HIVShamba R01NCT02815579
Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
A study of HIV, run by University of California, San Francisco at 16 sites in Kenya.
Trial summary
The purpose of this study is to determine whether this multisectoral agricultural and microcredit loan intervention improves food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 746 participants
- Where
- 16 sitesKenya
- Study dates
- Jun 2016to Dec 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-infected adults
- Currently receiving ART
- Belong to a patient support group or demonstrate willingness to join a support group
- Agree to save the down payment (~$10) required for the microcredit loan
- Have evidence of moderate to severe food insecurity based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI<18.5) based on FACES medical records during the year preceding recruitment
- Have access to farming land and available surface water in the form of lakes, rivers, ponds and shallow wells
Who cannot join
- People who do not speak Dholuo, Swahili, or English
- Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the research assistant
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Kenya16 sites
Hongo Ogosa
Kisumu
Kisumu District Hospital
Kisumu
Lumumba
Kisumu
Nyangande
Kisumu
Pandiperi
Kisumu
Railways
Kisumu
Osingo
Migori
Suna Ragana
Migori
Muhuru Bay
Nyatike, Migori County
Sori Lakeside
Nyatike, Migori County
Minyenya
Rongo, Migori County
Ngode
Rongo, Migori County
Oyani
Rongo, Migori County
Kitare
Suba, Homa Bay County
Sindo
Suba, Homa Bay County
Nyamasare
Uriri, Migori County
About this study
The purpose of this study is to determine whether this multisectoral agricultural and microcredit loan intervention improves food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS.
Read the detailed description
Despite major advances in care and treatment for those living with HIV, morbidity and mortality among people living with HIV/AIDS (PLHIV) remains unacceptably high in sub-Saharan Africa (SSA), largely due to the parallel challenges of poverty and food insecurity.[1] In the Nyanza Region of Kenya, 15.1% of the adult population is infected by HIV,[2] and over 50% of the rural population is food insecure, primarily due to unpredictable rainfall and limited irrigation.[3,4] The investigators have previously shown that food insecurity delays antiretroviral therapy (ART) initiation, reduces ART adherence, contributes to worse immunologic and virologic outcomes, and increases morbidity and mortality among PLHIV.[5-16] There has been increasing international recognition that improved food security and reduced poverty are essential components for a successful global response to the HIV epidemic.[17-21] Yet, to date few studies have systematically evaluated the impacts of sustainable food security interventions on health, economic, and behavioral outcomes among PLHIV. Agricultural interventions, which have potential to raise income and bolster food security, are an important but understudied route through which to sustainably improve nutritional and HIV outcomes in SSA, including Kenya where agriculture accounts for > 75% of the total workforce, and 51% of the gross domestic product.[22]
Building on the investigators successful completion of the pilot intervention trial in Kenya and the investigators collective experience studying structural barriers to HIV care in SSA, the investigators plan to test the hypothesis that a multisectoral agricultural and microcredit loan intervention will improve food security, prevent ART treatment failure, and reduce co-morbidities among PLHIV. The investigators' intervention was co-developed with KickStart, a prominent non-governmental organization (NGO) based in SSA that has introduced a human-powered pump, enabling farmers to grow high yield crops year-round. This technology has reduced food insecurity and poverty for 800,000 users in 22 countries in the subcontinent since 1991.[23] The investigators' intervention 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 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. This study is a cluster randomized controlled trial (RCT) of this intervention with the following specific aims:
Aim 1: To determine the impact of a multisectoral agricultural intervention among HIV-infected farmers on ART on HIV clinical outcomes. The investigators hypothesize that the intervention will lead to improved viral load suppression (primary outcome) and changes in CD4 cell count, physical health status, WHO stage III/IV disease, and hospitalizations (secondary outcomes) in the intervention arm compared to the control arm.
Aim 2: To understand the pathways through which the multisectoral intervention may improve HIV health outcomes. Using the investigator's theoretical model,[1,24] the investigators hypothesize that the intervention will improve food security and household wealth, which in turn will contribute to improved outcomes through nutritional (improved nutritional status measured with Body Mass Index), behavioral (improved ART adherence, and retention in care), and mental health (improved mental health/less depression, improved empowerment) pathways (secondary outcomes).
Aim 3: To determine the cost-effectiveness of the intervention and obtain the information necessary to inform scale-up in Kenya and similar settings in SSA. The investigators will quantify the cost per disability-adjusted life year averted, and identify lessons to inform successful scale-up.
To accomplish Aims 1 \& 2, the investigators will randomize 8 matched pairs of health facilities in the Nyanza Region in a 1:1 ratio to the intervention and control arms, and enroll 44 participants per facility (total n=704). All participants will be followed for 2 years. Impacts of the investigator's intervention on primary health outcomes and mediators will be investigated to provide definitive data of direct and indirect intervention effects. To accomplish Aim 3, the investigators will: a) conduct a cost-effectiveness analysis; b) identify the characteristics of individuals most likely to benefit from the intervention (e.g., gender, educational attainment, family size, wealth, risk tolerance, and entrepreneurial ability); and c) perform a mixed-methods process evaluation with study participants, staff, and various stakeholders to determine what worked and did not work to guide future scale-up efforts of the intervention.
The investigator's ultimate goal is to develop and test an intervention to reverse the cycle of food insecurity and HIV/AIDS morbidity and mortality in SSA.
- Conditions
- HIV
- Being tested
- Shamba Maisha Intervention
- Keywords
- HIV, Food insecurity, Microcredit loan, Agriculture, Livelihoods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shamba Maisha InterventionOther
- A loan (~$175) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Shamba Maisha Intervention 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 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. Receives: Other: Shamba Maisha Intervention |
| Control | No intervention | Participants in the control arm will receive the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proportion of Viral Load Suppression (<=200 Copies/mL)
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.
Measured: Baseline and endline (2 years after enrollment)
Secondary outcomes (10)
Change (i.e., Linear Trend) in Proportion of Absolute CD4 Count <=500 Cells/mm^3
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Physical Health Status
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e., Linear Trend) in the Proportion of Participants With AIDS-Defining Condition
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e., Linear Trend) in the Proportion of Participants Who Were Hospitalized in the Previous 6 Months
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in the Mean Score of Food Insecurity Score
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Nutritional Status (Represented by Body Mass Index (BMI))
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Self-reported Adherence to Antiretroviral Therapy
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Self-confidence Score
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Proportion of Probable Depression
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.
Measured: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in the Mean Internalized Stigma Score
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.
Measured: Baseline and endline (2 years after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019
- Study completionDec 2019
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 (31)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 746 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 South Carolina, University of Connecticut, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Sheri D Weiser, MD, MPH, Principal investigator, Departments of Medicine, UCSFCraig R Cohen, MD, MPH, Principal investigator, Department of Obstetrics, Gynecology & Reproductive Sciences, UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815579
- Sponsor's protocol ID
- P0503135
- Other IDs
- R01MH107330-01
- Acronym
- Shamba R01
- Status last verified
- Apr 2024
- First submitted
- 11 May 2016
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiser SD, Young SL, Cohen CR, Kushel MB, Tsai AC, Tien PC, Hatcher AM, Frongillo EA, Bangsberg DR. Conceptual framework for understanding the bidirectional links between food insecurity and HIV/AIDS. Am J Clin Nutr. 2011 Dec;94(6):1729S-1739S. doi: 10.3945/ajcn.111.012070. Epub 2011 Nov 16.
PubMed 22089434National AIDS and STI Control Programme, Ministry of Health, Kenya. September 2013. Kenya AIDS Indicator Survey 2012: Preliminary Report. Nairobi, Kenya
Place F, Adato M, Hebinck P. Understanding rural poverty and investment in agriculture: an assessment of integrated quantitative and qualitative research in western Kenya. World Dev. 2007;35(2):312-325.
Stoorvogel J, Smaling E. Assessment of soil nutrient depletion in sub-Saharan Africa: 1983-2000. Report No. 28, Vols. I-IV. Wageningin, Netherlands: Winand Staring Center; 1990.
McMahon JH, Wanke CA, Elliott JH, Skinner S, Tang AM. Repeated assessments of food security predict CD4 change in the setting of antiretroviral therapy. J Acquir Immune Defic Syndr. 2011 Sep 1;58(1):60-3. doi: 10.1097/QAI.0b013e318227f8dd.
PubMed 21694604Wang EA, McGinnis KA, Fiellin DA, Goulet JL, Bryant K, Gibert CL, Leaf DA, Mattocks K, Sullivan LE, Vogenthaler N, Justice AC; VACS Project Team. Food insecurity is associated with poor virologic response among HIV-infected patients receiving antiretroviral medications. J Gen Intern Med. 2011 Sep;26(9):1012-8. doi: 10.1007/s11606-011-1723-8. Epub 2011 May 15.
PubMed 21573882Weiser SD, Palar K, Frongillo EA, Tsai AC, Kumbakumba E, Depee S, Hunt PW, Ragland K, Martin J, Bangsberg DR. Longitudinal assessment of associations between food insecurity, antiretroviral adherence and HIV treatment outcomes in rural Uganda. AIDS. 2014 Jan 2;28(1):115-20. doi: 10.1097/01.aids.0000433238.93986.35.
