AzTrials
AzTrials

HIV InfectionsIWPrEPNCT03930654

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

A study testing iPrEP in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
iPrEP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
13 Nov 2019to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

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
Being tested
iPrEP, Usual Care
Keywords
African American women, HIV risk, substance use, sexual risk
Medical subject headings
HIV Infections, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iPrEPBehavioural

    • 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 CareBehavioural

    • 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
Study groups in NCT03930654
Study groupRoleWhat they receive
iPrEP InterventionExperimentaliPrEP 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
Receives: Behavioral: iPrEP; Behavioral: Usual Care
Usual CareActive comparatorControl 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
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake

    Participants will be assessed for social norms and risk.

    Measured: 1 month

  2. Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake

    Participants will be assessed for social norms and risk.

    Measured: 3 months

  3. Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake

    Participants will be assessed for social norms and risk.

    Measured: 6 months

Secondary outcomes (18)

  1. Number of participants with decreased high risk sex

    Measured: 1 month

  2. Number of participants with decreased high risk sex

    Measured: 3 months

  3. Number of participants with decreased high risk sex

    Measured: 6 months

  4. Number of participants with decrease in substance use

    Measured: 1 month

  5. Number of participants with decrease in substance use

    Measured: 3 months

  6. Number of participants with decrease in substance use

    Measured: 6 months

  7. Number of participants with a new sexually transmitted disease diagnosis

    Measured: 1 month

  8. Number of participants with a new sexually transmitted disease diagnosis

    Measured: 3 months

  9. Number of participants with a new sexually transmitted disease diagnosis

    Measured: 6 months

  10. Number of participants with HIV seroconversion

    Measured: 1 month

  11. Number of participants with HIV seroconversion

    Measured: 3 months

  12. Number of participants with HIV seroconversion

    Measured: 6 months

  13. 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.

    Measured: baseline

  14. 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

    Measured: baseline

  15. 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

    Measured: baseline

  16. 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.

    Measured: baseline

  17. 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

    Measured: baseline

  18. 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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study start13 Nov 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03930654
Sponsor's protocol ID
HSC-MS-16-0892
Acronym
IWPrEP
Status last verified
Aug 2022
First submitted
16 Apr 2019
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hill MJ, Heads AM, Suchting R, Stotts AL. A survey with interventional components delivered on tablet devices versus usual care to increase pre-exposure prophylaxis uptake among cisgender Black women: a pilot randomized controlled trial. BMC Infect Dis. 2023 Jan 27;23(1):57. doi: 10.1186/s12879-023-08019-z.

    PubMed 36707778

Questions about this trial

What is this clinical trial studying?

A study testing iPrEP in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03930654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in