An Experimental Investigation of the Effects of an Entertainment Education Short Film on Internalized HIV-related Stigma, Sexual Partner Status Disclosure, and Medical Adherence Intentions Among Black HIV-positive Women in Miami-Dade County
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of Miami

Investigating the Effectiveness of an Entertainment Education Short Film for Internalized HIV 
Stigma Reduction, Intimate Partner Status Disclosure Intentions, and Antiretroviral Medical 
Adherence Intentions: A Randomized Controlled Trial Among Black Women Living with HIV 
in the Southern U.S. 
ClinicalTrials.Gov Identifier: NCT03898063 
April 1, 2020 

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1)
Protocol Title
An experimental investigation of the effects of an entertainment education short film on
internalized HIV-related stigma, sexual partner status disclosure and antiretroviral therapy
(ART) medical adherence among Black HIV-positive women in the Southern U.S.
2)
Objectives*
This investigation seeks to understand if and how, the 90 Days film can be used as an
intervention to address HIV-related stigmas, intimate partner status disclosure and HIV
ART medical adherence among Black HIV positive women. HIV-related internalized
stigma is unique to this population as it relates to the negative internalized attitudes
possessed by an HIV positive individual (Kalichman et al., 2009). Therefore, conducting
this research with HIV positive participants is paramount in understanding the impact of
entertainment education on internalized stigma and status disclosure.
3)
Background*
The Joint United Nations Programme on HIV/AIDS (UNAIDS; 2015) has proposed the 90-
90-90 treatment target with hopes of ending the AIDS epidemic. “By 2020, 90% of all
people living with HIV will know their HIV status. By 2020, 90% of all people with
diagnosed HIV infection will receive sustained antiretroviral therapy (ART). By 2020, 90%
of all people receiving antiretroviral therapy will have viral suppression” (UNAIDS, 2015).
Within the Southern U.S., among all women, Black women account for 67% of new
diagnoses (CDC, 2019). Nationally, Blacks are less likely to adhere to ART regimens and
reach viral suppression. Such combination poses a local public health crisis to reaching the
national goals for HIV prevention. The CDC (2017a) recommends HIV status disclosure
among sexual partners as a primary preventive measure to reduce the HIV burden by
increasing the likelihood of using prophylactic measures. Furthermore, HIV status
disclosure has been empirically linked to increased ART adherence (Stirratt et al., 2006)
another advocated HIV prevention method. Problematically, psychological inhibitions such
as internalized HIV stigma, negative beliefs and devaluing of one’s self due to positive
HIV status, often inhibit status disclosure and medical adherence (Chaudoir & Fisher,
2010; Herek, 1999; Turan et al., 2017). In the case of HIV-positive Black women, race and
gender-related stigmas make status disclosure markedly more difficult (Henkel, &
Kalichman, 2008).
Considering the central role of status disclosure and medical adherence in managing the 
HIV epidemic, identifying effective strategies that address such inhibiting mechanisms is 
critical. The present proposal contributes to this literature by conducting an experimental 
evaluation of a short entertainment education (EE) film about HIV status disclosure and 
management among Black HIV positive women living in Miami. EE refers to prosocial, 
persuasive messaging embedded into entertainment media (Moyer-Gusé, 2008). 
Entertaining media can influence persuasive outcomes through a variety of cognitive and 
emotional mechanisms. However, one particular strength of EE is it can provide social 
scripts for complex social interactions like HIV status disclosure. Moyer-Gusé, Chung and 
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Jain (2011) found participants who viewed a television program addressing HIV testing 
and sexual health dialogue reported higher levels of self-efficacy for engaging in these 
difficult conversations. Moreover, in comparison to a condition in which sexual discussion 
modeling was not demonstrated, participants who viewed the full episode were more likely 
to discuss HIV storylines with others (Moyer-Gusé, et al., 2011). In this regard, EE may 
provide a less threatening method for initiating sexual health discourse (Moyer-Gusé, et al., 
2011). For understandable reasons, people are hesitant to disclose their HIV status. Moyer-
Gusé’s (2008) entertainment overcoming resistance model (EORM) provides a rationale 
for how EE can overcome this resistance. 
4)
Inclusion and Exclusion Criteria*
Participants for the manipulation check will be Black women between the ages of 18-45, 
clinically diagnosed with HIV/AIDS. For the main study, participants will be Black women 
ages 18-50, clinically diagnosed with HIV/AIDS. Women who are pregnant or think they 
may be pregnant will not be excluded from the study; as there is minimal risk associated 
with this research. No data will be collected regarding one’s pregnancy or baby. In 
addition, the study will require participants to speak and comprehend English. Respondents 
will also need to have a working email address so that they can receive their compensation. 
Additionally, for those currently enrolled, they will need an email address to receive a 
study reminder for their follow up survey. Participants from the previous iteration of the 90 
DAYS focus group will only be able to participate in the manipulation check. For the main 
study, participants from the previous 90 DAYS focus group iteration will be excluded. 
5)
Procedures Involved*
We propose a randomized clinical trial (RCT) with a pre and post questionnaire 
assessing two conditions: (1) standard-of-care brochure (control condition) and (2) 
the EE film (treatment condition). For those currently enrolled in the study (N = 3) 
outcomes will be assessed with two post questionnaires, the first to assess intentions 
immediately after exposure to the study conditions and the second to assess lasting 
effects of the intervention on behavior one month later. The second questionnaire 
will primarily evaluate participants’ disclosure attitudes and beliefs, intimate 
partner disclosure intentions, medical adherence intentions, disclosure behavior, 
adherence behavior and reported internalized stigma. However, for newly enrolled 
participants only one post questionnaire will be assigned. Therefore, after 
completing the pre-test, intervention, and immediate post-test, they will not 
complete a follow up questionnaire. Thus, instead of participating in two waves of 
data collection, newly enrolled participants will only participate in one wave of data 
collection.
Prior to beginning the study, researchers will conduct a manipulation check for the 
PSA to ensure it is yielding the intended effects. The pre-test of the PSA will be 
conducted with 15-30 research participants. For the manipulation check, 
participants will provide verbal consent in place of signed consent. Therefore, 
completing the pre and post-test questionnaires will serve as their agreement to 
study participation. Participants will either be randomly assigned to view the PSA 
or to the control condition in which no stimulus will be used. Study conditions will 
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be randomly assigned based upon the dates of data collection. Participants viewing 
the PSA will complete a brief pre-stimulus questionnaire. Once completed, 
respondents will view a brief (30-60 seconds) PSA addressing key points displayed 
in the 90 DAYS narrative. At the conclusion of viewing the PSA, participants will 
complete a brief post-test questionnaire. If assigned to the control condition, 
participants will only complete the brief post-test questionnaire. All participants in 
the manipulation check will be compensated $25 for their participation in the 
manipulation check.
Traditionally, Black women within the U.S. are a hard to reach population for 
research involvement (Jones, Lacroix, & Porcher, 2017). Literature suggests that 
Black women often experience an amalgam of barriers to research engagement such 
as: lack of transportation, need for a babysitter, and extensive caregiving 
responsibilities for loved ones (Webster et al., 2018). Considering this, the National 
Institutes of Health is strongly encouraging researchers to identify strategies that 
increase study participation among this demographic (Jones, Lacroix, & Porcher, 
2017). For this reason, the current study will align with peer reviewed research and 
conduct the experimental sessions for the main study via the online Qualtrics 
platform (Jones, Lacroix, & Porcher, 2017). All responses to questionnaires will be 
anonymous. 
Due to the sensitive and hard to reach nature of this study population, multiple 
recruitment strategies will be implemented. Firstly, a two-step recruitment process 
will be employed. Based upon the inclusion and exclusion criteria, clinic staff 
throughout the Jackson Health System as well as other HIV service providers across 
the state of Florida, will inform patients of the study via print and virtual flyers, sent 
via email. Dependent upon the study schedule, research team members maybe 
stationed at recruitment sites to speak with interested patients who desire further 
information. If research staff are not onsite, interested participants can contact the 
identified study team member listed on the recruitment flyer should they have 
further questions. All virtual flyers will be sent by clinic staff via a restricted email 
server to patients who have agreed to be contacted via email by their health 
provider. For patients who receive a printed or virtual copy of the study flyer, if 
they are interested in participating, they will visit the Qualtrics link provided on the 
flyer. Once they are on the study site, participants will read the consent form which 
thoroughly outlines the study’s purpose, inclusion criteria, risks, benefits, 
compensation, voluntariness, and researchers’ contact information. Should 
participants decide the study is a good fit for them, they will be able asked to 
consent by clicking the “next” button. Upon clicking the “next” button participants 
will be asked screening questions based upon the study’s inclusion criteria (See 
updated measures guide). Once screened, if participants meet the eligibility 
requirements they will be guided through the study. Should participants not meet 
the eligibility criteria, they will be redirected to the end of the study and thanked for 
their time. Participants will be fully aware via the consent form that they can 
withdraw from the study at any time. 
