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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced intervention | Experimental |
| |
| Usual Care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment feasibility as measured by percentage of eligible individuals screened | end of study (1 month after baseline) | |
| Recruitment feasibility as measured by percentage of eligible individuals enrolled | end of study (1 month after baseline) | |
| Recruitment feasibility as measured by time delay from screening to enrollment | end of study (1 month after baseline) | |
| Recruitment feasibility as measured by time to enroll sufficient sample size | end of study (1 month after baseline) | |
| Recruitment feasibility as measured by percentage loss to exclusion criteria. | end of study (1 month after baseline) | |
| Randomization strategies as measured by proportion randomized to intervention and control | end of study (1 month after baseline) | |
| Retention as measured by the number of participants that completed the one month follow-up survey | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of post-assault HIV prevention as measured by self report of nPEP uptake | 1-month follow-up | |
| Uptake of substance use treatment as self reported as reported on the self report questionnaire | 1-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM | Contact | (713) 500-2002 | Diane.M.SantaMaria@uth.tmc.edu | |
| Jennifer T Jones | Contact | 713-500-9928 | Jennifer.D.Torres@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Data collectors will be blinded
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| 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 |
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| end of study (1 month after baseline) |
| Adherence to intervention as measured by percentage of content completed in the fidelity checklist | end of study (1 month after baseline) |
| Acceptability as measured by percentage of data loss | 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. | 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. | end of study (1 month after baseline) |
| Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake | 1-month follow-up |
| Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire | 1-month follow-up |
| Adherence of substance use treatment as reported on the self report questionnaire | 1-month follow-up |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |