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.

Food is Medicine for HIV: Improved health and hospitalizations in the Changing Health through Food Support (CHEFS-HIV) pragmatic randomized trial.

BACKGROUND: Policy support for "Food is Medicine"-medically tailored meals or groceries to improve health-is rapidly growing. No randomized trials have heretofore investigated the benefits of medically tailored food programs for people living with HIV (PLHIV). METHODS: The CHEFS-HIV pragmatic randomized trial included PLHIV who were clients of Project Open Hand (POH), a San Francisco-based nonprofit food organization. The intervention arm (n = 93) received comprehensive medically tailored meals, groceries, and nutritional education. Control participants (n = 98) received less intensive (POH "standard of care") food services. Health, nutrition, and behavioral outcomes were assessed at baseline and 6 months later. Primary outcomes measured were viral non-suppression and health related quality of life. Mixed models estimated treatment effects as differences-in-differences between arms. RESULTS: The intervention arm had lower odds of hospitalization (odds ratio [OR] = 0.11), food insecurity (OR = 0.23), depressive symptoms (OR = 0.32), antiretroviral therapy adherence <90% (OR = 0.18), and unprotected sex (OR = 0.18), and less fatty food consumption (ß= -0.170 servings/day) over 6 months, compared to the control arm. There was no difference between study arms in viral non-suppression and health-related quality of life over 6 months. CONCLUSIONS: A "Food-is-Medicine" intervention reduced hospitalizations and improved mental and physical health among PLHIV, despite no impact on viral suppression. CLINICAL TRIALS REGISTRATION: NCT03191253.

An agricultural livelihood intervention is associated with reduced HIV stigma among people living with HIV.

OBJECTIVE: HIV stigma undermines antiretroviral treatment (ART) adherence and viral suppression. Livelihood interventions may target drivers of negative attitudes towards people living with HIV (PLHIV) by improving their health and strengthening their economic contributions. We examined the effects of a multisectoral agricultural livelihood intervention on HIV stigma among PLHIV in western Kenya. DESIGN: Sixteen health facilities were randomly allocated (1:1) to intervention or control arms in Shamba Maisha, a cluster randomized controlled trial that aimed to improve HIV-related health through behavioral, mental health, and nutritional pathways. METHODS: The intervention included a farming loan and agricultural and financial training. Participants had access to farmland and surface water and were ≥18 years old, on ART >six months, and moderately-to-severely food insecure. We measured internalized, anticipated, and enacted HIV stigma semiannually over two years using validated scales. In blinded intent-to-treat analyses, we compared changes in scores over 24 months, by study arm, using longitudinal multi-level difference-in-differences linear regression models that accounted for clustering. RESULTS: Of 720 enrolled participants (354 intervention), 55% were female, and the median age was 40 years (interquartile range 34-47 years). Two-year retention was 94%. Compared to the control arm, the intervention resulted in significant decreases (p < 0.001) of 0.42 points (95% confidence interval (CI) -0.52, -0.31) in internalized stigma, 0.43 points (95% CI -0.51, -0.34) in anticipated stigma, and 0.13 points (95% CI -0.16, -0.09) in enacted stigma over 24 months. CONCLUSIONS: The agricultural livelihood intervention reduced HIV stigma among PLHIV. Poverty-reduction approaches may be a novel strategy for reducing HIV stigma.

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.

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.

Food Insecurity and Engagement in Transactional Sex Among Female Secondary Students in Rwanda.

The relationship between food insecurity and transactional sex is well recognized, but less is known about this relationship among adolescents. We analyzed cross-sectional baseline data from 3,130 female secondary students aged 12-19 enrolled in a three-arm, cluster randomized controlled trial to examine the association between food insecurity and transactional sex. The explanatory variable was food security and the outcome was ever engaging in transactional sex. Over one quarter (28.7%) reported any food insecurity and 1.9% of all participants (9.6% of sexually active participants) reported ever engaging in transactional sex. In adjusted models, ever experiencing any food insecurity was associated with a higher prevalence of ever transactional sex (PR: 1.60; 95% CI: 1.02, 2.49) compared to little to no food insecurity. These results provide insight into potential predictors of higher-risk sexual behavior in Rwanda; they also provide policy-makers with populations with whom to intervene on upstream determinants of transactional sex, notably poverty and food insecurity.

Impact of a livelihood intervention on gender roles and relationship power among people with HIV.