The second recruitment method will consist of paid targeted Facebook advertising. 
This recruitment strategy has yielded successful results in similar populations as the 
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current study (Jones, Lacroix, & Porcher, 2017; Mitchell & Petroll, 2012). Using 
data provided by the Centers for Disease Control and Prevention (CDC) and 
geographic information systems mapping, researchers will run Facebook 
advertisements in specific states, across the Southern U.S., that are identified to 
have moderate to increased prevalence of  HIV among Blacks. In addition to using 
specific states, as carried out by other researchers, study investigators will set 
specific criteria to distinguish which Facebook users will be exposed to the ad 
(Jones, Lacroix, & Porcher, 2017). The inclusion criteria for the Facebook 
advertisements will include: Black women between the ages of 18-50 living within 
the Southern U.S. Similarly to those who receive the print or virtual flyer, 
participants recruited via Facebook will be able to click on the link in the 
advertisement to be redirected to the study’s consent form. If they deem the study is 
a good fit for them, they will proceed by clicking the “next” button. Once they 
select “next”, participants will complete the pre-test questionnaire, view one of the 
assigned stimuli, and complete the initial post questionnaire. Once all anonymous 
responses have been submitted, a randomized code will be provided to participants. 
Participants will be instructed to enter this randomized code along with their email 
address to receive compensation. Three weeks after completing the pre- and post-
test questionnaire, participants will receive a reminder, via the provided email, to 
complete the follow up questionnaire. Similarly, to part one of the main study, once 
all anonymous responses are submitted, participants will receive a randomized 
code. They will be asked to enter the randomized code and their email address to 
receive their final compensation. Lastly, researchers will also request HIV servicing 
agencies to post the study flyer on their Facebook pages. 
The third recruitment strategy consists of using a Qualtrics panel. According to 
Qualtrics, “A market research panel, also known as an online sample, is a group of 
people recruited to respond to a survey. They are typically chosen from a pre-
arranged pool of respondents who’ve agreed to be contacted by a market research 
service in order to respond to surveys.” Employing the study inclusion/exclusion 
criteria, Qualtrics panel, recruits willing participants for study participation. 
Participants recruited via the Qualtrics panel will be compensated directly via 
Qualtrics. They will receive a $50 gift card for their participation.
Across all forms of recruitment, study conditions will be randomly assigned via the 
Qualtrics system. Once a participant provides consent and is screened for study 
inclusion, participants will complete the pre-test questionnaire. After completing the 
pre-test questionnaire, respondents will be assigned to one of two study conditions. 
They will either be asked to view one of the following: a brochure on safe 
disclosure or the 90 DAYS film. Upon completing one of the interventions, 
participants will be asked to immediately complete the post-test questionnaire. For 
participants recruited outside of the Qualtrics Panel, once all anonymous responses 
are submitted, they will be directed to a separate link to enter their randomized 
generated code and email address. The purpose of the randomized code is to verify 
that the participant completed the study. The purpose of the email address for those 
currently enrolled is two-fold. Firstly, it will allow researchers to compensate 
participants with a virtual $30 Amazon gift card. Secondly, it will allow researchers 
to provide a follow up email, within 3-4 weeks, containing the link to the second 
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post-test survey. Participants will be compensated with a $20 virtual Amazon gift 
card. Altogether, currently enrolled respondents in the main study (N = 3), will 
receive a total of $50 for their participation in the study. After each data collection, 
participants will be reminded of their right to withdraw their responses from the 
study without penalty. 
For newly enrolled participants, whether recruited via Qualtrics, social-media, 
health agencies, or word-of-mouth, only one wave of data collection will occur. 
Once participants complete the pre-test, intervention, and immediate post-test, they 
will not be re-contacted 3-4 weeks later for a follow up post-test. Newly enrolled 
participants who complete one wave of data collection will also be compensated 
with a total of $50 in e-gift cards; just as their counterparts who were enrolled in 
two waves of data collection.
For participants randomly assigned to the pamphlet only condition, an opportunity to view 
the short film will be available upon submitting their anonymous responses to the post test 
survey.  
6)
Data and Specimen Banking*
N/A
7)
Data Management
To maintain participants’ privacy, identifying information will be safely maintained 
in a secured password protected file that only study team members will have access 
to. The study will be administered using Qualtrics survey software. All quantitative 
data will be analyzed using SPSS 24 and Mplus. 
