Background
The current research
Primary aims: HIV/AIDS and HIV testing knowledge acquisition and retention (information)
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HA1 (3-way interaction of information delivery mode, language, and health literacy): e.g., improvement and/or retention of knowledge will be greatest among participants in the video arm who are English speakers and have higher health literacy, and will be least among those in the pictorial brochure arm who are Spanish speakers and have lower health literacy
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HA2 (2-way interaction of information delivery mode with language or health literacy): e.g., improvement and/or retention of knowledge will be greatest among participants in the video arm who are English speakers or higher health literacy patients, and will be least among those in the pictorial brochure arm who are Spanish speakers or lower health literacy patients
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HA3 (no interaction with information delivery mode): e.g., improvement and/or retention of knowledge will be greater in the video arm than the pictorial brochure arm regardless of language and health literacy level
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HA4 (no difference): improvement and/or retention of knowledge will be the same regardless of information delivery mode, language, and health literacy level (i.e., either a pictorial brochure or a video is useful for all patients)
Secondary aims: HIV testing motivation, behavioral skills and behaviors
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Motivation: Improved/increased (1) attitudes toward need for HIV testing for oneself, (2) beliefs regarding the value of HIV testing, and (3) self-perceived risk for having an HIV infection;
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Behavioral skills: Increased skills and perceived self-efficacy on (1) initiating/seeking HIV testing, (2) interpretation and response to HIV test results, and (3) assessment of HIV risk and need for repeat testing;
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Behavior: Greater (1) HIV testing uptake 12-months post-enrollment when offered in the study, (2) HIV testing not part of the study during the study period, and (3) HIV testing utilization 12-months post- vs. pre-enrollment
Exploratory aims
Methods/design
Theoretical framework of study
Study sites and recruitment feasibility
Location | Annual ED patient volume | ED patient demography | HIV prevalence |
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UAB Hospital ED | 55,000 visits | • 54% black, 42% white, 3% Latino | • 0.4% in Jefferson County |
Birmingham, AL | 18–64-year-olds/year | • 53% female, 47% male | • 0.3% seroprevalence among those tested in ED |
UCMC ED | 83,000 visits | • 51% black, 44% white, 1% Latino | • 0.15% in Cincinnati metro area |
Cincinnati, OH | 18–64-year-olds/year | • 48% female, 42% male | • 0.4% seroprevalence among those tested in ED |
Olive View-UCLA | 63,000 | • 5% black, 20% white, 70% Latino | • 0.38% in Los Angeles |
Medical Center ED | 18–64-year-olds/year | • 51% female, 49% male | • 4.4% seroprevalence among those tested in ED |
Los Angeles, CA | • 75% of Latinos primarily speak Spanish | ||
Rhode Island Hospital ED | 87,000 visits | • 10% black, 60% white, 30% Latino | • 0.2% in Providence metro area |
Providence, RI | 18–64-year-olds/year | • 48% female, 52% male | • 0.01% seroprevalence among those tested in ED |
• 50% of Latinos primarily speak Spanish |
Study materials and instruments
HIV/AIDS and HIV testing video
HIV/AIDS and HIV testing pictorial brochure
Study instruments (see Additional file 1 for English-language copies)
Instrument | Description | Administration |
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Screening, eligibility and enrollment questionnaire | • Karliner, et al. Spanish language proficiency & preference [54] | • Baseline |
• Ballard and Tighe Idea Proficiency Test II | • Administered by RA | |
• Demographic characteristics & nativity | • < 5 min | |
• US acculturation (for Latinos) per the SASH [63] | ||
• HIV testing history & HIV-related exclusion screen | ||
• Willingness to undergo rapid HIV testing | ||
Short Assessment of Health Literacy-Spanish & English (SAHL-S&E [22]) | • Measures health literacy level | • Baseline |
• Score of ≤14 indicates lower health literacy | • Administered by RA | |
• SAHL-S is highly correlated with TOFHLA (r = 0.62), & SAHL-E is highly correlated with REALM (r = 0.94) & TOFHLA (r = 0.68) | • 3–5 min | |
• SAHL-S&E reliability is 0.80 & 0.89, respectively | ||
• Derived from the S-TOHFLA | • Baseline | |
• AUCs for 3 questions vs. S-TOHFLA (0.66–0.74) vs. REALM (0.72–0.84) | • Administered by RA | |
• < 1 min for each question | ||
HIV testing motivation and behavioral skills questionnaire (Behavioral Skills and motivation) | • Measures Motivation: (1) attitudes toward need for HIV testing for oneself, (2) beliefs regarding the value of HIV testing, and (3) self-perceived risk for having an HIV infection; and Behavioral skills: skills and self-efficacy on (1) initiation/seeking of HIV testing, (2) interpretation and response to HIV test results, and (3) assessment of HIV risk and need for repeat testing | • Baseline (pre- and post-information by video or pictorial brochure) |
• Self-administered by telephone | ||
• < 2 min | ||
HIV/AIDS and HIV testing information delivery mode preferences and satisfaction questionnaire | • Measures preferences and satisfaction with pictorial brochure or video | • Baseline (pre- and post-information by video or pictorial brochure) |
• Adapted from our prior research [20] | • Self-administered by telephone | |
• 1 Pre- and post-information question on preferences with delivery mode | • 1 min | |
• 1 post-information question on satisfaction with delivery mode information | ||
HIV/AIDS and HIV testing knowledge questionnaire [21] (Information) | • Measures HIV/AIDS and HIV testing knowledge applicable to CDC-recommended information at the time of testing | • Baseline (pre- and post-information by video or pictorial brochure) |
• Cronbach’s α = 0.80; See A.1. Preliminary research for more details about development, testing, and utilization of this instrument | • 3, 6, 9 and 12-month follow-up | |
• 25 questions; yes/no/don’t know responses | • Self-administered by telephone | |
• 5–10 min | ||
HIV risk-taking questionnaire | • Measures number of partners and frequency of condom usage by gender and type of partner (main, casual and exchange partners) and injection-drug use | • Baseline |
• Based upon CDC National HIV Behavioral Surveillance System (NHBS) | • 3, 6, 9, and 12-month follow-up | |
• Self-administered by telephone | ||
• 5–10 min | ||
HIV test utilization questionnaire | • Queries participants about HIV testing in the follow-up period | • 3, 6, 9, and 12-month follow-up |
• Self-administered by telephone | ||
• < 2 min | ||
Repeat rapid HIV testing acceptance questionnaire | • Measures participant acceptance of offer of repeat rapid HIV testing at 1 year post-enrollment and reasons for acceptance/decline | • 12-month follow-up |
• Self-administered by telephone | ||
• < 2 min |
Study preparation (months 1–6): RA hiring and training, study preparation, and brief pilot study
RA hiring and training (months 1–5)
Study instrument preparation (months 1–2)
Brief pilot study (month 6)
Randomized, controlled trial (recruiting months 7–42; follow-up ends month 54)
Study inclusion criteria
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18–64-years-old (per CDC HIV screening recommendations [1])
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Speak English or Spanish
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Negative baseline rapid HIV test (described below)
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Not enrolled in a conflicting HIV study (described below)
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Can provide informed consent and can participate
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Plan to remain in the US for 12 months
Enrollment (months 7–42)
Pre-information delivery questionnaires
Information delivery and post-information delivery questionnaires
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Arm (1): HIV/AIDS and HIV testing video: Participants in Arm 1 will watch the video, “What do you know about HIV and HIV testing?” (in English or Spanish) on a tablet computer in the ED while the RA waits. They will listen to the audio components using disposable headphones.
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Arm (2): HIV/AIDS and HIV testing pictorial brochure: Participants in Arm 2 will be provided with a copy of our HIV/AIDS and HIV testing pictorial brochure (in English or Spanish) to review in the ED. Arm 2 participants will read the brochure while the RA waits. The RAs will not provide clarifications or assistance with the information in the pictorial brochure.
Rapid HIV testing and assurance of linkage-to-care
Follow-up assessments (months 10–54)
Repeat rapid HIV testing
Retention of study participants
Sample size considerations
Primary Aims | Minimum sample by stratum | Total minimum sample | Rationale and assumptions for minimum sample sizes and final sample sizes for each primary aim |
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Aim 1. Short-term improvement in HIV/AIDS and HIV testing knowledge HA1: 3-way interaction (mode*language*literacy level) HA2: 2-way interaction (mode*language or literacy level) HA3: no interaction (difference by mode only) HA4: no difference |
125
This minimum sample size by stratum will yield a power of 0.80, 0.97 and 0.99 for testing HA1, HA2, HA3 versus HA4 (HA4 as the NULL) Final sample per stratum (information delivery mode, language, and health literacy level) is 150 |
1000
The final sample after adding 20% to account for the heterogeneity in patients among study sites is 1200 = 1000*(1 + 20%) | • Based on our prior video studies [17, 19, 21], we assume that the scores on the 25-item questionnaire is a normal distribution with a standard deviation of ~ 3 • Before information delivery, mean scores of the two arms are assumed to be the same (due to random assignment) per stratum • Short-term within-person correlation is 0.7 or higher [21] • The pictorial brochure will improve knowledge by an average of 2 points. The video will improve the knowledge by an average of 3.5 points. The effect size is Δ = 3.5–2 = 1.5. (HA3) • 2-way intrxn (mode*language or literacy level) effect size is Δ = 1.5 + 0.75 = 2.25. (HA2), e.g. for those speaking English OR with high health literacy • 3-way intrxn (mode*language*literacy level) effect size is Δ = 1.5 + 0.75 + 0.75 = 3.0, e.g. for those speaking English AND having high literacy AND watching the video |
