Contraception BehaviorCESNCT03012659
Contraceptive Equity Study 2016
A study testing Contraceptive Counseling Training in people with Contraception Behavior and Contraceptive Usage, run by Planned Parenthood Federation of America at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior, Contraceptive Usage, Contraceptive Method Switching
- What is being tested?
- Contraceptive Counseling Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,015 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Females who have received contraceptive counseling at participating health centers.
- Ability to understand written and spoken English.
Who cannot join
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood South Atlantic
Raleigh, North Carolina, 27603
About this study
Official title: Contraceptive Equity Study
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.
Read the 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).
- Being tested
- Contraceptive Counseling Training
- Keywords
- contraceptive counseling, cluster randomized trial, provider counseling training
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive Counseling TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Full-day contraceptive counseling training for health center staff Receives: Behavioral: Contraceptive Counseling Training |
| Control Arm | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Continuation
Patient-reported contraceptive continuation
Measured: 3 months
Secondary outcomes (5)
Method Satisfaction
Patient-reported satisfaction with contraceptive method
Measured: 1 month and 3 months
Dual-Use
Patient-reported dual-use of condoms plus other method
Measured: 1 month and 3 months
Missed Pills
Number of patient-reported missed oral contraceptive pills among pill users
Measured: 1 month and 3 months
Method Switching
Patient-reported method switching
Measured: 1 month and 3 months
Patient experience of counseling best practices during their visit
Patient-report of staff implementation of the best counseling practices during their visit
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion29 Jun 2017
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood Federation of America
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood South Atlantic
- Responsible party
- Sponsor
- Investigators
- Hannah R. Simons, DrPH, Principal investigator, Planned Parenthood Federation of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012659
- Sponsor's protocol ID
- Pro00019792
- Acronym
- CES
- Status last verified
- Apr 2018
- First submitted
- 4 Jan 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Equity Study
- ClinicalTrials.gov ID
- NCT03012659
- Acronym / sponsor ID
- CES / Pro00019792
- Keywords
- contraceptive counseling, cluster randomized trial, provider counseling training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Planned Parenthood Federation of AmericaUniversity, hospital or other
- Collaborators
- Planned Parenthood South Atlantic
- Study start
- Dec 2016 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Contraceptive Counseling TrainingFull-day contraceptive counseling training for health center staff |
| Control Arm | No intervention | –Usual care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Females who have received contraceptive counseling at participating health centers.
- Ability to understand written and spoken English.
Key exclusion criteria (1 listed)
- Non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraceptive Counseling TrainingIntervention 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. | Behavioural | Intervention Arm |
Primary outcome
Contraceptive Continuation
Time frame: 3 months
Patient-reported contraceptive continuation
5 secondary outcomes
Method Satisfaction
Time frame: 1 month and 3 months
Dual-Use
Time frame: 1 month and 3 months
Missed Pills
Time frame: 1 month and 3 months
Method Switching
Time frame: 1 month and 3 months
Patient experience of counseling best practices during their visit
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah R. Simons, DrPH principal investigator
Planned Parenthood Federation of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraceptive Counseling Training in people with Contraception Behavior and Contraceptive Usage, run by Planned Parenthood Federation of America at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Continuation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.