Improving HIV Prevention and Substance Use Post-Sexual Assault Services

The University of Texas System (UT)

Status: Begins enrollment in 10 months

Conditions: Sexual Assault; Substance Use; HIV Infections

Treatments: Behavioral: Enhanced intervention; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07225062

HSC-SN-25-0423

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 17 to 25 years old

Volunteers: No Healthy Volunteers

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
• are overtly having severe, untreated mental illness symptoms

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Enhanced intervention

Experimental group

Treatment:

Behavioral: Enhanced intervention

Usual Care

Active Comparator group

Treatment:

Behavioral: Usual Care