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NCT Number: NCT07225062

Improving HIV Prevention and Substance Use Post-Sexual Assault Services

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexual Assault Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance Use Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Recruitment feasibility as measured by percentage of eligible individuals screened

    Time frame: end of study (1 month after baseline)

  2. Recruitment feasibility as measured by percentage of eligible individuals enrolled

    Time frame: end of study (1 month after baseline)

  3. Recruitment feasibility as measured by time delay from screening to enrollment

    Time frame: end of study (1 month after baseline)

  4. Recruitment feasibility as measured by time to enroll sufficient sample size

    Time frame: end of study (1 month after baseline)

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

    Time frame: end of study (1 month after baseline)

  6. Randomization strategies as measured by proportion randomized to intervention and control

    Time frame: end of study (1 month after baseline)

  7. 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)

  8. 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)

  9. 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)

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

    Time frame: end of study (1 month after baseline)

  11. Acceptability as measured by percentage of data loss

    Time frame: end of study (1 month after baseline)

  12. 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.

  13. 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.

Secondary outcomes

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

    Time frame: 1-month follow-up

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

    Time frame: 1-month follow-up

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

    Time frame: 1-month follow-up

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

    Time frame: 1-month follow-up

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

    Time frame: 1-month follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

(713) 500-2002

Jennifer T Jones

CONTACT

[email protected]

713-500-9928

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2025
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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