Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis

Study Overview
=================
Brief Summary
-----------------
African American (AA) women are more vulnerable to HIV infection than other women. Truvada, when used as pre-exposure prophylaxis (PrEP), is one of the most effective approaches for HIV prevention; however, PrEP use among AA women remains low and has not responded to traditional interventions. This study proposes for the first time an innovative computer-based motivational intervention, increasing PrEP uptake (iPrEP), which couples motivational messages woven into a traditional survey to raise awareness of risky sex and substance use behaviors.

Official Title
-----------------
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: iPrEP
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current HIV negative status (based on ED' HIV test outcome) Condomless sex in the last 3 months Substance use in the last 3 months HIV testing during ED visit (usual care) Has a non-emergent health condition Has a working mobile device with them Exclusion Criteria: Ineligible for PrEP (see eligibility criteria to the right) Assigned male at birth An HIV positive status Currently taking medication that are known contraindications for PrEP (brand name: Truvada) Currently on PrEP

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPrEP Intervention<br>iPrEP Intervention: Women will receive the iPrEP intervention on an iPAD Air tablet device iPrEP serves a dual role as a data collection instrument and an intervention--the survey incorporates brief, informational messages into a traditional survey instrument iPrEP uses qualitative themes iPrEP is divided into sections addressing factors with historical success at predicting pre-exposure prophylaxis (PrEP) adherence Scales chosen to measure themes and sections were retained from the original HIV Prevention Trials Network (HPTN) 073 instrument Scales were modified (in some cases) for cultural competency and tailoring to women | Behavioral: iPrEP<br>* iPrEP transforms the standard emergency department (ED) visit experience through an intervention presented as a standard assessment that is equipped to: 1) increase knowledge of HIV transmission and 2) provide information on how to reduce an individual's risk for HIV. Women will receive the iPrEP intervention on an iPAD Air tablet device iPrEP serves a dual role as a data collection instrument and an intervention--the survey incorporates brief, informational messages into a traditional survey instrument iPrEP uses qualitative themes iPrEP is divided into sections addressing factors with historical success at predicting pre-exposure prophylaxis (PrEP) adherence Scales chosen to measure themes and sections were retained from the original HIV Prevention Trials Network (HPTN) 073 instrument Scales were modified (in some cases) for cultural competency and tailoring to women<br>Behavioral: Usual Care<br>* Women will receive usual care Usual care includes an assessment visit with an emergency department (ED)-assigned social worker who specializes in substance use Social worker will offer a list of substance abuse treatment referral agencies<br>|
| Active Comparator: Usual Care<br>Control Intervention: Women will receive usual care Usual care includes an assessment visit with an emergency department (ED)-assigned social worker who specializes in substance use Social worker will offer a list of substance abuse treatment referral agencies | Behavioral: Usual Care<br>* Women will receive usual care Usual care includes an assessment visit with an emergency department (ED)-assigned social worker who specializes in substance use Social worker will offer a list of substance abuse treatment referral agencies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake | Participants will be assessed for social norms and risk. | 1 month | 
| Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake | Participants will be assessed for social norms and risk. | 3 months | 
| Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake | Participants will be assessed for social norms and risk. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with decreased high risk sex |  | 1 month | 
| Number of participants with decreased high risk sex |  | 3 months | 
| Number of participants with decreased high risk sex |  | 6 months | 
| Number of participants with decrease in substance use |  | 1 month | 
| Number of participants with decrease in substance use |  | 3 months | 
| Number of participants with decrease in substance use |  | 6 months | 
| Number of participants with a new sexually transmitted disease diagnosis |  | 1 month | 
| Number of participants with a new sexually transmitted disease diagnosis |  | 3 months | 
| Number of participants with a new sexually transmitted disease diagnosis |  | 6 months | 
| Number of participants with HIV seroconversion |  | 1 month | 
| Number of participants with HIV seroconversion |  | 3 months | 
| Number of participants with HIV seroconversion |  | 6 months | 
| iPrEP feasibility and acceptability as assessed by the number of participants who believe that they had more information to make a better decision about being in a PrEP program after completing the survey intervention | As part of the survey, participants will be asked if they believe that they had more information to make a better decision about being in a PrEP program after completing the survey intervention. | baseline | 
| iPrEP feasibility and acceptability as assessed by how much participant liked or disliked completing the survey | As part of the survey, participants will asked How much did you like or dislike completing this questionnaire? and will choose one of the following 5 categorical choices: Liked it, Liked it somewhat, Neither liked nor disliked it, Disliked it somewhat, Disliked it | baseline | 
| iPrEP feasibility and acceptability as assessed by how often participants relied on the survey questions being read aloud to be able to answer them | As part of the survey, participants will asked As you completed this questionnaire, how often did you rely on the questions being read aloud to be able to answer them? and will choose one of the following 4 categorical choices: For all the questions, For most of the questions, For some of the questions, For none of the questions | baseline | 
| iPrEP feasibility and acceptability as assessed by number of participants who needed help from site staff in order to complete the survey | As part of the survey, participants will be asked if they needed help from site staff in order to complete the survey. | baseline | 
| iPrEP feasibility and acceptability as assessed by the kind of help that participants needed from site staff in order to complete the survey | As part of the survey, participants will asked What kind of help did you need? Please check all that apply and will choose among the following categorical 4 choices: I had to have some of the questions explained to me, I needed help using the iPAD, I needed to have the questionnaire read to me by a staff member, I needed help for a different reason | baseline | 
| iPrEP feasibility and acceptability as assessed by how participants felt about the length of the survey | As part of the survey, participants will asked how they felt about the length of the survey and will choose one of the following 3 categorical choices: Too long, Too short, The right length | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
African American women, HIV risk, substance use, sexual risk