Podcasting HIV Prevention Within African American Communities to Decrease New Infection
Phase: NA
Conditions: HIV Prevention
Sponsor: University of Houston

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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Podcasting HIV Prevention within African American Communities to Decrease New Infection. 
NCT: NCT05365958 
February 27, 2025 
 
 
 
PRINCIPAL INVESTIGATOR: 
Chakema Carmack 
Psychological Health & Human Sciences 
713-743-6231 
ccarmack@central.uh.edu 
 
 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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1.0 
Objectives 
1.1 Aim 1 (Phase 1): To conduct 5 focus groups for the development of two 
theory-based, video podcast-delivered, HIV prevention interventions for 
self-identified heterosexual African American males and females.  
Aim 2 (Phase 2): To evaluate the effectiveness of the two theory-based, 
video podcast-delivered, HIV prevention interventions for self-identified 
heterosexual African American males and females. 
 
2.0 
Background 
2.1 There is a need to implement more evidence-based HIV prevention 
messaging in the African American community in order to mitigate HIV 
incidence and prevalence disparities. However, the resource expenditure 
associated with implementing evidence-based HIV prevention interventions 
may not coalesce with community resources and expertise available to 
successfully implement such interventions.  Thus, the scientific premise for 
this mixed-methods study is grounded in 1) progressing the field of HIV 
prevention to create accessible and acceptable modes of science-driven 
interventions for behavior change; and 2) engaging the community as 
participants in the development of, as well as, recipients of HIV prevention 
science. 
2.2 NA 
2.3 African Americans in the U.S. continue to experience the highest rates of 
HIV incidence.  African Americans are one of the most affected populations 
in the U.S., and HIV is among the top 10 causes of death among African 
Americans between 20 – 54 years old.1  Of the 37,968 newly HIV-infected 
persons in 2018, 42% were African American.2  The latest available data 
shows that HIV testing has decreased and HIV prevalence has increased in 
the state of Texas between 2015 and 2019.3 Likewise in Harris County, TX, 
the estimated HIV incidence rate has increased from 2018 to 2019, while 
HIV testing has showed a decrease during that time.3 HIV incidence has 
seen an increase among African Americans, ages 25 to 34, in particular. 
While men who have sex with men (MSM) comprise the majority of new 
HIV cases in 2018, heterosexual sexual contact comprised 34% of new 
cases among African Americans.2 Systems dynamics methodology has 
illustrated causal loops that suggest how heterosexual individuals may 
directly spread infection through heterosexual contact, but can also be 
directly infected by bi-sexual sexual contact and/or indirectly through 
homosexual sexual contact4; indicating that, in a community system, the 
spread of HIV does not occur within a group-specific vacuum. Thus tackling 
HIV prevention among heterosexual African American individuals is also 
important. 
1. Heron M, Centers for Disease Control and Prevention. Deaths: Leading 
Causes for 2018, National Vital Statistics Reports, Vol 70(4). 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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https://www.cdc.gov/nchs/data/nvsr/nvsr70/nvsr70-04-508.pdf. Published 
May 17, 2021. Retrieved June 28, 2021.  
2. Centers for Disease Control. HIV and African American People. 
https://www.cdc.gov/hiv/group/racialethnic/africanamericans/index.html. 
Published January 21, 2021. Retrieved June 11, 2021. 
3. Centers for Disease Control. NCHHSTP AtlasPlus. 
http://www.cdc.gov/nchhstp/atlas/. Updated April 29, 2021. Accessed June 
17, 2021.  
4. Waring A. Practical System Thinking. Hampshire, UK: Cengage 
Learning EMEA; 1996. 
3.0 
Inclusion and Exclusion Criteria 
3.1 Phase 1 & 2: Individuals eligible to participate will: (1) self-identify as 
African American; (2) reside in a low SES predominantly African American 
super neighborhood; (3) speak and read English; (4) be 18 years old or 
older; and (5) not previously diagnosed with HIV. The screening 
questionnaire will assess these eligibility criteria (attached in the 
smartforms). 
3.2 Phase 1 & 2:  Potential participants will call dedicated university phoneline 
or email study team email account. Flyers will be distributed at African 
American-based community events; contact information will be displayed 
on the flyers. 
3.3 The following groups will be excluded. The research may possibly involve 
economically and/or disadvantaged persons. 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
• 
Students for whom you have direct access to/influence on grades 
 
4.0 
Vulnerable Populations 
4.1 Additional safeguards to protect their rights and welfare of economically 
and/or educationally disadvantaged persons. 
 
• 
Phase 1 (focus groups):  Individuals who are 
economically/educationally disadvantaged:  Participants’ incentives 
for research participation are proportionate with the risks. Participants 
will be paid $45 for their participation. Discomforts and 
inconveniences involved in the research, and financial or other gains 
are not overly compelling. Consent documents are written in language 
that is easily understandable to participant. Research team will read 
consent document out loud for each participant and participant will 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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have the ability to ask questions. Eligibility criteria includes the ability 
to read and speak English. 
• 
Phase 2 (effectiveness phase):  Individuals who are 
economically/educationally disadvantaged:  Participants’ incentives 
for research participation are proportionate with the risks. Upon pre-
test completion, participants will be emailed (or pick up in person) a 
$20 Walmart, Target, or Amazon gift card; $80 Walmart, Target, or 
Amazon gift card upon post-test completion; and $25 Walmart, Target, 
or Amazon gift card upon 3 month follow-up completion; for an 
opportunity to receive $125 for complete participation. (For 
participants who do not have email addresses, research assistants will 
assist them in obtaining one; alternately, participants will be able to 
schedule a time to meet at one of the community centers in order to 
complete pre- and post-test surveys in person, (and/or to pick up gift 
card) if needed.) Discomforts and inconveniences involved in the 
research, and financial or other gains are not overly compelling. 
Consent documents are written in language that is easily 
understandable to participant. Participants will email or call a 
dedicated study email/phone line, where research assistants will screen 
them, answer any questions they may have, and get them formally 
consented and enrolled, if applicable. Eligibility criteria includes the 
ability to read and speak English. 
 
5.0 
Number of Subjects 
 
LOCAL: 
5.1 Phase 1: Total number of subjects to be accrued locally = 35; Phase 2: Total 
number of subjects to be accrued locally = 128 
5.2 NA - The participant procedures involve no more than minimal risk. 
5.3 Phase 1: We are seeking to conduct 5 focus groups with 7 people each. 
Phase 2:  We are seeking to assess 128 African American adults (64 male; 
64 female). 
 
6.0 
Recruitment Methods 
 
LOCAL: 
6.1 When and Where:  Phase 1 - Rolling recruitment and focus group 
facilitation will occur over 3 months (Year 1). Participants will be recruited 
through postings on community bulletin boards in African American 
communities and churches, at public community events within African 
American communities, and at events held by UH HEALTH Research 
Institute (HRI). Flyers and email list serves will be used to recruit 
participants. Community based service organizations that serve many 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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predominantly African American communities will assist in the active 
recruitment of participants as well (see letters of support). Dr. Ezemenari 
Obasi, an established investigator, faculty mentor, and collaborator for the 
associated grant proposal submission, currently serves as director at the HRI 
and will assist in recruitment efforts via the center’s community engagement 
core.  
Phase 2:  Participants will be recruited on a rolling basis with the assistance 
of community partners, through postings on community bulletin boards, and 
flyers at public community events within African American communities; as 
well as at events held by HRI (virtually or in-person), and the center’s 
RCMI websites; as well as with the assistance of community partners (see 
letters of support). 
Appropriate permissions for recruitment at the above-mentioned locations 
are ensured: Community partner support for recruitment at their local events 
is evidenced through the community partner letters of support (attached in 
the smartforms), the funded project will be conducted through the HRI 
which lend their recruitment support for all projects funded within their 
center (i.e., the HRI community engagement core), and community bulletin 
postings are free for public use.  
6.2 Participants will be sourced from community events (market gatherings, 
various local festivals, events held by community partners) and through HRI 
events throughout the African American community. 
6.3 Methods and materials for recruitment:   
Phase 1:  Flyers will be distributed as indicated above. Inclusion criteria will 
be printed on flyers. Potential participants who presumably fit the study 
criteria and are interested will call the study phone or send correspondence 
via the study email and will be screened for eligibility. For phone screening:  
the potential participant will call the study hotline and be asked a series of 
short screening questions estimated to take approximately 3 minutes. If 
eligible, the research team member will inquire on the preferred 
participation day/time (during one of the evening or weekend focus group 
sessions). If ineligible, the research team member will notify the potential 
participant that s/he is not eligible and thank him/her for interest as indicated 
in the screening script. For email screening: interested participants will 
email the study using the email provided on the recruitment flyer. A 
research team member will reply to them, asking all eligibility questions via 
email and ask that the potential participant send an email reply, responding 
to each screening question. If eligible, the research team member will reply 
with a list of available study day/times and ask the participant to reply with 
the most convenient time she wishes to participate. After confirming her 
preferred time, s/he will be sent a confirmation email to participate in the 
scheduled focus group. This constitutes a total of three email exchanges. If 
ineligible (via email screening), the research team member will send a 
follow-up email notifying the potential participant that she is not eligible 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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and thank the participant for their interest as indicated in the screening 
script.  
Phase 2:  Flyers will be distributed as indicated above. Inclusion criteria will 
be printed on flyers. Potential participants who presumably fit the study 
criteria and are interested will call the study phone or send correspondence 
via the study email and will be screened for eligibility. For phone screening:  
the potential participant will call the study hotline and be asked a series of 
short screening questions estimated to take approximately 3 minutes and 
answer any questions they may have, and get them formally enrolled, if 
applicable.  If ineligible, the research team member will notify the potential 
participant that s/he is not eligible and thank him/her for interest as indicated 
in the screening script. For email screening: interested participants will 
email the study using the email provided on the recruitment flyer. A 
research team member will reply to them, asking all eligibility questions via 
email and ask that the potential participant send an email reply, responding 
to each screening question. If eligible, the research team member will enroll 
participant, assign a unique ID to participant, and email them the secure link 
which will include the consent form and pre-test. If ineligible (via email 
screening), the research team member will send a follow-up email notifying 
the potential participant that she is not eligible and thank the participant for 
their interest as indicated in the screening script.  
 
6.4 Phase 1 & 2:  Materials for recruitment include a study flyer indicating the 
abbreviated purpose of the study, solicitation for participation, eligibility 
criteria, incentives offered, and study contact information (phone and 
email). Phase 1 & 2 flyers are attached to the SmartForm. 
 
7.0 
Multisite – N/A 
 
8.0 
Study Timelines 
• 
Phase 1: The total duration of an individual’s participation in the study 
is no more than 1.5 hours. The number of study visits is 1 per 
participant. No follow-up is included in the study. It is anticipated that 
it will take approximately 10 minutes to consent each participant.  The 
estimated date of completion for this phase of the study (focus group 
phase) and primary analyses is March 30, 2022. 
• 
Phase 2:   The total composite time duration of an individual’s 
participation in the study is estimated to be about 60 minutes. The 
number of study visits is 3 per participant. All study “visits” are in the 
form of online survey and video viewing. The first study visit will 
consist of consenting via cover letter and pre-test. The second study 
visit will consist of a 1 month-follow-up survey video podcast 
viewing. The third study visit will consist of a short follow-up survey 
3 months following post-test completion. It is anticipated that it will 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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take approximately 5 minutes to recruit/enroll each participant; 15 
minutes to complete the pre-test; 20 minutes to watch draft podcast 
video; 15 minutes to complete the posttest; and 5 minutes to complete 
the 3-month follow-up.  The estimated date of completion for this 
phase of the study and primary analyses is August 30, 2023. 
 
9.0 
Study Endpoints 
 
9.1 The primary study endpoint for the proposed study shall be 3 months 
following the last participant’s post-test in Phase 2 and been analyzed. 
9.2 There are no primary or secondary safety endpoints to be described. 
9.3 “There are no safety endpoints given that there are no safety risks associated 
with the study.” 
 
10.0 Procedures Involved 
10.1 Study Design:   
Phase 1:  The study design is focus group methodology, a qualitative 
research design in which participants are guided through a freeform 
discussion of a particular issue. The results of will reflect perceptions about 
HIV that are validated directly from the participants themselves. Five focus 
groups will be conducted. 
Phase 2:  The study design is quantitative repeated measures methodology. 
Participant data will be de-identified and used aggregately in repeated 
measures analyses (N=128). 
 
