three clinics to receive either usual care (control) or up to 6 months of cash or food transfers (~US$11/month) contingent on timely attendance at monthly clinic appointments. The primary intention-to-treat analysis estimated 24-month and 36-month marginal risk differences (RD) between incentive and control groups for retention in care and all-cause mortality, using multiple imputation for a minority of missing outcomes. We also estimated mortality HRs from time-stratified Cox regression. RESULTS: From 3 March 2018 to 19 September 2019, we determined 36-month retention and mortality statuses for 737 (92%) and 700 (88%) participants, respectively. Overall, approximately 660 (83%) participants were in care at 36 months while 43 (5%) had died. There were no differences between groups in retention at 24 months (86.5% intervention vs 84.4% control, RD 2.1, 95% CI -5.2 to 9.3) or 36 months (83.3% vs 77.8%, RD 5.6, -2.7 to 13.8), nor in mortality at either time point. The intervention group had a lower rate of death during the first 18 months (HR 0.27, 95% CI 0.10 to 0.74); mortality was similar thereafter (HR 1.13, 95% CI 0.33 to 3.79). CONCLUSION: These findings confirm that incentives are a safe and effective tool to promote short-term adherence and potentially avert early deaths at the critical time of HIV treatment initiation. Complementary strategies are recommended to sustain lifelong retention in HIV care. TRIAL REGISTRATION NUMBER: NCT01957917.
Assuntos
Infecções por HIV , Motivação , Adulto , Seguimentos , Infecções por HIV/tratamento farmacológico , Humanos , Adesão à Medicação , TanzâniaRESUMO
Despite tremendous progress in cell-based therapies for heart repair, many challenges still exist. To enhance the therapeutic potential of cell therapy one approach is the combination of cells with biomaterial delivery vehicles. Here, we developed a biomimetic and biodegradable micro-platform based on polymeric microparticles (MPs) capable of maximizing the therapeutic potential of cardiac progenitor cells (CPCs) and explored its efficacy in a rat model of chronic myocardial infarction. The transplantation of CPCs adhered to MPs within the infarcted myocardial microenvironment improved the long-term engraftment of transplanted cells for up to one month. Furthermore, the enhancement of cardiac cellular retention correlated with an increase in functional recovery. In consonance, better tissue remodeling and vasculogenesis were observed in the animals treated with cells attached to MPs, which presented smaller infarct size, thicker right ventricular free wall, fewer deposition of periostin and greater density of vessels than animals treated with CPCs alone. Finally, we were able to show that part of this beneficial effect was mediated by CPC-derived extracellular vesicles (EVs). Taken together, these findings indicate that the biomimetic microcarriers support stem cell survival and increase cardiac function in chronic myocardial infarction through modulation of cardiac remodeling, vasculogenesis and CPCs-EVs mediated therapeutic effects. The biomimetic microcarriers provide a solution for biomaterial-assisted CPC delivery to the heart. STATEMENT OF SIGNIFICANCE: In this study, we evaluate the possibility of using a biomimetic and biodegradable micro-platform to improve cardiovascular progenitor therapy. The strategy reported herein serves as an injectable scaffold for adherent cells due to their excellent injectability through cardiac catheters, capacity for biomimetic three-dimensional stem cell support and controllable biodegradability. In a rat model of chronic myocardial infarction, the biomimetic microcarriers improved cardiac function, reduced chronic cardiac remodeling and increased vasculogenesis through the paracrine signaling of CPCs. We have also shown that extracellular vesicles derived from CPCs cultured on biomimetic substrates display antifibrotic effects, playing an important role in the therapeutic effects of our tissue-engineered approach. Therefore, biomimetic microcarriers represent a promising and effective strategy for biomaterial-assisted CPC delivery to the heart.
