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

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          Key Points

          Question

          Does a multisectoral, climate-adaptive, agricultural livelihood intervention improve health outcomes for individuals living with HIV and food insecurity?

          Findings

          In this cluster randomized clinical trial of 720 participants, the intervention did not lead to improvements in HIV viral suppression for adults living with HIV and receiving antiretroviral therapy. Viral suppression approached the UNAIDS goal of at least 95% in both study groups in the setting of widespread test and treatment policies launched during the study, and the intervention led to improvements of predefined secondary outcomes, including food security, mental health, self-confidence, and social support.

          Meaning

          In the setting of high-quality HIV service delivery, a multisectoral agricultural and livelihood intervention did not affect viral suppression.

          Abstract

          This cluster randomized clinical trial assesses whether a multisectoral agricultural livelihood intervention improves viral load suppression, reduces food insecurity, and improves nutrition, mental health, and empowerment indicators among people living with HIV in sub-Saharan Africa.

          Abstract

          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

          Related collections

          Most cited references39

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          The Lancet Commission on global mental health and sustainable development

          The Lancet, 392(10157), 1553-1598
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            Conceptual framework for understanding the bidirectional links between food insecurity and HIV/AIDS.

            Food insecurity, which affects >1 billion people worldwide, is inextricably linked to the HIV epidemic. We present a conceptual framework of the multiple pathways through which food insecurity and HIV/AIDS may be linked at the community, household, and individual levels. Whereas the mechanisms through which HIV/AIDS can cause food insecurity have been fairly well elucidated, the ways in which food insecurity can lead to HIV are less well understood. We argue that there are nutritional, mental health, and behavioral pathways through which food insecurity leads to HIV acquisition and disease progression. Specifically, food insecurity can lead to macronutrient and micronutrient deficiencies, which can affect both vertical and horizontal transmission of HIV, and can also contribute to immunologic decline and increased morbidity and mortality among those already infected. Food insecurity can have mental health consequences, such as depression and increased drug abuse, which, in turn, contribute to HIV transmission risk and incomplete HIV viral load suppression, increased probability of AIDS-defining illness, and AIDS-related mortality among HIV-infected individuals. As a result of the inability to procure food in socially or personally acceptable ways, food insecurity also contributes to risky sexual practices and enhanced HIV transmission, as well as to antiretroviral therapy nonadherence, treatment interruptions, and missed clinic visits, which are strong determinants of worse HIV health outcomes. More research on the relative importance of each of these pathways is warranted because effective interventions to reduce food insecurity and HIV depend on a rigorous understanding of these multifaceted relationships.
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              • Article: not found

              Understanding the impact of a microfinance-based intervention on women's empowerment and the reduction of intimate partner violence in South Africa.

              We sought to obtain evidence about the scope of women's empowerment and the mechanisms underlying the significant reduction in intimate partner violence documented by the Intervention With Microfinance for AIDS and Gender Equity (IMAGE) cluster-randomized trial in rural South Africa. The IMAGE intervention combined a microfinance program with participatory training on understanding HIV infection, gender norms, domestic violence, and sexuality. Outcome measures included past year's experience of intimate partner violence and 9 indicators of women's empowerment. Qualitative data about changes occurring within intimate relationships, loan groups, and the community were also collected. After 2 years, the risk of past-year physical or sexual violence by an intimate partner was reduced by more than half (adjusted risk ratio=0.45; 95% confidence interval=0.23, 0.91). Improvements in all 9 indicators of empowerment were observed. Reductions in violence resulted from a range of responses enabling women to challenge the acceptability of violence, expect and receive better treatment from partners, leave abusive relationships, and raise public awareness about intimate partner violence. Our findings, both qualitative and quantitative, indicate that economic and social empowerment of women can contribute to reductions in intimate partner violence.
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                Author and article information

