Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34MH094215-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Kenya Medical Research Institute | OTHER |
| University of California, Davis | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-sectoral agricultural intervention | Experimental | Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-sectoral agricultural intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Craig R Cohen, MD, MPH | University of California, San Francisco | Principal Investigator |
| Sheri Weiser, MD | University of California, San Francisco | Principal Investigator |
| Elizabeth Bukusi, MBChB, M.Med | Kenya Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Migori District Hospital | Migori | Nyanza | Kenya | |||
| Rongo District Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36516159 | Derived | Nicastro TM, Pincus L, Weke E, Hatcher AM, Burger RL, Lemus-Hufstedler E, Bukusi EA, Cohen CR, Weiser SD. Perceived impacts of a pilot agricultural livelihood and microfinance intervention on agricultural practices, food security and nutrition for Kenyans living with HIV. PLoS One. 2022 Dec 14;17(12):e0278227. doi: 10.1371/journal.pone.0278227. eCollection 2022. | |
| 31998859 | Derived | Butler LM, Bhandari S, Otieno P, Weiser SD, Cohen CR, Frongillo EA. Agricultural and Finance Intervention Increased Dietary Intake and Weight of Children Living in HIV-Affected Households in Western Kenya. Curr Dev Nutr. 2020 Jan 11;4(2):nzaa003. doi: 10.1093/cdn/nzaa003. eCollection 2020 Feb. |
| Label | URL |
|---|---|
| Research Article on Shamba Maisha: A pilot study assessing impacts of a micro-irrigation intervention on the health and economic wellbeing of HIV patients | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants received the multisectoral agricultural Intervention |
| FG001 | Control Arm | Participants received the standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants received the fiance and agricultural Intervention |
| BG001 | Control Arm | Participants received the standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All 140 enrolled participants | Posted | Count of Participants | Participants | 1 year |
|
Not provided
We did not assess participants for serious or other adverse events, other than all-cause mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Participants received the multisectoral agricultural Intervention |
Not provided
Not provided
We could not definitively separate intervention effects from cluster-level variables with 2 communities randomized. The 12-month follow-up could not detect the full range & sustainability of effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheri Weiser | University of California, San Francisco | (415) 314-0665 | Sheri.Weiser@ucsf.edu |
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 1 year |
| 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). | Baseline and 1 year |
| 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. | 1 year |
| Rongo |
| Nyanza |
| Kenya |
| 31242065 | Derived | Hatcher AM, Lemus Hufstedler E, Doria K, Dworkin SL, Weke E, Conroy A, Bukusi EA, Cohen CR, Weiser SD. Mechanisms and perceived mental health changes after a livelihood intervention for HIV-positive Kenyans: Longitudinal, qualitative findings. Transcult Psychiatry. 2020 Feb;57(1):124-139. doi: 10.1177/1363461519858446. Epub 2019 Jun 26. |
| 27637497 | Derived | Weiser SD, Hatcher AM, Hufstedler LL, Weke E, Dworkin SL, Bukusi EA, Burger RL, Kodish S, Grede N, Butler LM, Cohen CR. Changes in Health and Antiretroviral Adherence Among HIV-Infected Adults in Kenya: Qualitative Longitudinal Findings from a Livelihood Intervention. AIDS Behav. 2017 Feb;21(2):415-427. doi: 10.1007/s10461-016-1551-2. |
| 25992307 | Derived | Cohen CR, Steinfeld RL, Weke E, Bukusi EA, Hatcher AM, Shiboski S, Rheingans R, Scow KM, Butler LM, Otieno P, Dworkin SL, Weiser SD. Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial. Springerplus. 2015 Mar 12;4:122. doi: 10.1186/s40064-015-0886-x. eCollection 2015. |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Education >= Secondary school | Count of Participants | Participants |
|
| Current married | Count of Participants | Participants |
|
| Number of people in household | Mean | Standard Deviation | people per household |
|
| Severely food insecure (vs. moderately) | Per the Household Food Insecurity Access Scale Indicator Guide, v.3, a moderately food insecure household sacrifices quality more frequently, by eating a monotonous diet or undesirable foods sometimes or often and/or has started to cut back on quantity by reducing the size of meals or number of meals, rarely or sometimes. A severely food insecure household has graduated to cutting back on meal size or number of meals often, and/or experiences running out of food, going to bed hungry, and/or going a whole day and night without eating, even as infrequently as rarely. | Count of Participants | Participants |
|
| BMI < 18.5 kg/m^2 | Count of Participants | Participants |
|
| Weekly food expenditures | Mean | Standard Deviation | Kenyan Shillings |
|
| Weekly nonfood expenditures | Mean | Standard Deviation | Kenyan Shillings |
|
| Frequency of food consumption | Mean | Standard Deviation | Times per week |
|
| CD4+ | Mean | Standard Deviation | (cells/microlitre) |
|
| Viral load <40 copies/ml | Count of Participants | Participants |
|
| OG001 | Control | 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. |
|
|
|
| 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. | All 140 enrolled participants | Posted | Mean | Standard Error | cells/microliter | 1 year |
|
|
|
|
| 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. | All 140 enrolled participants | Posted | Mean | Standard Error | Total times consumed/week | Baseline and 1 year |
|
|
|
|
| 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. | 118 sexually active participants who completed endline data collection. | Posted | Number | Percentage of participants | 1 year |
|
|
|
|
| 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). | All 140 enrolled participants | Posted | Mean | Standard Error | Units on a scale | Baseline and 1 year |
|
|
|
|
| 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. | All 140 participants enrolled | Posted | Mean | Standard Error | Kenyan shillings/week | 1 year |
|
|
|
|
| 2 |
| 72 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Arm | Participants received the standard of care | 1 | 68 | 0 | 0 | 0 | 0 |
Not provided
Not provided