Trial Outcomes & Findings for Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya (NCT NCT02815579)

NCT ID: NCT02815579

Last Updated: 2024-04-25

Results Overview

The outcome was the change from baseline to the end of follow-up (2 years) in the proportion of participants in viral load suppression (≤200 copies/mL) compared between study groups using difference-in-differences analyses.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 746 participants
• Primary outcome timeframe: Baseline and endline (2 years after enrollment)
• Results posted on: 2024-04-25

Participant Flow

Unit of analysis: Health Facilities

Participant milestones

Measure	Intervention Participants received the Shamba Maisha Intervention that includes: a) a loan (\~$175) from a well-established Kenyan bank for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the microcredit loan including the KickStart treadle pump, seeds, fertilizers and pesticides; and c) education in financial management and sustainable farming practices occurring in the setting of patient support groups.	Control Participants in the control arm received the standard of care (HIV care and treatment only). Participants were eligible for the Shamba Maisha intervention at the end of 2 years of follow-up.
Overall Study STARTED	390 8	356 8
Overall Study Started Study Activities	366 8	354 8
Overall Study COMPLETED	344 8	333 8
Overall Study NOT COMPLETED	46 0	23 0

Reasons for withdrawal

Measure	Intervention Participants received the Shamba Maisha Intervention that includes: a) a loan (\~$175) from a well-established Kenyan bank for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the microcredit loan including the KickStart treadle pump, seeds, fertilizers and pesticides; and c) education in financial management and sustainable farming practices occurring in the setting of patient support groups.	Control Participants in the control arm received the standard of care (HIV care and treatment only). Participants were eligible for the Shamba Maisha intervention at the end of 2 years of follow-up.
Overall Study Non-payment of loan down-payment	16	0
Overall Study Withdrawal by Subject	7	1
Overall Study Moved out of study area before receiving any study activities	9	11
Overall Study Lost to Follow-up	7	4
Overall Study Hospitalized before receipt of any study activities	1	0
Overall Study Uncomfortable with MEMS adherence monitoring cap	1	0
Overall Study Death	5	4
Overall Study Imprisoned	0	2
Overall Study Did not meet enrollment criteria	0	1

Baseline Characteristics

Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

Baseline characteristics by cohort

Measure	Intervention n=366 Participants Participants received the multisectoral agricultural intervention.	Control n=354 Participants Participants in the control arm received the standard of care.	Total n=720 Participants Total of all reporting groups
Age, Continuous	40.3 years STANDARD_DEVIATION 8.9 • n=5 Participants	40.4 years STANDARD_DEVIATION 9.3 • n=7 Participants	40.4 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	202 Participants n=5 Participants	194 Participants n=7 Participants	396 Participants n=5 Participants
Sex: Female, Male Male	164 Participants n=5 Participants	160 Participants n=7 Participants	324 Participants n=5 Participants
Race/Ethnicity, Customized Black Kenyan	366 Participants n=5 Participants	354 Participants n=7 Participants	720 Participants n=5 Participants
Region of Enrollment Kenya	366 Participants n=5 Participants	354 Participants n=7 Participants	720 Participants n=5 Participants
Currently married	271 Participants n=5 Participants	251 Participants n=7 Participants	522 Participants n=5 Participants
Number of people in household	6.5 people STANDARD_DEVIATION 2.6 • n=5 Participants	6.1 people STANDARD_DEVIATION 2.7 • n=7 Participants	6.3 people STANDARD_DEVIATION 2.7 • n=5 Participants
Severely food insecure (vs. moderately)	293 Participants n=5 Participants	275 Participants n=7 Participants	568 Participants n=5 Participants
BMI <18.5 kg/m^2	41 Participants n=5 Participants	45 Participants n=7 Participants	86 Participants n=5 Participants
CD4+	603 cells/mm^3 STANDARD_DEVIATION 276 • n=5 Participants	561 cells/mm^3 STANDARD_DEVIATION 235 • n=7 Participants	582 cells/mm^3 STANDARD_DEVIATION 257 • n=5 Participants
Viral load <=200 copies/mL	314 Participants n=5 Participants	291 Participants n=7 Participants	605 Participants n=5 Participants
Religion Catholic	363 Participants n=5 Participants	353 Participants n=7 Participants	716 Participants n=5 Participants
Religion Muslim	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Religion Other religion	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change from baseline to the end of follow-up (2 years) in the proportion of participants in viral load suppression (≤200 copies/mL) compared between study groups using difference-in-differences analyses.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change in Proportion of Viral Load Suppression (<=200 Copies/mL)	327 Participants	314 Participants

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e., linear trend) from baseline to the end of follow-up (2 years) of the proportion of participants with a CD4 cell count <=500 cells/mm^3, compared between study groups using difference-in-differences analyses.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e., Linear Trend) in Proportion of Absolute CD4 Count <=500 Cells/mm^3	128 Participants	129 Participants

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean physical health score compared between study groups using the differences-in-differences analyses. We used the Medical Outcomes Study HIV Health Survey (MOS-HIV), a tool used to assess health-related quality of life that has been validated in resource-limited settings. Scores standardized to a range of 0 to 100. Higher scores mean a better outcome.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e. Linear Trend) in Mean Physical Health Status	86.0 units on a scale Interval 81.6 to 87.3	86.2 units on a scale Interval 80.5 to 87.6

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e., linear trend) from baseline to the end of follow-up (2 years) of the proportion of participants with an AIDS-defining condition, compared between study groups using difference-in-differences analyses. AIDS-defining conditions including HIV-related illnesses included in the Centers for Disease Control and Prevention's (CDC) list of diagnostic criteria for AIDS. AIDS-defining conditions include opportunistic infections and cancers that are life-threatening in a person with HIV.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e., Linear Trend) in the Proportion of Participants With AIDS-Defining Condition	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e. linear trend) from baseline to end of follow-up (2 years) of the proportion of participants hospitalized in the previous 6 months (yes/no), compared between study groups using difference-in-differences analyses.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e., Linear Trend) in the Proportion of Participants Who Were Hospitalized in the Previous 6 Months	21 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean household food insecurity score, compared between study groups using difference-in-differences analyses.

using the Household Food Insecurity Access Scale (HFIAS). The HFIAS is a tool to assess household food insecurity (access). The scale scores range from 0 to 27, with higher scores indicating greater food insecurity.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e. Linear Trend) in the Mean Score of Food Insecurity Score	14.0 score on a scale Interval 11.0 to 18.0	15.0 score on a scale Interval 14.0 to 19.0

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean body mass index (BMI) compared between study grouops using the differences-in-differences analyses.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e. Linear Trend) in Mean Nutritional Status (Represented by Body Mass Index (BMI))	22.1 kg/m^2 Interval 20.2 to 24.6	21.8 kg/m^2 Interval 19.0 to 24.5

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean self-reported adherence to antiretroviral therapy compared between study groups using the differences-in-differences analyses.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e. Linear Trend) in Mean Self-reported Adherence to Antiretroviral Therapy	100 percentage of doses taken Interval 100.0 to 100.0	100 percentage of doses taken Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e. linear tend) from baseline to the end of follow-up (2 years) in the mean self-confidence score, compared between study groups using difference-in-differences analyses. Self-confidence is measured using the three-item Power Within scale, which has a range of 3 to 9 points where lower scores indicate greater self-confidence.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e. Linear Trend) in Mean Self-confidence Score	4.0 score on a scale Interval 4.0 to 6.0	4.0 score on a scale Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

Population: 677 participants who completed endline data collection

The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) in the proportion with probable depression using the Hopkins Symptom Check-list for Depression, compared between study groups using difference-in-differences analyses.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e. Linear Trend) in Proportion of Probable Depression	36 Participants	41 Participants

SECONDARY outcome

Timeframe: Baseline and endline (2 years after enrollment)

The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) in the mean internalized stigma score compared between study groups using the differences-in-differences analyses. Internalized HIV stigma arises when someone has accepted and endorsed the negative attitudes towards her/himself due to their HIV status. The internalized HIV stigma sub-scale consisted of six items asking respondents to agree with statements related to how they feel about being HIV positive, such as "having HIV makes me feel like I'm a bad person" and "I feel ashamed of having HIV." Response options ranged from 1 "strongly disagree" to 5 "strongly agree." During the analysis phase, the composite scores of each stigma sub-scale were rescaled to a row average of 1-5, with higher scores indicating greater stigma.

Outcome measures

Measure	Intervention n=344 Participants Participants received the multisectoral agricultural intervention.	Control n=333 Participants Participants in the control arm received the standard of care.
Change (i.e. Linear Trend) in the Mean Internalized Stigma Score	1.40 units on a scale Standard Deviation 0.68	1.72 units on a scale Standard Deviation 0.71

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sheri Weiser

University of California, San Francisco

Phone: (628) 206-2427

Email: Sheri.Weiser@ucsf.edu

Results disclosure agreements

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