Improving HIV Prevention and Substance Use Post-Sexual Assault Services

November 3, 2025 updated by: Diane Santa Maria, The University of Texas Health Science Center, Houston

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
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
Experimental: Enhanced intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment feasibility as measured by percentage of eligible individuals screened
Time Frame: end of study (1 month after baseline)
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)
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)
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)
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)
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)
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)
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)
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)
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)
end of study (1 month after baseline)
Acceptability as measured by percentage of data loss
Time Frame: end of study (1 month after baseline)
end of study (1 month after baseline)
Acceptability as measured by score on the credibility/expectancy questionnaire
Time Frame: end of study (1 month after baseline)
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
Time Frame: end of study (1 month after baseline)
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 Outcome Measures

Outcome Measure
Time Frame
Uptake of post-assault HIV prevention as measured by self report of nPEP uptake
Time Frame: 1-month follow-up
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
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
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
1-month follow-up
Adherence of substance use treatment as reported on the self report questionnaire
Time Frame: 1-month follow-up
1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 4, 2027

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 3, 2025

First Posted (Estimated)

November 5, 2025

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SN-25-0423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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