Nurse Family Partnership (NFP) Contraceptive Study

The investigators intend to accomplish this goal by strengthening the family planning
component of a well-known, effective, home-based intervention, the Nurse Family Partnership
(NFP), by enhancing the nurses' access to contraceptive supplies. The investigators believe
that proposed modification to the intervention, giving the nurses the ability to deliver
hormonal contraception in the home, will enable the nurses to bring about greater change in
the reproductive health behavior of women at-risk for unintended pregnancy. Ultimately, the
investigators believe this will increase the impact the NFP has had on conception rates
during the first two postpartum years.

Participants will be enrolled through the Nurse Family Partnership program in the Public
Health Departments in Seattle/King County, Thurston County and Clark County, Washington. The
NFP program provides home visits for women anticipating a first birth. Inclusion criteria
for participation include English or Spanish speaking (or both), enrolled in the NFP
program, pregnant and anticipating a first birth, and 32 weeks or less gestation. NFP nurses
will obtain written consent for the study as well as consent for family planning services.

The study will be a randomized clinical trial. After consent and enrollment in the study, we
will randomize participants to receive either the usual NFP intervention or the enhanced NFP
intervention that includes contraceptive administration and distribution. The usual NFP
intervention includes interventions focused on pregnancy planning and contraceptive advice,
with the prescription and dispensing of contraceptives provided through the women's primary
care settings. The primary difference between routine NFP care and the enhanced intervention
is the administration and distribution of hormonal contraception in the home with one
exception. Because it is part of the usual intervention, when requested, NFP nurses will
provide emergency contraceptives for participants in both arms of the study. Each
participant assigned to the enhanced intervention will receive the routine NFP family
planning counseling beginning during pregnancy, including information on available
contraceptives. The nurse will also counsel participants on when to begin using
contraceptives post-partum. Following delivery, the nurse will take a history to determine
whether there are any contraindications to oral contraceptives, the contraceptive patch, the
contraceptive vaginal ring or the depomedroxyprogesterone shot. The nurse will follow study
protocols, approved by the Clark County, Thurston County and Seattle/King County Public
Health Departments, when taking the history, and if necessary, obtain a urine pregnancy
test. The nurse will obtain written consent for family planning services before providing
contraceptives. The written consent form is similar to consent forms used in clinic
settings. The nurse will continue to provide family planning counseling, including
counseling on sexually transmitted infection (STI) prevention and cervical cancer screening,
and a supply of condoms. The nurse will also offer a choice of a three-month supply of
combination oral contraceptives, progestin-only oral contraceptives, contraceptive patches,
the contraceptive vaginal ring or a depomedroxyprogesterone injection at no cost to the
participant. Depending on the contraceptive method chosen, the nurse will provide education,
counseling, and obtain written request and consent forms for the specific method. All
written materials will be available in English and Spanish. Monolingual Spanish-speaking
patients will receive services from Spanish speaking NFP nurses. The nurses will follow
guidelines and standing orders developed by Dr. Gipson, the Co-Investigator for the study,
subject to approval by the county Health Officer, when providing oral contraceptives,
contraceptive patches, or the contraceptive vaginal ring or when administering the
depomedroxyprogesterone shot. For women currently breastfeeding, the nurse will recommend
and provide progestin-only oral contraceptives or administer the depomedroxyprogesterone
shot. During frequent home visits, the NFP nurse will continue to counsel the participants
while providing additional three to twelve-month supplies of contraceptives or administering
the depomedroxyprogesterone injections for up to two years after delivery. By phone or
through subsequent visits, the nurse will address any adverse reactions or other participant
concerns and will provide refills or an alternative hormonal method as necessary.

For both groups (usual NFP care and enhanced intervention), the Research Associates (RAs)
will gather data related to gaps in contraceptive coverage and repeat pregnancy every three
months beginning six months after delivery (except at 12 months and two years postpartum).
In addition, RAs will conduct phone surveys following enrollment and again at 3 months, 12
months and 24 months post delivery. The surveys will address factors that influence the rate
and timing of subsequent pregnancy, including pregnancy intendedness, utilization of
reproductive health services, perceived barriers to contraceptive use, satisfaction with
birth control methods, and self-efficacy related to contraceptive use.

Aim 1 is to determine whether fewer participants in the enhanced intervention group
experience more than a one month gap in effective contraceptive use (defined as methods with
which < 10% of women experience an accidental pregnancy during a year of typical use)
compared to participants in the usual care group. The investigators will answer this by
comparing the incidence of gaps that occur in the twenty-four months after delivery using
survival analysis methods. Aim 2 is to examine whether fewer participants in the enhanced
intervention group experience a second pregnancy compared to participants in the usual care
group. The methodology for Aim 2 will be the same as for Aim 1, with analysis based on
incidence of second pregnancy rather than gap in effective contraceptive use. Aim 3 will be
to explore how pregnancy intendedness modifies the outcomes in Aim 1 and Aim 2, using the
same methodology as aims 1 and 2.

Inclusion Criteria:

- English or Spanish speaking (or both)

- Enrolled in the NFP (Nurse Family Partnership) program

- 32 weeks or less gestation.

Exclusion Criteria:

- Not enrolled in the NFP program

- More than 32 weeks gestation