OBJECTIVE: To evaluate the impact of an agricultural livelihood intervention on gender role conflict and sexual relationship power among people with HIV (PWH) in western Kenya. DESIGN: Study participants were enrolled in Shamba Maisha , a cluster randomized controlled trial of an agricultural intervention conducted among PWH across 16 health facilities during 2016-2020. Intervention participants received a water pump, seeds, and agricultural and financial training; control participants received standard of HIV care. METHODS: We assessed men's views on masculinity and gender roles via the validated gender role conflict score (GRCS; range 18-78, higher = greater gender role conflict). We measured gender power imbalances among women via the validated Sexual Relationship Power Scale (SRPS), which combines subscales of relationship control and decision-making dominance (range 1-4, higher = female holds more power). We compared changes over the study period by arm using longitudinal multilevel difference-in-difference linear regression models accounting for clustering of facilities using the intention-to-treat cohort. RESULTS: We enrolled 720 participants (366 intervention, 354 control); 2-year retention was 94%. Median age was 40 and approximately 55% of participants were female. Among men, after 24-months the decrease in GRCS scores was 4.3 points greater in the intervention than the control arm ( P  < 0.001). Among women, the intervention resulted in 0.25 points greater increase in the SRPS compared to the control arm ( P  < 0.001). CONCLUSIONS: Shamba Maisha resulted in less gender role conflict in men and greater sexual relationship power for women. Agricultural livelihood interventions may be a powerful tool to improve gender power imbalances, which may subsequently mitigate poverty and food insecurity.

Links between Household-Level Income-Generating Agricultural Intervention and the Psychological Well-Being of Adolescent Girls in Human Immunodeficiency Virus-Affected Households in Southwestern Kenya: A Qualitative Inquiry.

BACKGROUND: Adolescent girls may experience poor psychological well-being, such as social isolation, shame, anxiety, hopelessness, and despair linked to food insecurity. OBJECTIVES: This study aimed to investigate the experiences with and perceived effects of a household-level income-generating agricultural intervention on the psychological well-being of adolescent girls in human immunodeficiency virus (HIV)-affected households in southwestern Kenya. METHODS: We conducted 62 in-depth interviews with HIV-affected adolescent girls and caregiver dyads in Adolescent Shamba Maisha (NCT03741634), a sub-study of adolescent girls and caregivers with a household member participating in Shamba Maisha (NCT01548599), a multisectoral agricultural and finance intervention trial aimed to improve food security and HIV health indicators. Participants were purposively sampled to ensure diversity in terms of age and location. Data were audiotaped, transcribed, translated, and uploaded into Dedoose (Sociocultural Research Consultants, LLC) software for management. Data were analyzed thematically based on reports from Dedoose. RESULTS: We found evidence that a household-level structural intervention aimed at increasing food and financial security among persons living with HIV can contribute to better psychological well-being among adolescent girls residing in these households. The intervention also affected: 1) reduction of social isolation, 2) reduction of shame and stigma, 3) increased attendance and concentration in school, 4) improved caregiver mental health, and 5) reduced parental aggression and improved household communication. These associations were reported more commonly among those in the intervention arm than the control arm. CONCLUSIONS: This study extends existing research by demonstrating how multisectoral structural interventions delivered at a household level can improve the psychological well-being of adolescents. We recommend that future research test livelihood interventions designed specifically for adolescent girls that integrate food-security interventions with other elements to address the social and psychological consequences of food insecurity holistically. This trial was registered at clinicaltrials.gov as NCT03741634.

Association of Higher Intake of Plant-Based Foods and Protein With Slower Kidney Function Decline in Women With HIV.

BACKGROUND: We investigated whether there exists an association between dietary acid load and kidney function decline in women living with HIV (WLWH) receiving antiretroviral therapy (ART). SETTING: One thousand six hundred eight WLWH receiving ART in the WIHS cohort with available diet data and a baseline estimated glomerular filtration rate (eGFR) ≥15 mL/minute/1.73 m2. METHODS: A brief dietary instrument conducted from 2013 to 2016 under the Food Insecurity Sub-Study was used for assessing fruits and vegetables (FV) and protein intake. A mixed-effects model with random intercept and slope was used to estimate subjects' annual decline rate in eGFR and the association between FV intake and eGFR decline, adjusting for sociodemographics, serum albumin, comorbidities, time on ART, ART drugs, HIV markers, and baseline eGFR. We evaluated whether markers of inflammation mediated the effect of FV intake on decline in eGFR, using causal mediation analysis. RESULTS: We found a dose-response relationship for the association of FV intake and eGFR decline, with lesser annual decline in eGFR in the middle and highest tertiles of FV intake. An increase of 5 servings of FV intake per day was associated with a lower annual eGFR decline (-1.18 [-1.43, -0.94]). On average, 39% of the association between higher FV intake and slower eGFR decline was explained by decreased levels of inflammation. CONCLUSIONS: Plant-rich diet was associated with slower decline in kidney function. Inflammation is a potential path through which diet may affect kidney function. The findings support an emerging body of literature on the potential benefits of plant-rich diets for prevention of chronic kidney disease.

Longitudinal Relationship Between Food Insecurity, Engagement in Care, and ART Adherence Among US Women Living with HIV.

Food insecurity disproportionately affects people with HIV and women in the United States (US). More evidence is needed to understand the interplay between levels of food insecurity and levels of antiretroviral therapy (ART) adherence over time, as well as how food insecurity relates to engagement in HIV care. We used random effects models with longitudinal data from the US Women's Interagency HIV Study to estimate the (1) adjusted associations of current and 6-month lagged food security with ART adherence categories (n = 1646), and (2) adjusted associations of food security with engagement-in-care (n = 1733). Very low food security was associated with a higher relative risk of ART non-adherence at prior and current visits compared with food security, and this association increased across non-adherence categories. Very low food security was associated with lower odds of receiving HIV care and higher odds of a missed visit. Food insecurity among US women with HIV is associated with poorer engagement in care and degree of ART non-adherence over time.

Preliminary Effects of an Urban Gardens and Peer Nutritional Counseling Intervention on HIV Treatment Adherence and Detectable Viral Load Among People with HIV and Food Insecurity: Evidence from a Pilot Cluster Randomized Controlled Trial in the Dominican Republic.

A pilot cluster randomized controlled trial involving two HIV clinics in the Dominican Republic assessed preliminary efficacy of an urban garden and peer nutritional counseling intervention. A total of 115 participants (52 intervention, 63 control) with moderate or severe food insecurity and sub-optimal antiretroviral therapy (ART) adherence and/or detectable viral load were assessed at baseline, 6- and 12-months. Longitudinal multivariate regression analysis controlling for socio-demographics and accounting for serial cluster correlation found that the intervention: reduced the prevalence of detectable viral load by 20 percentage points at 12 months; reduced any missed clinic appointments by 34 and 16 percentage points at 6 and 12 months; increased the probability of "perfect" ART adherence by 24 and 20 percentage points at 6 and 12 months; and decreased food insecurity at 6 and 12 months. Results are promising and warrant a larger controlled trial to establish intervention efficacy for improving HIV clinical outcomes.Trial registry Clinical Trials Identifier: NCT03568682.

RESUMEN: Un estudio piloto de un ensayo controlado aleatorio por conglomerados que involucró a dos clínicas del VIH en la República Dominicana evaluó de forma preliminar la eficacia de una intervención de huertos urbanos y consejería nutricional entre pares. Un total de 115 participantes (52 de intervención, 63 de control) con inseguridad alimentaria moderada o grave y con adherencia subóptima a la terapia antirretroviral (TARV) y/o carga viral detectable fueron evaluados al inicio del estudio, y a los 6 y 12 meses. El análisis de regresión longitudinal multivariada controlando por variables sociodemográficas y tomando en cuenta la correlación serial de clúster encontró que la intervención: redujo la prevalencia de carga viral detectable en 20 puntos porcentuales a los 12 meses; redujo las citas clínicas perdidas en 34 y 16 puntos porcentuales a los 6 y 12 meses; aumentó la probabilidad de adherencia "perfecta" al TARV en 24 y 20 puntos porcentuales a los 6 y 12 meses; y disminuyó la inseguridad alimentaria a los 6 y 12 meses. Los resultados son prometedores y justifican un ensayo controlado más grande para establecer la eficacia de la intervención en mejorar los resultados clínicos del VIH.

Depression, anxiety, and burnout among hospital workers during the COVID-19 pandemic: A cross-sectional study.

