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

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ClinicalTrials.gov Identifier: NCT03930654
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mandy Hill, The University of Texas Health Science Center, Houston

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

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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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930654


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

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet 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
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Principal Investigator: Mandy J Hill, DrPH, MPH The University of Texas Health Science Center, Houston

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Responsible Party: Mandy Hill, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03930654     History of Changes
Other Study ID Numbers: HSC-MS-16-0892
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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HIV Infections
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes