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Adolescent BehaviorNCT03741634

Assessing the Preliminary Effects of a Multisectoral Agricultural Intervention on Adolescent Girls' Health

A study testing Multi-sectoral agricultural intervention in people with Adolescent Behavior and Sexual Behavior, run by University of California, San Francisco at 16 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to understand how the Shamba Maisha household agricultural and economic intervention impacts the sexual, reproductive, and nutritional health of adolescent girls. Read more about this study

Who is it for?
Ages 13 to 20 years, women onlyHealthy volunteers can take part
What is being tested?
Multi-sectoral agricultural intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
16 sitesKenya
Study dates
5 Dec 2018to 20 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

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 13 to 20 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • an adult participating in the parent study
  • a currently unmarried adolescent girl aged 13-20 years old (preferred target of 15-19)
  • the adolescent girl has a parent/primary guardian age >18 years old who resides in the household

Who cannot join

  • adolescent girls with a confirmed HIV diagnosis by clinical records prior to the start of SM
  • married adolescent girls
  • those who do not speak Dholuo, Swahili, or English
  • those who are heads of households
  • those ages 18 to 20 who are enrolled in the parent study
  • those with inadequate cognitive and/or hearing capacity.

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

  • Osingo

    Kisumu

  • Pandiperi

    Kisumu

  • Railways

    Kisumu

  • 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

Other trials in Kenya

About this study

Official title: Shamba Maisha: Assessing the Preliminary Effects of a Multisectoral Agricultural Intervention on the Sexual and Reproductive Health of HIV-affected Adolescent Girls in Western Kenya

The goal of this study is to understand how the Shamba Maisha household agricultural and economic intervention impacts the sexual, reproductive, and nutritional health of adolescent girls. The intervention includes: 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 (FI) and poverty are important drivers of HIV vulnerability among adolescent girls, and contribute to worse sexual and reproductive health (SRH) outcomes. While most approaches to improving adolescent SRH outcomes have focused on individual-centered approaches alone, integrated family-level interventions that address the underlying context for risk behaviors such as poverty and FI may be more effective in reducing adverse SRH outcomes. A household-level multisectoral agricultural and finance intervention in Nyanza Region, Kenya called Shamba Maisha (SM) designed to mitigate household FI and improve health in HIV-affected households has been successfully developed and piloted. In mid-2016, a large cluster-randomized controlled trial (RCT) of SM was launched, targeting 704 adults and 352 young children to test the effectiveness of this intervention. This pilot study leverages the SM RCT infrastructure to recruit up to 240 adolescent girls residing in SM households and assess the impact of the SM intervention at the household level on adolescent girls' SRH outcomes at study endline. The central hypothesis is that improvements in household FI and wealth will contribute to reduced sexually transmitted infections (STIs), HIV, and unintended pregnancies among adolescent girls. To test this hypothesis, demographic, behavioral, clinical, and biological data from adolescent girls and their caregivers living in intervention and control SM households will be collected. The primary outcomes are food security, depressive symptoms, and sexual risk behaviors in the adolescent girls. The secondary outcomes are pregnancy/unintended pregnancy, HIV, herpes simplex virus 2 (HSV-2), and nutritional status in the adolescent girl.

The ultimate goal is to develop an intervention tailored specifically to the needs of adolescent girls to help reverse the cycle of FI, poverty, low empowerment, and poor SRH outcomes among adolescent girls. If proven efficacious, the proposed intervention may: 1) halt or slow down the cycle of incident HIV, other STIs, and unintended pregnancies to improve the lives of adolescent girls in similar settings, and 2) help achieve several top Sustainable Development Goals (SDG) including SDG 1 (zero poverty), SDG 2 (zero hunger), SDG 3 (good health and wellbeing), and SDG 5 (gender equality).

Being tested
Multi-sectoral agricultural intervention
Keywords
adolescent health, sexual health, reproductive health, food security
Medical subject headings
Adolescent Behavior, Sexual Behavior, Reproductive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-sectoral agricultural interventionOther

    Adult participants in the intervention arm receive a loan (~$175) from a well-established Kenyan bank used to get a human-powered water pump, seeds, fertilizers and, pesticides, and education in financial management and sustainable farming practices.