10.2 Phase 1:  Participants will be introduced to the study and given written 
informed consent, with an opportunity to ask any study related questions. 
Participants will be notified that they will be digitally audio recorded 
throughout the duration of the focus group session. The moderator will 
introduce herself and instruct the participants to identify themselves with a 
pseudonym of their choice, and not to use their real names. The moderator 
will begin by asking the first question. Once discussion has begun, the 
moderator will guide the focus group discussion with a series of questions 
using the focus group script. [The focus group script of questions can be 
found in the SmartForms.] The moderator will take notes throughout the 
focus group sessions that will provide context, if needed, throughout the 
discussion. The moderator will carefully watch the time, making sure that all 
questions are asked during discussion within the 1.5-hour time allotted for 
participation. Participants will be thanked for their participation, provided 
light refreshments, and will be given a Target, Amazon, or Wal-mart gift 
card of $45 for participation. 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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Phase 2:  Participants will email or call a dedicated study email/phone line, where 
research assistants will screen them, answer any questions they may have, and get 
them formally enrolled, if applicable. Participants will be given a unique ID 
number. Participants will be emailed a secure unique link to the pre-test survey 
(which will include cover letter consent information – See Section 22.1). 
Participants will complete the pre-test measure. One month after pre-test survey 
completion, participants will be emailed a secure unique line to the post-test survey 
in which they will view the podcast video and complete the post-test measures. 
Participants will be emailed a secure unique link 3 months later to complete a brief 
behavioral outcome questionnaire. The research team will be knowledgeable about 
the podcasting software in order to assist participants in trouble-shooting, if 
necessary. Dark Light Studios will also provide consulting throughout the entire 
research process, if needed. Upon pre-test completion, participants will be emailed 
(or pick up in person) a $20 Walmart, Target, or Amazon gift card; $80 Walmart, 
Target, or Amazon gift card upon post-test completion; and $25 Walmart, Target, or 
Amazon gift card upon 3 month follow-up completion; for an opportunity to receive 
$125 for complete participation. For participants who do not have email addresses, 
research assistants will assist them in obtaining one, within the recruitment 
procedures, if desired; alternately, participants will be able to schedule a time to 
meet at one of the community centers in order to complete pre- and post-test 
surveys in person, and/or to pick up gift card, if needed. 
 
10.3  
There will be no drugs, devices, or biologics used in the research. 
Eligibility Screening Form/Script:  For Phase 1 and 2, the eligibility 
screening form/script will indicate age, race, preferred language, and 
Houston residence status (i.e., “Do you currently reside in Houston MSA?”). 
Phase 1 - Focus Group Script:  The focus group script will contain questions 
that ask about condom use and perceptions of HIV and other STIs. The first 
part of the discussion will ask about familial and media messages 
concerning safer sex (35 minutes); the second part will ask about safe sex 
curriculum materials (25 minutes); and the third part will discuss 
perceptions about condom use (20 minutes). 10 minutes is allotted for 
“anything else” participants would like to share. 
[Eligibility Screening Script and Focus Group Script are attached in 
SmartForms] 
Phase 2 – Survey Data:  Demographics will include age, biological sex, education, 
and income. Based upon the behavioral outcomes we expect participants to adopt 
from the HIV prevention podcasts, we will inquire (pre, 1 mo post, & 3mo): (1) 
frequency of penetrative sexual intercourse acts in the past month, (2) unprotected 
penetrative sexual intercourse in the past month, (3) number of sexual partners in 

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
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the past month, (4) PhenXToolkit Self-reported HIV Results, and (5) condom use 
during the last act of penetrative sexual intercourse.  Based on the knowledge and 
psychosocial cognitions we expect to influence, measures (pre & post) will consist 
of (1) Motivations to use condoms scale, (2) HIV knowledge, (3) attitudes toward 
condom use, (4) condom use self-efficacy, and (5) condom use communication, (6) 
perceived social and subjective norms, (7) feedback concerning HIV prevention 
video content and presentation (1 mo post only), and (8) Marlowe-Crowne social 
desirability scale(1 mo post only). [A copy of the survey measures is attached in the 
SmartForm section]  
10.4 1 month and 3 month follow-up data will be collected from Phase 2 
participants. No follow-up data will be collected form Phase 1 participants.  
 
11.0 Setting 
 
11.1  Phase 1:  Research procedures will be performed within a closed-door conference 
room at a community center in the evenings and/or on Saturdays. Letter of support 
is attached in Smartforms. Phase 2:  Procedures will be performed on participants’ 
individual personal computing device (computer, smart phone, etc.) Participants 
will have the opportunity to arrange to complete study procedure (survey data 
collection and podcast viewing) in person, at a designated community center, if 
needed. 
• 
There will be no involvement of a community advisory board. 
• 
The Blacklist Association, MMOA, Action One Media group, and 
research team will recruit primarily through word-of-mouth and 
directing community members to check out the  IRB-approved study 
flyers that will posted on community bulletin boards within the 
Houston MSA. Community bulletin boards at community centers are 
free to the public. Community centers are available for scheduling 
usage of closed-door conference areas. [Letters of Support are attached 
in Smartforms.] 
 
