Evaluation of "Plan A"

Evaluation of "Plan A" Video Intervention

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.

Study Overview

• Status: Completed
• Conditions: Teen Pregnancy Prevention
• Intervention / Treatment: Behavioral: Plan A; Behavioral: Toxic Life Cycle of a Cigarette

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.

• Study Type: Interventional
• Enrollment (Actual): 1770
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Multiple Locations, California, United States
      • The Policy & Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 19 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plan A; Plan A is the treatment condition. It is a 23-minute video that is 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.	Behavioral: Plan A
Active Comparator: Toxic Life Cycle of a Cigarette; The Toxic Life Cycle of a Cigarette is the counterfactual condition. It is a 17-minute video, but contains no information about reproductive health. Instead, the video teaches about the harms of cigarettes.	Behavioral: Toxic Life Cycle of a Cigarette; Video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARC Use	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.	Three months after intervention
STI Testing	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.	Three months after intervention
Times Having Sex Without a Condom	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.	Three months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Other Effective Contraception	Participant self-report on the use of other effective contraceptive methods (oral contraceptives, patch, ring, and shot/injection). Measured through one survey question which asks the participant to select all methods of prescription birth control currently being used.	Three months after intervention
Dual Methods of Contraception	Participant self-report on the use of dual methods of contraception (using a condom and another prescription birth control). Measured through two survey questions which ask participants how many times they have had vaginal sex in the past three months and how many times, of the times they had vaginal sex in the past three months, did they use both a condom and a form of prescription birth control.	Three months after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Risk of Pregnancy	Participant self-report on perceived risk and severity of becoming pregnant and acquiring sexually transmitted infections or HIV. Measured through four survey questions which ask participants to rate their likelihood of becoming pregnant and acquiring HIV and STIs given various risky behaviors.	Three months after intervention
Intention to Use LARC	Participant self-report on intention to use LARC. Measured through one survey question which asks participants to indicate how likely they are to use LARC in the next year.	Three months after intervention
Intention to Use Other Effective Contraception Methods	Participant self-report on intention to use other effective contraception. Measured through two survey questions which asks participants to indicate how likely they are to use short-acting and long-acting prescription birth control in the next year.	Three months after intervention
Provider Communication Self-efficacy	Participant self-report on perceived confidence in being able to communicate with health care providers. Measured through five survey questions where participants are asked to indicate their confidence level with talking to and receiving information from a health care provider.	Three months after intervention
Condom Negotiation Self-efficacy	Participant self-report on perceived confidence in being able to negotiate condom use with her partner during sex. Measured through four survey questions which ask participants to report their level of confidence in discussing and using condoms with their partners.	Three months after intervention
Knowledge and Awareness of Contraception Options/LARC	Participant self-report on knowledge and awareness of contraceptive options. Measured through 10 survey questions which ask participants to answer True/False questions about various kinds of contraception.	Three months after intervention

Collaborators and Investigators

• Sponsor: The Policy & Research Group
• Collaborators: The Office of Adolescent Health, HHS; Sentient Research; Planned Parenthood Mar Monte
• Investigators: Principal Investigator: Eric Jenner, PhD, MMC, BA, The Policy & Research Group

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2016
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TP2AH000036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program sessions were attended). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
• IPD Sharing Time Frame: The individual participant dataset will become available twelve months after the study has concluded.

Study Data/Documents

1. Information on publicly available dataset
   Information comments: For any individuals interested in accessing a copy of this public use dataset, please email info@policyandresearch.com with your inquiry.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No