CompletedNot Applicable

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

Kenya64 participantsStarted 2024-04-11

Plain-language 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.

Who can participate

Age range

19 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum iron levels

Timeframe: Baseline and week 16

Serum zinc levels

Timeframe: Baseline and week 16

Serum selenium levels

Timeframe: Baseline and week 16

Body mass Index (kg/m2)

Timeframe: Baseline and week 16

Trial details

NCT IDNCT07620197

SponsorMaseno University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-29

View on ClinicalTrials.gov More HIV (Human Immunodeficiency Virus) trials

Plain-language summary

Who can participate

Age range

19 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.