8)
Risks to Subjects
There are no physical risks anticipated with participation in this study.  It is possible 
that participants may experience some stress in completing the questionnaire, and/or 
some inconvenience in the time taken to participate in the two waves of this study. 
A breach of confidentiality is also a potential risk, but measures will be taken to 
minimize that risk (please see confidentiality section below). Due to anticipating 
minimal risks, this study will not assess adverse effects.
9)
Potential Benefits to Subjects
No direct benefit can be promised to you from being in this study.  
10) Compensation
Participants in the PSA pre-test will be compensated $25. Light refreshments or lunch will 
be served during PSA pre-test sessions. Currently enrolled participants in the main study 
will be compensated with virtual Amazon gift cards oppose to cash. Participants will 
receive $30 for the first part of the main study and $20 for the follow up questionnaire of 
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the main study. Due to only participating in one wave of data collection, newly enrolled 
participants will receive one payment. However, just as those currently enrolled, newly 
enrolled participants will also be compensated with $50 via gift card. Altogether, all 
participants in the main study (current and new) will be compensated $50 in virtual gift 
cards. Participants recruited via Qualtrics will be compensated directly through Qualtrics. 
They will be compensated the amount agreed upon by their provider, which will be a 
minimum of $50 in Tango gift cards. Participants recruited via all other strategies will be 
compensated via email with a total of $50 in Amazon e-gift cards. 
11) Vulnerable Populations
Minors, prisoners and those unable to consent will be excluded from the study. 
Pregnant women will not be excluded from the study. This study is presumed to 
have minimal risk. No data will be collected regarding one’s pregnancy or baby.
12) Setting
Participant referrals and onsite recruitment will take place at the UM HIV Clinics at 
Jackson Memorial Hospital as well as other HIV service providing agencies across 
the Southern U.S., such as the AIDS Healthcare Foundation (AHF), Care Resource, 
Big Bend Cares, Neighborhood Medical Center, and Bond Community Health 
Center. Lastly, virtual recruitment will be conducted via Facebook and Qualtrics 
panel. 
The PSA manipulation check will be conducted in the University of Miami’s 
Clinical Translational Science Institute room or on the 7th Floor of the Soffer 
Clinical Research Center (CRB; rooms 710N or 710Q) located at 1120 NW 14th 
Street, Miami, Fl, 33136 and the Batchelor Childrens Research Institute, 1580 NW 
10th Avenue, Miami, FL, 33136, 2nd floor conference room. 
Paper data for the PSA manipulation check will be stored at in the principle 
investigator’s office at 5100 Brunson Drive, room 3013, Coral Gables, FL, 33146. 
All electronic data and audio/video recordings will be stored on the password 
protected computers of research team members responsible for data analysis.
The main study will be conducted virtually, via Qualtrics software.
13) Resources Available
All researchers have completed CITI certification. The principal investigator, Dr. 
Nick Carcioppolo, is an expert in health communication and entertainment 
persuasion. He has published in a number of scholarly journals including 
Communication Research, American Journal of Health Behavior, and Journal of 
Health Communication. Dr. JoNell Potter is an expert in HIV/AIDS and women’s 
health and much of her research focuses on status disclosure among intimate 
partners. In addition, Dr. Potter is also the Chief of Women’s HIV Service at the 
University of Miami. Some of Dr. Potter’s scholarly research has been published in 
the Journal of Health Communication, Health Communication, and Journal of the 
Association of Nurses in AIDS Care. Lastly, Jazmyne Simmons has worked as a 
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certified HIV/AIDS tester and counselor. To this end, her expertise will be 
employed in conducting the focus groups and onsite participant recruitment.
14) Prior Approvals
N/A
15) Recruitment Methods
Multiple strategies will be employed for participant recruitment. For the PSA pre-test 
phase, participants will be recruited by self-referral, word of mouth, or referred by a staff 
member or provider from the University of Miami, Jackson Memorial Hospital, including 
the HIV clinics, as well as other HIV service providers. More specifically, the research 
team will partner with Care Resource and AIDS Healthcare Foundation for participant 
referrals. Each of these agencies service our target population. As part of a memorandum of 
understanding, Care Resource will be compensated for their assistance with patient 
referrals for the study. Their referral process will include contacting qualified participants 
to inform them of the study, as well as referring interested patients within clinic to the 
study. AIDS Healthcare Foundation will inform patients within clinic of the study and refer 
them to the research team if they desire to participate. Dependent upon the study schedule, 
research team members maybe stationed at recruitment sites to immediately enroll 
participants. To maintain confidentiality throughout the recruitment process, the two-step 
approach will be employed. Firstly, potential participants may view the recruitment flyer or 
be referred by UM or JMH staff, or other HIV service providers, who will inform patients 
of the study, including the purpose of the study and participation criteria. Second, patients 
who express interest in participating will be referred to a research team member who will 
provide further information. Due to the sensitive nature of this study, should a patient 
decline to participate, they will not be referred to the research team.
