Evaluation of "Plan A"

Teen Pregnancy Prevention Clinical Trial

Official title:

Evaluation of "Plan A" Video Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238313
• Other study ID #: TP2AH000036
• Status: Completed
• Phase: N/A
• Start date: June 15, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2021
• Source: The Policy & Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1770
• Est. completion date: June 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Teen Pregnancy Prevention

Intervention

Behavioral:
• Plan A

• Toxic Life Cycle of a Cigarette
Video

Locations

Country	Name	City	State
United States	The Policy & Research Group	Multiple Locations	California

Sponsors (4)

Lead Sponsor	Collaborator
The Policy & Research Group	Planned Parenthood Mar Monte, Sentient Research, The Office of Adolescent Health, HHS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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