Sexually Transmitted DiseasesCH-IINCT04320186
Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health
A study testing Entertainment education and video in people with Sexually Transmitted Diseases and HIV Infections, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this protocol is to develop and evaluate an HIV prevention Entertainment Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged 18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, HIV Infections
- What is being tested?
- Entertainment education and video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2015to 31 Dec 2020
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- African American young adults Aged 18-25 Living in the Birmingham USA Competent to give informed consent
Who cannot join
- Obvious psychosis, dementia, inability to hear. Plan to move within the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0022
About this study
Official title: Community Influences Transitions in Youth Health II - Center for the Study of Community Health
The purpose of this protocol is to develop and evaluate an HIV prevention Entertainment Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged 18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area.
Read the detailed description
The goal of this 5 year project is to promote HIV testing and improve HIV-related risk behaviors (e.g. condom use, substance use before sex, regular Sexually Transmitted Infection (STI) testing) via population-sensitive and population-specific HIV prevention videos that are appealing, evidence-based, scalable, and sustainable to the target population. Formative research was conducted in Phase I (Year 1-2), to pre-test the questionnaire and gather in-depth data (via focus groups, intercept interviews, and individual structured interviews) to inform intervention development. Phase 2 of the project involved developing, delivering, and subsequently evaluating the efficacy of peer-driven EE HIV prevention messaging to broader social networks via a social media platform, with the platform contingent on formative data. An HIV education video series, "The Beat HIVe", was produced and served as intervention materials for the quasi-experimental research project. Respondent Driven Sampling (RDS) was used to access and use the social networks of high-risk youths as channel and agents for change. RDS is a recent innovative adaptation of chain-referral network sampling that provides peer-driven access to hard-to-reach subpopulations while reducing sampling biases associated with conventional snowball sampling.
- Conditions
- Sexually Transmitted Diseases, HIV Infections
- Being tested
- Entertainment education, video
- Keywords
- prevention and control, young adults, african americans, education entertainment, condom use
- Medical subject headings
- Sexually Transmitted Diseases, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entertainment educationBehavioural
videoOther
video
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Participants viewed informational video content plus entertainment content Receives: Behavioral: Entertainment education; Other: video |
| Control | Placebo comparator | Participants viewed entertainment content only Receives: Behavioral: Entertainment education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Knowledge Questionnaire-18
This scale assess an individual level of HIV-related knowledge. For each of the 18 true/false, HIV- related questions, a score of 1 was assigned to each 'correct' answer. Assessments were based on the analysis of the summation of these scores, which had a possible range of 0 to 18, whereby higher scores indicated greater knowledge of HIV.
Measured: Baseline
HIV Knowledge Questionnaire-18
This scale assess an individual level of HIV-related knowledge. For each of the 18 true/false, HIV- related questions, a score of 1 was assigned to each 'correct' answer. Assessments were based on the analysis of the summation of these scores, which had a possible range of 0 to 18, whereby higher scores indicated greater knowledge of HIV.
Measured: 3 months
HIV Knowledge Questionnaire-18
This scale assess an individual level of HIV-related knowledge. For each of the 18 true/false, HIV- related questions, a score of 1 was assigned to each 'correct' answer. Assessments were based on the analysis of the summation of these scores, which had a possible range of 0 to 18, whereby higher scores indicated greater knowledge of HIV.
Measured: 6 months
Perceived HIV-related Stigma
The scores are scaled in the positive direction implying that the higher the score, the higher the level of stigma. The possible overall stigma score ranges from 40 to 160, low-level stigma is between 25th percentile and 50th percentile (40-80), middle-level stigma is between 50th percentile and 75th percentile (81-120), while high-level stigma is for values greater than 75th percentile (121-160).
Measured: Baseline
Perceived HIV-related Stigma
The scores are scaled in the positive direction implying that the higher the score, the higher the level of stigma. The possible overall stigma score ranges from 40 to 160, low-level stigma is between 25th percentile and 50th percentile (40-80), middle-level stigma is between 50th percentile and 75th percentile (81-120), while high-level stigma is for values greater than 75th percentile (121-160).
Measured: 3 months
Perceived HIV-related Stigma
The scores are scaled in the positive direction implying that the higher the score, the higher the level of stigma. The possible overall stigma score ranges from 40 to 160, low-level stigma is between 25th percentile and 50th percentile (40-80), middle-level stigma is between 50th percentile and 75th percentile (81-120), while high-level stigma is for values greater than 75th percentile (121-160).
Measured: 6 months
Condom Use Self-Efficacy Scale
This is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. After reversing for negatively worded items, scores are summed. The possible range of scores is 0-112, with higher scores indicating greater condom use self-efficacy.
Measured: Baseline, 3- and 6 months
Condom Use Self-Efficacy Scale
This is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. After reversing for negatively worded items, scores are summed. The possible range of scores is 0-112, with higher scores indicating greater condom use self-efficacy.
Measured: Baseline
Condom Use Self-Efficacy Scale
This is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. After reversing for negatively worded items, scores are summed. The possible range of scores is 0-112, with higher scores indicating greater condom use self-efficacy.
Measured: 3 months
Secondary outcomes (2)
Timeline Followback
Assesses sexual activity over the previous 90-days. The baseline assessment collected sexual risk behavior data for the 3 months prior to enrolling in the study; the 3-month data collection visit examined participant's sexual risk behavior in the 90 days since their baseline visit; and their 6-month data collection visit used TLFB to record sexual risk behavior since their last visit. Following each interview, TLFB data are coded in accordance with a discrete coding algorithm that allows the research team to summarize all of this information directly on the daily blocks on the calendar.
Measured: 6 months
HIV Testing Questionnaire
HIV testing uptake-after initial education. Participants were asked if they wanted to take a free and optional HIV test. If the participant declined they were asked additional 6 questions about their reason for declining. If they accepted the HIV test, they were asked additional 20 questions regarding how often they tested, knowledge of testing resources, sexual practices, and reason for accepting a test. This questionnaire was developed by study staff and is not scored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start3 Apr 2015
- Primary completion1 Jun 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups design with approximately equal allocation, but assignment based on respondent drive sampling
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Susan Davies, University of Alabama at Birmingham
- Investigators
- Susan L Davies, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320186
- Sponsor's protocol ID
- 150219009
- Acronym
- CH-II
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2020
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davies SL, Smith TL, Murphy B, Crawford MS, Kaiser KA, Clay OJ. CITY Health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the Beat HIVe project. Contemp Clin Trials. 2020 Dec;99:106167. doi: 10.1016/j.cct.2020.106167. Epub 2020 Oct 5.
PubMed 33031956
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Influences Transitions in Youth Health II - Center for the Study of Community Health
- ClinicalTrials.gov ID
- NCT04320186
- Acronym / sponsor ID
- CH-II / 150219009
- Conditions
- Sexually Transmitted Diseases, HIV Infections
- Keywords
- prevention and control, young adults, african americans, education entertainment, condom use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 3 Apr 2015 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Mar 2020 (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 purpose of this protocol is to develop and evaluate an HIV prevention Entertainment Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged 18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area.
Detailed description
The goal of this 5 year project is to promote HIV testing and improve HIV-related risk behaviors (e.g. condom use, substance use before sex, regular Sexually Transmitted Infection (STI) testing) via population-sensitive and population-specific HIV prevention videos that are appealing, evidence-based, scalable, and sustainable to the target population. Formative research was conducted in Phase I (Year 1-2), to pre-test the questionnaire and gather in-depth data (via focus groups, intercept interviews, and individual structured interviews) to inform intervention development. Phase 2 of the project involved developing, delivering, and subsequently evaluating the efficacy of peer-driven EE HIV prevention messaging to broader social networks via a social media platform, with the platform contingent on formative data. An HIV education video series, "The Beat HIVe", was produced and served as intervention materials for the quasi-experimental research project. Respondent Driven Sampling (RDS) was used to access and use the social networks of high-risk youths as channel and agents for change. RDS is a recent innovative adaptation of chain-referral network sampling that provides peer-driven access to hard-to-reach subpopulations while reducing sampling biases associated with conventional snowball sampling.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups design with approximately equal allocation, but assignment based on respondent drive sampling
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Behavioral: Entertainment education, Other: videoParticipants viewed informational video content plus entertainment content |
| Control | Placebo comparator | Behavioral: Entertainment educationParticipants viewed entertainment content only |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- African American young adults Aged 18-25 Living in the Birmingham USA Competent to give informed consent
Key exclusion criteria (1 listed)
- Obvious psychosis, dementia, inability to hear. Plan to move within the next 6 months
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 |
|---|---|---|
| Entertainment education | Behavioural | Control, Treatment |
| videovideo | Other | Treatment |
Primary outcome
HIV Knowledge Questionnaire-18
Time frame: Baseline
This scale assess an individual level of HIV-related knowledge. For each of the 18 true/false, HIV- related questions, a score of 1 was assigned to each 'correct' answer. Assessments were based on the analysis of the summation of these scores, which had a possible range of 0 to 18, whereby higher scores indicated greater knowledge of HIV.
