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.

Social network strategy (SNS) for HIV testing: a new approach for identifying individuals with undiagnosed HIV infection in Tanzania.

Social network strategy (SNS) testing uses network connections to refer individuals at high risk to HIV testing services (HTS). In Tanzania, SNS testing is offered in communities and health facilities. In communities, SNS testing targets key and vulnerable populations (KVP), while in health facilities it complements index testing by reaching unelicited index contacts. Routine data were used to assess performance and trends over time in PEPFAR-supported sites between October 2021 and March 2023. Key indicators included SNS social contacts tested, and new HIV-positives individuals identified. Descriptive and statistical analysis were conducted. Univariable and multivariable analysis were applied, and variables with P-values <0.2 at univariable analysis were considered for multivariable analysis. Overall, 121,739 SNS contacts were tested, and 7731 (6.4%) previously undiagnosed individuals living with HIV were identified. Tested contacts and identified HIV-positives were mostly aged ≥15 years (>99.7%) and females (80.6% of tests, 79.4% of HIV-positives). Most SNS contacts were tested (78,363; 64.7%) and diagnosed (6376; 82.5%) in communities. SNS tests and HIV-positives grew 11.5 and 6.1-fold respectively, from October-December 2021 to January-March 2023, with majority of clients reached in communities vs. facilities (78,763 vs. 42,976). These results indicate that SNS testing is a promising HIV case-finding approach in Tanzania.

Risk Factors for Recent HIV Infections among Adults in 14 Countries in Africa Identified by Population-Based HIV Impact Assessment Surveys, 2015-2019.

Identifying persons who have newly acquired HIV infections is critical for characterizing the HIV epidemic direction. We analyzed pooled data from nationally representative Population-Based HIV Impact Assessment surveys conducted across 14 countries in Africa for recent infection risk factors. We included adults 15-49 years of age who had sex during the previous year and used a recent infection testing algorithm to distinguish recent from long-term infections. We collected risk factor information via participant interviews and assessed correlates of recent infection using multinomial logistic regression, incorporating each survey's complex sampling design. Compared with HIV-negative persons, persons with higher odds of recent HIV infection were women, were divorced/separated/widowed, had multiple recent sex partners, had a recent HIV-positive sex partner or one with unknown status, and lived in communities with higher HIV viremia prevalence. Prevention programs focusing on persons at higher risk for HIV and their sexual partners will contribute to reducing HIV incidence.

Emerging integrase strand transfer inhibitor drug resistance mutations among children and adults on ART in Tanzania: findings from a national representative HIV drug resistance survey.

BACKGROUND: Despite the scale-up of ART and the rollout in Tanzania of dolutegravir, an integrase strand transfer inhibitor (INSTI), treatment success has not been fully realized. HIV drug resistance (HIVDR), including dolutegravir resistance, could be implicated in the notable suboptimal viral load (VL) suppression among HIV patients. OBJECTIVES: To determine the prevalence and patterns of acquired drug resistance mutations (DRMs) among children and adults in Tanzania. METHODS: A national cross-sectional HIVDR survey was conducted among 866 children and 1173 adults. Genotyping was done on dried blood spot and/or plasma of participants with high HIV VL (≥1000 copies/mL). HIV genes (reverse transcriptase, protease and integrase) were amplified by PCR and directly sequenced. The Stanford HIVDR Database was used for HIVDR interpretation. RESULTS: HIVDR genotyping was performed on blood samples from 137 participants (92 children and 45 adults) with VL ≥ 1000 copies/mL. The overall prevalence of HIV DRMs was 71.5%, with DRMs present in 78.3% of children and 57.8% of adults. Importantly, 5.8% of participants had INSTI DRMs including major DRMs: Q148K, E138K, G118R, G140A, T66A and R263K. NNRTI, NRTI and PI DRMs were also detected in 62.8%, 44.5% and 8% of participants, respectively. All the participants with major INSTI DRMs harboured DRMs targeting NRTI backbone drugs. CONCLUSIONS: More than 7 in 10 patients with high HIV viraemia in Tanzania have DRMs. The early emergence of dolutegravir resistance is of concern for the efficacy of the Tanzanian ART programme.

