Clinical trial NCT03238313: Evaluation of "Plan A"
Official title: Evaluation of "Plan A" Video Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: The Office of Adolescent Health, HHS
name: Sentient Research
name: Planned Parenthood Mar Monte
First posted: 2017-08-03
Enrollment: 1770
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: LARC Use
timeFrame: Three months after intervention
measure: STI Testing
timeFrame: Three months after intervention
measure: Times Having Sex Without a Condom
timeFrame: Three months after intervention
Secondary outcomes:
measure: Use of Other Effective Contraception
timeFrame: Three months after intervention
measure: Dual Methods of Contraception
timeFrame: Three months after intervention
Other outcomes:
measure: Perceived Risk of Pregnancy
timeFrame: Three months after intervention
measure: Intention to Use LARC
timeFrame: Three months after intervention
measure: Intention to Use Other Effective Contraception Methods
timeFrame: Three months after intervention
measure: Provider Communication Self-efficacy
timeFrame: Three months after intervention
measure: Condom Negotiation Self-efficacy
timeFrame: Three months after intervention
measure: Knowledge and Awareness of Contraception Options/LARC
timeFrame: Three months after intervention
Locations:
city: Multiple Locations
country: United States
facility: The Policy & Research Group
state: California
Study officials:
affiliation: The Policy & Research Group
name: Eric Jenner, PhD, MMC, BA
role: PRINCIPAL_INVESTIGATOR
References: