HIV/AIDSNCT03433053
Developing and Examining Evidenced-Based HIV Testing Messages
A study testing HIV Testing Message Intervention in people with HIV/AIDS, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The goals of this study are to: 1. 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. 2. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- HIV Testing Message Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 24 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identified Black or African American women
Who cannot join
- Women who have never had sex, are married, or are pregnant/attempting to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- HIV Testing Message Intervention, Control
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Testing Message InterventionBehavioural
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).
ControlBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will be exposed to a generic HIV testing message. Receives: Behavioral: Control |
| Experiment | Experimental | Participants will be exposed to a targeted HIV testing message, developed specifically for African American women. Receives: Behavioral: HIV Testing Message Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start24 Oct 2018
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Faye Belgrave, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433053
- Sponsor's protocol ID
- HM20009273
- Other IDs
- 1F31MD011278-01A1
- Status last verified
- Jul 2019
- First submitted
- 7 Feb 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Evidenced-Based Health Messages to Increase HIV Testing Among African-American Young Adult Women
- ClinicalTrials.gov ID
- NCT03433053
- Acronym / sponsor ID
- HM20009273
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: ControlParticipants will be exposed to a generic HIV testing message. |
| Experiment | Experimental | Behavioral: HIV Testing Message InterventionParticipants will be exposed to a targeted HIV testing message, developed specifically for African American women. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Self-identified Black or African American women
Key exclusion criteria (1 listed)
- Women who have never had sex, are married, or are pregnant/attempting to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Testing Message InterventionThe 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). | Behavioural | Experiment |
| ControlCondition 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). | Behavioural | Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faye Belgrave, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Testing Message Intervention in people with HIV/AIDS, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Test Intentions (time frame: Three month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.