HIV, Malnutrition
Conditions
Keywords
HIV, Malnutrition, Food Security, Kenya
Brief 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.
Detailed description
Food insecurity and HIV/AIDS are two leading causes of morbidity and mortality in sub-Saharan Africa and are inextricably linked. Since food insecurity contributes to increased HIV transmission risk and higher HIV-related morbidity and mortality, the World Health Organization (WHO), United Nations Programme on HIV/AIDS (UNAIDS), and the World Food Programme have recommended integrating sustainable food production strategies into HIV/AIDS programming. Yet, to date there have been few studies to systematically evaluate the impact of promising food security interventions on health, economic and behavioral outcomes among people living with HIV and AIDS. To address this gap, the investigators plan to test the hypothesis that a multi-sectoral agricultural intervention delivered in Nyanza Province, Kenya will prevent highly active antiretroviral (HAART) treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk. 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. To develop our intervention, th investigators have formed an interdisciplinary collaboration with organizations in the healthcare, agriculture, and microfinance sectors. Our study aims include: 1. The investigators will operationalize and pilot test key design elements of a future cluster randomized clinical trials (RCT) aimed to improve health outcomes among HAART-treated patients in Western Kenya. In conjunction with our collaborating partners, the investigators will develop the different components of the intervention, including: a) randomization procedures for cluster RCT using detailed site assessments; b) agricultural training protocols; c) procedures for control group; d) manual of operations. 2. The investigators will conduct a pilot study of an agricultural intervention to determine the preliminary impact of the intervention on mediating outcomes (food security, and household economic indicators), and on primary health outcomes of interest for the planned RCT (HIV treatment outcomes, HIV transmission risk and women's empowerment). Up to one hundred and sixty HIV-infected farmers on HAART in Western Kenya (80 at an intervention clinic and 80 at a control clinic) will be enrolled and followed for 1 year. Impacts of our intervention on mediating and primary health outcomes will be investigated separately and jointly to provide a preliminary assessment of possible direct and indirect intervention effects. 3. The investigators will assess the acceptability and feasibility of intervention and control conditions, and systematically translate lessons learned in the pilot study into the design of a cluster RCT. To accomplish Aim 3, the investigators will conduct a mixed methods process evaluation of the different intervention components and their implementation using quantitative, qualitative, and observational methods. The investigators will prepare an R01 grant for submission based on lessons learned. The ultimate goal of this work is to contribute to sustainable solutions to tackle the intersecting challenges of food insecurity, poverty, and HIV/AIDS in sub-Saharan Africa. The ultimate goal of this work is to contribute to sustainable solutions to tackle the intersecting challenges of food insecurity, poverty, and HIV/AIDS in sub-Saharan Africa.
Interventions
Participants in the intervention arm will receive a micro-finance loan and training on financial management and marketing skills. With the loan, each participant will receive vouchers to purchase the following items: the Money Maker hip pump, 50 feet of hosing, fertilizer, and government certified seeds. Participants in the intervention group will also receive training on the use of the Money Maker hip pump, a portable, low-cost, human-powered water pump developed by KickStart. Participants in the intervention group will also receive training from Kickstart on the use of the pump as well as complementary training in best horticultural practices.
Sponsors
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
University of California, Davis
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year | 1 year | Compare the percentage of participants who achieve HIV viral suppression (defined as \<40 copies/mL) at 1 year among intervention and control arms. |
| Change From Baseline in CD4 Count at 1 Year | 1 year | Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Frequency of Food Consumption at 1 Year | Baseline and 1 year | Food frequency will be measured as the number of different foods or food groups and the frequency consumed over a given reference period, as adapted from the World Food Programme Food Consumption Score. Minimum = 0, maximum = 392. Higher scores reflect more frequent food consumption. |
| Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year | 1 year | Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus. |
| Change From Baseline in Food Insecurity at Year 1 | Baseline and 1 year | Collect and analyze measures of food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS). Minimum=9, maximum=36. A higher score means worse outcomes (i.e. greater food insecurity). |
| Change From Baseline in Weekly Household Food Expenditures at Year 1 | 1 year | Assess weekly household food expenditures in Kenyan shillings. A modification of the World Bank Living Standards Measurement Study (LSMS) questionnaire will be used to measure expenditures for food consumption. |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants received the fiance and agricultural Intervention | 72 |