                Journal
                JAMA Netw Open
                JAMA Netw Open
                JAMA Network Open
                American Medical Association
                2574-3805
                12 December 2022
                December 2022
                12 December 2022
                : 5
                : 12
                : e2246158
                Affiliations
                [1 ]Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco
                [2 ]Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi
                [3 ]Arnold School of Public Health, University of South Carolina, Columbia
                [4 ]Department of Medicine, University of California, San Francisco
                [5 ]KickStart International, San Francisco, California
                [6 ]Department of Land, Air and Water Resources, University of California, Davis
                [7 ]Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia
                [8 ]School of Nursing and Health Studies, University of Washington-Bothell, Bothell
                [9 ]Department of Epidemiology and Biostatistics, University of California, San Francisco
                [10 ]Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs
                Author notes
                Article Information
                Accepted for Publication: October 26, 2022.
                Published: December 12, 2022. doi:10.1001/jamanetworkopen.2022.46158
                Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Cohen CR et al. JAMA Network Open.
                Corresponding Author: Craig R. Cohen, MD, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, 550 16th St, Third Floor, San Francisco, CA 94143 ( craig.cohen@ 123456ucsf.edu ).
                Author Contributions: Dr Frongillo had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: Cohen, Weke, Frongillo, Fisher, Scow, Thirumurthy, Dworkin, Butler, Bukusi, Weiser.
                Acquisition, analysis, or interpretation of data: Cohen, Frongillo, Sheira, Burger, Mocello, Wekesa, Dworkin, Shade, Butler, Bukusi, Weiser.
                Drafting of the manuscript: Cohen, Weke, Frongillo, Sheira, Burger, Mocello, Scow, Weiser.
                Critical revision of the manuscript for important intellectual content: Cohen, Frongillo, Burger, Mocello, Wekesa, Fisher, Thirumurthy, Dworkin, Shade, Butler, Bukusi, Weiser.
                Statistical analysis: Frongillo, Sheira, Mocello, Weiser.
                Obtained funding: Cohen, Frongillo, Weiser.
                Administrative, technical, or material support: Cohen, Frongillo, Burger, Scow, Thirumurthy, Shade, Bukusi, Weiser.
                Supervision: Cohen, Weke, Frongillo, Sheira, Burger, Wekesa, Butler, Bukusi, Weiser.
                Conflict of Interest Disclosures: Dr Cohen reported receiving grant funding from the National Institute of Mental Health (NIMH) to the University of California, San Francisco (UCSF), during the conduct of the study. Dr Frongillo reported receiving grant funding from the National Institutes of Health (NIH) during the conduct of the study. Ms Burger reported receiving grant funding from the NIMH during the conduct of the study and grants from the NIH to Fogarty International Center outside the submitted work. Ms Mocello reported receiving grant funding from the NIMH during the conduct of the study. Dr Fisher reported receiving funding from UCSF to purchase the irrigation pumps (KickStart International made a small commercial margin on each pump), funding provided to KickStart International to help cover direct costs associated with training farmers for the study during the conduct of the study, and having a patent for Pump Valves issued with KickStart International. Dr Thirumurthy reported receiving grant funding from the NIH and Bill & Melinda Gates Foundation outside the submitted work. Dr Weiser reported receiving grant funding from the NIH during the conduct of the study. No other disclosures were reported.
                Funding/Support: The research described was supported by grant 1R01MH107330 from the NIMH, NIH.
                Role of the Funder/Sponsor: The NIMH had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
                Disclaimer: The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the NIH or the US government.
                Data Sharing Statement: See Supplement 3.
                Article
                zoi221305
                10.1001/jamanetworkopen.2022.46158
                9856331
                36508217
                5367633d-dce1-493d-8c08-795414553915
                Copyright 2022 Cohen CR et al. JAMA Network Open.

                This is an open access article distributed under the terms of the CC-BY License.

                History
                : 22 February 2022
                : 26 October 2022
                Categories
                Research
                Original Investigation
                Online Only
                Infectious Diseases

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