Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001356752
Ethics application status
Not yet submitted
Date submitted
2/12/2013
Date registered
11/12/2013
Date last updated
11/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing unplanned pregnancy in women in drug and alcohol health services
Scientific title
Improving uptake of long acting contraceptive methods and reducing unplanned pregnancy in women in drug and alcohol health services: Evaluation of a pilot
Secondary ID [1] 283668 0
Nil
Universal Trial Number (UTN)
U1111-1150-9065
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unplanned pregnancy
290621 0
Long acting reversible contraceptive (LARC) methods 290716 0
Women attending drug and alcohol treatment services 290717 0
Condition category
Condition code
Reproductive Health and Childbirth 291012 291012 0 0
Contraception
Public Health 291013 291013 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A three month lead in period will measure the rate of uptake of contraception in the standard care scenario within a drug and alcohol treatment service. After 3 months, an integrated contraception clinic will be established and women invited to attend. All participants will be followed up at 12 months.

This integrated contraceptive clinic will employ a medical officer for one session every second week (0.05FTE). All doctors employed will be specifically trained and accredited in family planning and will offer women participants the range of contraceptive options as per standard care including condoms, pills and LARC methods. If a LARC method is chosen then standard care involves follow-up of patients with implants at 2 weeks and IUDs at 6 weeks post-insertion. Treatment will be delivered according to current clinical practice guidelines developed by family planning organisations across Australia.

All women accessing the drug health service will be initially screened for eligibility by their treating multidisciplinary team who regularly undertake physical, mental and social health assessments on their clients. These clients will be invited to take part and will be referred to the research nurse who will obtain informed consent and conduct baseline interviews.
Intervention code [1] 288366 0
Prevention
Comparator / control treatment
1-3 months: External referral
Eligible women enrolled and referred to appropriate external services for their contraceptive needs (general practitioner, Family Planning services or community health) as per standard care.
Control group
Historical

Outcomes
Primary outcome [1] 290996 0
Self-reported unplanned pregnancy measured via self-report in a structured interview (12 months post baseline). Also consent will be obtained to access medical records including pregnancy services.
Timepoint [1] 290996 0
12 months after baseline interview
Secondary outcome [1] 305787 0
Self-reported increased use of long acting reversible contraceptive measured via structured interview (12 months post baseline) and, where possible, medical record review.
Timepoint [1] 305787 0
12 months after baseline interview

Eligibility
Key inclusion criteria
a) female patient of the drug and alcohol service; b) aged between 18 and 49 years; c) heterosexually active as defined as any heterosexual activity within the past 12 months; d) currently using no contraception, using less reliable contraceptive methods (e.g. withdrawal, rhythm, condoms, oral contraceptive) or considering a change of method; e) expects to be available for follow-up at 12 months; f) able to provide informed consent, including unaffected by substance use (intoxicated or in withdrawal), and adequate English language to complete study procedures.
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) women with serious mental or physical illness or disability likely to impact on capacity to complete study procedures or uptake of a contraceptive method; b) opposed to the use of contraception on religious or other grounds; c) women who are pregnant at the time; d) women who are planning a pregnancy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288356 0
Self funded/Unfunded
Name [1] 288356 0
Dr Kirsten Black
Country [1] 288356 0
Australia
Primary sponsor type
Individual
Name
Dr Kirsten Black
Address
Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 287063 0
None
Name [1] 287063 0
Address [1] 287063 0
Country [1] 287063 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290237 0
Sydney Local Health Distriact Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 290237 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 290237 0
Australia
Date submitted for ethics approval [1] 290237 0
02/12/2013
Approval date [1] 290237 0
Ethics approval number [1] 290237 0
HREC/13/RPAH/532

Summary
Brief summary
Women who misuse alcohol and other drugs have low rates of contraceptive use and higher rates of pregnancies
(including unplanned pregnancies) compared to the general population. Once pregnant, these women and their
babies experience higher rates of adverse health outcomes such as preterm birth, low birth weight and adverse
developmental and social outcomes. Our research aims to explore whether women in drug and alcohol treatment
who do not wish to conceive will have better rates of contraceptive use when contraceptive services are integrated into drug treatment clinics, compared to standard care where women are referred to primary health care services for their contraceptive needs. With this model we seek to increase use of all contraceptive methods but particularly methods that do not require daily adherence such as injections, implants and intrauterine devices that are reversible but extremely reliable. These methods are known collectively as the long acting reversible contraceptive (LARC) methods.

A pilot integrated contraceptive medical service will be introduced within a drug and alcohol clinical setting. We
propose to evaluate this pilot, to determine whether integrated care is feasible, and if it is more effective in
increasing the use of contraceptive methods and reducing unplanned pregnancy than the standard of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44642 0
Dr Kirsten Black
Address 44642 0
Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050
Country 44642 0
Australia
Phone 44642 0
+61 2 9515 7245
Fax 44642 0
Email 44642 0
[email protected]
Contact person for public queries
Name 44643 0
Dr Kirsten Black
Address 44643 0
Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050
Country 44643 0
Australia
Phone 44643 0
+61 2 9515 7245
Fax 44643 0
Email 44643 0
[email protected]
Contact person for scientific queries
Name 44644 0
Dr Kirsten Black
Address 44644 0
Department of Obstetrics and Gynaecology
Central Clinical School
The University of Sydney
Royal Prince Alfred Hospital
Level 4, Building 63
Missenden Road
Camperdown NSW 2050
Country 44644 0
Australia
Phone 44644 0
+61 2 9515 7245
Fax 44644 0
Email 44644 0
[email protected]

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.