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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPrEP
Usual Care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring African American women, HIV risk, substance use, sexual risk

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iPrEP Intervention

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
Participants will be assessed for social norms and risk.
Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
Participants will be assessed for social norms and risk.
Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
Participants will be assessed for social norms and risk.

Secondary Outcome Measures

Number of participants with decreased high risk sex
Number of participants with decreased high risk sex
Number of participants with decreased high risk sex
Number of participants with decrease in substance use
Number of participants with decrease in substance use
Number of participants with decrease in substance use
Number of participants with a new sexually transmitted disease diagnosis
Number of participants with a new sexually transmitted disease diagnosis
Number of participants with a new sexually transmitted disease diagnosis
Number of participants with HIV seroconversion
Number of participants with HIV seroconversion
Number of participants with HIV seroconversion
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.
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
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
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.
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
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

Full Information

First Posted
April 16, 2019
Last Updated
August 16, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03930654
Brief Title
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
Acronym
IWPrEP
Official Title
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
African American women, HIV risk, substance use, sexual risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients will be assigned to either an intervention or usual care
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iPrEP Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
iPrEP
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
Description
Participants will be assessed for social norms and risk.
Time Frame
1 month
Title
Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
Description
Participants will be assessed for social norms and risk.
Time Frame
3 months
Title
Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
Description
Participants will be assessed for social norms and risk.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with decreased high risk sex
Time Frame
1 month
Title
Number of participants with decreased high risk sex
Time Frame
3 months
Title
Number of participants with decreased high risk sex
Time Frame
6 months
Title
Number of participants with decrease in substance use
Time Frame
1 month
Title
Number of participants with decrease in substance use
Time Frame
3 months
Title
Number of participants with decrease in substance use
Time Frame
6 months
Title
Number of participants with a new sexually transmitted disease diagnosis
Time Frame
1 month
Title
Number of participants with a new sexually transmitted disease diagnosis
Time Frame
3 months
Title
Number of participants with a new sexually transmitted disease diagnosis
Time Frame
6 months
Title
Number of participants with HIV seroconversion
Time Frame
1 month
Title
Number of participants with HIV seroconversion
Time Frame
3 months
Title
Number of participants with HIV seroconversion
Time Frame
6 months
Title
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
Description
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.
Time Frame
baseline
Title
iPrEP feasibility and acceptability as assessed by how much participant liked or disliked completing the survey
Description
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
Time Frame
baseline
Title
iPrEP feasibility and acceptability as assessed by how often participants relied on the survey questions being read aloud to be able to answer them
Description
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
Time Frame
baseline
Title
iPrEP feasibility and acceptability as assessed by number of participants who needed help from site staff in order to complete the survey
Description
As part of the survey, participants will be asked if they needed help from site staff in order to complete the survey.
Time Frame
baseline
Title
iPrEP feasibility and acceptability as assessed by the kind of help that participants needed from site staff in order to complete the survey
Description
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
Time Frame
baseline
Title
iPrEP feasibility and acceptability as assessed by how participants felt about the length of the survey
Description
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
Time Frame
baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who were assigned a male sex at birth are excluded from study participation.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandy J Hill, DrPH, MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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