12.0 Drugs or Devices – N/A 
 
13.0 Risks to Subjects 
13.1 The focus group questions ask about attitudes, efficacy, and perceptions of 
sexual behaviors. This may be minimally uncomfortable psychologically for 
more conservative participants. Participants may decline participation at any 
time while in the study. Participants may also elect not to participate in 
discussing any question that they are not comfortable talking about. No 
procedures are in place by the PI personally to reduce the potential minimal 
psychological discomfort, other than encouraging and allowing participants 

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Communities to Decrease New Infection. 
 
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to self-select out of the study if they are experiencing significant 
psychological discomfort. 
13.2 Phase 2:  The survey questions ask about sexual behaviors and prevention 
behavior. This may be minimally uncomfortable psychologically for more 
conservative participants. Participants may decline and stop participation at 
any time while in the study. Participants may also elect not to answer any 
question that they are not comfortable answering. No procedures are in 
place by the PI personally to reduce the potential minimal psychological 
discomfort, other than encouraging participants to self-select out of the 
study if they are experiencing significant psychological discomfort. 
 
 
14.0 Potential Benefits to Subjects 
There are no direct benefits for participation. 
 
15.0 Provisions to Monitor Data to Ensure the Safety of Subjects – N/A 
 
16.0 Withdrawal of Subjects 
16.1 There are no anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
16.2 If a participant wishes to withdraw from the research during the focus group 
procedure (phase 1), they will be free to leave, the moderator will note this 
in her notes, and their audio data thus far will not be used during 
transcription and analysis. No further contact will be initiated by the 
researcher. If a participant wishes to withdraw from the research during the 
effectiveness phase (phase 2), they will be free to stop all study procedures 
at that time. As stated in the Cover Letter (consent information), they can 
call or email the study contact information and request that they be 
withdrawn from the study, so that no other follow up will be initiated. No 
further contact will be initiated by the researcher.  
 
17.0 Costs/Payments to Subjects 
17.1 There are no costs that subjects may be responsible for due to their 
participation in the described research. 
17.2 Describe the amount and timing of any payments or inducements to 
subjects. 
Phase 1:  Participants will receive a Target, Wal-mart, or Amazon gift card 
in the amount of $45 upon completion of the study procedures. Participants 

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Communities to Decrease New Infection. 
 
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will need to remain in the focus group throughout the duration prior to 
receiving any remuneration; the payment will not be pro-rated. 
Phase 2:  Upon pre-test completion, participants will be emailed (or pick up in 
person) a $20 Walmart, Target, or Amazon gift card; $80 Walmart, Target, or 
Amazon gift card upon post-test completion; and $25 Walmart, Target, or Amazon 
gift card upon 3 month follow-up completion; for an opportunity to receive $125 for 
complete participation. For participants who do not have email addresses, research 
assistants will assist them in obtaining one, if they wish, within the recruitment 
procedures; alternately, participants will be able to schedule a time to meet at one of 
the community centers in order to complete pre- and post-test surveys in person (on 
a university laptop), and/or to pick up gift card, if needed. At each survey activity 
(pre-test, post-test 3mo follow up), participants will need to electronically submit 
the survey prior to receiving any remuneration; the payments will not be pro-rated. 
 
 
18.0 Compensation for Research-Related Injury – N/A 
Research involves no more than minimal risk 
 
19.0 Confidentiality 
19.1 Phase 1:  The PI will not be able to identify any individual’s real identity 
during playback of the audio recordings, only their pseudonym.  The PI will 
physically take digital audio data to the university and it will be downloaded 
with encryption immediately after each focus group on the PI’s university 
office computer, stored there, transcribed, and analyzed on the PI’s UH 
office computer. There will be nothing to connect the participant to any 
transcribed statement. 
Phase 2:  The PI will assign each enrolled and consented individual a unique 
ID number that will be matched to their email address via a study key code. 
Email addresses are needed in order to email each participant their e-gift 
card for participation, should they wish to receive it electronically. The 
study key code will be a spreadsheet and will be encrypted and located on 
the PI’s secure university computer. 
Phase 1:  Study participation will collect consent forms that will not be 
linked to any audio file data and will be kept stored and locked in 
researcher’s on-campus office. The consent form will include participant 
signatures which are direct identifiers. However, the consent form will not 
be linked to audio file data. 
Phase 2:  ID numbers will be linked to their pre, post, and follow-up 
assessment. Email addresses will be collected in the pre-test. This will be 
the only identifying information for study participation. An encrypted 

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spreadsheet will identify participant’s email address and study ID number 
(study key code); stored on the PI’s secure university computer. Email 
addresses are needed for the distribution of electronic gift cards. Gift cards 
will be emailed with encryption. If participants do not wish to provide an 
email address, they will be given the option to pick-up their gift card at a 
designated community center at each point of study participation (pre, post, 
and follow-up). 
 
A certificate of confidentiality will be used in this research. The following 
language is documented in the consent form and cover letter: 
“This research is covered by a Certificate of Confidentiality. The researchers with 
this Certificate may not disclose or use information, documents, or email addresses 
that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, 
if there is a court subpoena. Information, documents, responses, and/or email 
addresses protected by this Certificate cannot be shared with anyone else who is not 
connected with the research except, if there is a federal, state, or local law that 
requires disclosure. The Certificate cannot be used to refuse a request for 
information from personnel of the United States federal or state government agency 
sponsoring the project that is needed for auditing or program evaluation by the 
National Institute of Heath which is funding this project.  You should understand 
that a Certificate of Confidentiality does not prevent you from voluntarily releasing 
information about yourself or your involvement in this research. If you want your 
research information released to an insurer, medical care provider, or any other 
person not connected with the research, you must provide consent to allow the 
researchers to release it.” 
19.2 No one outside the research team will have access to any identifiers. 
19.3 The key to the study code will be destroyed following completion of all data 
collection procedures or at the end of study completion.  
19.4 Phase 1:  The recordings will be destroyed upon transcription.  
20.0 Provisions to Protect the Privacy Interests of Subjects 
 
Phase 1:  Participants will be told that they are not required to interact with anyone they 
do not wish during the group discussion. They will not have to give any written personal 
information except for signature on consent form. Participants will be told that they do 
not have to participate in discussion that they do not want to. Participants will also be told 
that if they feel uncomfortable or if any question is too intrusive, they can discontinue 
participation and help themselves to light refreshments upon leaving, without incidence 
or penalty. 
 
Phase 2:  Participants will be told that they are not required to answer any question that 
they do not feel comfortable answering. They will not have to give any written personal 
information except for email address, should they wish to have their gift card emailed. 

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Participants will be told that they can discontinue participation at any time, and/or 
withdraw themselves through emailing the study team (information found on Cover 
Letter – See Section 22.1).  
 
21.0 Informed Consent Process 
 
21.1 The researcher will be obtaining consent: 
• 
Phase 1:  Consent will take place in a closed-door conference room at 
Jacob’s Group Home conference room on the day of anticipated study 
participation.  Phase 2:  Consent will take place via the “accept” button 
on the electronic survey (See Section 22.1). 
• 
There is no waiting period between informing the prospective subject 
and obtaining the consent. 
• 
Phase 1:  There will be no ongoing consent. Participation is cross-
sectional, meaning no other participation is required upon completion 
of their focus group. Additionally, participants who were a part of a 
previous focus group will not be allowed to attend or participate in a 
subsequent focus group.  
Phase 2:  There will be no ongoing consent. Consent to the initial pre-
test (in the form of electronic cover letter – See Section 22.1) will 
consent participants for the current data collection and follow-ups.  
Participants are able to leave any question blank they do not wish to 
answer, or withdraw from the study any time, via email, and no further 
contact will be initiated (-as stated in the Cover Letter consent 
information document).  
• 
I will be following “SOP: Informed Consent Process for Research 
(HRP-090).”  
Non-English Speaking Subjects:  N/A  
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception):  N/A 
Subjects who are not yet adults (infants, children, teenagers):  N/A 
Cognitively Impaired Adults:  N/A 
Adults Unable to Consent:  N/A 
 
22.0 Process to Document Consent in Writing 
22.1 Phase 1:  I will be following “SOP: Written Documentation of Consent 
(HRP-091).”  
Phase 2:  We are requesting a Waiver of Written Consent because survey 
data collection will be obtained online through a secure survey portal. This 
research presents no more than minimal risk of harm to subjects; and the 

