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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: iPrEP; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: African American women, HIV risk, substance use, sexual risk
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; HIV Infections; Emergencies
• Other Study ID Numbers: HSC-MS-16-0892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No