OBJECTIVES: Healthcare personnel have faced unprecedented mental health challenges during the COVID-19 pandemic. The study objective is to assess differences in depression, anxiety, and burnout among healthcare personnel with various occupational roles and whether financial and job strain were associated with these mental health outcomes. METHODS: We employed an anonymous survey between July and August 2020 at an urban county hospital in California, USA. We assessed depression, anxiety, and burnout using validated scales, and asked questions on financial strain and job strain. We performed logistic and linear regression analyses. RESULTS: Nurses (aOR 1.93, 95% CIs 1.12, 3.46), social workers (aOR 2.61, 95% CIs 1.35, 5.17), service workers (aOR 2.55, 95% CIs 1.20, 5.48), and administrative workers (aOR 2.93, 95% CIs 1.57, 5.61) were more likely than physicians to screen positive for depression. The odds of screening positive for anxiety were significantly lower for ancillary workers (aOR 0.32, 95% CIs 0.13-0.72) compared with physicians. Ancillary (aB = -1.77, 95% CIs -1.88, -0.47) and laboratory and pharmacy workers (aB -0.70, 95% CI -1.34, -0.06) reported lower levels of burnout compared with physicians. Financial strain partially accounted for differences in mental health outcomes across job categories. Lack of time to complete tasks and lack of supervisory support were associated with higher odds of screening positive for depression. Less job autonomy was associated with higher odds of screening positive for anxiety and higher burnout levels. CONCLUSIONS: We found significant disparities in mental health outcomes across occupational roles. Policies to mitigate the adverse impact of COVID-19 on health workers' mental health should include non-clinical staff and address financial support and job characteristics for all occupational roles.

Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial.

Importance: Food insecurity and HIV health outcomes are linked through nutritional, mental health, and health behavior pathways. Objective: To examine the effects of a multisectoral agriculture and livelihood intervention on HIV viral suppression and nutritional, mental health, and behavioral outcomes among HIV-positive adults prescribed antiretroviral therapy (ART). Design, Setting, and Participants: This cluster randomized clinical trial was performed in 8 pairs of health facilities in Kenya. Participants were 18 years or older, living with HIV, and receiving ART for longer than 6 months; had moderate to severe food insecurity; and had access to arable land and surface water and/or shallow aquifers. Participants were followed up every 6 months for 24 months. Data were collected from June 23, 2016, to June 13, 2017, with follow-up completed by December 16, 2019. Data were analyzed from June 25 to August 31, 2020, using intention-to-treat and per-protocol methods. Interventions: A loan to purchase a human-powered irrigation pump, fertilizer, seeds, and pesticides combined with the provision of training in sustainable agriculture and financial literacy. Main Outcomes and Measures: The primary outcome was the relative change from baseline to the end of follow-up in viral load suppression (≤200 copies/mL) compared between study groups using difference-in-differences analyses. Secondary outcomes included clinic attendance, ART adherence, food insecurity, depression, self-confidence, and social support. Results: A total of 720 participants were enrolled (396 women [55.0%]; mean [SD] age, 40.38 [9.12] years), including 366 in the intervention group and 354 in the control group. Retention included 677 (94.0%) at the 24-month visit. HIV viral suppression improved in both groups from baseline to end of follow-up from 314 of 366 (85.8%) to 327 of 344 (95.1%) in the intervention group and from 291 of 353 (82.4%) to 314 of 333 (94.3%) in the control group (P = .86). Food insecurity decreased more in the intervention than the control group (difference in linear trend, -3.54 [95% CI, -4.16 to -2.92]). Proportions of those with depression during the 24-month follow-up period declined more in the intervention group (from 169 of 365 [46.3%] to 36 of 344 [10.5%]) than the control group (106 of 354 [29.9%] to 41 of 333 [12.3%]; difference in trend, -0.83 [95% CI, -1.45 to -0.20]). Self-confidence improved more in the intervention than control group (difference in trend, -0.37 [95% CI, -0.59 to -0.15]; P = .001), as did social support (difference in trend, -3.63 [95% CI, -4.30 to -2.95]; P < .001). Conclusions and Relevance: In this cluster randomized trial, the multisectoral agricultural intervention led to demonstrable health and other benefits; however, it was not possible to detect additional effects of the intervention on HIV clinical indicators. Agricultural interventions that improve productivity and livelihoods hold promise as a way of addressing food insecurity and the underpinnings of poor health among people living with HIV in resource-limited settings. Trial Registration: ClinicalTrials.gov Identifier: NCT02815579.

Mechanisms linking gender-based violence to worse HIV treatment and care outcomes among women in the United States.

OBJECTIVE: To test whether substance use mediates the associations between gender-based violence (GBV) and suboptimal adherence to antiretroviral therapy (ART), and GBV and poor engagement in care, among women living with HIV (WLHIV) in the United States (US). DESIGN: We analyzed longitudinal data collected among 1717 WLHIV in the Women's Interagency HIV Study (WIHS). METHODS: From 2013 to 2017, WLHIV completed semi-annual assessments on GBV, substance use, and HIV treatment and care. Adjusted multilevel logistic regression models were built to estimate the impact of GBV on; suboptimal (<95%) adherence and at least one missed HIV care appointment without rescheduling in the past 6 months. Mediation analyses were performed to test whether heavy drinking and illicit drug use mediated the associations between GBV and the two HIV outcomes. RESULTS: The mean age was 47 (standard deviation = 9), 5% reported experiencing GBV, 17% reported suboptimal adherence and 15% reported at least one missed appointment in the past 6 months. Women who experienced GBV had a significantly higher odds of suboptimal adherence [adjusted odds ratio (aOR) = 1.99; 95% confidence interval (CI) = 1.40-2.83] and missed appointments (aOR = 1.92, 95% CI = 1.32-2.33). Heavy drinking and illicit drug use mediated 36 and 73% of the association between GBV and suboptimal adherence and 29 and 65% of the association between GBV and missed appointments, respectively. CONCLUSIONS: Substance use is an underlying mechanism through which GBV affects outcomes along the HIV care continuum among WLHIV in the US. To optimize HIV treatment and care among women, interventions should address the combined epidemics of substance use, violence, and HIV.

Testing a social network approach to promote HIV self-testing and linkage to care among fishermen at Lake Victoria: study protocol for the Owete cluster randomized controlled trial.

BACKGROUND: Nearly 50% of men living with HIV in many countries are unaware of their HIV status; men also have lower uptake of HIV treatment and pre-exposure prophylaxis (PrEP). In SSA, highly mobile men such as those working in fishing communities alongside Lake Victoria have low uptake of HIV testing and low rates of linkage to HIV treatment and PrEP, despite increasing availability of these services. HIV self-testing (HIVST) kits hold promise for overcoming barriers to HIV testing and linkage to services for HIV-positive and HIV-negative men. We describe here a protocol for an HIV status-neutral, social network-based approach to promote HIV testing, linkage to care and prevention, and better health outcomes, including adherence, in fishermen around Lake Victoria. METHODS: Utilizing beach management unit (BMU) registries of fishermen operating in three Lake Victoria fishing communities in Siaya County, Kenya, we completed a census and social network mapping to identify close social networks of men. Network clusters identified by a socially-central lead ("promotor") and selected to ensure maximal separation between treatment and control will be randomized. Promotors in both arms will receive basic HIV training; intervention promotors are further trained in HIVST to distribute kits to their cluster, while control promotors will distribute to their cluster vouchers for free HIVST at nearby clinics. We will test whether these promoters can enhance linkage to ART and PrEP after self-testing, thereby addressing a key limitation of HIVST. We will also measure 6- and 12-month viral load in those living with HIV and PrEP adherence among those without HIV via urine tenofovir levels as objective markers of adherence. DISCUSSION: This study has the potential to improve HIV health and promote HIV prevention among a hard to reach, at-risk, and highly mobile population of men in Western Kenya-a critical population in Kenya's HIV prevention and treatment program. Further, if successful, this innovative social networks-based model could be scaled at the regional level to address HIV prevention and care among similarly at-risk populations of men in eastern Africa and inland fisheries settings across the continent. TRIAL REGISTRATION: Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men, registered on February 26, 2021, registration # NCT04772469 .

Menopause Is Associated With Immune Activation in Women With HIV.

