HIV Oral Testing Infographic Experiment (HOTIE)
Phase: NA
Conditions: HIV/AIDS
Sponsor: New York University

HIV Oral Testing Infographic Experiment (HOTIE) 
NCT04061915 
Date of Update: October 23, 2021  
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Introduction 
 
In the United States, approximately 1.1 million persons are living with HIV. Despite novel 
pharmacological breakthroughs, comprehensive models of health care, and targeted HIV testing 
initiatives, over 160,000 persons are still unaware of their HIV serostatus. Emerging adult, 
sexual minority, men of color are disproportionately affected. Premised on the National AIDS 
Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of 
this formative pilot study is to develop and test an integrated HIV self-testing strategy that 
utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of 
color. 
The overall study will focus on: (a) understanding facilitators and barriers to HIV self-
testing among emerging adult MSM, (b) designing a HIV self-testing infographic that utilizes a 
simplicity model, (c) finalizing the HIV self-testing infographic with input from a leadership group 
of HIV community members, (d) conducting a pilot clinical trial with 300 emerging adult (ages 
18-34), sexual minority, men of color to test if a collaboratively-designed HIV self-testing 
infographic can facilitate accurate and effective understanding of how to self-test for HIV when 
compared to paper-based, HIV self-testing information. 
By conducting this study, we will gain beneficial insights necessary for presenting HIV 
self-testing instructions in a meaningful, relevant, and comprehensible way. The results of this 
pilot study have the potential to inform strategies regarding how self-testing instructions can be 
worded or visually presented in order to break both literacy and language barriers that affect 
testing utilization and results accuracy. 
 
Methods  
The HOTIE intervention was a sequential, mixed methods pilot randomized controlled 
trial. Mixed methods were an appropriate study design as we sought to describe the context for 
needing to develop an HIV self-testing infographic and the process of steps that lead to testing 

of the infographic. The study methods are consistent with the approaches for conducting mixed 
methods research by Curry and Nunez-Smith.  
Participants were recruited online from a HIPAA-compliant data management national 
survey panel recruitment company. Participants were screened for eligibility online. Once 
considered eligible, they were informed about the purpose, risks and benefits of the study and 
then completed an online consent to participate or decline to participate. Those who consented 
to participate were then randomly assigned, using automated random selection to either the 
intervention group (HIV self-testing infographic) or to the control group (HIV self-testing text-
based instructions). The primary outcome was comprehension of the HIV Self-testing 
Infographic and Usefulness, Ease of Use, Ease of Learning and Satisfaction of the HIV Self-
testing Infographic. Health literacy was a secondary outcome. More detailed information on the 
development and design of the infographic can be found elsewhere. 
 
Measures 
Sociodemographic data collected will include age (in years), gender, sexual attraction, 
race-ethnicity, educational attainment, employment status, annual income, and other 
information to characterize the sample. Outcomes of interest include health literacy, oral HIV 
self-testing knowledge, HIV knowledge, oral HIV self-testing infographic usability as well as 
PrEP use, familiarity, and attitudes. The following instruments will be administered. 
 
Oral HIV self-testing knowledge. Oral HIV self-testing knowledge will be assessed using an 
Oral HIV self-testing questionnaire. The Oral HIV self-testing questionnaire will assess accuracy 
in using oral HIV self-testing kits. Correct responses will be coded as “1” and incorrect 
responses “0”. Responses to the five-items will be summed to yield a total Oral HIV self-testing 
knowledge score ranging from 0 to 5. 
 

Oral HIV self-testing infographic usability questionnaire. The Oral HIV self-testing 
infographic usability questionnaire is a 14-item measure designed to assess usefulness and 
usability of the HIV oral self-testing infographic. The Oral HIV self-testing infographic usability 
questionnaire was derived from the Usefulness, Satisfaction, and Ease Questionnaire[1]. 
Responses will be recorded using a 7-point Likert scale ranging from strongly disagree (1) to 
strongly agree (7). This measure assessed four domains that included usefulness of the HIV 
oral self-testing infographic (M = 5.47, SD = 1.40; Cronbach’s α =.92), ease of use of the HIV 
oral self-testing infographic (M = 5.51, SD = 1.23; Cronbach’s α =.85), ease of learning using 
the HIV oral self-testing infographic (M = 5.41, SD = 1.37; Cronbach’s α =.86), and satisfaction 
with the HIV oral self-testing infographic (M = 5.34, SD = 1.33; Cronbach’s α =.79). Responses 
to the 14-item measure will be summed to yield a mean score on usability among experimental 
group participants only ranging from 15 to 98. 
 
Health literacy. The Short Assessment of Health Literacy-English, or SAHL-E is an 18-item 
measure designed to assess an English-speaker’s ability to read and understand common 
medical terms [2]. The test contains a printed common medical term, a key word (the correct 
response), and a distractor word. Responses will be recorded dichotomously with either false 
(0) or true (1). Prior studies have demonstrated good internal consistency ranging from .80 to 
.89 [2]. Responses to 18-items will be summed to yield a total score on Health literacy ranging 
from 0 to 18.  Higher scores indicate greater health literacy.  
 
HIV knowledge. The Brief HIV Knowledge Questionnaire (HIV-KQ18)[3] is an 18-item true or 
false response measure that distinguishes understanding about HIV transmission, prevention, 
and consequences. Correct responses will be coded as “1” with incorrect responses coded as 
“0”. Prior studies have demonstrated good internal consistency ranging from 0.75 - 0.89 [3]. The 
measure has been identified as suitable for those with low health literacy [3]. Responses to the 
18-items will be summed to yield a total score on HIV knowledge ranging from 0 to 18.  

PrEP Use, Familiarity, and Attitudes. PrEP Use, Familiarity, and Attitudes will be assessed 
using three separate multiple-choice questions. PrEP use will be assessed using the question: 
“PrEP is the use of a medication taken before having sex as protection against HIV infection. 
Are you currently taking PrEP?” and measured dichotomously (0 = No, 1 = Yes). PrEP 
familiarity will be assessed using the question: “Truvada is a pill that HIV negative people can 
take to prevent HIV. This is called PrEP or Pre-Exposure Prophylaxis. How familiar are you with 
Truvada also called PrEP?” Responses will be collected using a three-item Likert scale from 1 
(not familiar or I do not know about PrEP) to 3 (Familiar or I know about PrEP). PrEP attitudes 
will be measured using the question “How do you feel about HIV-negative people taking 
Truvada as PrEP to prevent transmission of HIV?” Responses will be collected using a four-
point Likert scale from 1 (extremely negative) to 4 (extremely positive).   
 
Statistical Analysis Plan. Post-hoc power analysis estimates will be performed using G*Power 
[4]. Analyses indicated that based on a type I error rate set at .05 and conservative effect size of 
.4 [5], and sample of 322 participants randomly assigned to experimental and control groups in 
this RCT study, we will have .95 power to reject the null hypothesis with our oral HIV self-testing 
knowledge questionnaire [5]. Analyses will be conducted in STATA. Between-group differences 
will be examined using chi-square and independent samples t-tests to determine significant 
sociodemographic differences. Between-group differences using independent samples t-tests 
will also be examined on outcomes including oral HIV self-testing knowledge, HIV knowledge, 
and health literacy. Cases with missing data will be excluded from the analyses.  
 
 
 
 
 

References 
1. 
Lund, A.M., Measuring usability with the use questionnaire12. Usability interface, 2001. 
8(2): p. 3-6. 
2. 
Lee, S.Y.D., et al., Short assessment of health literacy—Spanish and English: a 
comparable test of health literacy for Spanish and English speakers. Health services 
research, 2010. 45(4): p. 1105-1120. 
3. 
Carey, M.P. and K.E. Schroder, Development and psychometric evaluation of the brief 
HIV Knowledge Questionnaire. AIDS education and prevention, 2002. 14(2): p. 172-182. 
4. 
Faul, F., et al., Statistical power analyses using G* Power 3.1: Tests for correlation and 
regression analyses. Behavior research methods, 2009. 41(4): p. 1149-1160. 
5. 
Faul, F., et al., G* Power 3: A flexible statistical power analysis program for the social, 
behavioral, and biomedical sciences. Behavior research methods, 2007. 39(2): p. 175-
191.