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

NCT04320186 | Completed DMC

• 1 other identifier: 150219009
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexually Transmitted Diseases; HIV Infections

Keywords

prevention and control; young adults; african americans; education entertainment; condom use

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Timeline Followback

  6 months

• HIV Testing Questionnaire

  6 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Participants viewed informational video content plus entertainment content

Behavioral: Entertainment education; Other: video

Control

PLACEBO COMPARATOR

Participants viewed entertainment content only

Behavioral: Entertainment education

Interventions

Entertainment education BEHAVIORAL

Control; Treatment

video OTHER

video

Treatment

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0022, United States

Location

Related Publications (1)

• 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.

  PMID: 33031956 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; HIV Infections

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Susan L Davies

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: two groups design with approximately equal allocation, but assignment based on respondent drive sampling

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 24, 2020
• Study Start: April 3, 2015
• Primary Completion: June 1, 2019
• Study Completion: December 31, 2020
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)