Clinical trial NCT02291224: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Sexually Transmitted Diseases
Keywords: dual protection
pregnancy
reproductive health
sexually transmitted diseases
condoms
contraception
adolescent health services
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Emory University
name: Grady Health System
First posted: 2014-11-14
Enrollment: 709
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* female,
* self-identify as African American,
* 14-19 years of age,
* present to clinic on date of potential enrollment for clinical care,
* has had vaginal sex with a male partner at least once in the past 6 months,
* HIV-negative by self-report,
* not currently pregnant (verified by urine pregnancy test),
* desire to avoid pregnancy for at least 12 months,
* plan to be in the Atlanta area for the next 12 months,
* competent to participate in consenting or assenting process per recruiter evaluation,
* willing to provide contact information, and
* not previously enrolled in the pilot study of this intervention.

Exclusion Criteria:

* pregnant
* HIV positive

Primary outcomes:
measure: Participant selection of an effective dual protection (DP) strategy
timeFrame: 6 months
measure: Participant report of adherence to DP strategy
timeFrame: 3 months
measure: Time to first biologic event (pregnancy or diagnosis with STI) in participants
timeFrame: Within 12 month period following enrollment
measure: Incidence of pregnancy and sexually transmitted infections (STIs)
timeFrame: Within 12 month period following enrollment
measure: Participant selection of an effective dual protection (DP) strategy
timeFrame: 12 months
measure: Participant report of adherence to DP strategy
timeFrame: 6 months
measure: Participant report of adherence to DP strategy
timeFrame: 9 months
measure: Participant report of adherence to DP strategy
timeFrame: 12 months
measure: Participant selection of an effective dual protection (DP) strategy
timeFrame: At enrollment visit
Secondary outcomes:
measure: Participant level of reproductive health knowledge (percentage correct of knowledge questions)
timeFrame: 6 months
measure: Participant intention to use DP strategy
timeFrame: 6 months
measure: Participant reproductive health self-efficacy
timeFrame: 6 months
measure: Participant report of STI testing
timeFrame: 6 months
measure: Participant report of partner communication
timeFrame: 6 months
measure: Participant level of reproductive health knowledge (percentage correct of knowledge questions)
timeFrame: 12 months
measure: Participant intention to use DP strategy
timeFrame: 12 months
measure: Participant report of STI testing
timeFrame: 12 months
measure: Participant reproductive health self-efficacy
timeFrame: 12 months
measure: Participant report of partner communication
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System Teen Services Clinic
state: Georgia
Study officials:
affiliation: Emory University; Grady Health System
name: Melissa Kottke, MD MPH MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Jessica Sales, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Athena Kourtis, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Peggy Goedken, MPH
role: STUDY_DIRECTOR
References:
citation: Kraft JM, Snead MC, Brown JL, Sales JM, Kottke MJ, Hatfield-Timajchy K, Goedken P. Reproductive Coercion Among African American Female Adolescents: Associations with Contraception and Sexually Transmitted Diseases. J Womens Health (Larchmt). 2021 Mar;30(3):429-437. doi: 10.1089/jwh.2019.8236. Epub 2020 Jul 13.