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Income Generation, Food and Nutrient Security for Improved Livelihoods and Health Outcomes Among HIV-Positive, Kenya

27 de mayo de 2026 actualizado por: Lucia Kaluki Mutwika, Maseno University

A Quasi-experimental Design of Income Generation, Food and Nutrient Security for Improved Livelihoods and Health Outcomes Among People Living With HIV (PLWHIV), Kenya

The goal of this trial is to evaluate whether cassava root and sesame seed granules combined with nutrition education can improve the nutritional status of HIV-seropositive adults. People living with HIV face food insecurity, and HIV also increases nutrient requirements and reduces nutrient intake, leading to weight loss, underweight, and impaired immune function, which worsens the situation, leading to increased deaths. The main question was:

Does improving food and nutrient security improve the livelihoods and health outcomes among people living with HIV Researchers compared cassava root and sesame (simsim) seed granules combined with nutrition education to nutrition education alone to see if it works to improve the nutritional status of HIV-positive underweight adults.

  • Participants received 230g of cassava root-simsim seed granules daily, and one session of structured individual nutrition education monthly during every visit to the hospital, totaling to 5 sessions during the 16-week study period
  • Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
  • Participants visited the hospital monthly for resupply and nutrition education
  • They brought back any unused granules during hospital visits.

Descripción general del estudio

Descripción detallada

Undernutrition remains a critical challenge among people living with HIV (PLWHIV) in Sub-Saharan Africa, contributing to high morbidity and mortality despite access to antiretroviral therapy. Globally, approximately 1.8 billion PLWHIV are affected by undernutrition. HIV infection and nutritional deficiencies increase nutrient requirements, impaired intake, and reduce nutrient utilization, causing weight loss and micronutrient deficiencies. Kisumu County has the second-highest HIV prevalence in the country. Kisumu West Sub-County serves a large population of PLWHIV in a resource-limited setting, where access to adequate nutrition remains a major challenge. This study evaluated the impact of cassava-simsim granules and nutrition education on the nutritional status of HIV seropositive adults in Kisumu West Sub-County, Kenya. Specific objectives were to assess nutritional status and nutrient intake of participants, determine nutrient levels, microbial load, and acceptability of cassava -simsim granules. A quasi-experimental design was adopted. Sample size was determined using a statistical formula by Bolarinwa (2020). A total of 64 moderately malnourished HIV-seropositive adults (BMI of > 16 kg/m2 - < 18.5 kg/m2) aged 19 -50 years were enrolled, with 52 completing the 16-week intervention. Participants were purposively allocated to either intervention group (n = 32), which received cassava-simsim granules 230g/day plus nutrition education, or the control group (n = 32), which received nutrition education alone. Data on nutritional status, nutrient intake, and product acceptability were collected using a questionnaire. Serum iron, zinc, and selenium levels and nutrient levels in the product were analyzed using flame atomic absorption spectroscopy (FAAS). Microbial load was determined using a conventional method, and sensory acceptability was evaluated using a 5-point hedonic scale. Nutrient intakes were analyzed in the NutriSurvey software. Data analysis included descriptive statistics, paired sample t-test, independent t-test, one-sample t-test, and analysis of covariance (ANCOVA).

Tipo de estudio

Intervencionista

Inscripción (Actual)

64

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Kisumu, Kenia, 40105
        • Chulaimbo County Hospital
      • Kisumu, Kenia, 40105
        • Nyahera Sub County Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • HIV-seropositive adults aged 19 - 50 years
  • Enrolled at the two study sites
  • willing to consent to participate in the study
  • Body Mass Index (BMI) of > 16 kg/m2 - < 18.5 kg/m2
  • Hemoglobin levels 8g/dL - 12g/dL for non-pregnant women
  • Hemoglobin levels 8g/dL - 13 g/dL for men

Exclusion Criteria:

  • Severe acute malnutrition BMI of < 16 kg/m2
  • Hemoglobin levels of < 8 g/dL
  • Chronic conditions
  • Pregnant mothers

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education
Participants received one serving of cassava root-simsim seed granules daily, each 230g, and one session of structured individual nutrition education monthly during every visit to the facility totaling to 5 sessions during the study period
cassava-simsim granules
Structured nutrition education
Comparador activo: Arm 2 - Nutrition education
Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
Structured nutrition education

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Serum iron levels
Periodo de tiempo: Baseline and week 16
Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
Baseline and week 16
Serum zinc levels
Periodo de tiempo: Baseline and week 16
Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
Baseline and week 16
Serum selenium levels
Periodo de tiempo: Baseline and week 16
Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status.
Baseline and week 16
Body mass Index (kg/m2)
Periodo de tiempo: Baseline and week 16
Calculated using measured weight (kg) and height (m) to determine nutritional status of participants
Baseline and week 16

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Meal Frequency
Periodo de tiempo: Baseline and week 16
Number of meals consumed per day among HIV-positive adults, used to assess dietary intake pattern
Baseline and week 16
Dietary Diversity
Periodo de tiempo: Baseline and Week 16
Variety of foods groups consumed by HIV-positive adults, assessed using dietary diversity score based on 10 food group classification
Baseline and Week 16
Food Quantity Intake
Periodo de tiempo: Baseline and week 16
Quantity of food consumed by HIV-positive adults, assessed in (grams) consumed per day to evaluate dietary intake levels.
Baseline and week 16
Vegetable Preparation Methods
Periodo de tiempo: Baseline and week 16
Methods used in vegetable preparation among HIV-positive adults, including steaming, boiling and draining water, boiling and not draining water.
Baseline and week 16
Cassava root -simsim seed granules consumption
Periodo de tiempo: Baseline and week 16
Daily consumption of cassava root-simsim seed food-based product among HIV-positive adults as part of the dietary intervention.
Baseline and week 16

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Florence F Habwe, PhD, Maseno University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de abril de 2024

Finalización primaria (Actual)

29 de noviembre de 2024

Finalización del estudio (Actual)

6 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de mayo de 2026

Publicado por primera vez (Actual)

2 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Individual participant data collected that support the results reported in this article will be shared

Marco de tiempo para compartir IPD

Immediately following publication, and upon completion of PhD course

Criterios de acceso compartido de IPD

Anyone who wishes to access the data for research purposes. IPD will be accessed at the Maseno University Institutional Repository in form of text, tables, figures, appendices

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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