NCT03741634

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

November 7, 2018

Last Update Submit

October 5, 2020

Conditions

Adolescent BehaviorSexual BehaviorReproductive Behavior

Keywords

adolescent healthsexual healthreproductive healthfood security

Outcome Measures

Primary Outcomes (3)

  • Food insecurity

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

    Endline / 2 years

  • Depressive symptoms

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

    Endline / 2 years

  • Unprotected sex

    Percentage of time not used condoms over past six months

    Endline / 2 years

Secondary Outcomes (7)

  • Percentage of participants who become pregnant

    Endline / 2 years

  • Unintended pregnancy

    Endline / 2 years

  • HIV

    Endline / 2 years

  • HSV-2

    Endline / 2 years

  • Body mass index-for-age-Z-score

    Endline / 2 years

  • +2 more secondary outcomes

Other Outcomes (3)

  • Anxiety

    Endline / 2 years

  • Empowerment

    Endline / 2 years

  • School attendance

    Endline / 2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.

Other: Multi-sectoral agricultural intervention

No intervention

NO INTERVENTION

During 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.

Interventions

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.

Intervention

Eligibility Criteria

Age13 Years - 20 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Kitare

Suba, Homa Bay County, Kenya

Location

Sindo

Suba, Homa Bay County, Kenya

Location

Muhuru Bay

Nyatike, Migori County, Kenya

Location

Sori Lakeside

Nyatike, Migori County, Kenya

Location

Minyenya

Rongo, Migori County, Kenya

Location

Ngode

Rongo, Migori County, Kenya

Location

Oyani

Rongo, Migori County, Kenya

Location

Nyamasare

Uriri, Migori County, Kenya

Location

Hongo Ogosa

Kisumu, Kenya

Location

Kisumu District Hospital

Kisumu, Kenya

Location

Lumumba

Kisumu, Kenya

Location

Nyangande

Kisumu, Kenya

Location

Osingo

Kisumu, Kenya

Location

Pandiperi

Kisumu, Kenya

Location

Railways

Kisumu, Kenya

Location

Suna Ragana

Migori, Kenya

Location

Related Publications (5)

  • 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.

    PMID: 20459841BACKGROUND

  • 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.

    PMID: 27507020BACKGROUND

  • 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.

    PMID: 26214684BACKGROUND

  • 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.

    PMID: 25992307BACKGROUND

  • 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.

    PMID: 37863268DERIVED

Related Links

MeSH Terms

Conditions

Adolescent BehaviorSexual BehaviorReproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sheri D Weiser, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 15, 2018

Study Start

December 5, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KE(16)