Contraceptive Equity Study 2016
- Conditions
- Contraceptive Method SwitchingContraception BehaviorContraceptive Usage
- Interventions
- Behavioral: Contraceptive Counseling Training
- Registration Number
- NCT03012659
- Lead Sponsor
- Planned Parenthood Federation of America
- 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1015
- Females who have received contraceptive counseling at participating health centers.
- Ability to understand written and spoken English.
- Non-English speakers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Contraceptive Counseling Training Full-day contraceptive counseling training for health center staff
- Primary Outcome Measures
Name Time Method Contraceptive Continuation 3 months Patient-reported contraceptive continuation
- Secondary Outcome Measures
Name Time Method Patient experience of counseling best practices during their visit Baseline Patient-report of staff implementation of the best counseling practices during their visit
Method Satisfaction 1 month and 3 months Patient-reported satisfaction with contraceptive method
Dual-Use 1 month and 3 months Patient-reported dual-use of condoms plus other method
Missed Pills 1 month and 3 months Number of patient-reported missed oral contraceptive pills among pill users
Method Switching 1 month and 3 months Patient-reported method switching
Trial Locations
- Locations (1)
Planned Parenthood South Atlantic
🇺🇸Raleigh, North Carolina, United States