Assessment of Cultural Acceptability of Long Acting Contraception in a Diverse, Urban Population



Status:Recruiting
Healthy:No
Age Range:18 - 45
Updated:10/12/2018
Start Date:April 15, 2018
End Date:October 1, 2019
Contact:John s Maier, MD/PhD
Email:jsmaier@pitt.edu
Phone:41238312319

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Preliminary data from our work with teen mothers suggest that many women would benefit from
contraception but do not actually make visits nor initiate conversations regarding
contraception unless the subject is raised by the clinician. Those coming for primary care
visits discuss their conditions and care with family and friends, spreading health care
information. A substantial proportion of citizens obtain their health information from
friends, family, internet, social media and other non-clinicians. Thus, educating women, even
when not coming expressly for contraceptive services, increases more accurate health
information throughout their communities and actually identifies fertility needs, ultimately
increasing use of contraception.

Seven clinical family medicine health centers will be included in the study. Target
participants are women aged 18-45 years old. These clinical sites are community-based health
centers within the University of Pittsburgh Medical Center (UPMC) system in greater
Pittsburgh that serve as teaching sites for medical, pharmacy and social work students
enrolled at the University of Pittsburgh and/or UPMC Family Medicine or clinical pharmacy
residents. In 2015, these sites served nearly 32,000 patients of whom more than 60% are
women. More than 10,000 females were in the target age group of 18-45 years old and more than
half were from underrepresented minority groups. The patients served by these family health
centers are diverse across race and ethnicity, family income level, neighborhoods and
literacy level . All are managed and documented in the EpicCare electronic medical record
system.

We target women aged 18-45 years because this study is designed to assess cultural beliefs
regarding Long Acting Reversible Contraception (LARC) in women in general and not
specifically those who are seeking contraception. Preliminary data from our work with teen
mothers suggest that many women would benefit from contraception but do not actually make
visits nor initiate conversations regarding contraception unless the subject is raised by the
clinician. Those coming for primary care visits discuss their conditions and care with family
and friends, spreading health care information. A substantial proportion of citizens obtain
their health information from friends, family, and other non-clinicians. Thus, educating
women, even when not coming expressly for contraceptive services, increases more accurate
health information throughout their communities and actually identifies fertility needs,
ultimately increasing use of contraception.

Seven clinical sites (UPMC Family Health Centers) will be included in the study. The best and
low-cost recruitment strategy will be to reach women aged 18-45 years who attend our health
centers for womens' health services. Our project team will engage personnel in these health
centers and inform them about the proposed study. We will place postcards at the check-in
desk, and encourage target women to take a postcards and follow up with the research team if
they are interested in participating.

Participants of the project will be identified by the nurses performing initial intakes of
patients presenting for care - also called "rooming" the patient. Research assistants will
also try to approach patients in the waiting room in the case they were not able to approach
them in the examination rooms. Those recruited from each site will be stratified to one of
two groups - one for those identifying contraception as the focus of their physician visit
and the other group for those seeking other women's health services at the physician visit.

In an effort to improve recruitment, we will work with the clinical staff to understand
particular hours during which potential participants are likely to present to the clinic.
Flyers will be placed in all seven health centers, In addition, a research assistant will be
on site at projected high utilization times. The research assistants will provide information
on the study to clinical staff, and will be available to distribute study postcards and
answer questions from potential participants. Interested young women will meet with the
research assistants for eligibility determination, completion of Institutional Review Board
(IRB) consents, and enrollment in the study. Incentives will be provided to all participants
enrolled in the study.

Three health centers received a substantial volume of the female patients who were in the
specific age group being targeted in the study will be invited to comprise the intervention
arm. The rest of the health centers will form the control arm.

It is important that the survey questions reflect the target population's perspectives of
using LARC or any contraceptive devices. Both the demographic and cultural surveys will be
distributed to women, 18-45 years of age, seeking womens' health services in participating
family health centers who expressed interest in the study. Surveys will be completed on a
tablet provided by a research assistant or on the participant's own mobile device or personal
computer. Participants will be given the option to complete the surveys at the family health
center or elsewhere at another time. Women participating in the focus groups are ineligible
for participation in the survey.

Participants in the intervention arm will complete both the demographic and the cultural
survey. After participating in the survey, the participants in the intervention arm will be
asked to watch an educational video on LARC to be taped by a professional team in the Center
for Instructional Development & Distance Education (CIDDE) at the University of Pittsburgh.
In this video, a family physician skilled in contraceptive education will provide useful and
easily understandable information on LARC. The video will include, but is not limited to, the
following key topics:

- What types of LARC are available?

- How each LARC method works?

- How and where the LARC method is inserted?

- How long LARC works?

- What are the risks and benefits of each LARC method?

- Can LARC be removed at any time, how it is removed and are there any potential side
effects such as slow return of fertility?

A short survey will be distributed to all participants who watched the video in the
intervention arm. The survey will include questions on LARC that were similar to the
questions included in the survey before watching the video. We will then evaluate both
surveys before and after watching the video. The participants will be given the option to
complete all study activities at the family health center or elsewhere at another time.

With improved understanding regarding how LARC is perceived through data obtained from the
cultural assessment, more targeted education for both clinicians, clinical staff, and
patients of childbearing age is possible. Therefore, if the cultural assessment (via focus
group feedback and/or survey responses) reveals that patients fear permanent sterilization or
believe use of LARC violates religious mores, patient education can be modified to address
their specific concerns. These study results may lead to further investigation to change
approaches to the target population and allow us to provide better clinical care

Following (1) assessment of historical data on LARC use in the seven health centers prior to
this study; (2) perceptions elicited from the focus groups(from phase one of the study); (3)
results of the group completing both demographic and cultural surveys; and (4) results of the
group completing demographic and cultural surveys and watching the informational video, the
final step involves assessing changes in LARC use. Electronic medical records and billing
data from the seven health centers will be reviewed to determine LARC utilization across the
targeted population served by these health centers and the impact of the interventions on
LARC usage.

Inclusion Criteria:

- Between age of 18 and 45

- Not currently pregnant

- Did not participate in phase I of the study

Exclusion Criteria:

- Below 18 years or above 45

- Currently pregnant

- Participated in Phase I of the study
We found this trial at
7
sites
301 11th St
New Kensington, Pennsylvania 15068
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New Kensington, PA
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McKeesport, Pennsylvania 15132
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McKeesport, PA
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373 Burrows Street
Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Pittsburgh, Pennsylvania 15217
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mi
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Pittsburgh, PA
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5475 Penn Avenue
Pittsburgh, Pennsylvania 15224
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mi
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Pittsburgh, PA
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Pittsburgh, Pennsylvania 15232
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mi
from
Pittsburgh, PA
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Pittsburgh, Pennsylvania 15232
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mi
from
Pittsburgh, PA
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