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Clinical Trials/NCT03238313
NCT03238313
Completed
Not Applicable

Evaluation of "Plan A" Video Intervention

The Policy & Research Group1 site in 1 country1,770 target enrollmentJune 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Teen Pregnancy Prevention
Sponsor
The Policy & Research Group
Enrollment
1770
Locations
1
Primary Endpoint
LARC Use
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of the study is to determine if exposure to the "Plan A" video influences viewers' uptake of LARC, reduces unprotected sexual activity, and increases receipt of STI testing.

Detailed Description

The Policy \& Research Group (PRG) is evaluating the "Plan A" video, which was designed to promote effective contraceptive use, use of dual methods of protection (condom use and prescription birth control use), and HIV/STI testing in African/American and Latina young women. The video is approximately 23 minutes in length and is shown immediately prior to a clinical appointment at a reproductive health center. By delivering the intervention prior to a clinic appointment, developers hope to reach high-risk teens at a teachable moment, when they can ask a health care provider about what they have learned. The primary focus of the study is to investigate the impact of the intervention on participants': 1) LARC use; 2) times having sex without a condom; and 3) STI testing. Secondary outcome measures include assessing the impact of the intervention on participants': 1) use of dual methods of protection during vaginal sex; and 2) use of other effective contraceptive methods. Finally, the evaluation will include exploratory analysis of participants': 1) perception of risk and/or severity for pregnancy and HIV/STI infection; (2) intention to use LARC; (3) intention to use other effective contraception methods; (4) provider communication self-efficacy; (5) condom negotiation self-efficacy; and (6) knowledge/awareness of contraception options/LARC. The control (counterfactual) condition consists of a 17-minute video titled "The Toxic Life Cycle of a Cigarette". The control video, which discusses the effects of smoking, is shown in the same manner as the treatment video: immediately prior to a clinic appointment at a reproductive health center. All eligible participants who provide the proper consent are randomized and enrolled into the study by a study coordinator who is an employee of the reproductive health clinic. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at three time points: baseline (enrollment, prior to watching the video); 3-month follow-up (3 months after baseline); and 9-month follow-up (9 months after baseline). The study is taking place at seven clinics within the Planned Parenthood Mar Monte system in California, all of which serve the target population.

Registry
clinicaltrials.gov
Start Date
June 15, 2016
End Date
June 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
The Policy & Research Group
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Be female
  • Be 18 or 19 years old
  • Self-identify as Latina and/or African-American
  • Be visiting a reproductive healthcare provider at the study site
  • Be deemed appropriate for the study by study staff/clinic staff with regards to physical and mental health and capacity
  • Consent to participate in the study

Exclusion Criteria

  • Knowingly pregnant
  • Trying to become pregnant
  • Previously enrolled in the study
  • Enrolled in studies in the same geographic area that aim to prevent teen pregnancy

Outcomes

Primary Outcomes

LARC Use

Time Frame: Three months after intervention

Participant self-report on the use of Long Acting Reversible Contraception (LARC). Measured through one survey question which asks the participant to select all methods of prescription birth control currently being used.

STI Testing

Time Frame: Three months after intervention

Participant self-report on if they have been tested for Sexually Transmitted Infections (STIs). Measured through two survey questions which ask the participant about whether they have ever been tested for STIs and if yes, whether they have been tested for STIs (other than HIV) in the past three months.

Times Having Sex Without a Condom

Time Frame: Three months after intervention

Participant self-report on the number of times they have had vaginal, oral, or anal sex without a condom in the last three months. Measured through three survey questions which ask the participant how many times they have had vaginal, oral, and anal sex in the past three months.

Secondary Outcomes

  • Use of Other Effective Contraception(Three months after intervention)
  • Dual Methods of Contraception(Three months after intervention)

Study Sites (1)

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