Evaluation of Momentary Affect Regulation - Safer Sex Intervention

Study Overview
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Brief Summary
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The purpose of the study is to determine the impact of the offer to participate in the Momentary Affect Regulation - Safer Sex Intervention (treatment) relative to the offer to participate in the control condition on participants' reported condom use, use of effective contraception, and number of sexual partners three months after the end of the treatment intervention.

Detailed Description
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The Policy & Research Group (PRG) will be conducting a rigorous evaluation of an innovative intervention designed to reduce unplanned pregnancy and sexually transmitted infections in young women with depression, entitled Momentary Affect Regulation - Safer Sex Intervention (MARSSI). MARSSI was developed by Dr. Lydia Shrier of Boston Children's Hospital. MARSSI has three components. The first is a manualized session with a sexual and reproductive health counselor, who uses motivational interviewing (MI) techniques to help the young woman identify a risk-reducing goal for her sexual behavior, develop a change plan, and provide depression education and skills, based on cognitive behavioral therapy. The second component is a mobile health (mhealth) application that the young woman loads on her smartphone and, for four weeks, uses to complete app-prompted reports 3 times a day and a scheduled report once a day. When she reports poor affect, low contraceptive or condom self-efficacy, pregnancy desire, or desire for sex to regulate affect, she receives personalized messages prompting healthy behaviors and cognitive behavioral skill use. The third component is a booster session that occurs after 4 weeks of app use. The young woman meets with the counselor again to review her behavior and relationships, discuss progress toward her goal, and learn a new skill. Through these components, MARSSI aims to enhance motivation to change risk behaviors, provides skills to address depression's effects on behavior, and prompts and reinforces healthy affect regulation, cognitive behavioral skill use, and behavior change in daily life. The Policy & Research Group (PRG) will conduct an implementation evaluation and an impact evaluation, using an individual randomized controlled trial, to test the efficacy of this new intervention. The study will target young women ages 16-21 who have depressive symptoms and are recent clients of sexual and reproductive health clinics. The primary focus of the study will be to investigate the impact of the intervention on three self-reported sexual behaviors: 1) condom use; 2) use of effective contraception; and 3) number of sexual partners. The study will also include exploratory investigations of a number of other sexual behaviors and theoretically relevant antecedents to change in behavior and sexual health, including but not limited to: 1) engagement in protective sexual behavior; 2) condom use at last vaginal sex; 3) effective contraceptive use at last vaginal sex; 4) dual methods of protection; 5) frequency of vaginal, anal, and oral sex; 6) substance use before any type of sex; 7) types of sexual partners/relationships; 8) depressive symptoms; 9) sexual communication self-efficacy; 10) motivation to change risky sexual behaviors; 11) contraceptive and condom knowledge; 12) contraceptive and condom planning self-efficacy; and 13) use of cognitive restructuring. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at four time points: baseline (enrollment); post-program (immediately after the end of the intervention period; 1 month post baseline); short-term (4 months post-baseline) follow-up; and long-term (7 months post baseline) follow-up. Starting in June 2021 and continuing for 23 months, 600 participants who have received reproductive health care in the past two years (nationally) will be recruited and enrolled into the study by trained Planned Parenthood research coordinators. The final year of the grant will be used to complete the following tasks: collect follow-up data from study participants; conduct implementation and impact evaluation analysis, reporting, and dissemination efforts; and manualize and package the curriculum and training materials.

Official Title
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Evaluation of Momentary Affect Regulation - Safer Sex Intervention

Conditions
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Teen Pregnancy Prevention

Intervention / Treatment
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* Behavioral: Momentary Affect Regulation - Safer Sex Intervention (MARSSI)
* Behavioral: Podcast Health Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Visited reproductive health care provider in the past two years Own a smartphone Have the technical capacity to participate Be fluent in English Be 16 to 21 years of age Be biologically able to become pregnant (to the best of their knowledge) Score at least 8 on the PHQ-8 Have had penile-vaginal sex in the past 3 months Have had penile-vaginal sex at least once a week, on average Report having done at least one of the following during the 3 months preceding eligibility screening: 1) Not using a condom every time they have sexual intercourse; 2) Used condoms, a diaphragm, cervical cap, spermicide, sponge, fertility awareness, or withdrawal as a primary form of birth control; 3) Had sexual intercourse with more than one person; 4) Had sexual intercourse within 2 hours after using drugs and alcohol; and/or 5) Been treated for an STI/STD Exclusion Criteria: Trying to get pregnant or currently pregnant at the time of eligibility screening Have given birth during the 6 months preceding eligibility screening Married or engaged to be married at the time of eligibility screening Identified as fraudulent

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Momentary Affect Regulation - Safer Sex Intervention<br>Momentary Affect Regulation - Safer Sex Intervention (MARSSI) is the treatment condition. MARSSI aims to enhance an individual's motivation to change risk behaviors, provides skills to address depression's effects on behavior, and prompts and reinforces healthy affect regulation, cognitive behavioral skill use, and behavior change in daily life. | Behavioral: Momentary Affect Regulation - Safer Sex Intervention (MARSSI)<br>* MARSSI is an individual-level intervention that involves a one-hour manualized session with a sexual reproductive health (SRH) counselor, followed by one-month of daily use of a mobile health app and a final 20-minute booster session with the SRH counselor.<br>|
| Sham Comparator: Podcast Health Group<br>The Podcast Health Group is the control counterfactual condition. | Behavioral: Podcast Health Group<br>* Participants assigned to the Podcast Health Group will listen to  20 minute podcast episode put out by the Susan G. Komen Foundation about family history of breast cancer; the podcast does not include information related to the outcomes of interest for the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times having vaginal sex without a condom | Participant self-report on the number of times having vaginal sex without using a condom during the past 30 days | Assessed three months after the intervention period has ended | 
| Number of sexual partners | Participant self-report of the number of sexual partners in the the past three months | Assessed three months after the intervention period has ended | 
| Effective contraceptive use | Participant self-report on whether or not they are currently using effective (prescription) contraception or not | Assessed three months after the intervention period has ended |