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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPrEP Intervention | Experimental | iPrEP Intervention:
|
|
| Usual Care | Active Comparator | Control Intervention:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iPrEP | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women who were assigned a male sex at birth are excluded from study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Mandy J Hill, DrPH, MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36707778 | Derived | 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. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Patients will be assigned to either an intervention or usual care
|
| Usual Care | Behavioral |
|
|
| 6 months |
| Number of participants with decrease in substance use | 1 month |
| Number of participants with decrease in substance use | 3 months |
| Number of participants with decrease in substance use | 6 months |
| Number of participants with a new sexually transmitted disease diagnosis | 1 month |
| Number of participants with a new sexually transmitted disease diagnosis | 3 months |
| Number of participants with a new sexually transmitted disease diagnosis | 6 months |
| Number of participants with HIV seroconversion | 1 month |
| Number of participants with HIV seroconversion | 3 months |
| Number of participants with HIV seroconversion | 6 months |
| 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. | baseline |
| 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 | baseline |
| 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 | baseline |
| 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. | baseline |
| 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 | baseline |
| 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 | baseline |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |