Evaluation of Momentary Affect Regulation - Safer Sex Intervention
MARSSI
1 other identifier
interventional
405
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
June 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 29, 2025
July 1, 2025
2.9 years
March 9, 2021
July 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Momentary Affect Regulation - Safer Sex Intervention
EXPERIMENTALMomentary 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.
Podcast Health Group
SHAM COMPARATORThe Podcast Health Group is the control counterfactual condition.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Policy & Research Grouplead
- Department of Health and Human Servicescollaborator
- Mathematica Policy Research, Inc.collaborator
Study Sites (2)
Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
Seattle, Washington, 98122, United States
Planned Parenthood of Wisconsin
Madison, Wisconsin, 53713, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Jenner, PhD
The Policy & Research Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 15, 2021
Study Start
June 19, 2021
Primary Completion
May 10, 2024
Study Completion
June 30, 2024
Last Updated
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- The individual participant dataset will become available twelve months after the study has concluded.
- Access Criteria
- For any individuals interested in accessing a copy of this public use dataset, please email info@policyandresearch.com with your inquiry.
A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.