NCT03930654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

April 16, 2019

Last Update Submit

August 16, 2022

Conditions

HIV Infections

Keywords

African American women, HIV risk, substance use, sexual risk

Outcome Measures

Primary Outcomes (3)

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

    Participants will be assessed for social norms and risk.

    1 month

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

    Participants will be assessed for social norms and risk.

    3 months

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

    Participants will be assessed for social norms and risk.

    6 months

Secondary Outcomes (18)

  • Number of participants with decreased high risk sex

    1 month

  • Number of participants with decreased high risk sex

    3 months

  • Number of participants with decreased high risk sex

    6 months

  • Number of participants with decrease in substance use

    1 month

  • Number of participants with decrease in substance use

    3 months

  • +13 more secondary outcomes

Study Arms (2)

iPrEP Intervention

EXPERIMENTAL

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

Behavioral: iPrEPBehavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

iPrEPBEHAVIORAL

* 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

iPrEP Intervention
Usual CareBEHAVIORAL

* 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 CareiPrEP Intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who were assigned a male sex at birth are excluded from study participation.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 36707778DERIVED

MeSH Terms

Conditions

HIV InfectionsSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental Disorders

Study Officials

  • Mandy J Hill, DrPH, MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will be assigned to either an intervention or usual care
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 29, 2019

Study Start

November 13, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)