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

NCT07620197 | Completed

• 3 other identifiers: MSU/DRPI/MUSERC/01295/231R01MH107330NACOSTI/P/24/32560
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

HIV (Human Immunodeficiency Virus); Malnutrition

Keywords

HIV; Malnutrition; Cassava-simsim granules; Nutrition education; Nutritional status; Kenya

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Meal Frequency

  Baseline and week 16

• Dietary Diversity

  Baseline and Week 16

• Food Quantity Intake

  Baseline and week 16

• Vegetable Preparation Methods

  Baseline and week 16

• Cassava root -simsim seed granules consumption

  Baseline and week 16

Study Arms (2)

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

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

Behavioral: Nutrition education

Interventions

Arm1 - Cassava root and (sesame) simsim seed granules DIETARY_SUPPLEMENT

cassava-simsim granules

Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education

Nutrition education BEHAVIORAL

Structured nutrition education

Arm 1 - Cassava root and (sesame) simsim seed granules and nutrition education; Arm 2 - Nutrition education

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maseno University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Chulaimbo County Hospital

Kisumu, 40105, Kenya

Location

Nyahera Sub County Hospital

Kisumu, 40105, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Florence F Habwe, PhD

  Maseno University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 2, 2026
• Study Start: April 11, 2024
• Primary Completion: November 29, 2024
• Study Completion: December 6, 2024
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication, and upon completion of PhD course
• 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

Locations

KE (2)