Assuntos
Infarto do Miocárdio , Remodelação Ventricular , Animais , Biomimética , Células Cultivadas , Infarto do Miocárdio/terapia , Miocárdio , Miócitos Cardíacos , Ratos , Transplante de Células-TroncoRESUMO
Background: The maturational period from age 10 to 14-often referred to as very young adolescents (VYAs)-represents a dynamic period of learning and neurobehavioral development as individuals transition from childhood to adolescence. This developmental period presents a window of opportunity for strategic investment to improve trajectories of health, education and well-being among young people. More specifically, neurodevelopmental changes during pubertal maturation influence neural circuitry involved in processing emotions, risks, rewards and social relationships. Technology can be leveraged to create social emotional learning experiences for VYAs and provide opportunities for flexible, distance learning in low-income countries. The aim of this study protocol is to detail how insights from developmental science can be used to inform the intervention design, implementation and evaluation of a distance learning, social emotional learning intervention for VYAs. Methods: This study will be delivered to 500 VYAs in Temeke District, Dar es salaam. Study participants will watch culturally-relevant, animated videos on social emotional mindsets and skills and content will be paired with experiential learning activities over a period of 10 weeks. A nested smart-phone based study will practice learning social emotional skills and mindsets through engagement with multi-media material via the WhatsApp messenger application. Surveys and in-depth interviews will be administered to adolescents, their parents/caregivers and teachers before and after the intervention to evaluate the effect of the intervention on study outcomes. Discussion: This study is among the first to provide results on how to effectively design a distance-learning intervention to promote social emotional learning and identity development within a low-resource context. The findings will provide substantial evidence to inform new intervention approaches that are effective in low-resource contexts and strategies to reach scale among similar programs invested in leveraging technology to support adolescent health and development. Clinical Trial registration: Study registered with ClinicalTrials.gov. Identifier number NCT0445807.
Assuntos
Educação a Distância , Adolescente , Criança , Cognição , Emoções , Humanos , Tanzânia , TecnologiaRESUMO
Heavy load carrying of water, firewood, and sand/stones is a ubiquitous activity for women living in developing countries. Although the intra-abdominal pressure associated with heavy load carrying is hypothesized to increase the risk of pelvic organ prolapse (POP) among women, relevant epidemiologic data are lacking. We conducted a comparative study involving two exploratory cross-sectional studies among convenience samples of women carrying heavy loads, with different characteristics: (1) as part of their activities for daily living, in Shinyanga region, Tanzania; and (2) working as sand miners in Pokhara, Nepal. Women were categorized has having "low" or "high" load-carrying exposures based on the measured weights of the loads being carried at the time of the survey, as well as on self-reported duration and frequency of load carrying. A summary score for lower abdominal discomfort suggestive of POP was generated using questions from the Pelvic Organ Prolapse Distress Inventory (POPDI-6). Women with higher load carrying exposures had on average higher discomfort scores in both Tanzania (adjusted prevalence difference (PDa) = 3.7; 95% CI: -3.8-11.3; p = 0.33) and Nepal (PDa = 9.3; 95% CI: -4.9-23.6; p = 0.18). We identified trends suggestive of an association between increasing heavy load carrying exposures and symptoms of lower abdominal discomfort. Our findings underscore the need for larger epidemiologic studies of the potential adverse reproductive health effects of heavy load carrying activities on women in developing countries.
Assuntos
Prolapso de Órgão Pélvico , Estudos Transversais , Feminino , Humanos , Nepal/epidemiologia , Prolapso de Órgão Pélvico/epidemiologia , Prolapso de Órgão Pélvico/etiologia , Inquéritos e Questionários , Tanzânia/epidemiologiaRESUMO
BACKGROUND: Inequitable gender norms, beliefs and behaviors, are shaped by learning experiences during key developmental stages in an individual's life course, and can have negative impacts on health and well-being outcomes. Very early adolescence represents one stage when formative learning experiences about gender inequity can have the potential to support or hinder more equitable gender norms, beliefs and behaviors. The aim of this qualitative study was to evaluate the effect of a gender transformative, social emotional learning intervention for very young adolescents (VYAs) that included experiential learning with peers, parents/caregivers and community members. METHODS: This study examined the effects of an intervention designed to provide social emotional learning opportunities for adolescents ages 10-11 in Dar es Salaam, Tanzania. The qualitative sample included 279 participants. Qualitative methods included 102 in-depth interviews with VYAs, 22 focus groups with 117 VYAs, 60 in-depth interviews with parents/caregivers and 54 participant observations. A grounded theory approach was used to identify emergent themes. RESULTS: Participants reported growth in targeted areas of social emotional mindsets and skills, including a shift in gender norms, beliefs and behaviors. VYAs reported that experiential learning in mixed gender teams provided opportunities to actively practice and reflect on gender norms, beliefs and behaviors. VYAs also reported active practice of social emotional mindsets and skills with peers, parents/caregivers and the community. Parents/caregivers reported changes in VYAs' social emotional mindsets and skills within the home, with the community and with siblings and peers. Both adolescents and parent/caregivers reported positive change towards more equitable gender norms, beliefs and behaviors through participation in experiential learning activities and reflective discussions. CONCLUSIONS: These findings suggest that an intervention providing social and emotional experiential learning opportunities during the developmental window of very young adolescence can be effective in transforming gender norms, beliefs and behaviors. Involvement of peers, parents/caregivers and community members was effective at supporting learning social emotional mindsets and skills in VYAs. Findings encourage local and global adolescent programming to include gender transformative content paired with social emotional experiential learning with peers, family and the community and can stimulate positive change in gender norms, beliefs and behaviors to promote gender equity.
Assuntos
Cuidadores/psicologia , Participação da Comunidade/psicologia , Emoções , Avaliação de Programas e Projetos de Saúde/métodos , Adolescente , Criança , Cognição , Feminino , Grupos Focais , Identidade de Gênero , Humanos , Entrevistas como Assunto , Masculino , Pesquisa Qualitativa , TanzâniaRESUMO
Transportation cost is a barrier to HIV treatment, yet no studies have examined its association with contraceptive use among women living with HIV. We analyzed cross-sectional data from women attending three public healthcare facilities in Shinyanga, Tanzania where they initiated antiretroviral therapy for HIV infection in the previous 90 days; all facilities offered free contraception. Women self-reported current contraceptive use and the round-trip cost of transportation to the facility. Among 421 women aged 18-49, 86 (20.4%) were using any modern contraceptive method, of which half were using modern methods other than condoms. Women who paid more than 2,000 Tanzanian shillings for transportation had a significantly lower prevalence of any modern method use than women who paid nothing (9.1% vs. 21.3%; adjusted difference: -12.9; 95% confidence interval: -21.3, -4.4). A similar difference was observed for non-condom modern method use. We conclude that high transportation cost may impede contraceptive use even among women accessing HIV treatment.
Assuntos
Antirretrovirais/uso terapêutico , Comportamento Contraceptivo/estatística & dados numéricos , Anticoncepcionais Femininos/administração & dosagem , Infecções por HIV/tratamento farmacológico , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Meios de Transporte/economia , Adolescente , Adulto , Terapia Antirretroviral de Alta Atividade , Preservativos/estatística & dados numéricos , Anticoncepção , Estudos Transversais , Feminino , Insegurança Alimentar , Necessidades e Demandas de Serviços de Saúde , Humanos , Pessoa de Meia-Idade , Tanzânia , Adulto JovemRESUMO
BACKGROUND: Financial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania. METHODS: In a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10â000 Tanzanian Shillings (TZS; about US$4·50) or 22â500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556. FINDINGS: Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation. INTERPRETATION: Small financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care. FUNDING: National Institute of Mental Health at the US National Institutes of Health.
Assuntos
Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , Retenção nos Cuidados/estatística & dados numéricos , Reforço por Recompensa , Adulto , Fármacos Anti-HIV/uso terapêutico , Feminino , Infecções por HIV/psicologia , Humanos , Masculino , Resposta Viral Sustentada , Tanzânia , Carga Viral/efeitos dos fármacosRESUMO
Background: Heavy load carrying has been associated with musculoskeletal discomfort (MSD) and disability. However, there is a lack of research investigating this association in resource-constrained settings where heavy load carrying by women is common. Objectives: We assessed the impact of heavy load carrying on musculoskeletal pain and disability among women in Shinyanga Region, Tanzania, in an exploratory cross-sectional study. Methods: Eligible participants were a convenience sample of women, at least 18 years of age, who passed a study recruitment site carrying a load. We collected information on load-carrying practices, including frequency and time spent carrying water, wood, agricultural products, coal, sand, or rocks, and measured the weight of the load carried at the time. Outcomes included self-reported MSDs, defined as experiencing pain lasting >3 days in the neck, head, back, knees, feet and/or ankles within the last 1 year, and related disability. Using multivariable logistic regression we assessed for associations between load carrying exposures and MSDs and disability. Findings: Results showed a high prevalence of MSDs across the body regions assessed and evidence to suggest a relationship of back pain and related disability with several measures of load-carrying, including duration, frequency, and weight. Multivariable analyses revealed associations of increased load carrying exposures with low back pain (LBP) and related disability, including statistically significant increases in odds of LBP with increasing weight, total duration of load carrying/week and cumulative loads/week. Conclusions: Findings indicate a substantial burden of MSDs and disability in this population of women who carry heavy loads daily. The extent of discomfort and disability increased with increasing exposure to various load-carrying measures, especially for LBP. Larger epidemiologic studies that definitively assess relationships of load carrying with MSDs and disability are warranted.