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.
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
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Malnutrition
- What is being tested?
- Arm1 - Cassava root and (sesame) simsim seed granules and Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- 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
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).
- Conditions
- HIV (Human Immunodeficiency Virus), Malnutrition
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education | Experimental | 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 Receives: Dietary Supplement: Arm1 - Cassava root and (sesame) simsim seed granules; Behavioral: Nutrition education |
| Arm 2 - Nutrition education | Active comparator | Participants 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.
Serum iron levels
Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
Measured: Baseline and week 16
Serum zinc levels
Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
Measured: Baseline and week 16
Serum selenium levels
Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status.
Measured: Baseline and week 16
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)
Meal Frequency
Number of meals consumed per day among HIV-positive adults, used to assess dietary intake pattern
Measured: Baseline and week 16
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
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
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
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.
- First posted2 Jun 2026
- Study start11 Apr 2024
- Primary completion29 Nov 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maseno University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lucia Kaluki Mutwika, Maseno University
- Investigators
- Florence F Habwe, PhD, Principal investigator, Maseno University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07620197
- Acronym / sponsor ID
- MSU/DRPI/MUSERC/01295/23
- Conditions
- HIV (Human Immunodeficiency Virus), Malnutrition
- Keywords
- HIV, Malnutrition, Cassava-simsim granules, Nutrition education, Nutritional status, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Maseno UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education | Experimental | Dietary Supplement: Arm1 - Cassava root and (sesame) simsim seed granules, Behavioral: Nutrition educationParticipants 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 |
| Arm 2 - Nutrition education | Active comparator | Behavioral: Nutrition educationParticipants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Severe acute malnutrition BMI of < 16 kg/m2
- Hemoglobin levels of < 8 g/dL
- Chronic conditions
- Pregnant mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm1 - Cassava root and (sesame) simsim seed granulescassava-simsim granules | Dietary supplement | Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education |
| Nutrition educationStructured nutrition education | Behavioural | Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education, Arm 2 - Nutrition education |
Primary outcome
Serum iron levels
Time frame: Baseline and week 16
Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
Serum zinc levels
Time frame: Baseline and week 16
Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status.
Serum selenium levels
Time frame: Baseline and week 16
Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status.
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
5 secondary outcomes
Meal Frequency
Time frame: Baseline and week 16
Dietary Diversity
Time frame: Baseline and Week 16
Food Quantity Intake
Time frame: Baseline and week 16
Vegetable Preparation Methods
Time frame: Baseline and week 16
Cassava root -simsim seed granules consumption
Time frame: Baseline and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data collected that support the results reported in this article will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence F Habwe, PhD principal investigator
Maseno University
2 sites in 1 country: see every site and its status.
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?
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.