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

HIV Infections Clinical Trial

— CH-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320186
• Other study ID #: 150219009
• Status: Completed
• Phase: N/A
• Start date: April 3, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Entertainment education

Other:
• video
video

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	3 months
Primary	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.	6 months
Primary	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).	Baseline
Primary	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).	3 months
Primary	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).	6 months
Primary	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.	Baseline, 3- and 6 months
Primary	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.	Baseline
Primary	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.	3 months
Secondary	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.	6 months
Secondary	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.	6 months