Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction

Enhanced anticipatory counseling detailing side effects when initiating progestin-only
injectable contraception improved its continued use among women.While continuation rates at
one year among levonorgestrel intrauterine system (LNG-IUS) users are considerably higher
than those for progestin-only injectable users in the United States (80% versus 56%),
enhanced anticipatory counseling could have an impact on the 20% of LNG IUS users who choose
to discontinue the method within one year of use. For this reason, the investigators propose
a study that would develop and pilot-test an anticipatory counseling intervention detailing
unscheduled bleeding and other side effects such as pelvic pain or cramping among new LNG IUS
users and compare this with a "control," using video technology. The investigators have
chosen video technology for the counseling intervention to ensure that all participants
receive the exact same information about LNG side effects, which would be not possible using
a face-to-face clinician-participant counseling model.

The investigators propose three phases for this study. In Phase 1, a systematic literature
search evaluating effective components in videos used for contraceptive counseling and the
development of two separate video scripts will lead to: (1) an intervention, detailing
expected side effects and safety of the LNG IUS, and (2) a similar-looking "control,"
detailing only recommended screening guidelines for women, as well as information about LNG
IUS safety. This phase of the study uses focus groups prior to the development of the video
interventions, initially with family planning experts for content accuracy and cultural
sensitivity, and secondarily with new LNG IUS users for acceptability. Findings from this
phase will be used to fine-tune the scripts prior to the development of the videos.

In Phase 2 of the study, the investigators will pilot a trial in the clinical setting to
evaluate the anticipatory counseling video intervention and its impact on LNG-IUS knowledge,
continuation, health care utilization, and satisfaction. After receiving comprehensive
contraceptive counseling from their clinicians, women who choose to have the LNG IUS inserted
will be given a brochure that asks them to participate in an online study. After signing-on
to an innovative website, participants will be randomized to either an intervention or
control video and complete short questionnaires related to demographics, baseline
menstruation, satisfaction, and LNG IUS knowledge before and after viewing their assigned
video. Women will be followed for six months. They will be asked to complete a short online
survey at three and six months regarding LNG IUS continuation, health care utilization, and
satisfaction. Findings from this study will serve to design a future, appropriately powered
randomized controlled trial assessing LNG IUS continuation, utilization, and satisfaction
rates at 12 months.

In Phase 3, we will use the findings from Phase 2 to develop a similar protocol and recruit
up to 178 women at three sites across the US to test the same primary aims of the video:
LNG-IUS continuation, utilization, and satisfaction over a 12 month period. In phase 3,
subjects will be randomized to watch either the control or intervention video.

Inclusion Criteria:

1. Women aged 18 and over who are deemed appropriate candidates be their healthcare
providers and choose to use LNG-IUS, either Mirena or Skyla.

2. Within five days of FIRST using either Mirena or Skyla

3. Willing to answer online questions before and after watching the assigned video
(intervention or control)

4. Willing to complete short online questionnaire at three and six months

5. Has working email and/or phone number

6. Able to understand verbal and written English

7. Appropriate LNG-IUS candidates whoa re being treated for other pre-existing medical
disorders while using the LNG IUS may continue to take their medications as directed
by their healthcare provider.

Exclusion Criteria:

1. Women aged less than 18 years old

2. Initiated LNG-IUS method more than five days from enrollment date.

3. Within six weeks postpartum

4. Breastfeeding

5. Using LNG-IUS for treatment other than contraception

6. Do not have access to the Web

7. Have neither working email or phone number

8. Does not understand written or verbal English

9. Inappropriate candidates for LNG IUS as deemed by healthcare provider