Improving HIV Prevention and Substance Use Post-Sexual Assault Services

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07225062
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
17 Years - 25 Years
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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).

Key Dates

Start date
Jan 4, 2027
Status verified
Nov 2025
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Enhanced intervention
  • Active Comparator: Usual Care

Primary Outcome Measure

Recruitment feasibility as measured by percentage of eligible individuals screened [ Time Frame: end of study (1 month after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM
[email protected]
(713) 500-2002
Jennifer T Jones
[email protected]
713-500-9928

Find similar trials in Houston, TX

By condition
HIVSubstance use disorder
By specialty
Infectious diseaseBehavioral healthAddiction medicine
By research site
The University of Texas Health Science Center at Houston· Houston, TX

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