Clinical trial NCT04320186: Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health
Official title: Community Influences Transitions in Youth Health II - Center for the Study of Community Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
HIV Infections
Keywords: prevention and control
young adults
african americans
education entertainment
condom use
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-03-24
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups design with approximately equal allocation, but assignment based on respondent drive sampling
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: HIV Knowledge Questionnaire-18
timeFrame: Baseline
measure: HIV Knowledge Questionnaire-18
timeFrame: 3 months
measure: HIV Knowledge Questionnaire-18
timeFrame: 6 months
measure: Perceived HIV-related Stigma
timeFrame: Baseline
measure: Perceived HIV-related Stigma
timeFrame: 3 months
measure: Perceived HIV-related Stigma
timeFrame: 6 months
measure: Condom Use Self-Efficacy Scale
timeFrame: Baseline, 3- and 6 months
measure: Condom Use Self-Efficacy Scale
timeFrame: Baseline
measure: Condom Use Self-Efficacy Scale
timeFrame: 3 months
Secondary outcomes:
measure: Timeline Followback
timeFrame: 6 months
measure: HIV Testing Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Susan L Davies
role: PRINCIPAL_INVESTIGATOR
References:
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.