Evaluation of Momentary Affect Regulation - Safer Sex Intervention (NCT04798248) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Momentary Affect Regulation - Safer Sex Intervention
United States405 participantsStarted 2021-06-19
Plain-language 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.
Who can participate
Age range
16 Years – 21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Times having vaginal sex without a condom
Timeframe: Assessed three months after the intervention period has ended
2
Number of sexual partners
Timeframe: Assessed three months after the intervention period has ended
3
Effective contraceptive use
Timeframe: Assessed three months after the intervention period has ended