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Completed

NCT Number: NCT03238313

Evaluation of "Plan A"

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.

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Key information

Age range

18 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Policy & Research Group

Multiple Locations, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plan A

Behavioral

Toxic Life Cycle of a Cigarette

Behavioral

Video

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Use of Other Effective Contraception

    Time frame: Three months after intervention

    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.

  2. Dual Methods of Contraception

    Time frame: Three months after intervention

    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.

Other outcomes

  1. Perceived Risk of Pregnancy

    Time frame: Three months after intervention

    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.

  2. Intention to Use LARC

    Time frame: Three months after intervention

    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.

  3. Intention to Use Other Effective Contraception Methods

    Time frame: Three months after intervention

    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.

  4. Provider Communication Self-efficacy

    Time frame: Three months after intervention

    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.

  5. Condom Negotiation Self-efficacy

    Time frame: Three months after intervention

    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.

  6. Knowledge and Awareness of Contraception Options/LARC

    Time frame: Three months after intervention

    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.

Sponsors and collaborators

Lead sponsor

The Policy & Research Group

Other

Collaborators

  • Planned Parenthood Mar Monte
  • Sentient Research
  • The Office of Adolescent Health, HHS

Registry information

Official study title

Evaluation of "Plan A" Video Intervention

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2017
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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