ContraceptionNCT05252052
Contraception Perspectives in Adolescents in Haiti
An observational study of Contraception, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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: Read more about this study
- Who is it for?
- Ages 14 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Interviews/Surveys
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 31 Jul 2023
- Phase
- Observational
- 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 14 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents 14-24 years old and health care providers in rural Haiti
Who may be able to join
- 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
Who cannot join
- -Subjects who are determined to have severe psychiatric illness or cognitive impairment (based on research team assessment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Barriers and Facilitators to Long-Acting Reversible Contraception: Perspectives of Adolescents and Healthcare Providers in Rural Haiti
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:
Read the detailed 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.
- Conditions
- Contraception
- Being tested
- Interviews/Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews/SurveysOther
This is a cross sectional survey and interviews of adolescents 14- 18 years old and HCPs living in rural Haiti
| Study group | Role | What they receive |
|---|---|---|
| Adolescents 14-24 years old | Adolescents 14-24 years old Receives: Other: Interviews/Surveys | |
| Health care providers in rural Haiti | Health care providers in rural Haiti Receives: Other: Interviews/Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collection will occur over one day for individual participants. Study data collection will occur over 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start22 Mar 2021
- Primary completion31 Mar 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbey Masonbrink, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252052
- Sponsor's protocol ID
- STUDY00001626
- Status last verified
- Jul 2023
- First submitted
- 7 Jan 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36539795Masonbrink 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.
PubMed 36973773
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Facilitators to Long-Acting Reversible Contraception: Perspectives of Adolescents and Healthcare Providers in Rural Haiti
- ClinicalTrials.gov ID
- NCT05252052
- Acronym / sponsor ID
- STUDY00001626
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 23 Feb 2022 (actual)
- 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 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:
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents 14-24 years old | – | Other: Interviews/SurveysAdolescents 14-24 years old |
| Health care providers in rural Haiti | – | Other: Interviews/SurveysHealth care providers in rural Haiti |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents 14-24 years old and health care providers in rural Haiti
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Subjects who are determined to have severe psychiatric illness or cognitive impairment (based on research team assessment).
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 |
|---|---|---|
| Interviews/SurveysThis is a cross sectional survey and interviews of adolescents 14- 18 years old and HCPs living in rural Haiti | Other | Adolescents 14-24 years old, Health care providers in rural Haiti |
Primary outcome
Identification of facilitators and barriers to contraception use
Time frame: Data collection will occur over one day for individual participants. Study data collection will occur over 18 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 36539795Rupe 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.
- Results publication: PubMed 36973773Masonbrink 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 2 Aug 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of facilitators and barriers to contraception use (time frame: Data collection will occur over one day for individual participants. Study data collection will occur over 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252052, which also lists 2 linked publications.
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 Aug 2023.