Evaluation of Plan A

Study Overview
=================
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.

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.

Official Title
-----------------
Evaluation of Plan A Video Intervention

Conditions
-----------------
Teen Pregnancy Prevention

Intervention / Treatment
-----------------
* Behavioral: Plan A
* Behavioral: Toxic Life Cycle of a Cigarette


Participation Criteria
=================
Eligibility 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 Enrolled in studies in the same geographic area that aim to prevent teen pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plan A<br>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. | Behavioral: Plan A<br> <br> |
| Active Comparator: Toxic Life Cycle of a Cigarette<br>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. | Behavioral: Toxic Life Cycle of a Cigarette<br>* Video<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Three months after intervention |