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Improving HIV Prevention and Substance Use Post-Sexual Assault Services

NCT07225062 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-04
Primary Completion
2027-05-31
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225062 on ClinicalTrials.gov