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

May 27, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Dietary supplement: Arm1 - Cassava root and (sesame) simsim seed granules
cassava-simsim granules
Behavioral: Nutrition education
Structured nutrition education
Active Comparator: Arm 2 - Nutrition education
Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
Behavioral: Nutrition education
Structured nutrition education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum iron levels
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: Baseline and week 16
Calculated using measured weight (kg) and height (m) to determine nutritional status of participants
Baseline and week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Meal Frequency
Time Frame: 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
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
Baseline and Week 16
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.
Baseline and week 16
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.
Baseline and week 16
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.
Baseline and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maseno University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Florence F Habwe, PhD, Maseno University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSU/DRPI/MUSERC/01295/23
  • 1R01MH107330 (U.S. NIH Grant/Contract)
  • NACOSTI/P/24/32560 (Other Identifier: National Commission for Science, Technology & Innovation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Immediately following publication, and upon completion of PhD course

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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