Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12613000534785
Ethics application status
Approved
Date submitted
10/05/2013
Date registered
14/05/2013
Date last updated
30/07/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Preventing early and unintended pregnancy in Vanuatu: a community-based intervention targeting adolescents.
Query!
Scientific title
Cluster randomised controlled trial of a peer-led, community-based health promotion intervention to improve knowledge, attitudes and use of contraception among adolescents (15-19 years) in Vanuatu
Query!
Secondary ID [1]
282487
0
Nil
Query!
Universal Trial Number (UTN)
Nil
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Contraception
289120
0
Query!
Condition category
Condition code
Public Health
289457
289457
0
0
Query!
Health promotion/education
Query!
Reproductive Health and Childbirth
289458
289458
0
0
Query!
Contraception
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
This study will assess a participatory health promotion intervention developed by Wan Smolbag Theatre in conjunction with Burnet Institute. The intervention will build on existing peer education models used by Wan Smolbag adapted to incorporate reproduction and family planning. The intervention will be conducted in communities by trained peer educators and will include at least one participatory group workshop (lasting at least 1-2 hours) for adolescents aged 15-19 years, followed by at least two individual sessions (each lasting approximately 1 hour) with a peer educator to provide personalised information, counselling and referral to youth-friendly health services. The workshops and individual sessions will focus on improving knowledge and fostering supportive attitudes towards pregnancy prevention, addressing misconceptions, promotion of voluntary contraception, identification of risk and protective factors, and building interpersonal and negotiation skills. Participants will also be provided with printed resources about sexual and reproductive health and offered condoms and referral to youth-friendly health services. The intervention will be conducted over 2 months, commencing with the community-based workshop, followed by individual sessions at approximately 3-week intervals. There is no maximum number of session that a participant may attend. Details will be recorded by peer educators regarding the length and number of sessions attended by each participant.
Query!
Intervention code [1]
287138
0
Prevention
Query!
Intervention code [2]
287148
0
Behaviour
Query!
Comparator / control treatment
The control group will receive printed resources about sexual and reproductive health (including family planning, sexually transmitted infections, HIV) and offered condoms and referral to youth-friendly health services.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
289562
0
Knowledge of reproduction and contraception assessed by 18 knowledge questions. Questions are adapted from the World Health Organisation Survey Questionnaire for Young People and the Demographic and Health Survey Young Adult Reproductive Health Survey.
Query!
Assessment method [1]
289562
0
Query!
Timepoint [1]
289562
0
Baseline and 2 months post-intervention. Questionnaire administered by interview.
Query!
Primary outcome [2]
289563
0
Attitudes towards contraception assessed by 10 attitude questions. Questions are adapted from the World Health Organisation Survey Questionnaire for Young People and the Demographic and Health Survey Young Adult Reproductive Health Survey.
Query!
Assessment method [2]
289563
0
Query!
Timepoint [2]
289563
0
Baseline and 2 months post-intervention. Questionnaire administered by interview.
Query!
Secondary outcome [1]
302745
0
Self-reported use of any modern method of contraception at last sex (within the last 6 months). Modern contraceptive methods include: condom (male or female); oral contraceptive pill; injectable; implant; intrauterine device; emergency contraception; other vaginal barrier method; and male and female sterilisation.
Query!
Assessment method [1]
302745
0
Query!
Timepoint [1]
302745
0
Baseline and 2 months post-intervention. Questionnaire administered by interview.
Query!
Secondary outcome [2]
302746
0
Contraceptive Self-Efficacy Scale score.
Query!
Assessment method [2]
302746
0
Query!
Timepoint [2]
302746
0
Baseline and 2 months post-intervention. Questionnaire administered by interview.
Query!
Eligibility
Key inclusion criteria
Aged 15-19 years
Residing in study communities
Query!
Minimum age
15
Years
Query!
Query!
