Sexual AssaultIDEA3NCT06058455
An Evaluation of an Online Sexual Assault Resistance Program (IDEA3)
A study testing IDEA3 Sexual Assault Resistance Intervention and Consent Workshop in people with Sexual Assault, run by University of Maryland, College Park at 6 sites in 2 countries.
Trial summary
The goal of this randomized trial is to test whether the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) sexual assault resistance education intervention reduces sexual violence victimization in undergraduate women. Read more about this study
- Who is it for?
- Ages 17 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault
- What is being tested?
- IDEA3 Sexual Assault Resistance Intervention and Consent Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,920 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 2 Oct 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1st- and 2nd-year university students at one of the 4 sites
- female-identifying students
- students between ages of 17-24
- able to attend one of the scheduled program groups
- able and willing to be matched with another eligible student
Who cannot join
- None
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States4 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Katie Edwards, PhD, edkatie@umich.edu
- Recruiting
University of Maryland
College Park, Maryland, 20742
Sarah M Peitzmeier, PhD, 301 405 2526, speitzme@umd.edu
speitzme@umd.edu
- Completed
University of Nebraska - Lincoln
Lincoln, Nebraska, 68588
- Recruiting
University of Central Florida
Orlando, Florida, 32816
Leanna J Papp, PhD, 407-266-1000, Leanna.Papp@ucf.edu
Canada2 sites, 1 recruiting
- Recruiting
University of Guelph
Guelph, Ontario, N1G 2W1
Paula Barata, PhD, pbarata@uoguelph.ca
Paula Barata, PhD
- Active, not recruiting
University of Windsor
Windsor, Ontario, N9B 3P4
About this study
Official title: A Randomized Controlled Trial of the Efficacy of IDEA3 - An Evidence-based Sexual Assault Resistance Intervention for Undergraduate Women Adapted for Internet Delivery
The goal of this randomized trial is to test whether the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) sexual assault resistance education intervention reduces sexual violence victimization in undergraduate women.
Participants in the intervention group will be asked to attend four three-hour group sessions of a sexual assault resistance program called IDEA3 with a partner, as well as fill out a number of surveys. Participants in the control group will be asked to attend a one-hour consent workshop with a partner and fill out surveys.
Researchers will compare sexual assault victimization between the groups in the one year following the intervention.
Read the detailed description
Sexual violence (SV), which occurs along a continuum from unwanted sexual contact to rape, is common among young women, with some 40% experiencing sexual assault during their time in college. Given the numerous negative consequences associated with SV, developing effective SV prevention and resistance programs for young adult women is critical for reducing victimization and improving health outcomes for adolescent girls. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program has been shown to substantially reduce rates of SV (50% for rape and attempted rape) in young women attending university (ages 17-24). The purpose of the current study is to test the efficacy of the newly adapted Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) program in reducing sexual violence victimization among undergraduate women over 12 months of follow-up. IDEA3 is a 12-hour psychoeducational intervention that provides information, skills, and practice aimed at a) decreasing the time needed for young women to assess sexually coercive situations as dangerous and to take action, b) reducing emotional obstacles to taking action, c) increasing the use of the most effective methods of verbal and physical self-defense, and d) identifying sexual and relationship values and boundaries and reinforcing the right to defend them.
- Conditions
- Sexual Assault
- Being tested
- IDEA3 Sexual Assault Resistance Intervention, Consent Workshop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEA3 Sexual Assault Resistance InterventionBehavioural
Internet-delivered EAAA (IDEA3), adapted from an in-person sexual assault resistance education intervention: Enhanced Assess, Acknowledge, Act (EAAA) intervention that was found in a randomized trial to reduce sexual assault victimization by about 50% at follow-up. IDEA3 designed for female identifying university students and focuses on resisting sexual assault committed by males in 4, 3-hour units: 1-ASSESS builds ability to detect risk with male acquaintances and develop risk reduction strategies. 2-ACKNOWLEDGE explores overcoming emotional barriers preventing women from acknowledging risk and employing effective resistance strategies with males. 3-ACT shows effectiveness of resistance strategies and teaches verbal and physical self-defense in common situations. 4-RELATIONSHIPS \& SEXUALITY adapts the Our Whole Lives curriculum to increase women's comfort in talking about sex/sexuality and identify sexual values/desires.
