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

The University of Texas Health Science Center, Houston1 site in 1 country40 target enrollmentNovember 13, 2019

ConditionsHIV Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infections
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 40
Locations: 1
Primary Endpoint: Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 13, 2019

End Date

December 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Mandy Hill

Associate Professor

The University of Texas Health Science Center, Houston

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

Outcomes

Primary Outcomes

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 Outcomes

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)
iPrEP feasibility and acceptability as assessed by how much participant liked or disliked completing the survey(baseline)
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)
iPrEP feasibility and acceptability as assessed by the kind of help that participants needed from site staff in order to complete the survey(baseline)
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)
iPrEP feasibility and acceptability as assessed by number of participants who needed help from site staff in order to complete the survey(baseline)