Relationship Power, Antiretroviral Adherence, and Physical and Mental Health Among Women Living with HIV in Rural Kenya.

Little is known about the association of gender-based power imbalances and health and health behaviors among women with HIV (WWH). We examined cross-sectional baseline data among WWH in a cluster-randomized control trial (NCT02815579) in rural Kenya. We assessed associations between the Sexual Relationship Power Scale (SRPS) and ART adherence, physical and mental health, adjusting for sociodemographic and social factors. SRPS consists of two subscales: relationship control (RC) and decision-making dominance. Women in the highest and middle tertiles for RC had a 7.49 point and 8.88 point greater Medical Outcomes Study-HIV mental health score, and a 0.27 and 0.29 lower odds of depression, respectively, compared to women in the lowest tertile. We did not find associations between SPRS or its subscales and ART adherence. Low sexual relationship power, specifically low RC, may be associated with poor mental health among WWH. Intervention studies aimed to improve RC among WWH should be studied to determine their effect on improving mental health.

RESUMEN: Poco se sabe acerca de su asociación con los desequilibrios de poder basados en el género y los comportamientos de salud y salud entre las mujeres con Virus de Inmunodeficiencia Humana (VIH). Examinamos los datos de referencia transversales entre mujeres con VIH en un ensayo de control aleatorizado por grupos (NCT02815579) en las zonas rurales de Kenia. Evaluamos las asociaciones entre la Escala de Poder de Relación Sexual y la adherencia a la Terapia Antirretroviral (TAR), la salud física y mental, ajustando por factores sociodemográficos y sociales. La Escala de Poder de Relación Sexual consiste de dos subescalas: control de relaciones y dominio en la toma de decisiones. Las mujeres en los terciles más alto y mediano para control de relaciones tenían una puntuación de salud mental de 7.49 puntos y 8.88 puntos mayor en el Medical Outcomes Study HIV Health Survey (MOS)-HIV, y una puntuación de salud mental de 0.27 y 0.29 menores probabilidades de depresión, respectivamente, en comparación con las mujeres en el tercil más bajo. El bajo poder de relación sexual, específicamente el control de relaciones bajo, puede estar asociado con una salud mental deficiente entre las mujeres con VIH. Se deben estudiar estudios de intervención destinados a mejorar el control de relaciones entre mujeres con VIH para determinar su efecto en mejorar la salud mental.

The Impact of Land Tenure Security on a Livelihood Intervention for People Living with HIV in Western Kenya.

Few studies have explored land access, a structural driver of health, and women's participation in livelihood interventions to improve food security and HIV outcomes. This qualitative study, embedded within Shamba Maisha (NCT02815579)-a randomized controlled trial (RCT) examining the impact of a multisectoral intervention among farmers living with HIV in western Kenya-sought to explore the influence of perceived access to and control of land on agricultural productivity, investments, and benefits. Thirty in-depth interviews (IDIs) were conducted with purposively sampled men and women, 3 to 6 months after receiving intervention inputs; data were deductively and inductively coded and analyzed. Farming practices and participation in Shamba Maisha were dependent on land tenure and participants' perceived strength of claim over their land, with participants who perceived themselves to be land insecure less likely to make long-term agricultural investments. Land tenure was influenced by a number of factors and posed unique challenges for women which negatively impacted uptake and success in the intervention. Data underscore the importance of secure land tenure for the success of similar interventions, especially for women; future interventions should integrate land security programming for improved outcomes for all.

HIV Testing and Treatment with the Use of a Community Health Approach in Rural Africa.

BACKGROUND: Universal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health. METHODS: We randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only). RESULTS: A total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39). CONCLUSIONS: Universal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.).

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.

Household Water and Food Insecurity Are Positively Associated with Poor Mental and Physical Health among Adults Living with HIV in Western Kenya.

BACKGROUND: Household food insecurity (FI) and water insecurity (WI) are prevalent public health issues that can co-occur. Few studies have concurrently assessed their associations with health outcomes, particularly among people living with HIV. OBJECTIVES: We aimed to investigate the associations between FI and WI and how they relate to physical and mental health. METHODS: Food-insecure adult smallholder farmers living with HIV in western Kenya were recruited to participate in a cluster-randomized controlled trial of a multisectoral agricultural and asset loan intervention. We used baseline data on experiences of FI (using the Household Food Insecurity Access Scale, range: 0-27) and WI (using a modified scale developed for this region, range: 0-51) in the prior month (n = 716). Outcomes included probable depression (using the Hopkins Symptom Checklist), fatigue and diarrhea in the prior month, and overall mental and physical health (using the Medical Outcomes Study HIV Health Survey, range: 0-100). We first assessed Pearson correlations between FI, WI, and sociodemographic characteristics. We then developed 3 regressions for each health outcome (control variables and FI; control variables and WI; control variables, FI, and WI) and compared model fit indexes. RESULTS: Correlations between household FI, WI, and wealth were low, meaning they measure distinct constructs. FI and WI were associated with numerous physical and mental health outcomes; accounting for both resource insecurities typically provided the best model fit. For instance, when controlling for FI, each 10-point higher WI score was associated with a 6.42-point lower physical health score (P < 0.001) and 2.92 times greater odds of probable depression (P < 0.001). CONCLUSIONS: Assessing both FI and WI is important for correctly estimating their relation with health outcomes. Interventions that address food- and water-related issues among persons living with HIV concurrently will likely be more effective at improving health than those addressing a single resource insecurity. This trial was registered at clinicaltrials.gov as NCT02815579.

Presence of Older Adolescents in the Household is Associated with Depressive Symptoms Among Women Living with HIV in Kenya.

The objective of this study was to determine the association between the number of adolescents in a household and depressive symptoms among adult caregivers living with HIV. We examined cross-sectional baseline data among adults enrolled in the Shamba Maisha multisectoral agricultural intervention (n = 705) in the Nyanza region of Kenya (NCT02815579). Each additional adolescent 15-19 years in a household was associated with a 1.35 (95% CI 1.06-1.71) higher odds of depressive symptoms among women, but not men, adjusting for potential confounders. Interventions to support the mental health of adults living with HIV may target women caring for dependent adolescents 15-19 years.

Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya.

BACKGROUND: Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. METHODS/DESIGN: We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up. DISCUSSION: The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability. TRIAL REGISTRATION: ClinicalTrials.gov NCT03466346, registered March 15, 2018.

Changes in Health and Antiretroviral Adherence Among HIV-Infected Adults in Kenya: Qualitative Longitudinal Findings from a Livelihood Intervention.

This longitudinal qualitative study sought to understand how and why a livelihood intervention affected the health and health behaviors of HIV-infected Kenyan adults. The intervention included a microfinance loan, agricultural and financial training, and a human-powered water pump. In-depth interviews were conducted at two time points with intervention and control participants and program staff. We double coded interviews (n = 117) and used thematic content analysis of transcripts following an integrative inductive-deductive approach. Intervention participants described improvements in HIV health, including increased CD4 counts and energy, improved viral suppression, and fewer HIV-related symptoms. Better health was linked to improved clinic attendance and ART adherence through several mechanisms: (1) reductions in food insecurity and abject hunger; (2) improved financial stability; (3) improved productivity which enhanced social support; (4) better control over work situations; and, (5) renewed desire to prioritize their own health. Livelihood interventions may improve health by influencing upstream determinants of health behavior including food security and poverty.

A Qualitative Investigation of the Impact of a Livelihood Intervention on Gendered Power and Sexual Risk Behaviors Among HIV-Positive Adults in Rural Kenya.

Despite the recognized links between food insecurity, poverty, and the risk of HIV/AIDS, few randomized trials have evaluated the impact of livelihood interventions on HIV risk behaviors. The current study draws upon data collected from a qualitative process evaluation that was embedded into a pilot randomized controlled trial that tested whether a multisectoral agricultural intervention (Shamba Maisha) affected the HIV-related health of HIV-positive adults in rural Kenya. In the current study, we drew upon longitudinal, in-depth interviews with 45 intervention participants and nine control participants (N = 54) in order to examine the impacts of the intervention on gendered power and sexual risk reduction among both women and men. Female and male participants in the intervention described positive changes in sexual practices and gendered power dynamics as a result of intervention participation. Changes included reduced sexual risk behaviors, improved gender-related power dynamics, and enhanced quality of intimate relationships. These findings illuminate how a multisectoral agricultural intervention may affect inequitable gender relations and secondary transmission risk. Further research is needed to explore how to best leverage agricultural interventions to address the important intersections between poverty and inequitable gender relations that shape HIV risks.

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.

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.

Defining a screening tool for post-traumatic stress disorder in East Africa: a penalized regression approach.

Background: Scalable PTSD screening strategies must be brief, accurate and capable of administration by a non-specialized workforce. Methods: We used PTSD as determined by the structured clinical interview as our gold standard and considered predictors sets of (a) Posttraumatic Stress Checklist-5 (PCL-5), (b) Primary Care PTSD Screen for the DSM-5 (PC-PTSD) and, (c) PCL-5 and PC-PTSD questions to identify the optimal items for PTSD screening for public sector settings in Kenya. A logistic regression model using LASSO was fit by minimizing the average squared error in the validation data. Area under the receiver operating characteristic curve (AUROC) measured discrimination performance. Results: Penalized regression analysis suggested a screening tool that sums the Likert scale values of two PCL-5 questions-intrusive thoughts of the stressful experience (#1) and insomnia (#21). This had an AUROC of 0.85 (using hold-out test data) for predicting PTSD as evaluated by the MINI, which outperformed the PC-PTSD. The AUROC was similar in subgroups defined by age, sex, and number of categories of trauma experienced (all AUROCs>0.83) except those with no trauma history- AUROC was 0.78. Conclusion: In some East African settings, a 2-item PTSD screening tool may outperform longer screeners and is easily scaled by a non-specialist workforce.

Comparing the effect of a multisectoral agricultural intervention on HIV-related health outcomes between widowed and married women.

INTRODUCTION: Widowed women make up 18-40% of the 12 million women living with HIV in eastern and southern Africa. Widowhood has also been associated with greater HIV morbidity and mortality. We compared the effectiveness of a multisectoral climate adaptive agricultural livelihood intervention (called Shamba Maisha) on food insecurity, and HIV related health outcomes among widowed and married women living with HIV in western Kenya. METHODS: We implemented Shamba Maisha (NCT02815579) using a cluster-randomized control trial design. The intervention arm received an US$175 in-kind loan to purchase a micro-irrigation pump, seeds, and fertilizer, and received eight training sessions on sustainable agriculture and financial management. Study outcomes were measured every 6 months over a 24-month follow-up period and trends in outcomes assessed using multilevel mixed-effects models. RESULTS: The trial enrolled 232 (61.5%) married and 145 (38.5%) widowed women. Widowed women (mean age 42.8 ± 8.4 years) were older than married women (35.8 ± 9.0 years) (p < 0.01). Almost all widowed women (97.2%) self-identified as household heads compared to 10.8% of married women. Comparing widowed vs married women, reduction in food insecurity (-3.13, 95%CI -4.42, -1.84 vs. -3.08, 95%CI -4.15, -2.02), depressive symptoms (-0.21, 95%CI -0.36, -0.07 vs. -0.19, 95%CI -0.29, -0.08), internalized stigma (-0.33, 95%CI -0.55, -0.11 vs. -0.38, 95%CI -0.57, -0.19), and anticipated stigma (-0.46 95%CI -0.65, -0.28 vs. -0.35, 95%CI -0.50, -0.21) was similar for both groups. In contrast, improvements in social support (-2.22, 95%CI -3.85, -0.59 vs. -4.00, 95%CI -5.16, -2.84; p = 0.08) and reduction in enacted stigma (0.01, 95%CI -0.06, 0.08 vs. -0.14, 95%CI -0.20, -0.09; p < 0.01) were weaker for widowed than married women. CONCLUSIONS: Our study is among the first comparing the effect of a livelihood intervention on HIV health outcomes among widowed and married women. Widowed women experienced similar benefits as married women on individual-level outcomes, but weaker benefit on outcomes dependent on their external environment like enacted stigma and social support. Future trials and programs targeting widowed women should bolster stigma reduction and social support.

Perceived impacts of a pilot agricultural livelihood and microfinance intervention on agricultural practices, food security and nutrition for Kenyans living with HIV.