HIV Knowledge Questionnaire-18
Time frame: 3 months
This scale assess an individual level of HIV-related knowledge. For each of the 18 true/false, HIV- related questions, a score of 1 was assigned to each 'correct' answer. Assessments were based on the analysis of the summation of these scores, which had a possible range of 0 to 18, whereby higher scores indicated greater knowledge of HIV.
HIV Knowledge Questionnaire-18
Time frame: 6 months
This scale assess an individual level of HIV-related knowledge. For each of the 18 true/false, HIV- related questions, a score of 1 was assigned to each 'correct' answer. Assessments were based on the analysis of the summation of these scores, which had a possible range of 0 to 18, whereby higher scores indicated greater knowledge of HIV.
Perceived HIV-related Stigma
Time frame: Baseline
The scores are scaled in the positive direction implying that the higher the score, the higher the level of stigma. The possible overall stigma score ranges from 40 to 160, low-level stigma is between 25th percentile and 50th percentile (40-80), middle-level stigma is between 50th percentile and 75th percentile (81-120), while high-level stigma is for values greater than 75th percentile (121-160).
Perceived HIV-related Stigma
Time frame: 3 months
The scores are scaled in the positive direction implying that the higher the score, the higher the level of stigma. The possible overall stigma score ranges from 40 to 160, low-level stigma is between 25th percentile and 50th percentile (40-80), middle-level stigma is between 50th percentile and 75th percentile (81-120), while high-level stigma is for values greater than 75th percentile (121-160).
Perceived HIV-related Stigma
Time frame: 6 months
The scores are scaled in the positive direction implying that the higher the score, the higher the level of stigma. The possible overall stigma score ranges from 40 to 160, low-level stigma is between 25th percentile and 50th percentile (40-80), middle-level stigma is between 50th percentile and 75th percentile (81-120), while high-level stigma is for values greater than 75th percentile (121-160).
Condom Use Self-Efficacy Scale
Time frame: Baseline, 3- and 6 months
This is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. After reversing for negatively worded items, scores are summed. The possible range of scores is 0-112, with higher scores indicating greater condom use self-efficacy.
Condom Use Self-Efficacy Scale
Time frame: Baseline
This is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. After reversing for negatively worded items, scores are summed. The possible range of scores is 0-112, with higher scores indicating greater condom use self-efficacy.
Condom Use Self-Efficacy Scale
Time frame: 3 months
This is a 28 item self-report questionnaire which elicits responses using a five-point Likert scale format, ranging from 'strongly disagree' to 'strongly agree'. Each of the responses is scored as follows: 'strongly disagree' = 0, 'disagree' = 1, 'undecided' = 2, 'agree' = 3 and 'strongly agree' = 4. After reversing for negatively worded items, scores are summed. The possible range of scores is 0-112, with higher scores indicating greater condom use self-efficacy.
2 secondary outcomes
Timeline Followback
Time frame: 6 months
HIV Testing Questionnaire
Time frame: 6 months
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 10 Apr 2023.
- Derived from this study: PubMed 33031956Davies SL, Smith TL, Murphy B, Crawford MS, Kaiser KA, Clay OJ. CITY Health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the Beat HIVe project. Contemp Clin Trials. 2020 Dec;99:106167. doi: 10.1016/j.cct.2020.106167. Epub 2020 Oct 5.
- Individual participant dataSharing planned: No
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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.
Susan L Davies principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entertainment education and video in people with Sexually Transmitted Diseases and HIV Infections, run by University of Alabama at Birmingham 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 10 Apr 2023. 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 Knowledge Questionnaire-18 (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320186, which also lists 1 linked publication.
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 10 Apr 2023.