LARC Forward Counselling

Study Overview
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Brief Summary
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Training of health care providers and structured LARC forward counseling may contribute to increased LARC uptake. The hypothesis to be tested is that by introducing LARC forward counselling an increase in LARC usage will be the result as well as decreased unplanned pregnancy and abortion. It is expected that the results of this study will highlight the importance of LARC forward counseling and thus provide the evidence needed to train health care providers and increase access to LARC in youth clinics, midwifery clinics and for post abortion contraception.

Official Title
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Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project

Conditions
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Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy

Intervention / Treatment
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* Other: LARC forward structured contraceptive counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At risk for pregnancy (sexually active with men or anticipate becoming sexually active in the next 6 months). Do not desire pregnancy . No contraindications to LARC Exclusion Criteria: Undergone tubal ligation or other sterilization procedure. Use of contraceptives for other purposes than contraception

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Clinics randomized to intervention will provide structured LARC centered counselling | Other: LARC forward structured contraceptive counselling<br>* Training of health care providers (HCPs), use of information material and counselling tools<br>|
| No Intervention: Routine counselling<br>Clinics randomized to routine counselling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LARC prescriptions (recorded electronic prescriptions) | The rate of women who receive a LARC prescription | Evaluated at the index visit to the clinic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LARC placements recorded in patient records | The rate of women who has a LARC method placed following the baseline visit | Evaluated at 3months follow up (FU) | 
| Contraceptive method used reported by participants | The rate of women who use a contraceptive method | Evaluated at 3,6 and 12 months FU | 
| Satisfaction with the chosen contraceptive method reported by participants | Satisfaction with the prescribed contraceptive method | Evaluated at 3,6 and 12 months FU | 
| (Unplanned) pregnancy reported by participants and recorded in patient records | (Unplanned) pregnancy rate | Evaluated at 3,6 and 12 months FU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LARC, contraception, counselling, unplanned pregnancy