Clinical trial NCT03930654: Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
Official title: Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: African American women, HIV risk, substance use, sexual risk
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
timeFrame: 1 month
measure: Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
timeFrame: 3 months
measure: Number of participants with an increased willingness for pre-exposure prophylaxis (PrEP) uptake
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with decreased high risk sex
timeFrame: 1 month
measure: Number of participants with decreased high risk sex
timeFrame: 3 months
measure: Number of participants with decreased high risk sex
timeFrame: 6 months
measure: Number of participants with decrease in substance use
timeFrame: 1 month
measure: Number of participants with decrease in substance use
timeFrame: 3 months
measure: Number of participants with decrease in substance use
timeFrame: 6 months
measure: Number of participants with a new sexually transmitted disease diagnosis
timeFrame: 1 month
measure: Number of participants with a new sexually transmitted disease diagnosis
timeFrame: 3 months
measure: Number of participants with a new sexually transmitted disease diagnosis
timeFrame: 6 months
measure: Number of participants with HIV seroconversion
timeFrame: 1 month
measure: Number of participants with HIV seroconversion
timeFrame: 3 months
measure: Number of participants with HIV seroconversion
timeFrame: 6 months
measure: 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
timeFrame: baseline
measure: iPrEP feasibility and acceptability as assessed by how much participant liked or disliked completing the survey
timeFrame: baseline
measure: iPrEP feasibility and acceptability as assessed by how often participants relied on the survey questions being read aloud to be able to answer them
timeFrame: baseline
measure: iPrEP feasibility and acceptability as assessed by number of participants who needed help from site staff in order to complete the survey
timeFrame: baseline
measure: iPrEP feasibility and acceptability as assessed by the kind of help that participants needed from site staff in order to complete the survey
timeFrame: baseline
measure: iPrEP feasibility and acceptability as assessed by how participants felt about the length of the survey
timeFrame: baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mandy J Hill, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: