N/A
N=140
Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
HIV · Malnutrition
Bottom Line
View on ClinicalTrials.gov: NCT01548599 ↗Enrolled (actual)
140
Serious AEs
—
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year — 52; 44 Participants — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multi-sectoral agricultural intervention (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year |
52; 44 | 0.002 sig |
| PRIMARY Change From Baseline in CD4 Count at 1 Year |
80.74; -89.25 | <0.001 sig |
| SECONDARY Change From Baseline in Frequency of Food Consumption at 1 Year |
9.621; 0.184 | 0.013 sig |
| SECONDARY Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year |
1.85; 3.125 | 0.378 |
| SECONDARY Change From Baseline in Food Insecurity at Year 1 |
-7.387; -3.702 | <0.001 sig |
| SECONDARY Change From Baseline in Weekly Household Food Expenditures at Year 1 |
304.0; 83.7 | 0.398 |
Summary
This pilot study aims to determine whether an agricultural intervention will improve food security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk among people living with HIV/AIDS. The intervention will include: a) a human-powered water pump and other required farm commodities, b) a micro-finance loan (~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices.
Eligibility Criteria
Inclusion Criteria
- HIV-infected
- 18-49 years old
- Currently receiving HAART
- Belong to a patient support group or demonstrate willingness to join a support group.
- Have access to farming land and available surface water
- Have evidence of food insecurity, hunger and/or malnutrition (BMI<18.5 kg) based on FACES medical records during the year preceding recruitment.
- Participants must also agree to save the down payment (~$7) required for the loan, participate in the Adok Timo training.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01548599). 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.