BACKGROUND: Persistent immune activation due to gut barrier dysfunction is a suspected cause of morbidity in HIV, but the impact of menopause on this pathway is unknown. METHODS: In 350 women with HIV from the Women's Interagency HIV Study, plasma biomarkers of gut barrier dysfunction (intestinal fatty acid binding protein; IFAB), innate immune activation (soluble CD14 and CD163; sCD14, sCD163), and systemic inflammation (interleukin-6 and tumor necrosis factor receptor 1; IL-6, TNFR1) were measured at 674 person-visits spanning ≤2 years. RESULTS: Menopause (post- vs premenopausal status) was associated with higher plasma sCD14 and sCD163 in linear mixed-effects regression adjusting for age and other covariates (ß = 161.89 ng/mL; 95% confidence interval [CI], 18.37-305.41 and 65.48 ng/mL, 95% CI, 6.64-124.33, respectively); but not with plasma IFAB, IL-6, or TNFR1. In piece-wise linear mixed-effects regression of biomarkers on years before/after the final menstrual period, sCD14 increased during the menopausal transition by 250.71 ng/mL per year (95% CI, 16.63-484.79; P = .04), but not in premenopausal or postmenopausal periods. CONCLUSIONS: In women with HIV, menopause may increase innate immune activation, but data did not support an influence on the gut barrier or inflammation. Clinical implications of immune activation during menopausal transition warrant further investigation.

Exploring antiretroviral therapy adherence, competing needs, and viral suppression among people living with HIV and food insecurity in the Dominican Republic.

Understanding factors related to suboptimal adherence to antiretroviral therapy (ART) and detectable viral load (VL), especially among vulnerable populations, is needed to improve HIV outcomes. The Caribbean is highly impacted by HIV and socioeconomic inequalities, but few studies have been conducted there to explore food insecurity among people with HIV and factors associated with viral suppression in this vulnerable population. Using baseline data from a pilot intervention trial among people living with HIV and food insecurity in the Dominican Republic, we examined psychosocial and behavioral factors associated with viral suppression, ART adherence, and competing needs. Among participants (n = 115), 61% had a detectable VL; the strongest factor associated with detectable VL was having missed taking ART in the last six months due to not having food (OR = 2.68, p = 0.02). Greater odds of reporting missed ART doses due to not having food were associated with severe food insecurity (OR = 4.60, p = 0.006), clinical depression (OR = 2.76, p = 0.018), Haitian background (OR = 6.62 p = 0.017), and internalized HIV stigma (OR = 1.09, p = 0.041), while lower odds were associated with social support (OR = 0.89, p = 0.03) and having health insurance (OR = 0.27, p = 0.017). Ensuring that people with HIV and food insecurity have food to take with their ART is essential for viral suppression.

Water Insecurity is Associated with Lack of Viral Suppression and Greater Odds of AIDS-Defining Illnesses Among Adults with HIV in Western Kenya.

Reliable access to safe and acceptable water in sufficient quantities (i.e., water security) is important for medication adherence and limiting pathogen exposure, yet prior studies have only considered the role of food security as a social determinant of HIV-related health. Therefore, the objective of this analysis was to assess the relationships between household water insecurity and HIV-related outcomes among adults living with HIV in western Kenya (N = 716). We conducted a cross-sectional analysis of baseline data from Shamba Maisha (NCT02815579), a cluster randomized controlled trial of a multisectoral agricultural and asset loan intervention. Baseline data were collected from June 2016 to December 2017. We assessed associations between water insecurity and HIV-related outcomes, adjusting for clinical and behavioral confounders, including food insecurity. Each five-unit higher household water insecurity score (range: 0-51) was associated with 1.21 higher odds of having a viral load ≥ 1000 copies/mL (95% CI 1.07, 1.36) and 1.26 higher odds of AIDS-defining illness (95% CI 1.11, 1.42). Household water insecurity was not associated with CD4 cell count (B: 0.27; 95% CI -3.59, 13.05). HIV treatment and support programs should consider assessing and addressing water insecurity in addition to food insecurity to optimize HIV outcomes.

RESUMEN: El acceso seguro al agua potable en cantidades suficientes (es decir, seguridad hídrica) es importante para la adherencia a la medicación y para limitar la exposición a patógenos; sin embargo, estudios anteriores solo han considerado el papel de la seguridad alimentaria como un determinante social de salud relacionado con el VIH. Por lo tanto, el objetivo de este análisis fue evaluar las relaciones entre la inseguridad hídrica en hogares y los resultados relacionados con el VIH en adultos que viven con VIH en el oeste de Kenia (N = 716). Realizamos un análisis transversal de los datos basales de la iniciativa Shamba Maisha (NCT02815579), un ensayo controlado aleatorio por conglomerados de una intervención multisectorial de créditos para insumos agrícolas. Los datos basales se recopilaron de junio de 2016 a diciembre de 2017. Evaluamos las asociaciones entre la inseguridad hídrica y resultados relacionados con el VIH, ajustando por factores de confusión clínicos y conductuales, incluyendo inseguridad alimentaria. Cada cinco unidades superiores de puntajes de inseguridad hídrica doméstica (rango: 0-51) fue asociado con 1.21 mayores probabilidades de tener una carga viral más alta ≥ 1000 copias / ml (CI 95%: 1,07-1,36) y con 1.26 mayores probabilidades de factores determinantes del SIDA (CI 95%: 1,11-1,42). La inseguridad de hídrica doméstica no se asoció con el recuento de células CD4 (B: −0,27; CI 95%: -13,59-13,05). Los programas de tratamiento y de apoyo al VIH deben considerar evaluar y abordar la inseguridad hídrica además de la inseguridad alimentaria para optimizar los resultados del VIH.