PubMed 23939234Nagata JM, Magerenge RO, Young SL, Oguta JO, Weiser SD, Cohen CR. Social determinants, lived experiences, and consequences of household food insecurity among persons living with HIV/AIDS on the shore of Lake Victoria, Kenya. AIDS Care. 2012;24(6):728-36. doi: 10.1080/09540121.2011.630358. Epub 2011 Dec 7.
PubMed 22150119Weiser SD, Tsai AC, Gupta R, Frongillo EA, Kawuma A, Senkungu J, Hunt PW, Emenyonu NI, Mattson JE, Martin JN, Bangsberg DR. Food insecurity is associated with morbidity and patterns of healthcare utilization among HIV-infected individuals in a resource-poor setting. AIDS. 2012 Jan 2;26(1):67-75. doi: 10.1097/QAD.0b013e32834cad37.
PubMed 21904186Young S, Wheeler AC, McCoy SI, Weiser SD. A review of the role of food insecurity in adherence to care and treatment among adult and pediatric populations living with HIV and AIDS. AIDS Behav. 2014 Oct;18 Suppl 5(0 5):S505-15. doi: 10.1007/s10461-013-0547-4.
PubMed 23842717Weiser SD, Gupta R, Tsai AC, Frongillo EA, Grede N, Kumbakumba E, Kawuma A, Hunt PW, Martin JN, Bangsberg DR. Changes in food insecurity, nutritional status, and physical health status after antiretroviral therapy initiation in rural Uganda. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):179-86. doi: 10.1097/QAI.0b013e318261f064.
PubMed 22692093Weiser S, Fernandes K, Anema A, et al. Food insecurity as a barrier to antiretroviral therapy (ART) adherence among HIV-infected individuals in British Columbia. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Cape Town, South Africa2009.
Weiser SD, Fernandes KA, Brandson EK, Lima VD, Anema A, Bangsberg DR, Montaner JS, Hogg RS. The association between food insecurity and mortality among HIV-infected individuals on HAART. J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):342-9. doi: 10.1097/QAI.0b013e3181b627c2.
PubMed 19675463Musumari PM, Feldman MD, Techasrivichien T, Wouters E, Ono-Kihara M, Kihara M. "If I have nothing to eat, I get angry and push the pills bottle away from me": A qualitative study of patient determinants of adherence to antiretroviral therapy in the Democratic Republic of Congo. AIDS Care. 2013;25(10):1271-7. doi: 10.1080/09540121.2013.764391. Epub 2013 Feb 6.
PubMed 23383757Musumari PM, Wouters E, Kayembe PK, Kiumbu Nzita M, Mbikayi SM, Suguimoto SP, Techasrivichien T, Lukhele BW, El-Saaidi C, Piot P, Ono-Kihara M, Kihara M. Food insecurity is associated with increased risk of non-adherence to antiretroviral therapy among HIV-infected adults in the Democratic Republic of Congo: a cross-sectional study. PLoS One. 2014 Jan 15;9(1):e85327. doi: 10.1371/journal.pone.0085327. eCollection 2014.
PubMed 24454841
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
- ClinicalTrials.gov ID
- NCT02815579
- Acronym / sponsor ID
- Shamba R01 / P0503135
- Conditions
- HIV
- Keywords
- HIV, Food insecurity, Microcredit loan, Agriculture, Livelihoods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 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 South Carolina, University of Connecticut, University of Pennsylvania
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 18 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether this multisectoral agricultural and microcredit loan intervention improves food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS.
