Improving HIV Prevention and Substance Use Post-Sexual Assault Services

NCT07225062 | Not Yet Recruiting

• 1 other identifier: HSC-SN-25-0423
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (13)

• Recruitment feasibility as measured by percentage of eligible individuals screened

  end of study (1 month after baseline)

• Recruitment feasibility as measured by percentage of eligible individuals enrolled

  end of study (1 month after baseline)

• Recruitment feasibility as measured by time delay from screening to enrollment

  end of study (1 month after baseline)

• Recruitment feasibility as measured by time to enroll sufficient sample size

  end of study (1 month after baseline)

• Recruitment feasibility as measured by percentage loss to exclusion criteria.

  end of study (1 month after baseline)

• Randomization strategies as measured by proportion randomized to intervention and control

  end of study (1 month after baseline)

• Retention as measured by the number of participants that completed the one month follow-up survey

  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

  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

  end of study (1 month after baseline)

• Adherence to intervention as measured by percentage of content completed in the fidelity checklist

  end of study (1 month after baseline)

• Acceptability as measured by percentage of data loss

  end of study (1 month after baseline)

• Acceptability as measured by score on the credibility/expectancy questionnaire

  The Credibility and Expectancy Questionnaire (CEQ) was used to assess the acceptability of the intervention. All participants completed both subscales: the credibility subscale and the expectancy subscale. Each subscale total score ranges from 0 to 10, with higher scores indicating greater perceived acceptability. The expectancy subscale is reported.

  end of study (1 month after baseline)

• Acceptability as measured by score on the credibility/expectancy questionnaire

  The Credibility and Expectancy Questionnaire (CEQ) was used to assess the acceptability of the intervention. All participants completed both subscales: the credibility subscale and the expectancy subscale. Each subscale total score ranges from 0 to 10, with higher scores indicating greater perceived acceptability. The credibility subscale is reported.

  end of study (1 month after baseline)

Secondary Outcomes (5)

• Uptake of post-assault HIV prevention as measured by self report of nPEP uptake

  1-month follow-up

• Uptake of substance use treatment as self reported as reported on the self report questionnaire

  1-month follow-up

• Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake

  1-month follow-up

• Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire

  1-month follow-up

• Adherence of substance use treatment as reported on the self report questionnaire

  1-month follow-up

Study Arms (2)

Enhanced intervention

EXPERIMENTAL

Behavioral: Enhanced intervention

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

Enhanced intervention 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.

Enhanced intervention

Usual Care 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

Usual Care

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• experienced a sexual assault within the last 72 hours
• speak English
• not planning to move out of the metro area during the study.

You may not qualify if:

• noticeably intoxicated or under the influence
• are overtly having severe, untreated mental illness symptoms

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

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

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(713) 500-2002; Diane.M.SantaMaria@uth.tmc.edu

Jennifer T Jones

CONTACT

713-500-9928; Jennifer.D.Torres@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors will be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)