N/A
N=746
Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02815579 ↗Enrolled (actual)
746
Serious AEs
—
Results posted
Jan 2024
Primary outcome: Primary: Change in Proportion of Viral Load Suppression (<=200 Copies/mL) — 327; 314 Participants — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shamba Maisha Intervention (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Proportion of Viral Load Suppression (<=200 Copies/mL) |
327; 314 | 0.86 |
| SECONDARY Change (i.e., Linear Trend) in Proportion of Absolute CD4 Count <=500 Cells/mm^3 |
128; 129 | 0.23 |
| SECONDARY Change (i.e. Linear Trend) in Mean Physical Health Status |
86.0; 86.2 | 0.26 |
| SECONDARY Change (i.e., Linear Trend) in the Proportion of Participants With AIDS-Defining Condition |
4; 2 | 0.31 |
| SECONDARY Change (i.e., Linear Trend) in the Proportion of Participants Who Were Hospitalized in the Previous 6 Months |
21; 18 | 0.44 |
| SECONDARY Change (i.e. Linear Trend) in the Mean Score of Food Insecurity Score |
14.0; 15.0 | <0.001 sig |
| SECONDARY Change (i.e. Linear Trend) in Mean Nutritional Status (Represented by Body Mass Index (BMI)) |
22.1; 21.8 | 0.02 sig |
| SECONDARY Change (i.e. Linear Trend) in Mean Self-reported Adherence to Antiretroviral Therapy |
100; 100 | 0.98 |
| SECONDARY Change (i.e. Linear Trend) in Mean Self-confidence Score |
4.0; 4.0 | 0.001 sig |
| SECONDARY Change (i.e. Linear Trend) in Proportion of Probable Depression |
36; 41 | 0.001 sig |
| SECONDARY Change (i.e. Linear Trend) in the Mean Internalized Stigma Score |
1.40; 1.72 | <0.001 sig |
Summary
The purpose of this study is to determine whether this multisectoral agricultural and microcredit loan intervention improves food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS.
Eligibility Criteria
Inclusion Criteria
- HIV-infected adults
- Currently receiving ART
- Belong to a patient support group or demonstrate willingness to join a support group
- Agree to save the down payment (~$10) required for the microcredit loan
- Have evidence of moderate to severe food insecurity based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI<18.5) based on FACES medical records during the year preceding recruitment
- Have access to farming land and available surface water in the form of lakes, rivers, ponds and shallow wells
Exclusion Criteria
- People who do not speak Dholuo, Swahili, or English
- Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the research assistant
Data sourced from ClinicalTrials.gov (NCT02815579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.