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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH107330 | U.S. NIH Grant/Contract | View source | |
| NACOSTI/P/24/32560 | Other Identifier | National Commission for Science, Technology & Innovation |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Arm 2 - Nutrition education | Active Comparator | Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm1 - Cassava root and (sesame) simsim seed granules | Dietary Supplement | cassava-simsim granules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum iron levels | Serum iron concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status. | Baseline and week 16 |
| Serum zinc levels | Serum zinc concentration (µg/dL) measured in HIV-seropositive adults as indicator of micronutrient status. | Baseline and week 16 |
| Serum selenium levels | Serum selenium concentration (µg/L) measured in HIV-seropositive adults as indicator of micronutrient status. | Baseline and week 16 |
| Body mass Index (kg/m2) | Calculated using measured weight (kg) and height (m) to determine nutritional status of participants | Baseline and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Meal Frequency | Number of meals consumed per day among HIV-positive adults, used to assess dietary intake pattern | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence F Habwe, PhD | Maseno University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulaimbo County Hospital | Kisumu | 40105 | Kenya | |||
| Nyahera Sub County Hospital |
Individual participant data collected that support the results reported in this article will be shared
Immediately following publication, and upon completion of PhD course
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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 23, 2023 |
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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.
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| Nutrition education | Behavioral | Structured nutrition education |
|
| 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. | 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. | 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. | Baseline and week 16 |
| Kisumu |
| 40105 |
| Kenya |
| May 27, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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