Contraceptive Equity Study 2016

Contraceptive Usage Clinical Trial

— CES  

Official title:

Contraceptive Equity Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03012659
• Other study ID #: Pro00019792
• Status: Active, not recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: April 4, 2018
• Start date: December 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: April 2018
• Source: Planned Parenthood Federation of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study builds upon prior research on a contraceptive counseling protocol and training developed and studied by partners at New York University and Planned Parenthood Federation of America. This contraceptive counseling protocol is informed by the literature on contraceptive behavior, expertise in decision and communication science, and formative qualitative research with Planned Parenthood providers and patients. Jaccard et al. (in press) conducted a cluster randomized control study of the counseling intervention with 10 Planned Parenthood health centers, where staff at intervention sites participated in a one-day training on the counseling protocol followed by a day of in-clinic shadowing. Patients were enrolled on-site and contacted for follow-up at six months and 12 months.

Results of this study indicated that patients at intervention sites were more satisfied with their contraceptive counseling and method choice, and at one or both follow-ups there were fewer gaps in contraceptive protection, more dual method use, and less non-use of birth control. There was no significant difference in accurate use of birth control pills.

Planned Parenthood Federation of America (PPFA) adapted and piloted training in this contraceptive counseling protocol during 2016 with 18 Planned Parenthood affiliated organizations across the country. This training was integrated into a one-day event that also included a provider training to address barriers in access to intrauterine devices and implants. A mixed-methods implementation evaluation was conducted to assess outcomes for staff and patients and identify challenges in implementation. Preliminary findings from the program pilot year demonstrated positive trends for outcome measures, produced lessons learned on implementation challenges, and provided support for new adaptations to the training program and counseling protocol. The previous pilot year evaluation was designed to assess patient satisfaction and method choice before and after the training, but could not answer questions about continued impact on other outcomes of interest. The current study will use a cluster randomized control design with 10 Planned Parenthood health centers to assess patient outcomes. Five health centers randomized to the intervention will receive the contraceptive counseling training. As the control group, the other five health centers will conduct usual care. Women will be enrolled onsite at the health center and then contacted for follow-up at approximately 30 and 90 days post-enrollment. Target enrollment is 100 women per site (1000 total).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1015
• Est. completion date: July 31, 2018
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Females who have received contraceptive counseling at participating health centers.

• Ability to understand written and spoken English.

Exclusion Criteria:

• Non-English speakers

Related Conditions & MeSH terms

• Contraception Behavior
• Contraceptive Method Switching
• Contraceptive Usage

Intervention

Behavioral:
• Contraceptive Counseling Training
Intervention sites will receive: In person training: All staff at an intervention health center will participate in a one-day counseling training. 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. Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance.

Locations

Country	Name	City	State
United States	Planned Parenthood South Atlantic	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood Federation of America	Planned Parenthood South Atlantic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Access to same-day services for all contraceptive methods	Patient report of being offered to start method on same day as their visit (if desired)	Baseline
Primary	Contraceptive Continuation	Patient-reported contraceptive continuation	3 months
Secondary	Method Satisfaction	Patient-reported satisfaction with contraceptive method	1 month and 3 months
Secondary	Dual-Use	Patient-reported dual-use of condoms plus other method	1 month and 3 months
Secondary	Missed Pills	Number of patient-reported missed oral contraceptive pills among pill users	1 month and 3 months
Secondary	Method Switching	Patient-reported method switching	1 month and 3 months
Secondary	Patient experience of counseling best practices during their visit	Patient-report of staff implementation of the best counseling practices during their visit	Baseline