Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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6 March 2023 |
Main ID: |
NCT03226730 |
Date of registration:
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07/10/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger
IMPACT-RMA |
Scientific title:
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Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger |
Date of first enrolment:
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May 2016 |
Target sample size:
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2898 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03226730 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Niger
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United States
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Contacts
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Name:
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Jay G Silverman, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Center on Gender Equity and Health, University of California, San Diego |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
For Women:
- Married
- 13-19 years old
- Fluent in Hausa or Zarma
- Residing in the village where recruitment is taking place with no plans to move away
in next 18 months or plan to travel for more than 6 months during that period
- Providing informed consent.
For Men:
- Must be the husband to an eligible adolescent participating in the study
- Hausa or Zarma speaking
- Providing informed consent.
Exclusion Criteria:
For Women:
- Plans to move away in next 18 months or plans to travel for more than 6 months during
that period;
- Currently sterilized (to enable measurement of changes in use of temporary methods of
contraception from baseline to 16-months follow-up)
Age minimum:
13 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Contraception
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Intervention(s)
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Behavioral: Household Visits
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Behavioral: Small Groups
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Primary Outcome(s)
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Contraception Use Questionnaire
[Time Frame: baseline and 18 month follow up]
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Intentions to Use Contraception Questionnaire
[Time Frame: baseline and 18 month follow up]
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Secondary Outcome(s)
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Knowledge of effective contraceptive methods Questionnaire
[Time Frame: baseline and 18 month follow up]
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Acceptance of effective contraceptive methods Questionnaire
[Time Frame: baseline and 18 month follow up]
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Female Empowerment Questionnaire
[Time Frame: baseline and 18 month follow up]
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Social norms regarding gender equity Questionnaire
[Time Frame: baseline and 18 month follow up]
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Secondary ID(s)
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2016-1430
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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