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

NCT03930654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-08-18

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Mandy J Hill, DrPH, MPH · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03930654 on ClinicalTrials.gov