- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03214848
Evaluation of an Intervention to Increase Post-abortion LARC Uptake.
Evaluation of an Intervention to Increase Post-abortion LARC Uptake: A Randomized Controlled Trial of Educational and Financial Counseling Prior to Clinical Presentation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
As repeat unintended pregnancy and abortion remain public health challenges, increasing long-acting reversible contraceptive (LARC), specifically intrauterine device (IUD) and contraceptive implant, use among women presenting for abortion care is a priority. Despite its efficacy and safety, LARC methods remain underutilized in the abortion setting.
This is a randomized prospective study evaluating the impact of a brief contraceptive education intervention with optional referral for financial counseling on post abortion long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post abortion.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Georgia
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Atlanta, Georgia, Forenede Stater, 30297
- Atlanta Women's Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Women calling to schedule an appointment for an abortion and/or those who receive abortion services at the Atlanta Women's Center with fluency in English and able to provide informed consent
- 16 years and older
Exclusion Criteria:
-Younger than 16 years old
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Standart of Care
Standard of care at the clinic is to discuss the abortion procedure without specific contraceptive counseling given prior to the day of abortion procedure.
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|
Eksperimentel: Contraceptive education prior to abortion
Addition (to the standard or care) of a brief phone contraceptive education with optional financial counseling referral prior to abortion visit.
|
Contraceptive education script will be delivered over the phone prior to abortion visit.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Long-Acting Reversible Contraception (LARC) methods inserted immediately post abortion in the intervention and standard of care arms.
Tidsramme: Immidiately post abortion (day of the procedure).
|
Proportion of LARC methods inserted immediately post abortion in the intervention and standard of care arms will be calculated based on data abstracted from patients' medical records.
|
Immidiately post abortion (day of the procedure).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Long-Acting Reversible Contraception (LARC) methods used in the intervention and standard of care arms three months post abortion.
Tidsramme: Three months post abortion.
|
This outcome is inclusive of immediate initiators and those who initiate by three months.
Proportion of LARC methods used in the intervention and standard of care arms will be calculated based on the 3-month follow-up phone interview.
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Three months post abortion.
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Cost-effectiveness analysis of the study intervention.
Tidsramme: Three months post abortion.
|
The cost-effectiveness analysis will involve multiple parts.
The study team will initially complete a cost description of the interventions involving time spent in developing the scripts for LARC education and financial counseling, and additional time spent making contact with women and providing the augmented counseling compared to the initial pre-communication session.Incremental cost-effectiveness ratios for the intervention overall will be calculated compared to a 'base-case' of standard of care in the primary analysis.
This value will provide cost per additional women using LARC.
In a secondary analysis, the study team will compare differences between women receiving the educational component only versus 'base-case', and also women receiving the educational and financial counseling component versus 'base-case'.
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Three months post abortion.
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00094882
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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