Nurse Family Partnership (NFP) Contraceptive Study
Condition: Pregnancy; Effective Contraceptive Use; Family Planning
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether nurses can help at-risk women reduce the
      incidence of unintended pregnancy by providing them access to hormonal contraceptives in
      their homes.
    

Detailed description: 
      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.
    

Intervention name(s): Enhanced NFP Care
Intervention type(s): Other
Intervention description(s): Usual NFP care plus the enhanced care that includes contraceptive administration and distribution during nurse home visits. Participants will have a choice of combined hormonal contraception (oral, patches or vaginal rings)or progestin-only contraception (oral or depomedroxyprogesterone acetate injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Female Contraception; Home Visits; CONTRACEPTIVE AGENTS; CONTRACEPTIVE DEVICES