Improving HIV Prevention and Substance Use Post-Sexual Assault Services
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-25
SponsorThe University of Texas Health Science Center, Houston
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
experienced a sexual assault within the last 72 hours
speak English
not planning to move out of the metro area during the study.
Disqualifiers
noticeably intoxicated or under the influence
are overtly having severe, untreated mental illness symptoms
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced intervention
BehavioralThe 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
BehavioralThe 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
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Enhanced interventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
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)Secondary outcomes
1
Uptake of post-assault HIV prevention as measured by self report of nPEP uptake
Time frame
1-month follow-up2
Uptake of substance use treatment as self reported as reported on the self report questionnaire
Time frame
1-month follow-up3
Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake
Time frame
1-month follow-up4
Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire
Time frame
1-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov
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