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Completed

NCT Number: NCT03930654

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

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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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPrEP

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

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

Primary outcomes

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

    Time frame: 1 month

    Participants will be assessed for social norms and risk.

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

    Time frame: 3 months

    Participants will be assessed for social norms and risk.

  3. 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

  1. Number of participants with decreased high risk sex

    Time frame: 1 month

  2. Number of participants with decreased high risk sex

    Time frame: 3 months

  3. Number of participants with decreased high risk sex

    Time frame: 6 months

  4. Number of participants with decrease in substance use

    Time frame: 1 month

  5. Number of participants with decrease in substance use

    Time frame: 3 months

  6. Number of participants with decrease in substance use

    Time frame: 6 months

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

    Time frame: 1 month

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

    Time frame: 3 months

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

    Time frame: 6 months

  10. Number of participants with HIV seroconversion

    Time frame: 1 month

  11. Number of participants with HIV seroconversion

    Time frame: 3 months

  12. Number of participants with HIV seroconversion

    Time frame: 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

    Time frame: 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.

  14. iPrEP feasibility and acceptability as assessed by how much participant liked or disliked completing the survey

    Time frame: 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

  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

    Time frame: 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

  16. iPrEP feasibility and acceptability as assessed by number of participants who needed help from site staff in order to complete the survey

    Time frame: baseline

    As part of the survey, participants will be asked if they needed help from site staff in order to complete the survey.

  17. iPrEP feasibility and acceptability as assessed by the kind of help that participants needed from site staff in order to complete the survey

    Time frame: 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

  18. iPrEP feasibility and acceptability as assessed by how participants felt about the length of the survey

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: IWPrEP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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