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Developing and Examining Evidenced-Based HIV Testing Messages

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV Testing Message Intervention
Control
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Self-identified Black or African American women

Exclusion Criteria:

  • Women who have never had sex, are married, or are pregnant/attempting to become pregnant

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Experiment

Arm Description

Participants will be exposed to a generic HIV testing message.

Participants will be exposed to a targeted HIV testing message, developed specifically for African American women.

Outcomes

Primary Outcome Measures

HIV Test Intentions
Difference in future HIV test intentions between the tailored message group and the control group as measured by a follow up questionnaire, with higher scores indicating greater intention to be tested for HIV

Secondary Outcome Measures

Full Information

First Posted
February 7, 2018
Last Updated
July 3, 2019
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03433053
Brief Title
Developing and Examining Evidenced-Based HIV Testing Messages
Official Title
Developing Evidenced-Based Health Messages to Increase HIV Testing Among African-American Young Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goals of this study are to: Develop a HIV test message tailored for African American women. A generic non-tailored message will be developed as well for comparison. A third group will be included that will not be exposed to any message at all. Test the effectiveness of both messages on reported future intentions to get tested for HIV and HIV test behavior at 3 month follow up.
Detailed Description
African American women have the highest risk and prevalence of HIV infection among women of all racial/ethnic groups in the United States. Many of the current HIV infections among young adult African American women remain undiagnosed. The established benefits of routine HIV testing, the limitations of safer sex programs, and the gap of research related to increasing HIV testing as prevention necessitates the need for future research that specifically targets mechanisms to increase HIV testing. Higher rates of HIV testing can decrease rates of HIV transmission, as individuals who are knowledgeable of their status are less likely to transmit the virus. The current literature is sparse on factors related to HIV testing among young adults and has largely only examined demographic and sexual behavior correlates of HIV testing. Additionally, no studies have developed evidence-based health messages to promote HIV testing specifically among African American young women, despite their high risk of HIV infection and the importance of HIV testing. Thus, the proposed study will intend to identify factors related to HIV testing beyond the demographic and sexual risk level through formative research. These identified factors will be included as important elements in the development of HIV testing messages to motivate increased HIV testing. An enhanced message (culturally tailored) and a knowledge only message will be developed and tested.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants will be exposed to a generic HIV testing message.
Arm Title
Experiment
Arm Type
Experimental
Arm Description
Participants will be exposed to a targeted HIV testing message, developed specifically for African American women.
Intervention Type
Behavioral
Intervention Name(s)
HIV Testing Message Intervention
Intervention Description
The Health Belief Model will be utilized as the primary theoretical framework in guiding the development of a tailored HIV testing message for young African American women in this intervention. Two conditions will be developed and compared as outlined below. Condition 1 participants will be exposed to an HIV testing message inclusive of culturally tailored information that addresses both culturally specific barriers and facilitators of HIV testing (as identified in Study 1). The message will be brief (will take less than 3 minutes to present/read).
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Condition 2 (generic message) participants will be exposed to a simple HIV educational message only, consisting of HIV statistics for women in the United States, information on how HIV is transmitted, where to get tested, and the benefits of HIV testing. The statistics on HIV and where to get tested will be taken directly from the CDC's website. The message will be brief (will take less than 3 minutes to present/read).
Primary Outcome Measure Information:
Title
HIV Test Intentions
Description
Difference in future HIV test intentions between the tailored message group and the control group as measured by a follow up questionnaire, with higher scores indicating greater intention to be tested for HIV
Time Frame
Three month follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Self-identified Black or African American women Exclusion Criteria: Women who have never had sex, are married, or are pregnant/attempting to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faye Belgrave, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Developing and Examining Evidenced-Based HIV Testing Messages

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