Consent WorkshopBehavioural
Participant pairs assigned to the control arm will receive a 60-minute session consisting of a 60-min interactive, virtual consent workshop. The workshop will include information on a) what consent is, including the idea that consent is about bodily autonomy and applies to interactions beyond sex, b) how to give and ask for consent, and c) examples of what it looks like to ask for and give/not give consent. This presentation will be given by a well-trained Research Assistant.
| Study group | Role | What they receive |
|---|---|---|
| IDEA3 sexual assault resistance intervention | Experimental | IDEA3 curriculum will be delivered by pairs of trained facilitators over Zoom to reach up to 8 pairs of female-identified university students in four, 3-hour units. The four units will be spread over two to four weeks' time. Receives: Behavioral: IDEA3 Sexual Assault Resistance Intervention |
| Consent workshop | Active comparator | Randomized participants who do not receive the intervention will receive one 60-minute session consisting of an internet delivered (Zoom) consent workshop. Receives: Behavioral: Consent Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completed rape
The Sexual Experiences Survey Short Form Victimization (SES-SFV) will be used to measure the primary sexual assault outcomes. Completed rape will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged completed (not attempted) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (2c, 2d, 2e, 3c, 3d, 3e, 4c, 4d, or 4e) in the period between the baseline measurement and the 12-month survey measurement.
Measured: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
Secondary outcomes (2)
Attempted rape
The SES-SFV will also be used to measure secondary sexual assault outcomes: Attempted rape will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged attempted (not completed) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (5c, 5d, 5e, 6c, 6d, 6e, 7c, 7d, or 7e) in the period between the baseline and the 12-month survey.
Measured: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
Other Forms of Sexual Assault
The SES-SFV will also be used to measure other sexual assault outcomes:
Non-penetrative forced sexual contact will have occurred when a participant indicates she has had at least one such experience of non-penetrative sexual contact by any perpetrator strategy - answered 'once' or more to any of 5 questions (1a, 1b, 1c, 1d, 1e).
Completed sexual coercion will have occurred when a participant indicates she has had at least one experience of coerced (not forced) completed sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 6 questions (2a, 2b, 3a, 3b, 4a, 4b).
Attempted sexual coercion will have occurred when a participant indicates she has had at least one experience of coerced (not forced) attempted (not completed) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 6 questions (5a, 5b, 6a, 6b, 7a, 7b).
Measured: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start2 Oct 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- University of Windsor, University of Nebraska, University of Guelph, Tufts University, University of Central Florida, University of Michigan
- Responsible party
- Principal investigator, Sarah Peitzmeier, University of Maryland, College Park
- Investigators
- Sarah M Peitzmeier, PhD, Principal investigator, University of MarylandCharlene Y Senn, PhD, Principal investigator, University of Windsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058455
- Sponsor's protocol ID
- HUM00229565
- Other IDs
- 23-063, 183649
- Acronym
- IDEA3
- Status last verified
- Oct 2025
- First submitted
- 12 Sep 2023
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified academic researchers will be allowed to access de-identified survey responses upon request to the PIs, or a designee such as a secure data repository, e.g. ICPSR. The final system for managing and approving requests has yet to be determined.
Publications
Cowan, G., & Campbell, R. R. (1995). Rape causal attitudes among adolescents. Journal of Sex Research, 32(2), 145-153.
Cowan, G., & Quinton, W. J. (1997). Cognitive style and attitudinal correlates of the perceived causes of rape scale. Psychology of Women Quarterly, 21(2), 227-245.
Frazier PA. Perceived control and distress following sexual assault: a longitudinal test of a new model. J Pers Soc Psychol. 2003 Jun;84(6):1257-69. doi: 10.1037/0022-3514.84.6.1257.
PubMed 12793588Gray, M. D., Lesser, D., Quinn, E., & Brounds, C. (1990). The effectiveness of personalizing acquaintance rape prevention: Programs on perception of vulnerability and on reducing risktaking behavior. Journal of College Student Development, 31, 217-220.
Marx BP, Calhoun KS, Wilson AE, Meyerson LA. Sexual revictimization prevention: an outcome evaluation. J Consult Clin Psychol. 2001 Feb;69(1):25-32. doi: 10.1037//0022-006x.69.1.25.
PubMed 11302273Messman-Moore, T. L., & Brown, A. L. (2006). Risk perception, rape and sexual revictimization: A prospective study of college women. Psychology of Women Quarterly, 30, 159-172. doi:10. 1111/j.1471-6402.2006.00279.x
Payne, D. L., Lonsway, K. A., & Fitzgerald, L. F. (1999). Rape myth acceptance: Exploration of its structure and its measurement using the Illinois Rape Myth Acceptance Scale. Journal of Research in Personality, 33, 27-68.
Senn, C. Y., Gee, S. S., & Thake, J. (2011). Emancipatory sexuality education and sexual assault resistance: Does the former enhance the latter?. Psychology of Women Quarterly, 35(1), 72-91.
Papp, L. J. (2023). Sexualized aggression in college drinking settings: A four-year prospective cohort study of undergraduate women [Unpublished doctoral dissertation]. University of Michigan.
Testa M, Vanzile-Tamsen C, Livingston JA, Buddie AM. The role of women's alcohol consumption in managing sexual intimacy and sexual safety motives. J Stud Alcohol. 2006 Sep;67(5):665-74. doi: 10.15288/jsa.2006.67.665.
PubMed 16847534Upadhyay UD, Danza PY, Neilands TB, Gipson JD, Brindis CD, Hindin MJ, Foster DG, Dworkin SL. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94. doi: 10.1016/j.jadohealth.2020.05.031. Epub 2020 Jul 17.
PubMed 32690468Peitzmeier SM, Senn CY, Eliasziw M, Edwards K, Barata P, Papp LJ, Hobden KL. An Internet-Delivered Sexual Assault Resistance Intervention for Undergraduate Women (The IDEA3 Trial): Protocol for a Multisite Randomized Controlled Efficacy Trial. JMIR Res Protoc. 2025 Oct 7;14:e72087. doi: 10.2196/72087.
PubMed 41055953
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Efficacy of IDEA3 - An Evidence-based Sexual Assault Resistance Intervention for Undergraduate Women Adapted for Internet Delivery
- ClinicalTrials.gov ID
- NCT06058455
- Acronym / sponsor ID
- IDEA3 / HUM00229565
- Conditions
- Sexual Assault
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- University of Windsor, University of Nebraska, University of Guelph, Tufts University, University of Central Florida, University of Michigan
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized trial is to test whether the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) sexual assault resistance education intervention reduces sexual violence victimization in undergraduate women.
Participants in the intervention group will be asked to attend four three-hour group sessions of a sexual assault resistance program called IDEA3 with a partner, as well as fill out a number of surveys. Participants in the control group will be asked to attend a one-hour consent workshop with a partner and fill out surveys.
Researchers will compare sexual assault victimization between the groups in the one year following the intervention.
Detailed description
Sexual violence (SV), which occurs along a continuum from unwanted sexual contact to rape, is common among young women, with some 40% experiencing sexual assault during their time in college. Given the numerous negative consequences associated with SV, developing effective SV prevention and resistance programs for young adult women is critical for reducing victimization and improving health outcomes for adolescent girls. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program has been shown to substantially reduce rates of SV (50% for rape and attempted rape) in young women attending university (ages 17-24). The purpose of the current study is to test the efficacy of the newly adapted Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) program in reducing sexual violence victimization among undergraduate women over 12 months of follow-up. IDEA3 is a 12-hour psychoeducational intervention that provides information, skills, and practice aimed at a) decreasing the time needed for young women to assess sexually coercive situations as dangerous and to take action, b) reducing emotional obstacles to taking action, c) increasing the use of the most effective methods of verbal and physical self-defense, and d) identifying sexual and relationship values and boundaries and reinforcing the right to defend them.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDEA3 sexual assault resistance intervention | Experimental | Behavioral: IDEA3 Sexual Assault Resistance InterventionIDEA3 curriculum will be delivered by pairs of trained facilitators over Zoom to reach up to 8 pairs of female-identified university students in four, 3-hour units. The four units will be spread over two to four weeks' time. |
| Consent workshop | Active comparator | Behavioral: Consent WorkshopRandomized participants who do not receive the intervention will receive one 60-minute session consisting of an internet delivered (Zoom) consent workshop. |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 1st- and 2nd-year university students at one of the 4 sites
- female-identifying students
- students between ages of 17-24
- able to attend one of the scheduled program groups
- able and willing to be matched with another eligible student
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDEA3 Sexual Assault Resistance InterventionInternet-delivered EAAA (IDEA3), adapted from an in-person sexual assault resistance education intervention: Enhanced Assess, Acknowledge, Act (EAAA) intervention that was found in a randomized trial to reduce sexual assault victimization by about 50% at follow-up. IDEA3 designed for female identifying university students and focuses on resisting sexual assault committed by males in 4, 3-hour units: 1-ASSESS builds ability to detect risk with male acquaintances and develop risk reduction strategies. 2-ACKNOWLEDGE explores overcoming emotional barriers preventing women from acknowledging risk and employing effective resistance strategies with males. 3-ACT shows effectiveness of resistance strategies and teaches verbal and physical self-defense in common situations. 4-RELATIONSHIPS \& SEXUALITY adapts the Our Whole Lives curriculum to increase women's comfort in talking about sex/sexuality and identify sexual values/desires. | Behavioural | IDEA3 sexual assault resistance intervention |
| Consent WorkshopParticipant pairs assigned to the control arm will receive a 60-minute session consisting of a 60-min interactive, virtual consent workshop. The workshop will include information on a) what consent is, including the idea that consent is about bodily autonomy and applies to interactions beyond sex, b) how to give and ask for consent, and c) examples of what it looks like to ask for and give/not give consent. This presentation will be given by a well-trained Research Assistant. | Behavioural | Consent workshop |
Primary outcome
Completed rape
Time frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
The Sexual Experiences Survey Short Form Victimization (SES-SFV) will be used to measure the primary sexual assault outcomes. Completed rape will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged completed (not attempted) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (2c, 2d, 2e, 3c, 3d, 3e, 4c, 4d, or 4e) in the period between the baseline measurement and the 12-month survey measurement.
2 secondary outcomes
Attempted rape
Time frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
Other Forms of Sexual Assault
Time frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- BackgroundCowan, G., & Campbell, R. R. (1995). Rape causal attitudes among adolescents. Journal of Sex Research, 32(2), 145-153.
- BackgroundCowan, G., & Quinton, W. J. (1997). Cognitive style and attitudinal correlates of the perceived causes of rape scale. Psychology of Women Quarterly, 21(2), 227-245.
- Background: PubMed 12793588Frazier PA. Perceived control and distress following sexual assault: a longitudinal test of a new model. J Pers Soc Psychol. 2003 Jun;84(6):1257-69. doi: 10.1037/0022-3514.84.6.1257.
- BackgroundGray, M. D., Lesser, D., Quinn, E., & Brounds, C. (1990). The effectiveness of personalizing acquaintance rape prevention: Programs on perception of vulnerability and on reducing risktaking behavior. Journal of College Student Development, 31, 217-220.
- Background: PubMed 11302273Marx BP, Calhoun KS, Wilson AE, Meyerson LA. Sexual revictimization prevention: an outcome evaluation. J Consult Clin Psychol. 2001 Feb;69(1):25-32. doi: 10.1037//0022-006x.69.1.25.
- BackgroundMessman-Moore, T. L., & Brown, A. L. (2006). Risk perception, rape and sexual revictimization: A prospective study of college women. Psychology of Women Quarterly, 30, 159-172. doi:10. 1111/j.1471-6402.2006.00279.x
- BackgroundPayne, D. L., Lonsway, K. A., & Fitzgerald, L. F. (1999). Rape myth acceptance: Exploration of its structure and its measurement using the Illinois Rape Myth Acceptance Scale. Journal of Research in Personality, 33, 27-68.
- BackgroundSenn, C. Y., Gee, S. S., & Thake, J. (2011). Emancipatory sexuality education and sexual assault resistance: Does the former enhance the latter?. Psychology of Women Quarterly, 35(1), 72-91.
- BackgroundPapp, L. J. (2023). Sexualized aggression in college drinking settings: A four-year prospective cohort study of undergraduate women [Unpublished doctoral dissertation]. University of Michigan.
- Background: PubMed 16847534Testa M, Vanzile-Tamsen C, Livingston JA, Buddie AM. The role of women's alcohol consumption in managing sexual intimacy and sexual safety motives. J Stud Alcohol. 2006 Sep;67(5):665-74. doi: 10.15288/jsa.2006.67.665.
- Background: PubMed 32690468Upadhyay UD, Danza PY, Neilands TB, Gipson JD, Brindis CD, Hindin MJ, Foster DG, Dworkin SL. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94. doi: 10.1016/j.jadohealth.2020.05.031. Epub 2020 Jul 17.
- Derived from this study: PubMed 41055953Peitzmeier SM, Senn CY, Eliasziw M, Edwards K, Barata P, Papp LJ, Hobden KL. An Internet-Delivered Sexual Assault Resistance Intervention for Undergraduate Women (The IDEA3 Trial): Protocol for a Multisite Randomized Controlled Efficacy Trial. JMIR Res Protoc. 2025 Oct 7;14:e72087. doi: 10.2196/72087.
- Individual participant dataSharing planned: Yes. Qualified academic researchers will be allowed to access de-identified survey responses upon request to the PIs, or a designee such as a secure data repository, e.g. ICPSR. The final system for managing and approving requests has yet to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah M Peitzmeier, PhD principal investigator
University of Maryland
Charlene Y Senn, PhD principal investigator
University of Windsor
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDEA3 Sexual Assault Resistance Intervention and Consent Workshop in people with Sexual Assault, run by University of Maryland, College Park at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah M Peitzmeier, PhD (301 405 2526, speitzme@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completed rape (time frame: Baseline, 1-week post-intervention, 6-months and 12-months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058455, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.