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HIV (Human Immunodeficiency Virus)NCT07620197

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

A study testing Arm1 - Cassava root and (sesame) simsim seed granules and Nutrition education in people with HIV (Human Immunodeficiency Virus) and Malnutrition, run by Maseno University at 2 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 50 years
What is being tested?
Arm1 - Cassava root and (sesame) simsim seed granules and Nutrition education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesKenya
Study dates
11 Apr 2024to 6 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites

  • Chulaimbo County Hospital

    Kisumu, 40105

  • Nyahera Sub County Hospital

    Kisumu, 40105

Other trials in Kenya

About this study

Official 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

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.
Read the 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).

Being tested
Arm1 - Cassava root and (sesame) simsim seed granules, Nutrition education
Keywords
HIV, Malnutrition, Cassava-simsim granules, Nutrition education, Nutritional status, Kenya
Medical subject headings
Acquired Immunodeficiency Syndrome, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm1 - Cassava root and (sesame) simsim seed granulesDietary supplement

    cassava-simsim granules

  • Nutrition educationBehavioural

    Structured nutrition education

Study groups in NCT07620197
Study groupRoleWhat they receive
Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition educationExperimentalParticipants 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
Receives: Dietary Supplement: Arm1 - Cassava root and (sesame) simsim seed granules; Behavioral: Nutrition education
Arm 2 - Nutrition educationActive comparatorParticipants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
Receives: Behavioral: Nutrition education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum iron levels

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

    Measured: Baseline and week 16

  2. Serum zinc levels

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

    Measured: Baseline and week 16

  3. Serum selenium levels

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

    Measured: Baseline and week 16

  4. Body mass Index (kg/m2)

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

    Measured: Baseline and week 16

Secondary outcomes (5)

  1. Meal Frequency

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

    Measured: Baseline and week 16

  2. Dietary Diversity

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

    Measured: Baseline and Week 16

  3. Food Quantity Intake

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

    Measured: Baseline and week 16

  4. Vegetable Preparation Methods

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

    Measured: Baseline and week 16

  5. Cassava root -simsim seed granules consumption

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

    Measured: Baseline and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start11 Apr 2024
  3. Primary completion29 Nov 2024
  4. Study completion6 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This was a quasi-experimental study, non-randomized parallel. Participants were assigned to either an intervention group receiving cassava root and simsim seed granules combined with nutrition education or to the control group receiving nutrition education only; both groups were on regular diets. baseline and post intervention data were collected. The outcome was compared between the two groups after a 16-week study period. All participants were dewormed at the beginning of the study and those who were to test positive for malaria were to be treated, however none of the participants tested positive for malaria.
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07620197
Sponsor's protocol ID
MSU/DRPI/MUSERC/01295/23
Other IDs
1R01MH107330, NACOSTI/P/24/32560
Status last verified
May 2026
First submitted
20 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data collected that support the results reported in this article will be shared

Questions about this trial

What is this clinical trial studying?

A study testing Arm1 - Cassava root and (sesame) simsim seed granules and Nutrition education in people with HIV (Human Immunodeficiency Virus) and Malnutrition, run by Maseno University at 2 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum iron levels (time frame: Baseline and week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07620197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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