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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05252052
Other study ID # STUDY00001626
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2021
Est. completion date July 31, 2023

Study information

Verified date July 2023
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall goal of this study is to assess facilitators and barriers to contraception with a focus on long-acting reversible contraception (LARC) among adolescents and health care providers (HCPs) in rural Haiti. The investigator plans to accomplish the following objectives:


Description:

Objective 1: Develop locally-informed surveys and in-depth interview guides, based on the ecologically-expanded Theory of Planned Behavior, to assess attitudes, social norms, perceived behavioral control, and intentions regarding contraception, with a focus on LARC, among adolescents and HCPs in rural Haiti. Objective 2: Conduct a formative mixed methods study of attitudes, social norms, perceived behavioral control, and intentions regarding contraception, with a focus on LARC, among female adolescents (N=150 survey, 25-50 in-depth interviews) and HCPs (N=15; survey and in-depth interviews) in rural Haiti.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 24 Years
Eligibility Inclusion Criteria:• - Adolescents who are biologically female and have reproductive potential (14-24 years old) - Adolescents who reside in the birthing clinic catchment area - Health care providers, including nurse midwives, who work at the local birthing clinic and providers at the local hospital Exclusion Criteria: -Subjects who are determined to have severe psychiatric illness or cognitive impairment (based on research team assessment).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interviews/Surveys
This is a cross sectional survey and interviews of adolescents 14- 18 years old and HCPs living in rural Haiti

Locations

Country Name City State
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (2)

Masonbrink AR, Hurley EA, Schuetz N, Rodean J, Rupe E, Lewis K, Boncoeur MD, Miller MK. Sexual behaviors, contraception use and barriers among adolescents and young adults in rural Haiti. BMC Womens Health. 2023 Mar 27;23(1):137. doi: 10.1186/s12905-023-0 — View Citation

Rupe ER, Rodean J, Hurley EA, Miller MK, Boncoeur MD, Masonbrink AR. Menstrual health among adolescents and young adults in rural Haiti. Reprod Health. 2022 Dec 20;19(1):227. doi: 10.1186/s12978-022-01533-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of facilitators and barriers to contraception use The primary outcome is identification of facilitators and barriers to contraception use among adolescent participants based on responses to the eTPB domains described in Table 1. The investigator will also explore facilitators and barriers to contraception use among HCP participants. Data collection will occur over one day for individual participants. Study data collection will occur over 18 months
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