INTRODUCTION: Agriculture is the primary source of income and household food for >75% of rural Kenyans, including people living with HIV (PLHIV), making agricultural yields an important factor in food security and nutrition. Previous studies have shown the interconnectedness of food insecurity, malnutrition, and poor HIV health by elucidating that having one of these conditions increases the likelihood and severity of having another. However, few studies have explored the linkages between agricultural practices, food security and nutrition for PLHIV, or how agricultural livelihood interventions may affect these domains. This study aimed to examine the mechanisms through which an agricultural livelihood intervention can positively or negatively affect agricultural practices, food security, and nutrition for PLHIV. METHODS: From July 2012-August 2013, we interviewed participants with HIV on antiretroviral therapy (ART) enrolled in a pilot randomized controlled trial (RCT) of an agricultural livelihood and finance intervention to understand the mechanisms through which the intervention may have affected HIV health outcomes. The intervention included agricultural and finance training and a microfinance loan to purchase the MoneyMaker hip pump, a human-powered water pump, seeds, and other farming implements. A purposive sample of 45 intervention and a random subset of 9 control participants were interviewed at 12-month endline visit with a subset of 31 intervention participants interviewed longitudinally at both the 3- and 12-month visits. Transcripts were double coded using an inductive-deductive approach and analyzed for impacts of the intervention on agricultural practices, food security, and nutrition using analytic reports for each key theme. RESULTS: All intervention participants described improvements in agricultural practices and yields attributed to the intervention while many also described improvements in income; these changes in turn contributed to improved HIV health, including suppressed viral loads, and a few people noted improved immunologic parameters. Key mechanisms included the knowledge gained from agricultural training which led to improved yields and access to new markets. The use of the irrigation pump was also identified as an additional, lesser important mechanism. All intervention participants reported sustained improvements in food security and nutrition through increased yields and income from the sale of excess crops used to purchase food, and diversification of fresh fruits and vegetables consumed through agricultural production. This led to self-reported weight gain which was a nutritional mechanism towards improved health. CONCLUSIONS: Agricultural and finance interventions that improve farming practices could lead to improved health outcomes through the pathways of improved food security, income, and diversified diet. The results from this study helped the team to enhance the intervention prior to implementation of the larger cluster RCT (cRCT). By understanding how agricultural livelihood interventions act upon pathways towards improved health, policy options can be developed and implemented to include components that are needed to achieve sustainable outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT01548599.

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.

Food Insecurity and Intimate Partner Violence Among HIV-Positive Individuals in Rural Kenya.

INTRODUCTION: Intimate partner violence and food insecurity are both structural drivers of HIV acquisition, care, and treatment, but little is known about how the 2 conditions intersect in the lives of those already living with HIV. METHODS: This study examined cross-sectional baseline data (collected in January 2016-December 2017) from an ongoing trial in southwestern Kenya. Trained interviewers asked enrolled participants living with HIV aged 18-60 years about household food insecurity (using the Household Food Insecurity Access Scale), intimate partner violence (using an adapted WHO multicountry study instrument), and sociodemographics. Negative binomial regression was used to examine the association between food insecurity and partner violence victimization (among women) or perpetration (among men). Secondary data were analyzed in August 2019-March 2020. RESULTS: Of 720 participants, more than half of women reported experiencing intimate partner violence (57.6%) and most men reported perpetrating it (58.4%). Participants reporting any partner violence had higher Household Food Insecurity Access Scale scores (21.8) compared with those reporting no violence (21.3, p=0.02). Each categorical change in food insecurity (mild, moderate, severe) was associated with a 41% increased risk of an additional partner violence episode. In models controlling for relationship status, wealth, season of interview (lean versus not lean), and baseline physical health, each 1-point increase in food insecurity was associated with a 6% higher risk of violence victimization among women and 4% greater risk of men perpetrating partner violence. CONCLUSIONS: This study highlights the interconnected nature of intimate partner violence and food insecurity among women and men living with HIV. This relationship suggests that enhancing food security may be a useful intervention strategy to prevent intimate partner violence and improve HIV-related health outcomes.

"When I Eat Well, I Will Be Healthy, and the Child Will Also Be Healthy": Maternal Nutrition among HIV-Infected Women Enrolled in a Livelihood Intervention in Western Kenya.

BACKGROUND: Food insecurity remains a major obstacle to achieving health and well-being for individuals living with HIV in western Kenya. Studies have shown that pregnant women are vulnerable to experiencing food insecurity worldwide, with significant consequences for both maternal and child health. The Shamba Maisha cluster randomized controlled trial in western Kenya (which means "farming for life" in Swahili) tested the effects of a multisectoral livelihood intervention consisting of agricultural and finance trainings, farm inputs, and a loan on health and food security among 746 farmers living with HIV in Kisumu, Homa Bay, and Migori Counties. OBJECTIVES: We conducted a qualitative substudy within the Shamba Maisha trial to understand the experiences and perspectives of pregnant women living with HIV enrolled in the trial. METHODS: Thirty women who had experienced a pregnancy during the Shamba Maisha study period, comprising 20 women in the intervention arm and 10 women in the control arm, completed in-depth interviews using a semistructured interview guide. RESULTS: Intervention participants interviewed noted improvements in maternal nutrition compared with previous pregnancies, which they attributed to the livelihood intervention. Key identified pathways to improved nutrition included improved access to vegetables, increased variety of diet through vegetable sales, and improved nutritional awareness. Women in the intervention arm also perceived increased weight gain compared with prior pregnancies and increased strength and energy throughout pregnancy. CONCLUSIONS: Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.This trial was registered at clinicaltrials.gov as NCT02815579.

High CD4 counts associated with better economic outcomes for HIV-positive adults and their HIV-negative household members in the SEARCH Trial.

BACKGROUND: Country decisions to scale-up "test and treat" approaches for HIV depend on consideration of both the health and economic consequences of such investments. Evidence about economic impacts of expanded antiretroviral therapy (ART) provision is particularly relevant for decisions regarding foreign assistance levels for HIV/AIDS programs. We used baseline data from the Sustainable East Africa Research in Community Health (SEARCH) cluster randomized controlled trial in Kenya and Uganda to examine the association between HIV status, CD4+ T-cell counts, viral suppression, and multiple indicators of economic well-being. METHODS AND FINDINGS: Socio-economic surveys were conducted in households with HIV-positive and HIV-negative adults sampled after a census of 32 communities participating in the SEARCH trial (NCT01864603). Data were obtained for 11,500 individuals from 5,884 households in study communities. Participants were stratified based on their own HIV status as well as CD4 counts and viral suppression status if they were HIV-positive. HIV-negative participants residing in households with no HIV-positive adults were considered separately from HIV-negative participants residing in households with ≥1 HIV-positive adult. Generalized estimating equation models were used to examine the relationship between HIV status, CD4 counts, ART, viral suppression, and outcomes of employment, self-reported illness, lost time from usual activities due to illness, healthcare utilization, health expenditures, and hospitalizations. In all models, HIV-negative participants in households with no HIV-positive persons were the reference group. There was no significant difference in the probability of being employed between HIV-positive participants with CD4>500 and the reference group of HIV-negative participants residing in households with no HIV-positive adults (marginal effect, ME, 1.49 percentage points; 95% confidence interval, CI, -1.09, 4.08). However, HIV-positive participants with CD4 351-500 were less likely to be employed than the reference group (ME -4.50, 95% CI -7.99, -1.01), as were HIV-positive participants with CD4 ≤350 (ME -7.41, 95% CI -10.96, -3.85). Similarly, there was no significant difference in employment likelihood between HIV-negative participants who resided in households with a CD4>500 HIV-positive person and the reference group (ME -1.78, 95% CI -5.16, 1.59). HIV-negative participants residing with an HIV-positive person with CD4 351-500, however, were less likely to be employed than the reference group (ME -7.03, 95% CI -11.49, -2.57), as were people residing with a household member with CD4 ≤350 (ME -6.28, 95% CI -10.76, -1.80). HIV-positive participants in all CD4 categories were more likely to have lost time from usual activities due to illness and have incurred healthcare expenditures. Those with CD4>500 had better economic outcomes than those with CD4 351-500, even among those not virally suppressed (p = 0.004) and not on ART (p = 0.01). CONCLUSIONS: Data from a large population-representative sample of households in east Africa showed a strong association between the health of HIV-positive persons and economic outcomes. The findings suggest there may be economic benefits associated with maintaining high CD4 counts, both for HIV-positive persons and their HIV-negative household members. The association of high CD4 counts with improved outcomes is consistent with the hypothesis that early ART initiation can avert declines in employment and other economic outcomes. Prospective longitudinal evaluation is needed to assess the causal impact of early ART initiation on economic functioning of households.

Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

OBJECTIVES: To determine if integration of family planning (FP) and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices) and decreased pregnancy rates. DESIGN: Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration) sites and oversaw integrated services at the original intervention (early integration) sites. SETTING: Eighteen health facilities in Kenya. SUBJECTS: Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2. INTERVENTION: "One-stop shop" approach to integrating FP and HIV services. MAIN OUTCOME MEASURES: Use of more effective contraceptive methods and incident pregnancy across two years of follow-up. RESULTS: Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR) = 1.39 (1.19-1.63). Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%). Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87). CONCLUSIONS: Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model. TRIAL REGISTRATION: ClinicalTrials.gov NCT01001507.