Evaluation of Momentary Affect Regulation - Safer Sex Intervention
Evaluation of Momentary Affect Regulation - Safer Sex Intervention
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.
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 17-20 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 May 2021 and continuing for 17 months, 600 participants who have received sexual
 or reproductive health care from partner implementation sites in Alaska, Idaho, Washington,
 Hawaii, Indiana, Wisconsin, and Kentucky will be recruited and enrolled into the study. 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.
Inclusion Criteria:

 -  Be an active patient of one of the participating Planned Parenthood health centers

 -  Own a smartphone

 -  Be fluent in English

 -  Be 17 to 20 years of age

 -  Be biologically able to become pregnant (to the best of their knowledge)

 -  Score at least 10 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