- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619305
Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda
December 1, 2015 updated by: Alexander Tsai, Massachusetts General Hospital
Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda: Randomized Controlled Trial
The objective of our study is to determine whether a livelihood intervention can change economic and psychosocial outcomes of social network ties and geographically proximate neighbors of impoverished women in rural Uganda.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Mbarara, Uganda
- Recruiting
- Mbarara University of Science and Technology
-
Contact:
- Alexander C Tsai, MD, PhD
- Phone Number: 617-724-1120
- Email: actsai@partners.org
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Principal Investigator:
- Alexander C Tsai, MD, PhD
-
Principal Investigator:
- Bernard Kakuhikire, MBA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eligibility will be limited to all adults living in Nyakabare Parish (i.e., aged 18 years and older), including emancipated minors. Emancipated minors will be defined as persons living below 18 years of age who are married, are pregnant, live with a biological child in the household, or are responsible for their own livelihood.
Exclusion Criteria:
- Persons under the age of 18 (other than emancipated minors as described above) and persons who do not live within Nyakabare Parish will not be permitted to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate treatment
Participants will be social network ties of women receiving a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises
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Participants will be social network ties of women receiving a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises.
|
|
No Intervention: Delayed treatment
Participants will be social network ties of women receiving no intervention but who will be placed on a waitlist to receive the intervention after a 12-month delay.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Household Food Insecurity Access Scale
Time Frame: 12 months
|
Scale items range from 0 (never) to 3 (more than 10 days in the past month)
|
12 months
|
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Hopkins Symptom Checklist Scale
Time Frame: 12 months
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Scale items range from 1 (not at all) to 4 (very much)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Norms about Intimate Partner Violence Scale
Time Frame: 12 months
|
Agreement (yes/no) with 5 different statements about the acceptability of intimate partner violence under 5 different scenarios (range, 0-5)
|
12 months
|
|
Social Integration Scale
Time Frame: 12 months
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Frequency of participation in 11 different community groups: vocational, positive living, local council, water, village health, agricultural extension, savings, religious, women's, gardening (range, 0-11)
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12 months
|
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Social Capital Scale
Time Frame: 12 months
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Agreement (yes/no) with 4 questions about social trust and social cohesion (range, 0-4)
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12 months
|
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HIV Stigma Scale
Time Frame: 12 months
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Agreement (yes/no) with 15 statements about persons living with HIV (range, 0-15), to be assessed among social network ties of HIV-positive study participants
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander C Tsai, MD, PhD, Massachusetts General Hospital
- Principal Investigator: Bernard Kakuhikire, MBA, Mbarara University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Anticipated)
June 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
August 15, 2015
First Submitted That Met QC Criteria
December 1, 2015
First Posted (Estimate)
December 2, 2015
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- MH096620-S5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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