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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02890628
Other study ID # SMRU 1602
Secondary ID
Status Completed
Phase N/A
First received July 13, 2016
Last updated March 13, 2017
Start date September 2016
Est. completion date September 21, 2016

Study information

Verified date March 2017
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The study will be conducted as follows:

- 12-24 individual interviews with pregnant or postnatal adolescent girls (<20 years);

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

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

- 1 Focus group discussion of 6-10 Shoklo malaria research unit antenatal care staff;

Interviews and focus group discussion will be conducted with study participants who agree to participate in discussions about teenage pregnancy and motherhood, sexual and reproductive health. In-depth interviews and focus group discussion will be conducted in private meeting rooms in proximity to the antenatal clinic waiting areas. In-depth interviews and Focus group discussion will be co-facilitated by the principal investigator and a trained counsellor/midwife fluent in Karen, Burmese and English. Focus group discussion will be run separately for Burmese- and Karen-speaking participants and participants will be separated by subgroup. Focus group discussion will include 6-10 participants per group and for each focus group discussion to last between 45-60 minutes. Individual in-depth interviews will last approximately 60 minutes each.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date September 21, 2016
Est. primary completion date September 21, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria:

Inclusion criteria for adolescent mothers (subgroup 1) are:

- 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

Inclusion criteria for non-pregnant female adolescents (subgroup 2) are:

- Aged <20 years

- Females

- Migrant or refugee status

- Myanmar nationality

- No past or current pregnancy

- Able and willing to participate and give informed consent

Inclusion criteria for adolescent men (subgroup 3) are:

- Aged <20 years

- Males

- Migrant or refugee status

- Myanmar nationality

- Able and willing to participate and give informed consent

Inclusion criteria for health staff (subgroup 4) are:

- No age restrictions

- Females or males

- Migrant, refugee or non-migrant status

- Any nationality

- Able and willing to participate and give informed consent

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Shoklo Malaria Research Unit Mae Sot Tak

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Descriptive summary of demographic, social and medical characteristics of study participants up to 1 year
Secondary Summary of antenatal clinic staff perceptions up to 1 year
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