Risks of Intimate Partner Violence for Women Living with HIV Receiving Cash Transfers: A Qualitative Study in Shinyanga, Tanzania.

Cash transfers are increasingly used to motivate adherence to HIV care. However, evidence on cash transfers and intimate partner violence (IPV) is mixed and little is known about their safety for women living with HIV. We conducted in-depth interviews with women living with HIV who participated in a randomized trial providing 6 months of cash transfers (~$4.5 or $11 USD) conditional on HIV clinic attendance in Shinyanga, Tanzania to assess how receiving cash affects IPV and relationship dynamics. Eligible participants were 18-49 years, received cash transfers, and in a partnership at baseline. Data were analyzed in Dedoose using a combined inductive-deductive coding approach. 25 interviews were conducted between November 2019-February 2020. Women's employment was found to be a source of household tension and violence. None of the participants reported physical or sexual IPV in relation to cash transfers, however, some women experienced controlling behaviors or emotional violence including accusations and withholding of money, particularly those who were unemployed. Cash transfers were predominantly used for small household expenses and were not viewed as being substantial enough to shift the financial dynamic or balance of power within relationships. Our findings suggest that small, short-term cash transfers do not increase physical or sexual IPV for women living with HIV however can exacerbate controlling behaviors or emotional violence. Modest incentives used as a behavioral nudge to improve health outcomes may affect women differently than employment or larger cash transfers. Nonetheless, consultations with beneficiaries should be prioritized to protect women from potential IPV risks.

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.

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.

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.

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.

HIV prevention at drug shops: awareness and attitudes among shop dispensers and young women about oral pre-exposure prophylaxis and the dapivirine ring in Shinyanga, Tanzania.

BACKGROUND: HIV risk remains high among adolescent girls and young women (AGYW, ages 15-24) in Tanzania. Many AGYW experience stigma and provider bias at health facilities, deterring their use of HIV prevention services. Privately-owned drug shops, ubiquitous in many communities, may be an effective and accessible channel to deliver HIV prevention products to AGYW, including oral pre-exposure prophylaxis (PrEP) and the dapivirine vaginal ring. METHODS: In July-August 2019, we enrolled 26 drug shops in Shinyanga, Tanzania in an ongoing study to create "girl-friendly" drug shops where AGYW can access HIV self-testing and contraception. At baseline, all shop dispensers were given basic information about oral PrEP and the dapivirine ring and were asked about their interest in stocking each. During the next 3-5 months, we surveyed AGYW (n = 56) customers about their interest in oral PrEP and the ring. RESULTS: Among dispensers, the median age was 42 years and 77% were female. Overall, 42% of dispensers had heard of a medication for HIV prevention. Almost all dispensers reported some interest in stocking oral PrEP (92%) and the dapivirine ring (96%). Most (85%) reported they would provide oral PrEP to AGYW who requested it. Among AGYW customers, the median age was 17 years; 29% of AGYW were married or had a steady partner and 18% had children. Only 20% of AGYW had heard of a medication to prevent HIV, yet 64% and 43% expressed some interest in using oral PrEP and the dapivirine ring, respectively, after receiving information about the products. PrEP interest was higher among AGYW who were partnered and had children. CONCLUSIONS: Despite low prior awareness of PrEP among shop dispensers and AGYW, we found high levels of interest in oral PrEP and the dapivirine ring in both groups. Community-based drug shops represent a promising strategy to make HIV prevention more accessible to AGYW.

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.

Sales and pricing decisions for HIV self-test kits among local drug shops in Tanzania: a prospective cohort study.

BACKGROUND: Public health initiatives must look for ways to cost-effectively scale critical interventions to achieve high coverage. Private sector distribution channels, can potentially distribute preventive healthcare products to hard-to-reach populations, decongest public healthcare systems, and increase the sustainability of programs by getting customers to share costs. However, little is known about how sellers set prices for new products. By introducing a new product, HIV self-test kits, to local drug shops, we observed whether shops experimented with pricing, charged different buyers different prices, and whether prices converged within the local market over our study period. METHODS: From August to December 2019, we provided free HIV self-test kits, a new product, to 26 drug shops in Shinyanga, Tanzania to sell to the local community. We measured sales volume, price, customer age and sex using shop records. Using a multiple linear regression model, we conducted F-tests to determine whether shop, age, sex, and time (week) respectively were associated with price. We measured willingness-to-pay to restock test kits at the end of the study. RESULTS: 514 test kits were sold over 18 weeks; 69% of buyers were male, 40% were aged 25-34 and 32% aged 35-44. Purchase prices ranged from 1000 to 6000 Tsh (median 3000 Tsh; ~$1.30 USD). Within shops, prices were 11.3% higher for 25-34 and 12.7% higher for 45+ year olds relative to 15-19-year olds (p = 0.029) and 13.5% lower for men (p = 0.023) on average. Although prices varied between shops, prices varied little within shops over time, and did not converge over the study period or cluster geospatially. Mean maximum willingness-to-pay to restock was 2000 Tsh per kit. CONCLUSIONS: Shopkeepers charged buyers different prices depending on buyers' age and sex. There was limited variation in prices within shops over time and low demand among shopkeepers to restock at the end of the study. Given the subsidized global wholesale price ($2 USD or ~ 4600 Tsh), further demand creation and/or cost-reduction is required before HIV self-test kits can become commercially viable in drug shops in this setting. Careful consideration is needed to align the motivations of retailers with public health priorities while meeting their private for-profit needs.

Vulnerable at Each Step in the PMTCT Care Cascade: High Loss to Follow Up During Pregnancy and the Postpartum Period in Tanzania.

In 2013, Tanzania adopted the World Health Organization's Option B+ guidelines for prevention of mother-to-child transmission of HIV (PMTCT), whereby all HIV-infected pregnant women initiate lifelong antiretroviral therapy. This study examined retention in PMTCT across critical junctures in the care continuum. This was a retrospective study of patient-level data for a cohort of women enrolled in PMTCT during the first year of Option B+ in Tanzania. Retention in care was described across three periods: (1) the first month of antenatal care (ANC), (2) pregnancy, and (3) the postpartum period. Logistic regression was used to identify factors associated with loss to follow up (LTFU) during the first month of ANC. Survival analyses were used to identify factors associated with LTFU during pregnancy and the postpartum periods. 650 participants were included in the cohort; 262 (40.3%) were newly diagnosed with HIV. Two years after delivery, 383/650 (58.7%) were LTFU. Of the 383 LTFU, 73 (19.1%) were lost during the first month of ANC, 44 (11.5%) during pregnancy, and 266 (69.5%) after delivery. Being newly diagnosed with HIV predicted higher LTFU during the first month of ANC (aOR 1.76; 95% CI 1.06-2.94) and faster time to LTFU during the postpartum period (adjusted relative time, 0.68; 95% CI 0.51-0.89). High LTFU occurred across the PMTCT continuum, including immediately after enrollment into ANC and the postpartum period. Ongoing research is needed to encourage treatment uptake and sustained engagement after delivery.

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.

It helps me live, sends my children to school, and feeds me: a qualitative study of how food and cash incentives may improve adherence to treatment and care among adults living with HIV in Tanzania.

Financial and in-kind incentives have been shown to improve outcomes along the HIV care cascade, however the potential mechanismsthrough which they work remain unclear. To identify the pathways through which incentives improve retention in care and adherence to antiretroviral therapy (ART), we conducted a qualitative study with participants in a trial evaluating conditional food and cash incentives for HIV-positive food insecure adults in Shinyanga, Tanzania. We found that the incentives acted through three pathways to potentially increase retention in care and adherence to ART: (1) addressing competing needs and offsetting opportunity costs associated with clinic attendance, (2) alleviating stress associated with attending clinic and meeting basic needs, and (3) by potentially increasing motivation. Participants did not report any harmful events associated with the incentives, but reported myriad beneficial effects on household welfare. Understanding how incentives are used and how they impact outcomes can improve the design of future interventions.

Rationale and design of a randomized study of short-term food and cash assistance to improve adherence to antiretroviral therapy among food insecure HIV-infected adults in Tanzania.

BACKGROUND: Food insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV). However, there is a lack of rigorous evidence about how to improve food security and HIV-related clinical outcomes. To address this gap, this randomized trial will evaluate three delivery models for short-term food and nutrition support for food insecure PLHIV in Shinyanga, Tanzania: nutrition assessment and counseling (NAC) alone, NAC plus food assistance, and NAC plus cash transfers. METHODS/DESIGN: At three HIV care and treatment sites, 788 participants will be randomized into one of three study arms in a 3:3:1 ratio, stratified by site: NAC plus food assistance, NAC plus cash transfer, and NAC only. Eligible participants are: 1) at least 18 years of age; 2) living with HIV infection; 3) initiated ART in the past 90 days; and 4) food insecure, as measured with the Household Hunger Scale. PLHIV who are severely malnourished (body mass index (BMI) < 16 kg/m(2)) will be excluded. Participants randomized to receive food or cash transfers are eligible to receive assistance for up to six months, conditional on attending regularly scheduled visits with their HIV care provider. Participants will be followed for 12 months: the initial 6-month intervention period and then for another 6 months post-intervention. The primary outcome is ART adherence measured with the medication possession ratio. Secondary outcomes include 1) retention in care; 2) nutritional indicators including changes in food security, BMI, and weight gain; 3) viral suppression and self-reported ART adherence; and 4) participation in the labor force. DISCUSSION: This rigorously designed trial will inform policy decisions regarding supportive strategies for food insecure PLHIV in the early stages of treatment. The study will measure outcomes immediately after the period of support ends as well as 6 months later, providing information on the duration of the interventions' effect. The comparison of food to cash transfers will better inform policies favoring cash assistance or will provide rationale for the continued investment in food and nutrition interventions for PLHIV. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01957917.

Food insecurity, socioeconomic status, and HIV-related risk behavior among women in farming households in Tanzania.

Food insecurity (FI) is associated with higher-risk sexual behavior in some studies. However, the overlap between FI and socioeconomic status (SES) has been poorly described. The study objectives were to: (1) determine the relationship between household FI and four dimensions of SES among sexually active Tanzanian women in farming households: expenditures, assets, flooring material of the home, and land ownership; and (2) determine whether FI is associated with higher-risk sexual behavior and relationship power. In male-headed households, FI was associated with assets, flooring material, and land ownership but not expenditures. There was no association between FI and the four dimensions of SES in female-headed households. Among women in male-headed households, but not female household heads themselves, severe FI was associated with a non-significant increase in the likelihood of being in a relationship because of material goods [adjusted prevalence ratio (PRa) = 1.76, 95 % confidence interval (CI) 0.81, 3.81] and was inversely associated with being able to ask partners to use condoms (PRa = 0.47, 95 % CI 0.25, 0.88). There was not a strong association between food security and relationship power. Our findings suggest that the association between FI and HIV risk behavior may differ depending on the type of household.

The Impact of Financial Incentives on Mental Health among Adults in HIV Care in Lake Zone, Tanzania: A Two-Arm Randomized Controlled Trial.

OBJECTIVE: Depression and anxiety are prevalent among people living with HIV (PLHIV), hindering retention in care. Though economic interventions can improve care engagement and mental health in the general population, this remains understudied among PLHIV. 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 2021-2023, 32 clinics were randomized to offer patients monthly financial incentives (22,500 TSH/$10 USD) for ≤6 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, 6, and 12 months. Difference-in-differences effects were used to estimate changes over time by arm using inverse probability of censoring sample weights (IPCW). RESULTS: Participants (n = 1990) 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%, respectively, with no differences by arm. Using IPCW, the differences in the prevalence of depression and anxiety symptoms between arms were 2.5 percentage points (95% CI: -3.0, 8.0) and 2.3 percentage points (95% CI: -3.2, 7.9) respectively after 6 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 12 months. CONCLUSION: Both study arms experienced substantial reductions in poor mental health, primarily within the first 6 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.

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.

Supporting young women's health through girl-friendly drug vendors in Lake Zone, Tanzania: protocol for the AmbassADDOrs for Health cluster-randomised controlled trial.

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.