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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-13

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Patients will be assigned to either an intervention or usual care

Study Groups

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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

Group Type EXPERIMENTAL

iPrEP

Intervention Type BEHAVIORAL

* 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

Intervention Type BEHAVIORAL

* 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

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

* 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes