Teen Pregnancy PreventionNCT03238313
Evaluation of "Plan A"
A study testing Plan A and Toxic Life Cycle of a Cigarette in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Plan A and Toxic Life Cycle of a Cigarette
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,770 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 19 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Policy & Research Group
Multiple Locations, California
About this study
Official title: 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.
Read the 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.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Plan A, Toxic Life Cycle of a Cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plan ABehavioural
Toxic Life Cycle of a CigaretteBehavioural
Video
| Study group | Role | What they receive |
|---|---|---|
| Plan A | Experimental | 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. Receives: Behavioral: Plan A |
| Toxic Life Cycle of a Cigarette | Active comparator | 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. Receives: Behavioral: Toxic Life Cycle of a Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Three months after intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Three months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start15 Jun 2016
- Primary completion31 Jan 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,770 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, Sentient Research, Planned Parenthood Mar Monte
- Responsible party
- Sponsor
- Investigators
- Eric Jenner, PhD, MMC, BA, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238313
- Sponsor's protocol ID
- TP2AH000036
- Status last verified
- Jul 2021
- First submitted
- 1 Aug 2017
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36735143
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of "Plan A" Video Intervention
- ClinicalTrials.gov ID
- NCT03238313
- Acronym / sponsor ID
- TP2AH000036
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,770 participants (actual)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, Sentient Research, Planned Parenthood Mar Monte
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plan A | Experimental | Behavioral: Plan APlan 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 comparator | Behavioral: Toxic Life Cycle of a CigaretteThe 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. |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plan A | Behavioural | Plan A |
| Toxic Life Cycle of a CigaretteVideo | Behavioural | Toxic Life Cycle of a Cigarette |
Primary outcome
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.
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.
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.
2 secondary outcomes
Use of Other Effective Contraception
Time frame: Three months after intervention
Dual Methods of Contraception
Time frame: Three months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 36735143Jenner 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Jenner, PhD, MMC, BA principal investigator
The Policy & Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plan A and Toxic Life Cycle of a Cigarette in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARC Use (time frame: Three months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03238313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.