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Not yet recruiting NCT07225062

Improving HIV Prevention and Substance Use Post-Sexual Assault Services

No phase Interventional HIV Infections Substance Use Sexual Assault

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced intervention, Usual Care.
Who it may be relevant to
Registry conditions: HIV Infections, Substance Use, Sexual Assault. Basic parameters: 17 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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

Primary outcome measures

  • Recruitment feasibility as measured by percentage of eligible individuals screened [Time frame: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by percentage of eligible individuals enrolled [Time frame: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by time delay from screening to enrollment [Time frame: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by time to enroll sufficient sample size [Time frame: end of study (1 month after baseline)]
  • Recruitment feasibility as measured by percentage loss to exclusion criteria. [Time frame: end of study (1 month after baseline)]
  • Randomization strategies as measured by proportion randomized to intervention and control [Time frame: end of study (1 month after baseline)]
  • Retention as measured by the number of participants that completed the one month follow-up survey [Time frame: end of study (1 month after baseline)]
  • Retention of the intervention group as measured by the number of participants that completed the one month follow-up survey [Time frame: end of study (1 month after baseline)]
  • Retention of the control group as measured by the number of participants that completed the one month follow-up survey [Time frame: end of study (1 month after baseline)]
  • Adherence to intervention as measured by percentage of content completed in the fidelity checklist [Time frame: end of study (1 month after baseline)]
Secondary outcome measures (5)
  • Uptake of post-assault HIV prevention as measured by self report of nPEP uptake [Time frame: 1-month follow-up]
  • Uptake of substance use treatment as self reported as reported on the self report questionnaire [Time frame: 1-month follow-up]
  • Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake [Time frame: 1-month follow-up]
  • Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire [Time frame: 1-month follow-up]
  • Adherence of substance use treatment as reported on the self report questionnaire [Time frame: 1-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07225062 · HSC-SN-25-0423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