Maximum age
19
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Nil
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Twenty-eight participating communities (rural and urban) on two islands of Vanuatu will be recruited by the study team following community consultation and consent from the community leader to participate. These 28 communities were identified during formative research. Trained peer educators will approach all young people residing in the community to ascertain eligibility. All eligible adolescents will be invited to participate, with a target of 14 participants (7 male, 7 female) per community (cluster). Following enrollment of all individual participants, communities will be randomly assigned to the intervention or control groups.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated series of random numbers will be used to allocate communities (clusters) to the intervention or control group. This will be conducted by a member of the team not involved in the recruitment of communities or individual participants.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
13/08/2012
Query!
Actual
13/08/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
19/10/2012
Query!
Date of last data collection
Anticipated
Query!
Actual
10/05/2013
Query!
Sample size
Target
370
Query!
Accrual to date
Query!
Final
392
Query!
Recruitment outside Australia
Country [1]
5079
0
Vanuatu
Query!
State/province [1]
5079
0
Query!
Funding & Sponsors
Funding source category [1]
287269
0
Government body
Query!
Name [1]
287269
0
The Australian Agency for International Development (AusAID)
Query!
Address [1]
287269
0
255 London Circuit
Canberra ACT 2601
Query!
Country [1]
287269
0
Australia
Query!
Primary sponsor type
Other
Query!
Name
Burnet Institute
Query!
Address
85 Commercial Road
Melbourne VIC 3004
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286022
0
Other
Query!
Name [1]
286022
0
Wan Smolbag Theatre
Query!
Address [1]
286022
0
PO Box 1024
Port Vila
Query!
Country [1]
286022
0
Vanuatu
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289249
0
Alfred Hospital Ethics Committee
Query!
Ethics committee address [1]
289249
0
55 Commercial Rd
Melbourne VIC 3004
Query!
Ethics committee country [1]
289249
0
Australia
Query!
Date submitted for ethics approval [1]
289249
0
Query!
Approval date [1]
289249
0
28/05/2012
Query!
Ethics approval number [1]
289249
0
185/12
Query!
Summary
Brief summary
Sexual activity during adolescence is common in many Pacific countries, however many young people lack adequate knowledge about reproduction and contraception to help protect themselves from unintended pregnancy. Up to a quarter of girls aged 15-19 in this region have already commenced childbearing. Many of these pregnancies are unintended and often have significant consequences for the health and wellbeing of girls and their families.
There are a number of peer education programs in the Pacific that aim to improve young people’s knowledge about sexual and reproductive health, howver there are limited examples of programs that focus on preventing unintended pregnancy. In addition, very little research has looked at the effectivess of peer education in this region.
This study will trial a peer education program that focuses on prevention of pregnancy, targeting adolescents aged 15-19 years in rural and urban communities of Vanuatu. The program will adapt other successful peer education activities and will include community-based workshops, one-on-one education and counselling, and printed materials. These activities will provide accurate and comprehensive information about reproduction and contraception and also help young people develop interpersonal and negotiation skills. The program aims to improve adolescents’ knowledge and attitudes about contraception with the overall goal of reducing early and unintended pregnancy.
Query!
Trial website
Query!
Trial related presentations / publications
Currently being prepared
Query!
Public notes
Query!
Contacts
Principal investigator
Name
39974
0
Dr Elissa Kennedy
Query!
Address
39974
0
Centre for International Health
Burnet Institute
85 Commercial Road
Melbourne VIC 3004
Query!
Country
39974
0
Australia
Query!
Phone
39974
0
+61 3 9282 2119
Query!
Fax
39974
0
Query!
Email
39974
0
[email protected]
Query!
Contact person for public queries
Name
39975
0
Dr Elissa Kennedy
Query!
Address
39975
0
Centre for International Health
Burnet Institute
85 Commercial Road
Melbourne VIC 3004
Query!
Country
39975
0
Australia
Query!
Phone
39975
0
+61 3 9282 2119
Query!
Fax
39975
0
Query!
Email
39975
0
[email protected]
Query!
Contact person for scientific queries
Name
39976
0
Dr Elissa Kennedy
Query!
Address
39976
0
Centre for International Health
Burnet Institute
85 Commercial Road
Melbourne VIC 3004
Query!
Country
39976
0
Australia
Query!
Phone
39976
0
+61 3 9282 2119
Query!
Fax
39976
0
Query!
Email
39976
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF