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

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.