- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03433053
Developing and Examining Evidenced-Based HIV Testing Messages
July 3, 2019 updated by: Virginia Commonwealth University
Developing Evidenced-Based Health Messages to Increase HIV Testing Among African-American Young Adult Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Participants will be exposed to a generic HIV testing message.
|
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).
|
|
Experimental: Experiment
Participants will be exposed to a targeted HIV testing message, developed specifically for African American women.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV Test Intentions
Time Frame: Three month follow up
|
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
|
Three month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Faye Belgrave, PhD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2018
Primary Completion (Actual)
June 24, 2019
Study Completion (Actual)
June 24, 2019
Study Registration Dates
First Submitted
February 7, 2018
First Submitted That Met QC Criteria
February 7, 2018
First Posted (Actual)
February 14, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- HM20009273
- 1F31MD011278-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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