NCT02890628

Brief Summary

This study is to explore perceptions, experiences, beliefs and knowledge around teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants and to identify demographic, social and medical characteristics of study participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2016

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

20 days

First QC Date

July 13, 2016

Last Update Submit

March 13, 2017

Conditions

Keywords

Thai-Myanmar border

Outcome Measures

Primary Outcomes (2)

  • Thematic summary of adolescents' perceptions, experiences and beliefs in teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants

    up to 1 year

  • Descriptive summary of demographic, social and medical characteristics of study participants

    up to 1 year

Secondary Outcomes (1)

  • Summary of antenatal clinic staff perceptions

    up to 1 year

Study Arms (4)

pregnant/post-natal adolescents (<20 years)

12-24 individual with pregnant or postnatal adolescent girls (\<20 years) will be interviewed.

non-pregnant female adolescents (<20 years)

1 Focus group discussion of 6-10 non-pregnant female adolescents (\<20 years)

male adolescents (<20 year)

1 Focus group discussion of 6-10 adolescent men (\<20 years)

SMRU health staff of antenatal clinics (ANC)

1 Focus group discussion of 6-10 Shoklo Malaria Research Unit antenatal clinic staff

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participant will be adolescent mothers and non-pregnant adolescent aged 12 - \<20 years, adolescent men aged \< 20 years and ANC staff.

You may qualify if:

  • Aged 12 - \<20 years
  • Females
  • Migrant or refugee status
  • Myanmar nationality
  • Any trimester of pregnancy or up to 12 month post partum
  • Able and willing to participate and give informed consent
  • Aged \<20 years
  • Females
  • Migrant or refugee status
  • Myanmar nationality
  • No past or current pregnancy
  • Able and willing to participate and give informed consent
  • Aged \<20 years
  • Males
  • Migrant or refugee status
  • +7 more criteria

You may not qualify if:

  • Any participant who is deemed by the researchers or health staff to be acutely physically or mentally unwell will be excluded.
  • Participants who do not meet the age requirements, migration status or nationality requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

September 7, 2016

Study Start

September 1, 2016

Primary Completion

September 21, 2016

Study Completion

September 21, 2016

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations