Enhanced Intervention for Sexual Assault

Overseen By Jennifer T Jones

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Intoxication, Untreated mental illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for adolescents and young adults who have recently experienced sexual assault. It tests an enhanced intervention that provides same-day HIV prevention and checks for substance use, compared to the usual care. The goal is to determine if this enhanced approach is more effective and acceptable for participants. Individuals may qualify if they have experienced a sexual assault within the last 72 hours, speak English, and do not plan to move from the metro area during the trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could significantly enhance care for future patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this enhanced intervention is safe for adolescents and young adults?

Research involving women who have survived sexual assault shows that joining studies soon after the assault can be safe. These studies focus on methods to help and support survivors, which can improve their mental health over time. Although specific side effects are not listed, evidence from similar studies suggests these methods are safe and well-tolerated. The goal is to provide immediate help safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the enhanced intervention for sexual assault because it offers a more comprehensive approach compared to usual care. While traditional treatments often focus on immediate physical health and basic counseling, this enhanced intervention aims to address a wider range of psychological and emotional needs. By integrating more personalized support strategies and potentially innovative therapeutic techniques, this approach could lead to better long-term recovery outcomes for survivors. This holistic focus is what makes it a promising advancement in the care of individuals who have experienced sexual assault.

What evidence suggests that this trial's treatments could be effective for sexual assault survivors?

This trial will compare an Enhanced Intervention with Usual Care for sexual assault survivors. Research has shown that improved support for these survivors can be beneficial. The Enhanced Intervention includes elements such as same-day HIV prevention treatment and substance use screening, which studies have found can lead to better outcomes. Evidence suggests that short support sessions can help reduce common mental health issues like anxiety and depression after an assault. Specifically, past patients have benefited from personalized support that includes these elements. This type of care aims to address the immediate health needs of survivors and improve their overall well-being. ^{6 7 8 9 10}

Who Is on the Research Team?

Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults who have experienced sexual assault. Participants should be in need of HIV prevention services and substance use interventions. The study aims to improve post-assault care, but details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Experienced a sexual assault within the last 72 hours

Speak English

Not planning to move out of the metro area during the study

Exclusion Criteria

Noticeably intoxicated or under the influence

Overtly having severe, untreated mental illness symptoms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive same-day HIV prophylaxis and substance use screening, brief intervention, or referral

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced intervention
• Usual Care

Trial Overview The study tests an enhanced intervention against usual care for sexual assault survivors. It includes same-day HIV prophylaxis, substance use screening, brief interventions or referrals, with the process shaped by interviews and co-design with youth groups.

How Is the Trial Designed?

Group I: Enhanced intervention Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. rainn.org rainn.org/help-and-healing/hotline/

RAINN's National Sexual Assault Hotline What To Expect When You Contact RAINN. Since 1994, RAINN's victim service programs have helped over 5 million survivors of sexual violence and their loved ones ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138126/

A Systematic Review of Evidence-Based Treatments for ... Sexual assault (SA) is a serious crime that is a prevalent mental and public health problem. Addressing the needs of SA victims and providing appropriate ...

3. crimevictim.utah.gov crimevictim.utah.gov/wp-content/uploads/2021/04/Mental-Health-Treatments-for-Adolescent-and-Adult-Victims-of-Sexual-Assualt_MilesValentine_Oct2020-1.pdf

Mental-Health-Treatments-for-Adolescent-and-Adult-Victims ... Abstract. Background. Neurobiology of Trauma. Responses to Sexual Assault. Acute Stress Disorder (ASD) and Posttraumatic Stress Disorder (PTSD).

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15248380251325215

Effectiveness of Brief Interventions for Sexual Assault ... Background:Sexual assault is a pervasive social issue worldwide, with significant harmful impacts on survivors' mental health and well-being ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/01612840.2019.1677830

The Effectiveness of Psychological Interventions for ... Women traumatized by sexual abuse as children or adults experience psychological disorders, such as post-traumatic stress, depression, anxiety, ...

6. nsvrc.org nsvrc.org/evaluation_tool_kit/outcomes-and-indicators/

Outcomes and Indicators Take a journey through the CDC's Sexual Violence Indicators Guide and Database to explore how to: Identify potential indicators and explore direct links to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541260/

An Internet-Delivered Sexual Assault Resistance Intervention ... Outcomes are measured at baseline, 1 week, 6 months, and 12 months post intervention. SA will be assessed using the Sexual Experiences Survey- ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395624004163

Research with women sexual assault survivors presenting ... Results from this study demonstrate that research studies enrolling women sexual assault survivors in the immediate aftermath of assault can be safe. Among ...

9. nij.ojp.gov nij.ojp.gov/topics/articles/advancing-situational-and-developmental-approaches-prevent-sexual-violence

Advancing Situational and Developmental Approaches To ... Growing evidence supports using situational and developmental crime prevention approaches to complement traditional law enforcement and criminal ...

10. cdc.gov cdc.gov/violence-prevention/media/pdf/resources-for-action/SV-Prevention-Resource_508.pdf

Sexual Violence Prevention Resource for Action These types of interventions are associated with improved psychological health and long-term positive impact for victims/survivors of SV.77,78 Some programs are ...