Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04798248 |
| Other study ID # |
1 TP2AH000076-01-00 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 19, 2021 |
| Est. completion date |
October 30, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
The Policy & Research Group |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
