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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: ClinicalTrials.gov
Last refreshed on: 6 March 2023
Main ID:  NCT03226730
Date of registration: 07/10/2016
Prospective Registration: No
Primary sponsor: University of California, San Diego
Public title: Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger IMPACT-RMA
Scientific title: Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger
Date of first enrolment: May 2016
Target sample size: 2898
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03226730
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Niger United States
Contacts
Name:     Jay G Silverman, PhD
Address: 
Telephone:
Email:
Affiliation:  Center on Gender Equity and Health, University of California, San Diego
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Contraception
Intervention(s)
Behavioral: Household Visits
Behavioral: Small Groups
Primary Outcome(s)
Contraception Use Questionnaire [Time Frame: baseline and 18 month follow up]
Intentions to Use Contraception Questionnaire [Time Frame: baseline and 18 month follow up]
Secondary Outcome(s)
Knowledge of effective contraceptive methods Questionnaire [Time Frame: baseline and 18 month follow up]
Acceptance of effective contraceptive methods Questionnaire [Time Frame: baseline and 18 month follow up]
Female Empowerment Questionnaire [Time Frame: baseline and 18 month follow up]
Social norms regarding gender equity Questionnaire [Time Frame: baseline and 18 month follow up]
Secondary ID(s)
2016-1430
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bill and Melinda Gates Foundation
Pathfinder International
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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