Detailed description
Despite major advances in care and treatment for those living with HIV, morbidity and mortality among people living with HIV/AIDS (PLHIV) remains unacceptably high in sub-Saharan Africa (SSA), largely due to the parallel challenges of poverty and food insecurity.[1] In the Nyanza Region of Kenya, 15.1% of the adult population is infected by HIV,[2] and over 50% of the rural population is food insecure, primarily due to unpredictable rainfall and limited irrigation.[3,4] The investigators have previously shown that food insecurity delays antiretroviral therapy (ART) initiation, reduces ART adherence, contributes to worse immunologic and virologic outcomes, and increases morbidity and mortality among PLHIV.[5-16] There has been increasing international recognition that improved food security and reduced poverty are essential components for a successful global response to the HIV epidemic.[17-21] Yet, to date few studies have systematically evaluated the impacts of sustainable food security interventions on health, economic, and behavioral outcomes among PLHIV. Agricultural interventions, which have potential to raise income and bolster food security, are an important but understudied route through which to sustainably improve nutritional and HIV outcomes in SSA, including Kenya where agriculture accounts for > 75% of the total workforce, and 51% of the gross domestic product.[22]
Building on the investigators successful completion of the pilot intervention trial in Kenya and the investigators collective experience studying structural barriers to HIV care in SSA, the investigators plan to test the hypothesis that a multisectoral agricultural and microcredit loan intervention will improve food security, prevent ART treatment failure, and reduce co-morbidities among PLHIV. The investigators' intervention was co-developed with KickStart, a prominent non-governmental organization (NGO) based in SSA that has introduced a human-powered pump, enabling farmers to grow high yield crops year-round. This technology has reduced food insecurity and poverty for 800,000 users in 22 countries in the subcontinent since 1991.[23] The investigators' intervention 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 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. This study is a cluster randomized controlled trial (RCT) of this intervention with the following specific aims:
Aim 1: To determine the impact of a multisectoral agricultural intervention among HIV-infected farmers on ART on HIV clinical outcomes. The investigators hypothesize that the intervention will lead to improved viral load suppression (primary outcome) and changes in CD4 cell count, physical health status, WHO stage III/IV disease, and hospitalizations (secondary outcomes) in the intervention arm compared to the control arm.
Aim 2: To understand the pathways through which the multisectoral intervention may improve HIV health outcomes. Using the investigator's theoretical model,[1,24] the investigators hypothesize that the intervention will improve food security and household wealth, which in turn will contribute to improved outcomes through nutritional (improved nutritional status measured with Body Mass Index), behavioral (improved ART adherence, and retention in care), and mental health (improved mental health/less depression, improved empowerment) pathways (secondary outcomes).
Aim 3: To determine the cost-effectiveness of the intervention and obtain the information necessary to inform scale-up in Kenya and similar settings in SSA. The investigators will quantify the cost per disability-adjusted life year averted, and identify lessons to inform successful scale-up.
To accomplish Aims 1 \& 2, the investigators will randomize 8 matched pairs of health facilities in the Nyanza Region in a 1:1 ratio to the intervention and control arms, and enroll 44 participants per facility (total n=704). All participants will be followed for 2 years. Impacts of the investigator's intervention on primary health outcomes and mediators will be investigated to provide definitive data of direct and indirect intervention effects. To accomplish Aim 3, the investigators will: a) conduct a cost-effectiveness analysis; b) identify the characteristics of individuals most likely to benefit from the intervention (e.g., gender, educational attainment, family size, wealth, risk tolerance, and entrepreneurial ability); and c) perform a mixed-methods process evaluation with study participants, staff, and various stakeholders to determine what worked and did not work to guide future scale-up efforts of the intervention.
The investigator's ultimate goal is to develop and test an intervention to reverse the cycle of food insecurity and HIV/AIDS morbidity and mortality in SSA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Shamba Maisha InterventionThe Shamba Maisha Intervention 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 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 | No intervention | –Participants in the control arm will receive the standard of care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- HIV-infected adults
- Currently receiving ART
- Belong to a patient support group or demonstrate willingness to join a support group
- Agree to save the down payment (~$10) required for the microcredit loan
- Have evidence of moderate to severe food insecurity based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI<18.5) based on FACES medical records during the year preceding recruitment
Key exclusion criteria (2 listed)
- People who do not speak Dholuo, Swahili, or English
- Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the research assistant
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 |
|---|---|---|
| Shamba Maisha InterventionA) A loan (~$175) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices | Other | Intervention |
Primary outcome
Change in Proportion of Viral Load Suppression (<=200 Copies/mL)
Time frame: Baseline and endline (2 years after enrollment)
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.
10 secondary outcomes
Change (i.e., Linear Trend) in Proportion of Absolute CD4 Count <=500 Cells/mm^3
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Physical Health Status
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e., Linear Trend) in the Proportion of Participants With AIDS-Defining Condition
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e., Linear Trend) in the Proportion of Participants Who Were Hospitalized in the Previous 6 Months
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in the Mean Score of Food Insecurity Score
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Nutritional Status (Represented by Body Mass Index (BMI))
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Self-reported Adherence to Antiretroviral Therapy
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Self-confidence Score
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Proportion of Probable Depression
Time frame: Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in the Mean Internalized Stigma Score
Time frame: Baseline and endline (2 years after enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22089434Weiser SD, Young SL, Cohen CR, Kushel MB, Tsai AC, Tien PC, Hatcher AM, Frongillo EA, Bangsberg DR. Conceptual framework for understanding the bidirectional links between food insecurity and HIV/AIDS. Am J Clin Nutr. 2011 Dec;94(6):1729S-1739S. doi: 10.3945/ajcn.111.012070. Epub 2011 Nov 16.
