HIVShambaNCT01548599
Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
A study testing Multi-sectoral agricultural intervention in people with HIV and Malnutrition, run by University of California, San Francisco at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- HIV, Malnutrition
- What is being tested?
- Multi-sectoral agricultural intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesKenya
- Study dates
- Apr 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Migori District Hospital
Migori, Nyanza
Rongo District Hospital
Rongo, Nyanza
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- HIV, Malnutrition
- Being tested
- Multi-sectoral agricultural intervention
- Keywords
- HIV, Malnutrition, Food Security, Kenya
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-sectoral agricultural interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-sectoral agricultural intervention | Experimental | Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention. Receives: Other: Multi-sectoral agricultural 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: Baseline and 1 year
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.
Measured: 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).
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Craig R Cohen, MD, MPH, Principal investigator, University of California, San FranciscoSheri Weiser, MD, Principal investigator, University of California, San FranciscoElizabeth Bukusi, MBChB, M.Med, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548599
- Sponsor's protocol ID
- Shamba Maisha
- Other IDs
- R34MH094215-01
- Acronym
- Shamba
- Status last verified
- Apr 2020
- First submitted
- 5 Mar 2012
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36516159Butler 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.
PubMed 31998859Hatcher 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.
PubMed 31242065Weiser 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.
PubMed 27637497Cohen 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.
PubMed 25992307
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
- ClinicalTrials.gov ID
- NCT01548599
- Acronym / sponsor ID
- Shamba / Shamba Maisha
- Conditions
- HIV, Malnutrition
- Keywords
- HIV, Malnutrition, Food Security, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of California, Davis
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-sectoral agricultural intervention | Experimental | Other: Multi-sectoral agricultural interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-sectoral agricultural interventionParticipants 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. | Other | Multi-sectoral agricultural intervention |
Primary outcome
Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year
Time frame: 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
Time frame: 1 year
Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.
4 secondary outcomes
Change From Baseline in Frequency of Food Consumption at 1 Year
Time frame: Baseline and 1 year
Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year
Time frame: 1 year
Change From Baseline in Food Insecurity at Year 1
Time frame: Baseline and 1 year
Change From Baseline in Weekly Household Food Expenditures at Year 1
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36516159Nicastro 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.
- Derived from this study: PubMed 31998859Butler 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.
- Derived from this study: PubMed 31242065Hatcher 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.
- Derived from this study: PubMed 27637497Weiser 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.
- Derived from this study: PubMed 25992307Cohen 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.
- Research Article on Shamba Maisha: A pilot study assessing impacts of a micro-irrigation intervention on the health and economic wellbeing of HIV patientsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig R Cohen, MD, MPH principal investigator
University of California, San Francisco
Sheri Weiser, MD principal investigator
University of California, San Francisco
Elizabeth Bukusi, MBChB, M.Med principal investigator
Kenya Medical Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-sectoral agricultural intervention in people with HIV and Malnutrition, run by University of California, San Francisco at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01548599, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.