Aim 2. Retention of HIV/AIDS and HIV testing knowledge at 3, 6, 9, and 12 months HA1: 3-way interaction (mode*language*literacy level) HA2: 2-way interaction (mode*language or literacy level) HA3: no interaction (difference by mode only) HA4: no difference |
100
This minimum sample size by stratum will yield a power of 0.80, 0.97 and 0.99 for testing HA1, HA2, and HA3, versus HA4 (as the NULL) |
800
After adding 25% to account for loss-to-follow-up and 20% for heterogeneity among study sites, the final sample size is 1200 = 800*(1 + 25%)*(1 + 20%) | • Long-term within-person correlation is 0.4 or higher • The scores on the knowledge questionnaire in the pictorial brochure arm will degrade to the pre-information baseline level with an average drop of 2 points by 12 months. The score in the video information arm will degrade by an average drop of 1 point. So, compared to baseline, the difference (effect size) in long-term retention of information in the video arm as compared to the pictorial brochure arm is Δ = (3.5–1)-(2–2) = 2.5. • We will assume a similar effect size for 2- and 3-way interactions |
Study analysis (begins at end of recruitment month 43)
Enrollment summary and comparison of participants at baseline
Primary aims analysis
Primary aims | Measurements | Analytic methods |
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Aim 1. Short-term improvement in HIV/AIDS and HIV testing knowledge HA1: 3-way interaction (mode*language*literacy level) HA2: 2-way interaction (mode*language or literacy level) HA3: no interaction (difference by mode only) HA4: no difference | HIV/AIDS and HIV testing knowledge questionnaire at baseline in ED at time of HIV testing, post- vs. pre-information delivery | • Paired t-tests • Signed-rank tests • MANOVA/ANCOVA • Generalized linear mixed-effects regression |
Aim 2. Retention of HIV/AIDS and HIV testing knowledge at 3, 6, 9, and 12 months HA1: 3-way interaction (mode*language*literacy level) HA2: 2-way interaction (mode*language or literacy level) HA3: no interaction (difference by mode only) HA4: no difference | HIV/AIDS and HIV testing knowledge questionnaire at 3, 6, 9, and 12 months vs. baseline (post-information delivery) | • Paired t-test for each follow-up vs. baseline • Linear mixed-effects regression (assuming constant degradation over time) • Broken-stick linear mixed-effects regression (for non-constant degradation over time) |
Secondary analyses of primary aims
Secondary aims and exploratory aim analyses
Secondary aims
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Measurements
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Analytic methods
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Motivation
(1) attitudes toward need for HIV testing for oneself, (2) beliefs regarding the value of HIV testing, and (3) self-perceived risk for having an HIV infection | HIV testing motivation and behavioral skills questionnaire; post- vs. pre-information delivery | • Paired t-tests or signed rank tests • Generalized linear mixed-effects regression |
Behavioral skills
(1) initiating or seeking of HIV testing, (2) interpretation and response to HIV test results, and (3) assessment of HIV risk and need for repeat testing | HIV testing motivation and behavioral skills questionnaire; post- vs. pre-information delivery | • Paired t-tests or signed rank tests • Generalized linear mixed-effects regression |
Behaviors
(1) testing uptake one-year post-enrollment when offered in the study, (2) testing utilization during the study period, and (3) change in testing utilization one-year pre- vs. post-enrollment | (1) Repeat rapid HIV testing acceptance questionnaire (2) HIV test utilization questionnaire (3) HIV testing history | • McNemar’s tests • Cochran-Mantel-Haenszel’s test • Generalized linear mixed-effects model |
Exploratory aims
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Measurements
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Analytic methods
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Utility of brief health literacy instruments | NVS and 3 single-item screens of health literacy level vs. SAHL-S&E and HIV/AIDS and HIV testing knowledge questionnaire | • Pearson/Spearman correlation • Cohen’s Kappa for agreement tests • ROC analyses • Test performance parameters |
Information delivery mode preferences and satisfaction | HIV/AIDS and HIV testing information delivery mode preferences and satisfaction questionnaire; post- vs. pre-information delivery | • Paired t-tests or signed rank tests • Generalized linear mixed-effects regression |
HIV risk-taking behaviors | HIV risk-taking questionnaire | • McNemar’s tests • Cochran-Mantel-Haenszel’s test • Generalized linear mixed-effects model |