Adolescent Behavior Clinical Trial
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
Verified date | October 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 241 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 13 Years to 20 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Kenya | Hongo Ogosa | Kisumu | |
Kenya | Kisumu District Hospital | Kisumu | |
Kenya | Lumumba | Kisumu | |
Kenya | Nyangande | Kisumu | |
Kenya | Osingo | Kisumu | |
Kenya | Pandiperi | Kisumu | |
Kenya | Railways | Kisumu | |
Kenya | Suna Ragana | Migori | |
Kenya | Muhuru Bay | Nyatike | Migori |
Kenya | Sori Lakeside | Nyatike | Migori |
Kenya | Minyenya | Rongo | Migori |
Kenya | Ngode | Rongo | Migori |
Kenya | Oyani | Rongo | Migori |
Kenya | Kitare | Suba | Homa Bay |
Kenya | Sindo | Suba | Homa Bay |
Kenya | Nyamasare | Uriri | Migori |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Kenya Medical Research Institute |
Kenya,
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum in: Arch Sex Behav. 2017 May;46(4):1135. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anxiety | Measured by the Generalized Anxiety Disorder Scale (GAD-7, 0-21 [least to most anxious]). | Endline / 2 years | |
Other | Empowerment | Measured by the Child and Youth Resilience Measure (CYRM-12, score range 12-60 [least to most resilient]). | Endline / 2 years | |
Other | School attendance | Days of school missed in previous term | Endline / 2 years | |
Primary | 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 | |
Primary | Depressive symptoms | Depression, assessed by the 15 item Hopkins Symptom Checklist-Depression (score range 1-4 [least to most depressed]. | Endline / 2 years | |
Primary | Unprotected sex | Percentage of time not used condoms over past six months | Endline / 2 years | |
Secondary | Percentage of participants who become pregnant | Measured by urine pregnancy test | Endline / 2 years | |
Secondary | Unintended pregnancy | Unintended pregnancy as assessed by the London Measure of Unplanned Pregnancy | Endline / 2 years | |
Secondary | HIV | Serial rapid HIV tests based on the Kenyan Ministry of Health guidelines | Endline / 2 years | |
Secondary | HSV-2 | HSV-2 by Kalon assay (Herpes Simplex Type 2 IgG ELISA, Kalon Biologics, Ltd.) | Endline / 2 years | |
Secondary | Body mass index-for-age-Z-score | Weight and height will be combined to report BMI in kg/m^2 as Z score | Endline / 2 years | |
Secondary | Physical health | Assessed by the Medical Outcomes Study Short Form (SF-36, score range 0-100 [poor to excellent health]) | Endline / 2 years | |
Secondary | Number of sexual partners | Number of sexual partners over past six months | Endline / 2 years |
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