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

HIV Infections Clinical Trial

— IWPrEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930654
• Other study ID #: HSC-MS-16-0892
• Status: Completed
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• HIV Infections

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake	Participants will be assessed for social norms and risk.	1 month
Primary	Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake	Participants will be assessed for social norms and risk.	3 months
Primary	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	Number of participants with decreased high risk sex		1 month
Secondary	Number of participants with decreased high risk sex		3 months
Secondary	Number of participants with decreased high risk sex		6 months
Secondary	Number of participants with decrease in substance use		1 month
Secondary	Number of participants with decrease in substance use		3 months
Secondary	Number of participants with decrease in substance use		6 months
Secondary	Number of participants with a new sexually transmitted disease diagnosis		1 month
Secondary	Number of participants with a new sexually transmitted disease diagnosis		3 months
Secondary	Number of participants with a new sexually transmitted disease diagnosis		6 months
Secondary	Number of participants with HIV seroconversion		1 month
Secondary	Number of participants with HIV seroconversion		3 months
Secondary	Number of participants with HIV seroconversion		6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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