- BackgroundNational AIDS and STI Control Programme, Ministry of Health, Kenya. September 2013. Kenya AIDS Indicator Survey 2012: Preliminary Report. Nairobi, Kenya
- BackgroundPlace F, Adato M, Hebinck P. Understanding rural poverty and investment in agriculture: an assessment of integrated quantitative and qualitative research in western Kenya. World Dev. 2007;35(2):312-325.
- BackgroundStoorvogel J, Smaling E. Assessment of soil nutrient depletion in sub-Saharan Africa: 1983-2000. Report No. 28, Vols. I-IV. Wageningin, Netherlands: Winand Staring Center; 1990.
- Background: PubMed 21694604McMahon JH, Wanke CA, Elliott JH, Skinner S, Tang AM. Repeated assessments of food security predict CD4 change in the setting of antiretroviral therapy. J Acquir Immune Defic Syndr. 2011 Sep 1;58(1):60-3. doi: 10.1097/QAI.0b013e318227f8dd.
- Background: PubMed 21573882Wang EA, McGinnis KA, Fiellin DA, Goulet JL, Bryant K, Gibert CL, Leaf DA, Mattocks K, Sullivan LE, Vogenthaler N, Justice AC; VACS Project Team. Food insecurity is associated with poor virologic response among HIV-infected patients receiving antiretroviral medications. J Gen Intern Med. 2011 Sep;26(9):1012-8. doi: 10.1007/s11606-011-1723-8. Epub 2011 May 15.
- Background: PubMed 23939234Weiser SD, Palar K, Frongillo EA, Tsai AC, Kumbakumba E, Depee S, Hunt PW, Ragland K, Martin J, Bangsberg DR. Longitudinal assessment of associations between food insecurity, antiretroviral adherence and HIV treatment outcomes in rural Uganda. AIDS. 2014 Jan 2;28(1):115-20. doi: 10.1097/01.aids.0000433238.93986.35.
- Background: PubMed 22150119Nagata JM, Magerenge RO, Young SL, Oguta JO, Weiser SD, Cohen CR. Social determinants, lived experiences, and consequences of household food insecurity among persons living with HIV/AIDS on the shore of Lake Victoria, Kenya. AIDS Care. 2012;24(6):728-36. doi: 10.1080/09540121.2011.630358. Epub 2011 Dec 7.
- Background: PubMed 21904186Weiser SD, Tsai AC, Gupta R, Frongillo EA, Kawuma A, Senkungu J, Hunt PW, Emenyonu NI, Mattson JE, Martin JN, Bangsberg DR. Food insecurity is associated with morbidity and patterns of healthcare utilization among HIV-infected individuals in a resource-poor setting. AIDS. 2012 Jan 2;26(1):67-75. doi: 10.1097/QAD.0b013e32834cad37.
- Background: PubMed 23842717Young S, Wheeler AC, McCoy SI, Weiser SD. A review of the role of food insecurity in adherence to care and treatment among adult and pediatric populations living with HIV and AIDS. AIDS Behav. 2014 Oct;18 Suppl 5(0 5):S505-15. doi: 10.1007/s10461-013-0547-4.
- Background: PubMed 22692093Weiser SD, Gupta R, Tsai AC, Frongillo EA, Grede N, Kumbakumba E, Kawuma A, Hunt PW, Martin JN, Bangsberg DR. Changes in food insecurity, nutritional status, and physical health status after antiretroviral therapy initiation in rural Uganda. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):179-86. doi: 10.1097/QAI.0b013e318261f064.
- BackgroundWeiser S, Fernandes K, Anema A, et al. Food insecurity as a barrier to antiretroviral therapy (ART) adherence among HIV-infected individuals in British Columbia. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Cape Town, South Africa2009.
- Individual participant dataSharing planned: No
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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.
Sheri D Weiser, MD, MPH principal investigator
Departments of Medicine, UCSF
Craig R Cohen, MD, MPH principal investigator
Department of Obstetrics, Gynecology & Reproductive Sciences, UCSF
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of HIV, run by University of California, San Francisco at 16 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 6 inclusion and 2 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 18 Jan 2024). 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?
Change in Proportion of Viral Load Suppression (<=200 Copies/mL) (time frame: Baseline and endline (2 years after enrollment)). 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 NCT02815579, which also lists 31 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 25 Apr 2024.