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

• ClinicalTrials.gov Identifier: NCT03930654
• Recruitment Status: Recruiting
• First Posted: April 29, 2019
• Last Update Posted: November 4, 2020
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Mandy Hill, The University of Texas Health Science Center, Houston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Behavioral: iPrEP; Behavioral: Usual Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Patients will be assigned to either an intervention or usual care
• Primary Purpose: Prevention
• Official Title: Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
• Actual Study Start Date: November 13, 2019
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: iPrEP Intervention; 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; 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; Behavioral: Usual Care; 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
Active Comparator: Usual Care; 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; 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Number of participants with decreased high risk sex [ Time Frame: 1 month ]
2. Number of participants with decreased high risk sex [ Time Frame: 3 months ]
3. Number of participants with decreased high risk sex [ Time Frame: 6 months ]
4. Number of participants with decrease in substance use [ Time Frame: 1 month ]
5. Number of participants with decrease in substance use [ Time Frame: 3 months ]
6. Number of participants with decrease in substance use [ Time Frame: 6 months ]
7. Number of participants with a new sexually transmitted disease diagnosis [ Time Frame: 1 month ]
8. Number of participants with a new sexually transmitted disease diagnosis [ Time Frame: 3 months ]
9. Number of participants with a new sexually transmitted disease diagnosis [ Time Frame: 6 months ]
10. Number of participants with HIV seroconversion [ Time Frame: 1 month ]
11. Number of participants with HIV seroconversion [ Time Frame: 3 months ]
12. Number of participants with HIV seroconversion [ Time Frame: 6 months ]
13. 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 [ Time Frame: baseline ]
    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.
14. iPrEP feasibility and acceptability as assessed by how much participant liked or disliked completing the survey [ Time Frame: baseline ]
    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
15. iPrEP feasibility and acceptability as assessed by how often participants relied on the survey questions being read aloud to be able to answer them [ Time Frame: baseline ]
    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
16. iPrEP feasibility and acceptability as assessed by number of participants who needed help from site staff in order to complete the survey [ Time Frame: baseline ]
    As part of the survey, participants will be asked if they needed help from site staff in order to complete the survey.
17. iPrEP feasibility and acceptability as assessed by the kind of help that participants needed from site staff in order to complete the survey [ Time Frame: baseline ]
    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
18. iPrEP feasibility and acceptability as assessed by how participants felt about the length of the survey [ Time Frame: baseline ]
    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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women who were assigned a male sex at birth are excluded from study participation.
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Mandy J Hill, DrPH, MPH; 713-500-7661; mandy.j.hill@uth.tmc.edu

Locations

United States, Texas

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Contact: Mandy J Hill, DrPH, MPH 713-500-7661 mandy.j.hill@uth.tmc.edu

Principal Investigator: Mandy Hill, DrPH, MPH

Sub-Investigator: Angela Heads, PhD

Sub-Investigator: Angela Stotts, PhD

Sub-Investigator: Charles Green, PhD

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Mandy J Hill, DrPH, MPH; The University of Texas Health Science Center, Houston

More Information

• Responsible Party: Mandy Hill, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03930654
• Other Study ID Numbers: HSC-MS-16-0892
• First Posted: April 29, 2019
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mandy Hill, The University of Texas Health Science Center, Houston:

African American women, HIV risk, substance use, sexual risk

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes