Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania.

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.

The impact of cash incentives on mental health among adults initiating antiretroviral therapy in Tanzania.

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.

Increased prevalence of depression and anxiety among adults initiating antiretroviral therapy during the COVID-19 pandemic in Shinyanga region, Tanzania.

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.

Risk and protective factors for mental health and wellbeing among adolescent orphans.

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, 75-90 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.

Psychometric validation of the collective asset Utu: associations with coping strategies and resilience during adolescence.

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.

Financial incentives to improve re-engagement in HIV care: results from a randomized pilot study.

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 (∼$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.

Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania.

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.

Machine learning with routine electronic medical record data to identify people at high risk of disengagement from HIV care in Tanzania.

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.

Promoting gender equity in very young adolescents: targeting a window of opportunity for social emotional learning and identity development.

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.

Durability of effects from short-term economic incentives for clinic attendance among HIV positive adults in Tanzania: long-term follow-up of a randomised controlled trial.

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.

Study Protocol of a Distance Learning Intervention to Support Social Emotional Learning and Identity Development for Adolescents Using Interactive Mobile Technology.

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.

Adolescent, caregiver and community experiences with a gender transformative, social emotional learning intervention.

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.

Heavy Load Carrying and Symptoms of Pelvic Organ Prolapse among Women in Tanzania and Nepal: An Exploratory Study.

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.

Transportation cost as a barrier to contraceptive use among women initiating treatment for HIV in Tanzania.

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.

Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial.

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: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 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.

The Impact of Heavy Load Carrying on Musculoskeletal Pain and Disability Among Women in Shinyanga Region, Tanzania.

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.

Effects of short-term cash and food incentives on food insecurity and nutrition among HIV-infected adults in Tanzania.

OBJECTIVE: Food insecurity impedes antiretroviral therapy (ART) adherence. We previously demonstrated that short-term cash and food incentives increased ART possession and retention in HIV services in Tanzania. To elucidate potential pathways that led to these achievements, we examined whether incentives also improved food insecurity. DESIGN: Three-arm randomized controlled trial. METHODS: From 2013 to 2015, 805 food-insecure adult ART initiates (≤90 days) at three clinics were randomized to receive cash or food transfers (∼$11 per month for ≤6 months, conditional on visit attendance) or standard-of-care (SOC) services. We assessed changes from baseline to 6 and 12 months in: food insecurity (severe; access; dietary diversity), nutritional status (body weight; BMI), and work status. Difference-in-differences average treatment effects were estimated using inverse-probability-of-censoring-weighted longitudinal regression models. RESULTS: The modified intention-to-treat analysis included 777 nonpregnant participants with 41.6% severe food insecurity. All three study groups experienced improvements from baseline in food insecurity, nutritional status, and work status. After 6 months, severe food insecurity declined within the cash (-31.4% points to 11.5%) and food (-30.3 to 10.4%) groups, but not within the SOC. Relative to the SOC, severe food insecurity decreased by an additional 24.3% points for cash (95% CI -45.0 to -3.5) and 23.3% percent points for food (95% CI -43.8 to -2.7). Neither intervention augmented improvements in severe food insecurity at 12 months, nor food access, dietary diversity, nutritional status, or work status at 6 or 12 months. CONCLUSION: Small cash and food transfers provided at treatment initiation may mitigate severe food insecurity. These effects may have facilitated previously observed improvements in ART adherence.

Do incentives undermine intrinsic motivation? Increases in intrinsic motivation within an incentive-based intervention for people living with HIV in Tanzania.

BACKGROUND: Cash and in-kind incentives can improve health outcomes in various settings; however, there is concern that incentives may 'crowd out' intrinsic motivation to engage in beneficial behaviors. We examined this hypothesis in a randomized trial of food and cash incentives for people living with HIV infection in Tanzania. METHODS: We analyzed data from 469 individuals randomized to one of three study arms: standard of care, short-term cash transfers, or short-term food assistance. Eligible participants were: 1) ≥18 years old; 2) HIV-infected; 3) food insecure; and 4) initiated antiretroviral therapy (ART) ≤90 days before the study. Food or cash transfers, valued at ~$11 per month and conditional on attending clinic visits, were provided for ≤6 months. Intrinsic motivation was measured at baseline, 6, and 12 months using the autonomous motivation section of the Treatment Self-Regulation Questionnaire (TSRQ). We compared the change in TSRQ score from baseline to 6 and 12 months and the change within study arms. RESULTS: The mean intrinsic motivation score was 2.79 at baseline (range: 1-3), 2.91 at 6 months (range: 1-3), and 2.95 at 12 months (range: 2-3), which was 6 months after the incentives had ended. Among all patients, the intrinsic motivation score increased by 0.13 points at 6 months (95% CI (0.09, 0.17), Cohen's d = 0.29) and 0.19 points at 12 months (95% CI (0.14, 0.24), Cohen's d = 0.49). Intrinsic motivation also increased within each study group at 6 months: 0.15 points in the food arm (95% CI (0.09, 0.21), Cohen's d = 0.37), 0.11 points in the cash arm (95% CI (0.05, 0.18), Cohen's d = 0.25), and 0.08 points in the comparison arm (95% CI (-0.03, 0.19), Cohen's d = 0.21); findings were similar at 12 months. Increases in motivation were statistically similar between arms at 6 and 12 months. CONCLUSION: Intrinsic motivation for ART adherence increased significantly both overall and within the food and cash incentive arms, even after the incentive period was over. Increases in motivation did not differ by study group. These results suggest that incentive interventions for treatment adherence should not be withheld due to concerns of crowding out intrinsic motivation.

The heterogeneous effect of short-term transfers for improving ART adherence among HIV-infected Tanzanian adults

A recently concluded randomized study in Tanzania found that short-term conditional cash and food transfers significantly improved HIV-infected patients' possession of antiretroviral therapy (ART) and reduced patient loss to follow-up (LTFU) (McCoy, S. I., Njau, P. F., Fahey, C., Kapologwe, N., Kadiyala, S., Jewell, N. P., & Padian, N. S. (2017). Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania. AIDS, 31(6), 815­825. doi:10.1097/QAD.0000000000001406 ). We examined whether these transfers had differential effects within population subgroups. In the parent study, 805 individuals were randomized to one of three study arms: standard-of-care (SOC) HIV services, food assistance, or cash transfer. We compared achievement of the medication possession ratio (MPR) ≥ 95% at 6 and 12 months and patient LTFU at 12 months between those receiving the SOC and those receiving food or cash (combined). Using a threshold value of p < 0.20 to signal potential effect measure modifiers (EMM), we compared intervention effects, expressed as risk differences (RD), within subgroups characterized by: sex, age, wealth, and time elapsed between HIV diagnosis and ART initiation. Short-term transfers improved 6 and 12-month MPR ≥ 95% and reduced 12-month LTFU in most subgroups. Study results revealed wealth and time elapsed between HIV diagnosis and ART initiation as potential EMMs, with greater effects for 6-month MPR ≥ 95% in the poorest patients (RD: 32, 95% CI: (9, 55)) compared to those wealthier (RD: 16, 95% CI: (5, 27); p = 0.18) and in newly diagnosed individuals (<90 days elapsed since diagnosis) (RD: 25, 95% CI: (13, 36)) compared to those with ≥90 days (RD: 0.3, 95% CI (−17, 18); p = 0.02), patterns which were sustained at 12 months. Results suggest that food and cash transfers may have stronger beneficial effects on ART adherence in the poorest patients. We also provide preliminary data suggesting that targeting interventions at patients more recently diagnosed with HIV may be worthwhile. Larger and longer-term assessments of transfer programs for the improvement of ART adherence and their potential heterogeneity by sub-population are warranted.

Pilot study of a multi-pronged intervention using social norms and priming to improve adherence to antiretroviral therapy and retention in care among adults living with HIV in Tanzania.

BACKGROUND: Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this hypothesis, we evaluated an intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming. METHODS: We used tools from marketing research and patient-centered design to develop a combination intervention that included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. We conducted a quasi-experimental pilot study with a random sample of exposed and unexposed adult patients living with HIV infection (PLHIV) to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months. Intervention acceptability was determined with a convenience sample of 405 PLHIV at baseline (n = 189) and endline (n = 216). RESULTS: Medical records were reviewed for 438 PLHIV (320 intervention, 118 standard of care). In adjusted analyses, PLHIV exposed to the intervention were significantly more likely to be in care after 6 months (87% vs. 79%, adjusted odds ratio (ORa) = 1.73, 95% CI: 1.08, 2.78, p<0.05) and were more likely to achieve MPR≥95% (70% vs. 59%, OR = 1.51, 95% CI: 0.96, 2.37, p = 0.07). The intervention was associated with increases in staff support of treatment goals (100% vs. 95%, p = 0.01) and life goals (66% vs. 50%, p<0.01), the perceived likelihood of other patients' adherence (54% vs. 32%, p<0.01), support from other patients (71% vs. 60%, p = 0.03), and being very satisfied with care (53% vs. 35%, p<0.01). CONCLUSIONS: This novel intervention has the potential to improve the clinic experience, short-term retention in care, and ART adherence. Future studies are needed to expand the generalizability of the approach and evaluate effectiveness on clinical outcomes. TRIAL REGISTRATION: Clinicaltrials.gov NCT02938533.