Should a participant agree to partake in the study, they will be provided consent forms from 
a study team member as well as the pre-questionnaire. If research staff are not onsite, 
interested participants will contact the identified study team member listed on the 
recruitment flyer. Researchers will partner with the Behavioral Registry Study at the 
University of Miami. This partnership will provide contact information for willing potential 
research participants that meet the inclusion criteria. 
Additionally, as a form of recruitment for the main study, HIV servicing agencies across 
the Southern U.S. will be asked to share the virtual flyer on their Facebook pages. Lastly, 
using data from the CDC and GIS mapping, researchers will employ targeted Facebook 
recruitment using Facebook ads. Ads will be run in Southern U.S. states that are identified 
to have a moderate to high prevalence of HIV. Further, ads will be displayed among 
Facebook users in the selected states, who meet the study criteria. 
Lastly, a Qualtrics panel will be used for recruitment. According to Qualtrics, “A market 
research panel, also known as an online sample, is a group of people recruited to respond to 
a survey. They are typically chosen from a pre-arranged pool of respondents who’ve agreed 
to be contacted by a market research service in order to respond to surveys.” Employing the 
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study inclusion/exclusion criteria, Qualtrics panel, recruits willing participants for study 
participation. Participants recruited via the Qualtrics panel will be compensated directly via 
Qualtrics. They will compensated the amount agreed upon by their provider. However, 
compensation will be at least $50 in gift cards for their participation.
Eligibility is restricted to black women ages 18-50, living in the Southern U.S., that have 
been clinically diagnosed with HIV/AIDS, who can read and comprehend English. 
Note that participation is voluntary, and all participants will have the right to choose 
whether to participate or not.
16) Local Number of Subjects
The first iteration of the study enrolled 50 participants. For the current iteration of 
the study up to 30 phase one participants will be enrolled for the PSA pre-test. Up 
to 400 study participants will be enrolled for the main study. Altogether, this study 
will enroll up to 500 participants. 
17) Confidentiality
The pre-test survey for the PSA will not ask any personally-identifying information. The 
pre- and post-film surveys and follow up-questionnaire will not ask any personally-
identifying information. However, we will collect contact details (email address) of 
participants in order to schedule the second wave of the investigation and compensate 
participants. Contact details will be stored separately from the survey responses and will be 
deleted after data collection is complete. No personally identifiable information will be 
included in any written reports of the results. 
18) Provisions to Protect the Privacy Interests of Subjects
Only authorized members of the study team will have access to the data. Lastly, an 
assigned research team member will contact participants to provide a reminder of 
the follow up survey. Participants will be individually contacted and compensated 
via email. 
19) Consent Process
The consent process for the PSA pre-test will be as follows. Firstly, clinic providers 
and staff will inform patients of the study, including the purpose of the study and 
participation criteria. Second, patients who express interest in participating will be 
provided contact information for a research team member who will be able to 
provide further information on the study. Due to the sensitive nature of this study, 
should a patient decline to participate, they will not be referred to the research team. 
The study team member will provide the interested participant with the consent 
forms to read and ask any questions to their full satisfaction and understanding.  
After the consent forms are signed and copies given to the participant, the study 
team member will administer the pre-questionnaire.
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Due to the main study being conducted via the Qualtrics survey software, 
participants will be provided a thorough consent form. Should the participant agree 
to participate, their consent will be determined based upon their decision to select 
“next” and complete the study. Moreover, all participants for the PSA manipulation 
check and main study will be informed of their right to remove themselves from the 
study or withdraw their responses at any time without penalty. Respondents will 
also have the contact information of the study team in case they have questions.
20) Process to Document Consent in Writing
For both the PSA manipulation check and the main study, participants will 
document their consent by completing the study questionnaires. Therefore, while 
informed consent will transpire, signed consent will not. This will reduce the 
amount of personal identifiable information reported.
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