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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.
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
Secondary ID [1] 282487 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 289120 0
Condition category
Condition code
Public Health 289457 289457 0 0
Health promotion/education
Reproductive Health and Childbirth 289458 289458 0 0
Contraception

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287138 0
Prevention
Intervention code [2] 287148 0
Behaviour
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.
Control group
Active

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.
Timepoint [1] 289562 0
Baseline and 2 months post-intervention. Questionnaire administered by interview.
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.
Timepoint [2] 289563 0
Baseline and 2 months post-intervention. Questionnaire administered by interview.
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.
Timepoint [1] 302745 0
Baseline and 2 months post-intervention. Questionnaire administered by interview.
Secondary outcome [2] 302746 0
Contraceptive Self-Efficacy Scale score.
Timepoint [2] 302746 0
Baseline and 2 months post-intervention. Questionnaire administered by interview.

Eligibility
Key inclusion criteria
Aged 15-19 years
Residing in study communities
Minimum age
15 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2012
Actual
13/08/2012
Date of last participant enrolment
Anticipated
Actual
19/10/2012
Date of last data collection
Anticipated
Actual
10/05/2013
Sample size
Target
370
Accrual to date
Final
392
Recruitment outside Australia
Country [1] 5079 0
Vanuatu
State/province [1] 5079 0

Funding & Sponsors
Funding source category [1] 287269 0
Government body
Name [1] 287269 0
The Australian Agency for International Development (AusAID)
Country [1] 287269 0
Australia
Primary sponsor type
Other
Name
Burnet Institute
Address
85 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 286022 0
Other
Name [1] 286022 0
Wan Smolbag Theatre
Address [1] 286022 0
PO Box 1024
Port Vila
Country [1] 286022 0
Vanuatu

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289249 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 289249 0
Ethics committee country [1] 289249 0
Australia
Date submitted for ethics approval [1] 289249 0
Approval date [1] 289249 0
28/05/2012
Ethics approval number [1] 289249 0
185/12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39974 0
Dr Elissa Kennedy
Address 39974 0
Centre for International Health
Burnet Institute
85 Commercial Road
Melbourne VIC 3004
Country 39974 0
Australia
Phone 39974 0
+61 3 9282 2119
Fax 39974 0
Email 39974 0
elissa.kennedy@burnet.edu.au
Contact person for public queries
Name 39975 0
Elissa Kennedy
Address 39975 0
Centre for International Health
Burnet Institute
85 Commercial Road
Melbourne VIC 3004
Country 39975 0
Australia
Phone 39975 0
+61 3 9282 2119
Fax 39975 0
Email 39975 0
elissa.kennedy@burnet.edu.au
Contact person for scientific queries
Name 39976 0
Elissa Kennedy
Address 39976 0
Centre for International Health
Burnet Institute
85 Commercial Road
Melbourne VIC 3004
Country 39976 0
Australia
Phone 39976 0
+61 3 9282 2119
Fax 39976 0
Email 39976 0
elissa.kennedy@burnet.edu.au

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.