HIV InfectionsNCT07225062
Improving HIV Prevention and Substance Use Post-Sexual Assault Services
A study testing Enhanced intervention in people with HIV Infections and Substance Use, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- HIV Infections, Substance Use, Sexual Assault
- What is being tested?
- Enhanced intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- experienced a sexual assault within the last 72 hours
- speak English
- not planning to move out of the metro area during the study.
Who cannot join
- noticeably intoxicated or under the influence
- are overtly having severe, untreated mental illness symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM contact
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM, (713) 500-2002, Diane.M.SantaMaria@uth.tmc.edu
Jennifer T Jones, 713-500-9928, Jennifer.D.Torres@uth.tmc.edu
About this study
Official title: 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).
- Conditions
- HIV Infections, Substance Use, Sexual Assault
- Being tested
- Enhanced intervention, Usual Care
- Medical subject headings
- HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced interventionBehavioural
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 CareBehavioural
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 group | Role | What they receive |
|---|---|---|
| Enhanced intervention | Experimental | Not described Receives: Behavioral: Enhanced intervention |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility as measured by percentage of eligible individuals screened
Measured: end of study (1 month after baseline)
Recruitment feasibility as measured by percentage of eligible individuals enrolled
Measured: end of study (1 month after baseline)
Recruitment feasibility as measured by time delay from screening to enrollment
Measured: end of study (1 month after baseline)
Recruitment feasibility as measured by time to enroll sufficient sample size
Measured: end of study (1 month after baseline)
Recruitment feasibility as measured by percentage loss to exclusion criteria.
Measured: end of study (1 month after baseline)
Randomization strategies as measured by proportion randomized to intervention and control
Measured: end of study (1 month after baseline)
Retention as measured by the number of participants that completed the one month follow-up survey
Measured: 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
Measured: 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
Measured: end of study (1 month after baseline)
Adherence to intervention as measured by percentage of content completed in the fidelity checklist
Measured: end of study (1 month after baseline)
Acceptability as measured by percentage of data loss
Measured: 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.
Measured: 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.
Measured: end of study (1 month after baseline)
Secondary outcomes (5)
Uptake of post-assault HIV prevention as measured by self report of nPEP uptake
Measured: 1-month follow-up
Uptake of substance use treatment as self reported as reported on the self report questionnaire
Measured: 1-month follow-up
Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake
Measured: 1-month follow-up
Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire
Measured: 1-month follow-up
Adherence of substance use treatment as reported on the self report questionnaire
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start4 Jan 2027 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Diane Santa Maria, The University of Texas Health Science Center, Houston
- Investigators
- Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225062
- Sponsor's protocol ID
- HSC-SN-25-0423
- Status last verified
- Nov 2025
- First submitted
- 3 Nov 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HIV Prevention and Substance Use Post-Sexual Assault Services for Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT07225062
- Acronym / sponsor ID
- HSC-SN-25-0423
- Conditions
- HIV Infections, Substance Use, Sexual Assault
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced intervention | Experimental | Behavioral: Enhanced intervention |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- experienced a sexual assault within the last 72 hours
- speak English
- not planning to move out of the metro area during the study.
Key exclusion criteria (2 listed)
- noticeably intoxicated or under the influence
- are overtly having severe, untreated mental illness symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced interventionThe 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. | Behavioural | Enhanced intervention |
| Usual CareThe 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 | Behavioural | Usual Care |
Primary outcome
Recruitment feasibility as measured by percentage of eligible individuals screened
Time frame: 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)
Recruitment feasibility as measured by time delay from screening to enrollment
Time frame: 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)
Recruitment feasibility as measured by percentage loss to exclusion criteria.
Time frame: 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)
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)
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)
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)
Adherence to intervention as measured by percentage of content completed in the fidelity checklist
Time frame: end of study (1 month after baseline)
Acceptability as measured by percentage of data loss
Time frame: 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.
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.
5 secondary outcomes
Uptake of post-assault HIV prevention as measured by self report of nPEP uptake
Time frame: 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
Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake
Time frame: 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
Adherence of substance use treatment as reported on the self report questionnaire
Time frame: 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM contact
Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced intervention in people with HIV Infections and Substance Use, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM ((713) 500-2002, Diane.M.SantaMaria@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility as measured by percentage of eligible individuals screened (time frame: end of study (1 month after baseline)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.