Evaluation of "Plan A"

The Policy & Research Group

Status: Completed

Conditions: Teen Pregnancy Prevention

Treatments: Behavioral: Plan A; Behavioral: Toxic Life Cycle of a Cigarette

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT03238313

TP2AH000036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,770 patients

Sex: Female

Ages: 18 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,770 participants in 2 patient groups

Plan A

Experimental group

Description:

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.

Treatment:

Behavioral: Plan A

Toxic Life Cycle of a Cigarette

Active Comparator group

Description:

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.

Treatment:

Behavioral: Toxic Life Cycle of a Cigarette