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

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT03930654
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Study Start: 2019-11-13
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake	6 months	Participants will be assessed for social norms and risk.

Secondary Outcome Measures

Name	Time	Method
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	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.
iPrEP feasibility and acceptability as assessed by how much participant liked or disliked completing the survey	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
Number of participants with decrease in substance use	6 months
Number of participants with HIV seroconversion	6 months
Number of participants with a new sexually transmitted disease diagnosis	6 months
iPrEP feasibility and acceptability as assessed by how often participants relied on the survey questions being read aloud to be able to answer them	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
iPrEP feasibility and acceptability as assessed by the kind of help that participants needed from site staff in order to complete the survey	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
Number of participants with decreased high risk sex	6 months
iPrEP feasibility and acceptability as assessed by how participants felt about the length of the survey	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
iPrEP feasibility and acceptability as assessed by number of participants who needed help from site staff in order to complete the survey	baseline	As part of the survey, participants will be asked if they needed help from site staff in order to complete the survey.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States