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

27. mai 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Faktiske)

64

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
cassava-simsim granules
Structured nutrition education
Aktiv komparator: Arm 2 - Nutrition education
Participants were offered structured individual nutrition education monthly, totaling to 5 sessions during the study period
Structured nutrition education

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum iron levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Baseline and week 16
Calculated using measured weight (kg) and height (m) to determine nutritional status of participants
Baseline and week 16

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Meal Frequency
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Florence F Habwe, PhD, Maseno University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. april 2024

Primær fullføring (Faktiske)

29. november 2024

Studiet fullført (Faktiske)

6. desember 2024

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

27. mai 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

Immediately following publication, and upon completion of PhD course

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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