Relationship between food insecurity and smoking status among women living with and at risk for HIV in the USA: a cohort study.

OBJECTIVES: People living with HIV (PLHIV) in the USA, particularly women, have a higher prevalence of food insecurity than the general population. Cigarette smoking among PLHIV is common (42%), and PLHIV are 6-13 times more likely to die from lung cancer than AIDS-related causes. This study sought to investigate the associations between food security status and smoking status and severity among a cohort of predominantly low-income women of colour living with and without HIV in the USA. DESIGN: Women enrolled in an ongoing longitudinal cohort study from 2013 to 2015. SETTING: Nine participating sites across the USA. PARTICIPANTS: 2553 participants enrolled in the Food Insecurity Sub-Study of the Women's Interagency HIV Study, a multisite cohort study of US women living with HIV and demographically similar HIV-seronegative women. OUTCOMES: Current cigarette smoking status and intensity were self-reported. We used cross-sectional and longitudinal logistic and Tobit regressions to assess associations of food security status and changes in food security status with smoking status and intensity. RESULTS: The median age was 48. Most respondents were African-American/black (72%) and living with HIV (71%). Over half had annual incomes ≤US$12 000 (52%). Food insecurity (44%) and cigarette smoking (42%) were prevalent. In analyses adjusting for common sociodemographic characteristics, all categories of food insecurity were associated with greater odds of current smoking compared with food-secure women. Changes in food insecurity were also associated with increased odds of smoking. Any food insecurity was associated with higher smoking intensity. CONCLUSIONS: Food insecurity over time was associated with smoking in this cohort of predominantly low-income women of colour living with or at risk of HIV. Integrating alleviation of food insecurity into smoking cessation programmes may be an effective method to reduce the smoking prevalence and disproportionate lung cancer mortality rate particularly among PLHIV.

Food insecurity and frailty among women with and without HIV in the United States: a cross-sectional analysis.

INTRODUCTION: Frailty is frequently observed among people with HIV, and food insecurity is associated with frailty in the general population. Evidence is scarce on the associations between food insecurity and frailty among women with HIV who may be particularly vulnerable to the impacts of food insecurity. The goal of this study was to assess associations between food insecurity and frailty among women with and without HIV. METHODS: There were 1265 participants from the Women's Interagency HIV Study who participated in frailty assessments in 2017. Frailty was measured using the Fried Frailty Phenotype, and women were subsequently categorized as robust, pre-frail or frail. Food insecurity was assessed using the U.S. Household Food Security Survey Module, with women categorized as having high, marginal, low or very low food security. Multinomial logistic regression models were conducted to examine cross-sectional associations between food insecurity and frailty while adjusting for socio-demographic, behavioural and HIV status covariates. RESULTS AND DISCUSSION: Approximately one-third (31.9%) of the women had marginal, low or very low food security, and the proportions of women who met the criteria for frailty or pre-frailty were 55.6% and 12.4% respectively. In the adjusted model, the relative risk ratio (RRR) of frailty for women with very low food security versus women with high food security was 3.37 (95% CI [1.38 to 8.24], p < 0.01); the corresponding RRR of pre-frailty was 3.63 (95% CI [1.76 to 7.51], p < 0.001). Higher annual household income was associated with lower RRRs of frailty or pre-frailty (p < 0.01). Similarly, older age was associated with more frequent frailty (RRR=1.06, 95% CI [1.03 to 1.09], p < 0.001). HIV serostatus was not significantly associated with either pre-frailty (RRR=0.97, 95% CI [0.71 to 1.31]) or frailty (RRR=0.75, 95% CI [0.48 to 1.16]). CONCLUSIONS: Very low food security was associated with more frequent frailty and pre-frailty among women with and without for HIV. HIV serostatus was not associated with frailty.