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Completed

NCT Number: NCT07620197

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm1 - Cassava root and (sesame) simsim seed granules

Dietary Supplement

cassava-simsim granules

Nutrition Education

Behavioral

Structured nutrition education

Primary outcomes

  1. Serum iron levels

    Time frame: Baseline and week 16

    Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.

  2. Serum zinc levels

    Time frame: Baseline and week 16

    Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.

  3. Serum selenium levels

    Time frame: Baseline and week 16

    Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status.

  4. Body mass Index (kg/m2)

    Time frame: Baseline and week 16

    Calculated using measured weight (kg) and height (m) to determine nutritional status of participants

Secondary outcomes

  1. Meal Frequency

    Time frame: Baseline and week 16

    Number of meals consumed per day among HIV-positive adults, used to assess dietary intake pattern

  2. Dietary Diversity

    Time frame: Baseline and Week 16

    Variety of foods groups consumed by HIV-positive adults, assessed using dietary diversity score based on 10 food group classification

  3. Food Quantity Intake

    Time frame: Baseline and week 16

    Quantity of food consumed by HIV-positive adults, assessed in (grams) consumed per day to evaluate dietary intake levels.

  4. Vegetable Preparation Methods

    Time frame: Baseline and week 16

    Methods used in vegetable preparation among HIV-positive adults, including steaming, boiling and draining water, boiling and not draining water.

  5. Cassava root -simsim seed granules consumption

    Time frame: Baseline and week 16

    Daily consumption of cassava root-simsim seed food-based product among HIV-positive adults as part of the dietary intervention.

Sponsors and collaborators

Lead sponsor

Maseno University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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