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Table 1 Measurements

From: Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial

Path Measurement Definition Frequency
Nutritional Pathway Nutritional status Nutritional status was assessed through body mass index (BMI) and mid-upper arm circumference (MUAC), commonly used to assess nutritional status (Physical Status 1995; Collins et al. 2000). The BMI reflects protein and fat reserves (James et al. 1988) and was assessed using an established grading system (Ferro-Luzzi et al. 1992). For MUAC, we used WHO sex-specific cut-offs of 22.0 cm for females and 23.0 cm for males with chronic energy deficiency (Doocy et al. 2005). Semi-annually
Food frequency Food frequency, the number of different foods or food groups and the frequency consumed over a given reference period (Hoddinott & Yohannes 2002), as adapted from the World Food Programme Food Consumption Score was collected. Quarterly
Behavioral Pathway Pill count ART adherence Participants received an unannounced visit to inventory medications and count pills (Bangsberg et al. 2001a; Bangsberg et al. 2001b; Bangsberg et al. 2000), a technique closely correlated with electronically monitored adherence, HIV viral load (Bangsberg et al. 2000) and progression to AIDS (Bangsberg et al. 2001c). The count of existing pills was reconciled with the participant’s pharmacy refill history to determine the percentage of pills not yet consumed. Quarterly
Competing demands Questions were modified from Gelberg and Anderson’s Behavioral Model for Vulnerable Populations (Gelberg et al. 2000; Gelberg et al. 1997) to assess how often lack of food interferes with ability to procure drugs or visit the clinic. Semi-annually
Healthcare access Utilization of health care services including hospitalizations and clinic visits over the preceding 6 months were collected. Semi-annually
Mental Health Pathway Mental health & depression Mental health status was measured using the Medical Outcomes Study HIV Health Survey (MOS-HIV), a tool for assessing health-related quality of life (Wu et al. 1991) that has been validated in resource-limited settings (Chatterton et al. 1999; Mast et al. 2004). Depression was screened using the Hopkins Symptom Check-list for depression, a 15-item scale (Derogatis et al. 1974) which has been validated in sub-Saharan Africa (Bolton et al. 2004). Semi-annually
HIV-related stigma We used the Internalized AIDS-Related Stigma Scale (Kalichman et al. 2009). Semi-annually
Disclosure of HIV status We asked about disclosure of HIV status to partners, family members, friends, colleagues, and public. These questions were adapted from our previous studies in Uganda, Botswana and Swaziland (Weiser et al. 2007; Wolfe et al. 2008; Tsai et al. 2013). Semi-annually
Alcohol use To measure alcohol use, we adapted the Alcohol Use Disorders Identification Test (AUDIT-C) indicators. The AUDIT-C is a 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders. Semi-annually
Empowerment Gender empowerment Empowerment indicators were adapted from a large cluster-randomized trial of an intervention including: greater challenges to established gender roles, communication with relationship partner about sexual matters in the prior 3 months, measures of financial decision-making, measures of attitudes towards gender roles and gender-based violence, and experience of controlling behavior by relationship partner in prior 3 months (Pronyk et al. 2006). In addition, we used the Sexual Relationship Power Scale (SRPS) (Pulerwitz et al. 2000), which conceptualizes sexual relationship power as a multi-dimensional construct consisting of relationship control and decision making dominance. The SRPS has been used successfully in observational research conducted in South Africa (Dunkle et al. 2004; Jewkes et al. 2010) and Uganda.(Weiser et al. 2010a, b) We also collected data on sexual victimization and perpetration in the prior 3 months. Semi-annually
Proximal Mediators Food insecurity The Household Food Insecurity Access Scale (HFIAS) has been validated in eight countries (Coates et al. 2006a; Swindale & Bilinsky 2006; Frongillo & Nanama 2006; Coates et al. 2006b) and used successfully by our team in rural Uganda. (Weiser et al. 2010a; Tsai et al. 2011; Weiser et al. 2012; Tsai et al. 2012; Weiser et al. 2010a, b; Miller et al. 2011; Tsai et al. 2011) Semi-annually
Agricultural measures Agricultural measures were adapted from outcome evaluations developed by Kickstart in Kenya and supplemented by outcome indicators found in an earlier pilot study and a rural assessment. These measures were designed to evaluate uptake and adoption, and to measure changes in agricultural practices including crop diversity and agricultural practices and production. In addition, we evaluated the effectiveness of the training, and specific topics within, so as to refine the training for the subsequent larger cluster-randomized trial. Quarterly
Household economic indicators A modification of the World Bank Living Standards Measurement Study (LSMS) questionnaire (Grosh & Glewwe 1998) was used to measure: a) expenditures (food, health, education and productive investments); b) consumption (food and non-food); c) income (from agriculture and all sources); and d) inter-household commodity and cash transfers. Quarterly
Behavioral Outcome Risky sexual behaviors The primary transmission risk outcome was unprotected sex. Other outcomes included: number of non-spousal/non-cohabiting sexual partners, sex-exchange (exchanging sex for money, food, or other resources) Dupas & Robinson 2010); Robinson & Yeh 2011). Semi-annually
Health Outcomes HIV-related mortality Burial permits and information from family members were used to determine cause of death. As needed
Viral load suppression Viral load testing was performed on venous blood on the COBAS TaqMan HIV viral load platform (Roche Molecular Diagnostics, Pleasanton, CA) with a lower limit of detection of <20 copies/mL. Semi-annually
CD4 Count We abstracted data for CD4 counts from participant’s medical records. Absolute CD4 count testing was performed on whole blood using the BD FACSCount (BD Bioscience, San Jose, CA). Semi-annually
HIV morbidity HIV morbidity was measured through key outcomes from the medical record. We abstracted data every 3 months for ART treatment interruptions and episodes of opportunistic infections. We also gathered self-report data on opportunistic infections and symptoms during structured interviews. Quarterly/Semi-annually
Physical health Health status was measured using the MOS-HIV, a tool for assessing health-related quality of life (Wu et al. 1991) that has been validated in resource-limited settings (Chatterton et al. 1999; Mast et al. 2004). Semi-annually
Covariates Demographics Age, religion, education, marital/partnership status, number of children and household census. Baseline
Social support To measure social support, we adapted the Functional Social Support Scale (Antelman et al. 2001), a modified version of the Duke University-University of North Carolina Functional Support Questionnaire (Broadhead et al. 1988) consisting of questions related to perceived emotional and instrumental support. Higher scores reflect higher levels of social support. Semi-annually
ART history and Self-reported ART adherence Detailed ART history, ART self-reported adherence and barriers to ART adherence were collected. For self-report adherence, we used the visual analog scale (Oyugi et al. 2004) and the three day recall. Semi-annually