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Trial record 7 of 16 for:    Recruiting, Not yet recruiting, Available Studies | "Pregnancy in Adolescence"

Evaluation of "Plan A"

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ClinicalTrials.gov Identifier: NCT03238313
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborators:
The Office of Adolescent Health, HHS
Sentient Research
Planned Parenthood Mar Monte
Information provided by (Responsible Party):
The Policy & Research Group

Brief Summary:
The purpose of the study is to determine if exposure to the "Plan A" video causes decreased risky sexual behavior among the target population.

Condition or disease Intervention/treatment Phase
Teen Pregnancy Prevention Behavioral: Plan A Behavioral: Toxic Life Cycle of a Cigarette Not Applicable

Detailed Description:

The Policy & Research Group (PRG) is evaluating the "Plan A" video, which was designed to educate high-risk teens about effective Long Acting Reversible Contraception (LARC). The video is approximately 23 minutes in length and is shown immediately prior to a clinical appointment at a reproductive health center. By teaching about LARC 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' self-reported sexual behaviors and contraceptive use (use of LARC, condom use, and STD testing). Additionally, the evaluation will include exploratory analysis on the following: (1) use of other effective contraception methods; (2) dual methods of protection; (3) perception of risk and/or severity for pregnancy and HIV/STD infection; (4) intention to use LARC; (5) intention to use other effective contraception methods; (6) provider communication self-efficacy; (7) condom negotiation self-efficacy; (8) 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  (Clinical Trial)
Estimated Enrollment : 2520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of "Plan A" Video Intervention
Actual Study Start Date : June 15, 2016
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2019

Arm Intervention/treatment
Experimental: Plan A
Plan A is the treatment condition. It is a 23 minute video that is designed to teach youth about LARC.
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 video of similar length to the treatment video but contains no information about reproductive health. Instead, the video teaches on the harms of cigarettes.
Behavioral: Toxic Life Cycle of a Cigarette
Video



Primary Outcome Measures :
  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 used.

  2. STD Testing [ Time Frame: Three months after intervention ]
    Participant self-report on if they have been tested for Sexually Transmitted Diseases (STDs). Measured through four survey questions which ask the participant about the presence and frequency of HIV and STD testing.


Secondary Outcome Measures :
  1. Use of Other Effective Contraception [ Time Frame: Three months after intervention ]
    Participant self-report on the use of other effective contraception (consistent and correct use of the pill, patch, ring, and shot). Measured through one survey question which asks the participant to select all methods of prescription birth control 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 form of contraception). Measured through one survey question which asks participants to report the number of times they had sex in the past three months while using both a condom and a form of prescription birth control.


Other Outcome Measures:
  1. Perceived Risk of Pregnancy [ Time Frame: Three months after intervention ]
    Participant self-report on perceived risk of becoming pregnant. Measured through two survey questions which ask participants to rate their likelihood of becoming pregnant given various risky behaviors.

  2. Intention to Use LARC [ Time Frame: Three months after intervention ]
    Participant self-report on her intention to use LARC. Measured through one survey question which asks participants to rank how likely they are to use LARC in the next year.

  3. Intention to Use Other Effective Contraception [ Time Frame: Three months after intervention ]
    Participant self-report on her intention to use other effective contraception. Measured through one survey question which asks participants to rank how likely they are to use any prescription birth control in the next year.

  4. Provider Communication Self-efficacy [ Time Frame: Three months after intervention ]
    Participant self-report on her ability and willingness to communicate with health care providers. Measured through five survey questions where participants are asked to rate 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 her ability and willingness to require her partner wear a condom during sex. Measured through four survey questions which ask participants to report their level of confidence in discussing and using condoms with her partner.

  6. Knowledge and Awareness of Contraception Options/LARC [ Time Frame: Three months after intervention ]
    Participant self-report on her knowledge of contraceptive options. Measured through 10 survey questions which ask participants to answer True/False questions about various kinds of contraception.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 19 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   To be eligible to participate in the study, participants must self-report that they identify as 'female' when given the following list of options: Female; Male; Transgender; Do not identify as female, male, or transgender; Unknown
Accepts Healthy Volunteers:   Yes
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
  • Previously enrolled in a study which is taking place in the same geographic area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238313


Contacts
Contact: Lynne W Jenner, MA 504-865-1545 ljenner@policyandresearch.com
Contact: Hilary Demby, MPH 504-865-1545 hilary@policyandresearch.com

Locations
United States, California
The Policy & Research Group Recruiting
Multiple Locations, California, United States
Contact: Hilary Demby, MPH    504-865-1545    hilary@policyandresearch.com   
Sponsors and Collaborators
The Policy & Research Group
The Office of Adolescent Health, HHS
Sentient Research
Planned Parenthood Mar Monte
Investigators
Principal Investigator: Eric Jenner, PhD, MMC, BA The Policy & Research Group

Responsible Party: The Policy & Research Group
ClinicalTrials.gov Identifier: NCT03238313     History of Changes
Other Study ID Numbers: TP2AH000036
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: The individual participant dataset will become available twelve months after the study has concluded.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No