Trial Outcomes & Findings for Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya (NCT NCT01548599)

NCT ID: NCT01548599

Last Updated: 2020-04-14

Results Overview

Compare the percentage of participants who achieve HIV viral suppression (defined as \<40 copies/mL) at 1 year among intervention and control arms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 140 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-04-14

Participant Flow

Participant milestones

Measure	Intervention Participants received the multisectoral agricultural Intervention	Control Arm Participants received the standard of care
Overall Study STARTED	72	68
Overall Study COMPLETED	66	66
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Measure	Intervention Participants received the multisectoral agricultural Intervention	Control Arm Participants received the standard of care
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	4	0
Overall Study Death	2	1

Baseline Characteristics

Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

Baseline characteristics by cohort

Measure	Intervention n=72 Participants Participants received the fiance and agricultural Intervention	Control Arm n=68 Participants Participants received the standard of care	Total n=140 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 0.8 • n=5 Participants	38 years STANDARD_DEVIATION 0.8 • n=7 Participants	37.5 years STANDARD_DEVIATION 0.8 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Education >= Secondary school	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Current married	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Number of people in household	6 people per household STANDARD_DEVIATION 0.2 • n=5 Participants	7 people per household STANDARD_DEVIATION 0.3 • n=7 Participants	6.5 people per household STANDARD_DEVIATION 0.2 • n=5 Participants
Severely food insecure (vs. moderately)	57 Participants n=5 Participants	58 Participants n=7 Participants	115 Participants n=5 Participants
BMI < 18.5 kg/m^2	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Weekly food expenditures	1694 Kenyan Shillings STANDARD_DEVIATION 117 • n=5 Participants	2176 Kenyan Shillings STANDARD_DEVIATION 127 • n=7 Participants	1928 Kenyan Shillings STANDARD_DEVIATION 122 • n=5 Participants
Weekly nonfood expenditures	5931 Kenyan Shillings STANDARD_DEVIATION 1559 • n=5 Participants	14788 Kenyan Shillings STANDARD_DEVIATION 1941 • n=7 Participants	10233 Kenyan Shillings STANDARD_DEVIATION 1750 • n=5 Participants
Frequency of food consumption	69.6 Times per week STANDARD_DEVIATION 3.1 • n=5 Participants	93.9 Times per week STANDARD_DEVIATION 3.2 • n=7 Participants	81.4 Times per week STANDARD_DEVIATION 3.1 • n=5 Participants
CD4+	497 (cells/microlitre) STANDARD_DEVIATION 32.7 • n=5 Participants	536 (cells/microlitre) STANDARD_DEVIATION 37.7 • n=7 Participants	516 (cells/microlitre) STANDARD_DEVIATION 35.2 • n=5 Participants
Viral load <40 copies/ml	35 Participants n=5 Participants	49 Participants n=7 Participants	84 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All 140 enrolled participants

Compare the percentage of participants who achieve HIV viral suppression (defined as <40 copies/mL) at 1 year among intervention and control arms.

Outcome measures

Measure	Multi-sectoral Agricultural Intervention n=72 Participants Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. Multi-sectoral agricultural intervention: 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.	Control n=68 Participants Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.
Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year	52 Participants	44 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All 140 enrolled participants

Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.

Outcome measures

Measure	Multi-sectoral Agricultural Intervention n=72 Participants Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. Multi-sectoral agricultural intervention: 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.	Control n=68 Participants Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.
Change From Baseline in CD4 Count at 1 Year	80.74 cells/microliter Standard Error 30.1	-89.25 cells/microliter Standard Error 30.1

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: All 140 enrolled participants

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.

Outcome measures

Measure	Multi-sectoral Agricultural Intervention n=72 Participants Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. Multi-sectoral agricultural intervention: 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.	Control n=68 Participants Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.
Change From Baseline in Frequency of Food Consumption at 1 Year	9.621 Total times consumed/week Standard Error 2.660	0.184 Total times consumed/week Standard Error 2.660

SECONDARY outcome

Timeframe: 1 year

Population: 118 sexually active participants who completed endline data collection.

Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus.

Outcome measures

Measure	Multi-sectoral Agricultural Intervention n=54 Participants Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. Multi-sectoral agricultural intervention: 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.	Control n=64 Participants Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.
Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year	1.85 Percentage of participants	3.125 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: All 140 enrolled participants

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).

Outcome measures

Measure	Multi-sectoral Agricultural Intervention n=72 Participants Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. Multi-sectoral agricultural intervention: 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.	Control n=68 Participants Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.
Change From Baseline in Food Insecurity at Year 1	-7.387 Units on a scale Standard Error 0.513	-3.702 Units on a scale Standard Error 0.513

SECONDARY outcome

Timeframe: 1 year

Population: All 140 participants enrolled

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.

Outcome measures

Measure	Multi-sectoral Agricultural Intervention n=72 Participants Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. Multi-sectoral agricultural intervention: 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.	Control n=68 Participants Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.
Change From Baseline in Weekly Household Food Expenditures at Year 1	304.0 Kenyan shillings/week Standard Error 184.5	83.7 Kenyan shillings/week Standard Error 184.5

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sheri Weiser

University of California, San Francisco

Phone: (415) 314-0665

Email: Sheri.Weiser@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place