Improving HIV Prevention and Substance Use Post-Sexual Assault Services

NCT ID: NCT07225062

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-01-04

Study Completion Date

2027-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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HIV Infections Substance Use Sexual Assault

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Data collectors will be blinded

Study Groups

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Enhanced intervention

Group Type EXPERIMENTAL

Enhanced intervention

Intervention Type BEHAVIORAL

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.

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Diane Santa Maria

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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

Role: CONTACT

(713) 500-2002

Jennifer T Jones

Role: CONTACT

713-500-9928

Facility Contacts

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

Role: primary

(713) 500-2002

Jennifer T Jones

Role: backup

713-500-9928

Other Identifiers

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HSC-SN-25-0423

Identifier Type: -

Identifier Source: org_study_id

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