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Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health (CH-II)

Primary Purpose

Sexually Transmitted Diseases, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Entertainment education
video
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring prevention and control, young adults, african americans, education entertainment, condom use

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

African American young adults Aged 18-25 Living in the Birmingham USA Competent to give informed consent

Exclusion Criteria:

Obvious psychosis, dementia, inability to hear. Plan to move within the next 6 months

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

Participants viewed informational video content plus entertainment content

Participants viewed entertainment content only

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).
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).
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 6, 2020
Last Updated
April 7, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04320186
Brief Title
Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health
Acronym
CH-II
Official Title
Community Influences Transitions in Youth Health II - Center for the Study of Community Health
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2015 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, HIV Infections
Keywords
prevention and control, young adults, african americans, education entertainment, condom use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups design with approximately equal allocation, but assignment based on respondent drive sampling
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Participants viewed informational video content plus entertainment content
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants viewed entertainment content only
Intervention Type
Behavioral
Intervention Name(s)
Entertainment education
Intervention Type
Other
Intervention Name(s)
video
Intervention Description
video
Primary Outcome Measure Information:
Title
HIV Knowledge Questionnaire-18
Description
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.
Time Frame
Baseline
Title
HIV Knowledge Questionnaire-18
Description
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.
Time Frame
3 months
Title
HIV Knowledge Questionnaire-18
Description
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.
Time Frame
6 months
Title
Perceived HIV-related Stigma
Description
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).
Time Frame
Baseline
Title
Perceived HIV-related Stigma
Description
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).
Time Frame
3 months
Title
Perceived HIV-related Stigma
Description
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).
Time Frame
6 months
Title
Condom Use Self-Efficacy Scale
Description
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.
Time Frame
Baseline, 3- and 6 months
Title
Condom Use Self-Efficacy Scale
Description
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.
Time Frame
Baseline
Title
Condom Use Self-Efficacy Scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Timeline Followback
Description
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.
Time Frame
6 months
Title
HIV Testing Questionnaire
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: African American young adults Aged 18-25 Living in the Birmingham USA Competent to give informed consent Exclusion Criteria: Obvious psychosis, dementia, inability to hear. Plan to move within the next 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Davies
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33031956
Citation
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.
Results Reference
derived

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Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health

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