Study groups in NCT03741634
Study groupRoleWhat they receive
InterventionExperimentalParticipants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.
Receives: Other: Multi-sectoral agricultural intervention
No interventionNo interventionDuring the study, participants enrolled at one study location will non receive the Multi-sectoral agricultural intervention. At the end of the study, participants in this arm will be eligible for education in financial management and sustainable farming practices and those who pay the loan down payment will be eligible for a small loan to purchase a human-powered water pump, seeds, fertilizers and, pesticides.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Food insecurity

    Food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS; score range 0-27 [least to most food insecure]).

    Measured: Endline / 2 years

  2. Depressive symptoms

    Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 [least to most depressed].

    Measured: Endline / 2 years

  3. Unprotected sex

    Percentage of time not used condoms over past six months

    Measured: Endline / 2 years

Secondary outcomes (7)

  1. Percentage of participants who become pregnant

    Measured by urine pregnancy test

    Measured: Endline / 2 years

  2. Unintended pregnancy

    Unintended pregnancy as assessed by the London Measure of Unplanned Pregnancy

    Measured: Endline / 2 years

  3. HIV

    Serial rapid HIV tests based on the Kenyan Ministry of Health guidelines

    Measured: Endline / 2 years

  4. HSV-2

    HSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.)

    Measured: Endline / 2 years

  5. Body mass index-for-age-Z-score

    Weight and height will be combined to report BMI in kg/m^2 as Z score

    Measured: Endline / 2 years

  6. Physical health

    Assessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 [poor to excellent health])

    Measured: Endline / 2 years

  7. Number of sexual partners

    Number of sexual partners over past six months

    Measured: Endline / 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start5 Dec 2018
  3. Primary completion20 Dec 2019
  4. Study completion20 Dec 2019

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03741634
Sponsor's protocol ID
1R21HD095739
Status last verified
Oct 2020
First submitted
7 Nov 2018
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pandit JA, Sirotin N, Tittle R, Onjolo E, Bukusi EA, Cohen CR. Shamba Maisha: a pilot study assessing impacts of a micro-irrigation intervention on the health and economic wellbeing of HIV patients. BMC Public Health. 2010 May 11;10:245. doi: 10.1186/1471-2458-10-245.

    PubMed 20459841

  • Zakaras JM, Weiser SD, Hatcher AM, Weke E, Burger RL, Cohen CR, Bukusi EA, Dworkin SL. A Qualitative Investigation of the Impact of a Livelihood Intervention on Gendered Power and Sexual Risk Behaviors Among HIV-Positive Adults in Rural Kenya. Arch Sex Behav. 2017 May;46(4):1121-1133. doi: 10.1007/s10508-016-0828-x. Epub 2016 Aug 9.

    PubMed 27507020

  • Weiser SD, Bukusi EA, Steinfeld RL, Frongillo EA, Weke E, Dworkin SL, Pusateri K, Shiboski S, Scow K, Butler LM, Cohen CR. Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes. AIDS. 2015 Sep 10;29(14):1889-94. doi: 10.1097/QAD.0000000000000781.

    PubMed 26214684

  • 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.

    PubMed 25992307

  • Weiser SD, Sheira LA, Wekesa P, Zakaras JM, Frongillo EA, Weke E, Nagata JM, Conroy AA, Lightfoot M, Neilands TB, Butler LM, Bukusi EA, Cohen CR, Onono MA. A livelihood intervention improved nutritional, mental health and sexual health outcomes among HIV-affected adolescents in western Kenya: results from the Shamba Maisha randomised controlled trial. BMJ Glob Health. 2026 Mar 26;11(3):e016886. doi: 10.1136/bmjgh-2024-016886.

    PubMed 41887665

  • Onono MA, Frongillo EA, Sheira LA, Odhiambo G, Wekesa P, Conroy AA, Cohen CR, Bukusi EA, Weiser SD. Links between Household-Level Income-Generating Agricultural Intervention and the Psychological Well-Being of Adolescent Girls in Human Immunodeficiency Virus-Affected Households in Southwestern Kenya: A Qualitative Inquiry. J Nutr. 2023 Dec;153(12):3595-3603. doi: 10.1016/j.tjnut.2023.10.008. Epub 2023 Oct 18.

    PubMed 37863268

Questions about this trial

What is this clinical trial studying?

A study testing Multi-sectoral agricultural intervention in people with Adolescent Behavior and Sexual Behavior, 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 3 inclusion and 6 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 8 Oct 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Food insecurity (time frame: Endline / 2 years). The study lists 3 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 NCT03741634, which also lists 6 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 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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