Evaluation of "Plan A"
1 other identifier
interventional
1,770
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2016
CompletedFirst Submitted
Initial submission to the registry
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 27, 2021
July 1, 2021
3.6 years
August 1, 2017
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Use of Other Effective Contraception
Three months after intervention
Dual Methods of Contraception
Three months after intervention
Other Outcomes (6)
Perceived Risk of Pregnancy
Three months after intervention
Intention to Use LARC
Three months after intervention
Intention to Use Other Effective Contraception Methods
Three months after intervention
- +3 more other outcomes
Study Arms (2)
Plan A
EXPERIMENTALPlan 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.
Toxic Life Cycle of a Cigarette
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Policy & Research Grouplead
- The Office of Adolescent Health, HHScollaborator
- Sentient Researchcollaborator
- Planned Parenthood Mar Montecollaborator
Study Sites (1)
The Policy & Research Group
Multiple Locations, California, United States
Related Publications (1)
Jenner E, Walsh S, Henley C, Demby H, Leger R, Falk G. Randomized Trial of a Sexual Health Video Intervention for Black and Hispanic Adolescent Females. Prev Sci. 2023 Dec;24(Suppl 2):262-271. doi: 10.1007/s11121-023-01499-0. Epub 2023 Feb 3.
PMID: 36735143DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Jenner, PhD, MMC, BA
The Policy & Research Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2017
First Posted
August 3, 2017
Study Start
June 15, 2016
Primary Completion
January 31, 2020
Study Completion
June 30, 2020
Last Updated
July 27, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The individual participant dataset will become available twelve months after the study has concluded.
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.