Clinical Trials Logo

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03012659
Study type Interventional
Source Planned Parenthood Federation of America
Contact
Status Active, not recruiting
Phase N/A
Start date December 2016
Completion date July 31, 2018

See also
  Status Clinical Trial Phase
Completed NCT03279120 - Safety, PK, and PD Study of IVRs Releasing TFV and LNG Phase 1
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT01170390 - Oral Contraceptives and Body Mass Index Phase 4
Recruiting NCT05932537 - Ablation of Subcutaneous Contraceptive Implants in the Operating Room
Withdrawn NCT04882137 - Barriers to Referring Adolescent Women for Etonogestrel Implant. N/A
Completed NCT02613039 - Oral Contraceptive Therapy and Sexuality Phase 4
Completed NCT01425060 - Improving Effective Contraceptive Use Among Opioid-maintained Women Phase 1
Completed NCT03626597 - Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services N/A
Recruiting NCT04558229 - RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users Phase 4
Recruiting NCT05644886 - Pilot Study on Engaging Family Physicians in Family Planning in Pakistan N/A
Completed NCT03253783 - The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program N/A
Completed NCT04043130 - The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program N/A
Completed NCT03571932 - Assessment of Family Planning and Immunization Service Integration in Liberia
Completed NCT03336346 - Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
Active, not recruiting NCT03984695 - Sexual Health Empowerment for Women's Health N/A
Completed NCT02411357 - Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II N/A
Completed NCT05806463 - Efficacy of Mother's Time in Ethiopia N/A
Recruiting NCT05328648 - Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings N/A
Active, not recruiting NCT05061472 - A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
Not yet recruiting NCT05988983 - The Over The Counter Pill National Study