NCT07225062

Improving HIV Prevention and Substance Use Post-Sexual Assault Services

Improving HIV Prevention and Substance Use Post-Sexual Assault Services for Adolescents and Young Adults

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 17 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to tailor existing sexual assault nurse examiner (SANE) services with same-day HIV prophylaxis and substance use screening, brief intervention, or referral using semi-structured adolescents and young adults (AYA) survivor and key informant interviews, and iterative co-design/pilot testing of adapted strategies with the youth working group (YWG), to optimize study mechanisms and outcome measures using cognitive interviews, analysis of community partner data, and recruitment and retention strategies with the youth working group (YWG) and community advisory board (CAB), to conduct a pilot randomized controlled trial with 40 AYA to test feasibility, acceptability, and initial efficacy compared to usual care, to evaluate recruitment, randomization, and follow-up strategies; adherence to intervention dose; retention benchmarks; and acceptability and to evaluate preliminary efficacy of outcome measures (uptake of post-assault HIV prevention and substance use treatment).

Conditions

• HIV Infections
• Substance Use
• Sexual Assault

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced intervention	The intervention has three components: 1). Exploring how to increase access to and promotion of SANE services among vulnerable AYA within the 72 hr window for nPEP treatment; 2). Enhanced SANE services to increase same-day access to nPEP and DoxyPEP and 3). An advocate-delivered screening, brief intervention, and referral to prevent and address substance misuse.
BEHAVIORAL	Usual Care	The usual care condition will be used with control participants and entail receiving typical SANE services without modifications to enhance HIV prevention or substance use screening, brief intervention, or referral to treatment

Timeline

• Start date: 2027-01-04
• Primary completion: 2027-05-31
• Completion: 2027-06-30
• First posted: 2025-11-05
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States