Development and Testing of a Clinic-Based Intervention to Increase Dual Protection Against Unintended Pregnancy and Sexually Transmitted Diseases (STDs) Among High Risk Female Teens
Condition: Pregnancy; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This trial will evaluate a multi-component, clinic-based intervention aimed at increasing
      dual protection strategy selection and adherence among young African American females at an
      urban family planning clinic. Dual protection is the use of contraceptive strategies to
      prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is
      an unblinded randomized controlled trial; participants will either get the interactive
      multimedia platform focused on DP strategies with intervention arm counseling or the standard
      of care arm counseling.

      The study will recruit 710 African American females aged 14-19 who are attending the Grady
      Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health
      care.

      The trial will recruit and enroll 710 young women presenting to the clinic for clinical care
      who have the following characteristics:

        -  self-identify as African American,

        -  14-19 years of age,

        -  have had vaginal sex with a male partner in the past 6 months,

        -  HIV-negative by self-report,

        -  not pregnant,verified by urine pregnancy test,

        -  no desire to be pregnant in next 12 months,

        -  plan to stay in the Atlanta area for the next year,

        -  are willing to provide contact information, and

        -  were not previously enrolled in the pilot study of this intervention.

      Those enrolled will be in the study for 12 months. Young women who are eligible and give
      written consent or assent for study participation will be enrolled. Half will be randomized
      to the control arm, half to the intervention arm.

        1. Control arm (standard of care) includes individual clinical care and standard of care
           counseling consistent with protocols at the TSC, with study visits for data collection
           at enrollment, 6 months, and 12 months, during which any medical care or counseling that
           they would normally get will also be provided. Control arm participants will also get
           telephone calls from clinic staff to update their contact information and remind them of
           upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5
           months after the 6 month visit.

        2. Intervention arm, consisting of the following intervention components:

             1. Enrollment visit

                  -  A culturally-appropriate interactive multimedia platform focused on DP
                     strategies and designed to prepare the individual for selection of a DP
                     strategy.

                  -  Individual intervention arm counseling to select the DP strategy that is best
                     suited for the participant (by a clinic health care provider).

                  -  Individual intervention arm counseling to build skills for correct and
                     consistent use of the selected DP strategy (by a nurse educator (NE)).

             2. Booster counseling via phone at about 3 weeks and 5 months after the enrollment
                visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE).

             3. 6 month visit

                  -  An abbreviated version of the interactive multimedia platform focused on dual
                     protection strategies and strategy adherence.

                  -  Individual intervention arm counseling to reinforce skills for correct and
                     consistent use of the DP strategy (by an NE).

      At the final study visit at 12 months there is no difference between the counseling provided
      to the two groups; participants in both arms will receive the clinic standard of care.

      Participants in both arms of the study will follow the same data collection procedures
      throughout the study:

        -  At all three study visits, participants in both arms will receive urine pregnancy and
           STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire.

        -  At 3 and 9 months after enrollment, participants in both arms will receive a data
           collection call with administration of a telephone questionnaire.

      Throughout the study, all participants will be encouraged to come in for evaluation if they
      have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will
      be later collected via chart review. If participants seek reproductive health care at other
      facilities during the study period, records will be requested with participant permission,
      and data from pregnancy or STI testing at these outside clinic visits will be collected via
      review of records received.

      We will examine the efficacy of the intervention arm relative to control arm across the
      following primary behavioral and biologic outcomes over the 12 months of follow-up:

        1. Self-reported dual protection strategy selection

        2. Self-reported dual protection strategy adherence

        3. Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as
           confirmed by laboratory testing)

      A small pilot study was be conducted prior to the initiation of enrollment in the main study.
    


Intervention name(s): Interactive multimedia platform; Intervention arm counseling; Standard of care counseling
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): An interactive platform that includes video vignettes of young women who are choosing dual protection strategies (based on a synthesis of focus group data from members of the TSC patient population), as well as true/false questions to build knowledge about dual protection and dispel common myths about contraceptive strategies. There will also be reflection questions that encourage participants to consider values and priorities in their own lives that may influence their dual protection strategy selection.; Counseling for the intervention group will follow carefully developed guides and incorporate the participants' answers to the reflection questions in the interactive multi-media component. This counseling has a set structure (set forth in separate counseling guides for health care providers and nurse educators), incorporates motivational interviewing techniques, includes multiple opportunities for role play, and is designed to be patient-centered.; Standard of care counseling is provided by health care providers and health educators at TSC. It incorporates extensive counseling on methods to prevent both unintended pregnancy and sexually transmitted infections, however the structure of the counseling and techniques used are dependent on the standard practice of each provider or educator. This counseling does not incorporate answers to reflection questions from the multi-media platform because control arm participants will not view this content.
Other intervention name(s): MMDP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dual protection; pregnancy; reproductive health; sexually transmitted diseases; condoms; contraception; adolescent health services