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research procedures include activities that would not require written consent 
outside of the research context. Consent information will appear as a cover 
letter on the first page of the online survey, followed by confirmation (click 
“accept” button) that the participant has read the consent information and 
agrees to take part in the research. If a participant disagrees, the survey is 
closed. If a participant agrees, their response is recorded as a part of their 
survey data. 
22.2 Written Consent form for phase 1 is attached in SmartForm  
22.3 Cover letter (consent information) for phase  2 is attached in SmartForm 
 
23.0 HIPAA- N/A 
24.0 FERPA – N/A 
 
25.0 Data Management 
25.1 Phase 1:  Data Analysis will include transcribing the focus group data, 
examining all the transcriptions aggregately and analyzing the qualitative 
data for common themes, as thematic analysis will constitute the analysis 
procedure. 
Phase 2:  Data analysis will include aggregating the data, eliminating any 
identifiers, and performing repeated measures t-tests on the study variables 
of interest.  
 
25.2 Phase 1:  Electronic data (audio files and transcripts) will be secured and 
encrypted on my on-campus university computer in my office.  Consent 
forms, will be stored in separate folders in a locked file cabinet.  
Phase 2:  Electronic data will be secured and encrypted on my on-campus 
university computer in my office. Study key code spreadsheet (linking 
participant ID number with email address) will be encrypted and stored 
securely on my office computer.  
25.3 Data will be stored for seven years 
25.4 Only the PI (researcher) and approved student research team members will 
have access to the raw data. 
25.5 The PI (researcher) will be responsible for receipt of the data (Both Phases). 
25.6 Phase 1:  One approved student research team member will have access to 
the audio files and will be responsible for all audio transcription. 
Transcription will take place only on the PI’s university-issued laptop within 
the researchers’ office during student researcher’s work hours. Audio 
transcription files will be password protected on the UH secure server.  

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
Page 15 of 16 
Revised: February 28, 2025 
Phase 2:  Approved student researchers will have access to the de-identified 
data. All data analyses will take place only on the PI’s university-issued 
laptop within the researchers’ office during student researcher work hours.  
25.7 Data will not be banked for future use. 
 
26.0 Specimen Use and Banking – N/A 
 
27.0 Community-Based Participatory Research – N/A 
 
28.0 Sharing of Results with Subjects 
28.1 Study results will be shared with participants only through public article 
publication only if participant contacts researcher about the study, post-
study. 
 
29.0 Resources  
29.1 I am an associate professor in the college of education. The proposed 
research consists of cross-sectional qualitative study data. The researcher 
has previous training in the facilitation of focus groups and extensive 
training in collecting and analyzing focus group data. The PI has completed 
a post-doctoral appointment at The Pennsylvania State University’s The 
Methodology Center and learned cutting-edge statistical procedures 
(quantitative and qualitative) involved in health and prevention research. 
The PI also currently instructs the research and methodology course within 
her department program, authors and co-authors manuscripts on sexual risk 
behavior, and often serves as qualitative (and quantitative) methodologist on 
student dissertation committees and research papers. 
 
29.2 Resources 
There are approximately 50-100 people to come out to various 
community service events (neighborhood cleanups, cultural fairs, other 
special events, etc.). With the assistance of a trusted community 
organization, the Blacklist Association, I anticipate that finding five  
groups of seven African American adults willing to participate is 
feasible.  
• 
I intend to devote my academic and summer months to the data 
collection period and data analysis. 
• 
Facilities include university office, university computer, and 
department access to schedule a classroom in Farish Hall for research 
team meetings.  

FULL PROTOCOL TITLE: Podcasting HIV Prevention within African American 
Communities to Decrease New Infection. 
 
Page 16 of 16 
Revised: February 28, 2025 
• 
There is no anticipated medical or psychological resource that subjects 
might need as a result of a consequence of the human research. 
• 
Any persons assisting with the research data analysis will be 
adequately informed about this protocol, the research procedures, and 
their duties and functions. All research team assistants who will 
potentially participate in either phase of the research will have been 
personally trained by the PI and are/will be added to the IRB before 
their human subjects interactions. The student research team member 
who will have access to the raw data for transcription will be added to 
the IRB. 
 
30.0 Additional Approvals – N/A