| Control Arm Participants received the standard of care | 68 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Total | Intervention | Control Arm |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 0.8 | 37 years STANDARD_DEVIATION 0.8 | 38 years STANDARD_DEVIATION 0.8 |
| BMI < 18.5 kg/m^2 | 18 Participants | 13 Participants | 5 Participants |
| CD4+ | 516 (cells/microlitre) STANDARD_DEVIATION 35.2 | 497 (cells/microlitre) STANDARD_DEVIATION 32.7 | 536 (cells/microlitre) STANDARD_DEVIATION 37.7 |
| Current married | 108 Participants | 54 Participants | 54 Participants |
| Education >= Secondary school | 26 Participants | 14 Participants | 12 Participants |
| Frequency of food consumption | 81.4 Times per week STANDARD_DEVIATION 3.1 | 69.6 Times per week STANDARD_DEVIATION 3.1 | 93.9 Times per week STANDARD_DEVIATION 3.2 |
| Number of people in household | 6.5 people per household STANDARD_DEVIATION 0.2 | 6 people per household STANDARD_DEVIATION 0.2 | 7 people per household STANDARD_DEVIATION 0.3 |
| Severely food insecure (vs. moderately) | 115 Participants | 57 Participants | 58 Participants |
| Sex: Female, Male Female | 72 Participants | 37 Participants | 35 Participants |
| Sex: Female, Male Male | 68 Participants | 35 Participants | 33 Participants |
| Viral load <40 copies/ml | 84 Participants | 35 Participants | 49 Participants |
| Weekly food expenditures | 1928 Kenyan Shillings STANDARD_DEVIATION 122 | 1694 Kenyan Shillings STANDARD_DEVIATION 117 | 2176 Kenyan Shillings STANDARD_DEVIATION 127 |
| Weekly nonfood expenditures | 10233 Kenyan Shillings STANDARD_DEVIATION 1750 | 5931 Kenyan Shillings STANDARD_DEVIATION 1559 | 14788 Kenyan Shillings STANDARD_DEVIATION 1941 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 72 | 1 / 68 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in CD4 Count at 1 Year
Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.
Time frame: 1 year
Population: All 140 enrolled participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multi-sectoral Agricultural Intervention | Change From Baseline in CD4 Count at 1 Year | 80.74 cells/microliter | Standard Error 30.1 |
| Control | Change From Baseline in CD4 Count at 1 Year | -89.25 cells/microliter | Standard Error 30.1 |
p-value: <0.001Mixed Models Analysis
Primary
Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year
Compare the percentage of participants who achieve HIV viral suppression (defined as \<40 copies/mL) at 1 year among intervention and control arms.
Time frame: 1 year
Population: All 140 enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-sectoral Agricultural Intervention | Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year | 52 Participants |
| Control | Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year | 44 Participants |
p-value: 0.00295% CI: [0.766, 3.289]Mixed Models Analysis
Secondary
Change From Baseline in Food Insecurity at Year 1
Collect and analyze measures of food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS). Minimum=9, maximum=36. A higher score means worse outcomes (i.e. greater food insecurity).
Time frame: Baseline and 1 year
Population: All 140 enrolled participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multi-sectoral Agricultural Intervention | Change From Baseline in Food Insecurity at Year 1 | -7.387 Units on a scale | Standard Error 0.513 |
| Control | Change From Baseline in Food Insecurity at Year 1 | -3.702 Units on a scale | Standard Error 0.513 |
p-value: <0.001Mixed Models Analysis
Secondary
Change From Baseline in Frequency of Food Consumption at 1 Year
Food frequency will be measured as the number of different foods or food groups and the frequency consumed over a given reference period, as adapted from the World Food Programme Food Consumption Score. Minimum = 0, maximum = 392. Higher scores reflect more frequent food consumption.
Time frame: Baseline and 1 year
Population: All 140 enrolled participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multi-sectoral Agricultural Intervention | Change From Baseline in Frequency of Food Consumption at 1 Year | 9.621 Total times consumed/week | Standard Error 2.66 |
| Control | Change From Baseline in Frequency of Food Consumption at 1 Year | 0.184 Total times consumed/week | Standard Error 2.66 |
p-value: 0.013Mixed Models Analysis
Secondary
Change From Baseline in Weekly Household Food Expenditures at Year 1
Assess weekly household food expenditures in Kenyan shillings. A modification of the World Bank Living Standards Measurement Study (LSMS) questionnaire will be used to measure expenditures for food consumption.
Time frame: 1 year
Population: All 140 participants enrolled
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multi-sectoral Agricultural Intervention | Change From Baseline in Weekly Household Food Expenditures at Year 1 | 304.0 Kenyan shillings/week | Standard Error 184.5 |
| Control | Change From Baseline in Weekly Household Food Expenditures at Year 1 | 83.7 Kenyan shillings/week | Standard Error 184.5 |
p-value: 0.398Mixed Models Analysis
Secondary
Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year
Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus.
Time frame: 1 year
Population: 118 sexually active participants who completed endline data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multi-sectoral Agricultural Intervention | Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year | 1.85 Percentage of participants |
| Control | Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year | 3.125 Percentage of participants |
p-value: 0.37895% CI: [0.013, 5.165]Mixed Models Analysis