Assessment of Cultural Acceptability of Long Acting Contraception in a Diverse, Urban Population
Condition: Contraception Behavior
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Educational video on LARC
Intervention type(s): Behavioral
Intervention description(s): Participants will watch a short educational video on long acting reversible contraceptive or LARC
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: different sites of participant recruitment will be randomized between the use of an informational video during the survey process and no video. The primary focus of the study is the survey that is designed to collect information about cultural perspectives on LARC in the participants.
Masking: None (Open Label)
Primary purpose: Other
Keywords: LARC contraception cultural acceptance