IndigencyNCT02619305
Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda
A study testing Social network tie in people with Indigency, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Indigency
- What is being tested?
- Social network tie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2015to Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara University of Science and Technology
Mbarara
Alexander C Tsai, MD, PhD, 617-724-1120, actsai@partners.org
Bernard Kakuhikire, MBA, 256-075-250-4030, baitwakaku@gmail.com
About this study
Official title: 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.
- Conditions
- Indigency
- Being tested
- Social network tie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social network tieOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Experimental | 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 Receives: Other: Social network tie |
| Delayed treatment | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household Food Insecurity Access Scale
Scale items range from 0 (never) to 3 (more than 10 days in the past month)
Measured: 12 months
Hopkins Symptom Checklist Scale
Scale items range from 1 (not at all) to 4 (very much)
Measured: 12 months
Secondary outcomes (4)
HIV Stigma Scale
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
Measured: 12 months
Norms about Intimate Partner Violence Scale
Agreement (yes/no) with 5 different statements about the acceptability of intimate partner violence under 5 different scenarios (range, 0-5)
Measured: 12 months
Social Integration Scale
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)
Measured: 12 months
Social Capital Scale
Agreement (yes/no) with 4 questions about social trust and social cohesion (range, 0-4)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndigencyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Alexander Tsai, Massachusetts General Hospital
- Investigators
- Alexander C Tsai, MD, PhD, Principal investigator, Massachusetts General HospitalBernard Kakuhikire, MBA, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619305
- Sponsor's protocol ID
- MH096620-S5
- Status last verified
- Dec 2015
- First submitted
- 15 Aug 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02619305
- Acronym / sponsor ID
- MH096620-S5
- Conditions
- Indigency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Study start
- Nov 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Experimental | Other: Social network tieParticipants 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 |
| Delayed treatment | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Social network tieParticipants 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. | Other | Immediate treatment |
Primary outcome
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)
Hopkins Symptom Checklist Scale
Time frame: 12 months
Scale items range from 1 (not at all) to 4 (very much)
4 secondary outcomes
HIV Stigma Scale
Time frame: 12 months
Norms about Intimate Partner Violence Scale
Time frame: 12 months
Social Integration Scale
Time frame: 12 months
Social Capital Scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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.
Alexander C Tsai, MD, PhD principal investigator
Massachusetts General Hospital
Bernard Kakuhikire, MBA principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social network tie in people with Indigency, run by Massachusetts General Hospital at 1 site in Uganda.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander C Tsai, MD, PhD (617-724-1120, actsai@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household Food Insecurity Access Scale (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2015.