NCT05252052

Brief 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:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

January 7, 2022

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Adolescents 14-24 years old

Adolescents 14-24 years old

Other: Interviews/Surveys

Health care providers in rural Haiti

Health care providers in rural Haiti

Other: Interviews/Surveys

Interventions

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

Adolescents 14-24 years oldHealth care providers in rural Haiti

Eligibility Criteria

Age14 Years - 24 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents 14-24 years old and health care providers in rural Haiti

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who are determined to have severe psychiatric illness or cognitive impairment (based on research team assessment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (2)

  • 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.

    PMID: 36539795BACKGROUND
  • 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/s12905-023-02268-5.

MeSH Terms

Interventions

Interviews as TopicSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Hospitalist

Study Record Dates

First Submitted

January 7, 2022

First Posted

February 23, 2022

Study Start

March 22, 2021

Primary Completion

March 31, 2023

Study Completion

July 31, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations