NCT03012659

Brief Summary

The purpose of this study is to assess the impact of a provider counseling training on patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10 Planned Parenthood health centers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,015

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

January 4, 2017

Last Update Submit

April 4, 2018

Conditions

Keywords

contraceptive counselingcluster randomized trialprovider counseling training

Outcome Measures

Primary Outcomes (1)

  • Contraceptive Continuation

    Patient-reported contraceptive continuation

    3 months

Secondary Outcomes (5)

  • Method Satisfaction

    1 month and 3 months

  • Dual-Use

    1 month and 3 months

  • Missed Pills

    1 month and 3 months

  • Method Switching

    1 month and 3 months

  • Patient experience of counseling best practices during their visit

    Baseline

Other Outcomes (1)

  • Access to same-day services for all contraceptive methods

    Baseline

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Full-day contraceptive counseling training for health center staff

Behavioral: Contraceptive Counseling Training

Control Arm

NO INTERVENTION

Usual care

Interventions

Intervention sites will receive: 1. In person training: All staff at an intervention health center will participate in a one-day counseling training. 2. On-site shadowing: Trainers will shadow staff in-clinic the day following the training to observe the counseling implementation and provide additional coaching and support. 3. Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance.

Intervention Arm

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Females who have received contraceptive counseling at participating health centers.
  • Ability to understand written and spoken English.

You may not qualify if:

  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood South Atlantic

Raleigh, North Carolina, 27603, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Hannah R. Simons, DrPH

    Planned Parenthood Federation of America

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 6, 2017

Study Start

December 1, 2016

Primary Completion

June 29, 2017

Study Completion

July 31, 2018

Last Updated

April 6, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations