Mitigating Sexual Stigma Within Healthcare Interactions to Improve Engagement of MSM in HIV Prevention
Phase: NA
Conditions: Human Immunodeficiency Virus, Stigma, Social, Patient Engagement
Sponsor: Albert Einstein College of Medicine

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1) Background/Significance 
 
Stigma remains a pernicious impediment to health for gay, bisexual, and other men who 
have sex with men (MSM), discouraging their disclosure of health-related conditions and 
sexual activities; deterring their access to HIV prevention tools; and impinging on their 
psychological wellbeing. During healthcare encounters in particular, stigma confronts 
MSM with a vexing dilemma: disclose sexual activity to access MSM-specific care or 
conceal it to avoid discrimination but remain distanced from the HIV interventions and 
services they desperately need. Engaging at-risk MSM requires that healthcare workers 
(HCWs) communicate in ways that mitigate rather than exacerbate pervasive stigma 
toward their sexual behavior, and specifically toward anal sex, the most proximate risk 
factor for HIV infection among MSM. HCWs report a lack of knowledge and skill assessing 
MSM’s sexual behavior and, unsurprisingly, discomfort conducting sexual histories, 
thereby missing opportunities to triage for HIV/STI interventions. Multicomponent, 
intersectional strategies can train HCWs to prevent enacting stigma, but are also needed 
to help HCWs proactively inoculate MSM against internalized and anticipated stigma that 
otherwise would continue to deter care. To date, however, there are no tested, evidence-
based programs to mitigate stigma toward anal sexuality. Consequently, MSM remain 
deterred from discussing the very sexual activity that places them at greatest risk of HIV 
acquisition and transmission. Through this study, we intend to develop, pilot, and evaluate 
a new behavioral HIV intervention for HCWs to mitigate anal sex stigma, in order to 
improve both the quality of care and HIV-related outcomes among MSM.  
 
2) Study Design 
  
We describe study design for Aim 1 and Aim 2, because we are awaiting approval from 
an NIMH program officer for Aim 3 study design changes to the funded protocol. An 
amendment will be submitted prior to conducting any activities for Aim 3.  
 
Aim 1: Explore drivers that perpetuate and techniques and mechanisms that mitigate anal 
sex stigma during healthcare encounters by interviewing a diverse sample of HCWs (N = 
20) and MSM (N = 20) in the US.  
 
Aim 2: Develop an intersectional stigma-mitigation intervention with mHealth, workshop 
and coaching components, in collaboration with an 8-person Advisory Board of 
MSM/healthcare consumers and HCWs and informed by Aim 1, to improve HCW 
competence to discuss anal health and sexuality and thereby promote HIV prevention.  
 
Aim 3: Pilot the intervention in a pre-post, sequential explanatory mixed method design 
among 120 HCWs who do not specialize in MSM care, working in two regions where HIV 
incidence among MSM remains high. Longitudinal surveys and select follow-up interviews 
will evaluate: (a) implementation outcomes (i.e., acceptability, feasibility, and 
appropriateness) and (b) preliminary impact on mechanisms of action (e.g., knowledge, 
skills, intention, resources) as well as HIV/STI screening activities (e.g., initiating 
assessment of sexual behavior).  
 
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In Aim 1, we conducted a mixed-methods sequential explanatory design. This involved 
an online survey to screen and purposively sample 20 cisgender MSM and 20 HCWs, 
followed by a onetime, hourlong in-depth interview with these same participants. To be 
eligible, MSM needed to report: being aged 18 or older, identifying as male, residing in 
the US, being able to read and communicate in English, and having had anal intercourse 
with a man in the past year or intend to in the next year. HCWs needed to report: being 
aged 18 or older, being able to read and communicate in English, bearing a role 
responsibility for HIV-related screening and referral (e.g., as a peer/outreach worker, test 
counselor, case manager, social worker, medical assistant, nurse, physician assistant, 
physician). The primary outcome of Aim 1 is to identify qualitatively a set of techniques 
and mechanisms that could mitigate anal sex stigma during clinical encounters between 
HCWs and MSM and that would be acceptable, feasible and appropriate for both HCWs 
and MSM populations. We conducted rapid qualitative analysis, using debriefing forms 
after each interview and then templates to extract constructs from our qualitative inquiry 
guide. These were then added to a spreadsheet that also contained survey responses, 
and then a matrix analysis was conducted to establish themes for barriers, facilitators, 
techniques and mechanisms of action. 
 
In Aim 2, we are consulting with an Advisory Board of up to 8 adult MSM/healthcare 
consumers and HCWs to develop the content of an intervention for HCWs, which is likely 
to comprise an online informational component, an in-person skills workshop, and 
coaching calls after the workshop. This involves periodic 60- to 90-minute online meetings 
with members of the Advisory Board to discuss their feedback about findings in Aim 1 
and to provide guidance as we develop the intervention. To be eligible, MSM/consumers 
need to report the same criteria as Aim 1, altered to allow for more gender inclusion: 
identifying as cisgender male/female/nonbinary/transgender. The gender criterion was 
expanded based on feedback from Aim 1, with participants recommending the 
development of an intervention that did not singularly address stigma among cisgender 
MSM. HCWs needed to report the same eligibility criteria as Aim 1. The primary outcome 
of Aim 2 is to elicit feedback from the Advisory Board and to develop the intervention. 
Data analysis involves taking notes based on each Advisory Board meeting and then 
consulting within the research team to revise plans for intervention development based 
on the Advisory Board’s recommendations. 
 
In Aim 3, we will pilot the intervention in two region where HIV incidence is high among 
MSM, the US Northeast and Southeast. In collaboration with two regional AETCs (AIDS 
Education and Training Centers), we will recruit HCWs from clinical sites that are under-
engaging MSM in HIV services. A link to an online Information Statement will describe 
study procedures and follow with demographic and psychosocial questions. To be eligible 
for participation in Aim 3, HCWs need to (1) bear a role responsibility for screening, 
referral or delivery of HIV services (e.g., education, counseling, testing, PrEP/ART); (2) 
be 18 or older; (3) read, speak, write English; and (4) be new to the study. Those who 
consent will be prompted to create a unique identification number (PTID). Select in-depth 
interviews prior to the implementation of the intervention will inform tailoring the 
intervention within the region. The intervention will then be delivered during a two-day in-
person workshop, where HCWs will be introduced to a website of resources. Participants 
will retain access to the website after the workshop and HCWs who work at a specific 
target site will receive additional coaching sessions. Baseline and follow-up surveys and 
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in-depth individual interviews will be administered to evaluate the intervention. The goal 
of Aim 3 is to assess the acceptability, feasibility, and appropriateness as well as 
preliminary impact on HCW’s ability to discuss anal sexuality and thereby to promote 
status neutral HIV/STI prevention among MSMs.  
  
3) Study Population  
 
a) In Aim 1, we sought to enroll a geographically, racially and ethnically diverse 250-
person sample of cisgender MSM living in the US, who report variable comfort 
discussing anal health and sexuality during healthcare encounters. For HCWs, we 
are likewise seeking to enroll a geographically, racially and ethnically diverse 
sample of 250 HCWs, including women and MSM HCWs, as well as limited 
enrollment of publicly recognized experts living outside the US in order to learn 
about stigma mitigation practices introduced in other contexts that may be relevant 
to evaluate in the US context. For HCWs, we also seek variable expertise working 
with MSM as well as variable comfort and frequency broaching anal health and 
sexuality in clinical encounters with their male clients.  
 
For in-depth interviews with 20 MSM and 20 HCWs, we intend to purposively 
sample from each of the 250-person samples, seeking representative of 
geographic, racial and ethnic diversity and variability in comfort discussing and 
broaching anal health and sexuality during clinical encounters. For HCWs, 
sampling will also seek to establish diversity in expertise working with MSM based 
on service population and specialty (e.g., LGBTQ/HIV/MSM services; anal health; 
general hospital).  
 
In Aim 2, we have sought to enroll healthcare consumers and healthcare workers 
to serve on an Advisory Board of up to 8 participants. The population of healthcare 
workers in Aim 2 remains the same as described above in Aim 1. In the funded 
proposal, we planned for Aim 2 consumers to reflect the same population of 
cisgender MSM as described above under Aim 1. However, Aim 1 feedback from 
participants included the recommendation that the intervention in Aim 2 should 
include content that is broadly relevant not just to serving cisgender MSM but also 
to serving additional populations (e.g., transgender and nonbinary people). We 
therefore added the option to expand the Advisory Board beyond cisgender MSM, 
so that the intervention reflects the recommendation of including content for HCWs 
that is more broadly applicable across patient populations. We received approval 
from the NIMH program officer.  
 
For both Aim 1 and Aim 2, participants needed to be 18 years or older for both Aim 
1 and Aim 2. We also purposefully sampled for participants living with HIV to 
ensure that we collected data on the lived experience of people living with HIV for 
the intervention. The sample sizes for Aim 1 and Aim 2 were established based on 
an estimate of saturation of qualitative themes, for Aim 1, and based on the 
likelihood of sustained engagement and group cohesion during meetings, for Aim 
2. 
 
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For Aim 3, a total of 120 HCWs will be recruited in two regions. To yield n = 60 
intervention participants per region, we will aim for n ~90 consented, estimating a 
conservative 70% retention rate based on the AETC and similar procedures in 
Ohio and China. Prior to implementation of the intervention, we plan to interview 
approximately 5 clinic staff within each region, to inform tailoring the intervention 
to their local context. A subset of 15 HCWs in each region will be purposively 
sampled for post-intervention interviews based on initial observations, survey 
responses and reactions during intervention, racial/ethnic diversity, and diversity 
of professional role.  
 
b) Inclusion criteria are the same as those stated in (2) Study Design.  
 
c) Minors were not included because a separate, age-specific study in adolescent 
cisgender males who have sex with males is warranted and preferable. Non-
English speaking people were excluded due to limitations in the study team’s ability 
to conduct surveys, interviews and Advisory Board meetings in languages other 
than English. There were no exclusion criteria. 
 
Please note that the Inclusion Enrollment Reports in the original K23 proposal (a 
resubmission) mistakenly did not include women, even though the initial proposal 
did include women. The correct gender, racial and ethnic breakdown is below.  
 
Women are overrepresented in the field of healthcare but will comprise ~40% of 
HCW interviews. The remaining ~60% of HCWs will be among men and other 
gender identities, some of whom identify as MSM themselves. We are targeting 
enrollment of more men and other gender identities than women in order to include 
MSM HCWs, who will likely have valuable insights to share in their dual role as 
both a sexual minority male and a HCW.  
 
Special efforts will be made to ensure the participation of individuals from diverse 
ethnic and racial backgrounds. Black/African American and Hispanic/Latino 
populations account for approximately 13% and 17% of the U.S. population, but 
37% and 30%, respectively, of new HIV diagnoses. There are also significant 
differences in the extent to which racial and ethnic minority MSM conceal their 
sexual orientation and sexual behavior during healthcare encounters, and these 
differences are associated with compromised engagement in services. The 
intervention seeks to address intersectional stigmas that influence both HCW and 
MSM behavior during healthcare encounters. Therefore Black/African American, 
Hispanic/Latino MSM, and additional ethnic/racial minority populations will be 
oversampled in order to increase the likelihood that the proposed intervention will 
be acceptable, feasible, appropriate and ultimately effective for those MSM who 
experience the greatest disparities in the HIV epidemic.  
 
d) Subjects who do not have the capacity to consent were not enrolled in Aim 1 or 
Aim 2 and will not be enrolled in Aim 3. 
 
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e) Materials will be obtained from individually identifiable living human subjects 
through typed responses to online surveys, audio recorded and transcribed in-
depth interviews, and audio recorded and transcribed Advisory Board meetings. 
 
4) Participant Recruitment  
 
Aim 1: Recruitment occurred online through distribution of a link to an online 
screening, consent and demographic survey, hosted by Qualtrics. The PI and study 
staff distributed a study link through electronic announcements to listservs of 
professional groups; online interest groups and social networking sites; email 
(including through the Qualtrics survey platform and direct outreach to potential 
participants known in the field); as well as paid advertisements through men-seeking-
men sites and geolocating applications (e.g., Grindr, Scruff) to encourage snowball 
sampling of online screening survey participants.  
 
Interested HCWs and MSM who clicked on the study link were shown an eligibility 
screening survey and asked to complete the entire screening regardless of their 
eligibility for any specific criteria. Those who consent by clicking past an Information 
Statement were asked to create a personal participant ID number (PTID) and to 
respond to questions about their demographics, their comfort and willingness to 
discuss anal health and sexuality during healthcare encounters, experience working 
with MSM (for HCWs), and preferences for communication by email, telephone 
voicemail, or text message. MSM respondents were offered the option to choose a 
pseudonym and to create an alternate email address for future contact. Based on 
these responses, we purposively sampled MSM and HCWs for in-depth interviews.  
Among consented HCW and MSM respondents purposively sampled for diversity, the 
PI/study staff called to schedule an interview or emailed or texted a link to a HIPAA-
secure online scheduling platform for participants to select an interview time. Those 
who received a link to schedule were asked to reenter their PTID to link their survey 
data to their scheduled interview. 
 
Recruitment materials and the eligibility screener will not indicate the full requirements 
for eligibility, in order to minimize the potential for deceptive enrollment. To ensure 
ethnic and racial diversity, electronic announcements will be adjusted to oversample 
racial/ethnic minority participants, as needed, with images and language specific to 
these groups. After completing the online survey, whether eligible and ineligible, 
respondents will be shown a screen at the end of the survey to forward the survey link 
to other potentially eligible respondents.  
 
Aim 2: Recruitment has occurred through telephone, email and text message 
outreach, including through REDCap. Within the Aim 1 online survey, participants 
were asked if they would like to be contacted about future research and, during Aim 1 
in-depth interviews, the PI (Dr. Kutner) asked participants about their interest in 
serving on an Advisory Board. Those who assented orally to follow up contact for 
inclusion in the Advisory Board had a note attached to their PTID in the data 
repository, assenting to future contact for recruitment. The PI/study staff have called, 
emailed or texted these participants, based on the preferences documented in their 
study record, to update them about the formation of the Advisory Board and to gauge 
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their interest in participation. This same process has been used to approach and 
recruit additional Advisory Board members who did not participate in Aim 1, with a 
slightly adapted message to introduce the study.  
 
For previous participants, no advertising or publicity is necessary; we will simply follow 
up with them about their interest in participating in Aim 2’s Advisory Board. For the 
additional Advisory Board members who did not participate in Aim 1, we do not plan 
advertising or publicity, except to consult within professional networks of healthcare 
providers and colleagues who collaborate with scholars and providers of nonbinary 
and transgender participants and patients, to develop a list of potential Advisory Board 
members.  
 
For both Aim 1 and Aim 2: Prior to interviews and Advisory Board meetings as well as 
during both of these procedures, participants were reminded that their participation is 
voluntary and that they could decline to answer any question posed during the course 
of the study and could decline to participate any further at any point during the study. 
 
For Aim 3, recruitment will be done in collaboration with two AETC regional 
collaborators. These AETC collaborators report sufficient community interest in this 
topic to feasibly recruit 120 HCWs and will introduce study staff to local healthcare 
leaders and community-based organizations to cultivate partnerships. Recruitment 
will occur through regional outreach, using the existing infrastructure and relationships 
of the AETC. Potential participants will then receive an email invitation, citing these 
partnerships. A link to an online Information Statement will describe study procedures 
and follow with demographic and psychosocial questions as part of the baseline 
assessment.  
 
5) Informed Consent  
 
Aim 1 Information Statement. Interested HCWs and MSM who click on the Qualtrics 
study link were prompted to answer eligibility questions in an online survey and, if 
eligible, shown an Information Statement describing study procedures and including 
a HIPAA form. The Information Statement detailed the purpose, procedures, benefits, 
and risks of participation and the right to withdraw from the study at any time. Eligible 
respondents who wished to consent could do so by clicking "Yes" in response to the 
question "Do you want to be part of this research study?" on the Information 
Statement. Respondents could also click "I'm not sure" and be prompted to enter a 
phone number or email or to contact the Principal Investigator to further discuss their 
concerns prior to consenting. All participants were provided with a copy of the 
Information Statement, which included contact information for the Principal 
Investigator and for the NYSPI IRB, as a downloadable PDF. Each page of the 
subsequent online survey of demographic characteristics also included the ability to 
email or call voicemail of the study PI directly through a hyperlink. Before each in-
depth interview, the PI also confirmed informed consent, provided time for questions 
from the participant, and provided any answers to questions that arose.  
 
Aim 2 Information Statement. Interested healthcare consumers and HCWs were sent 
a study link as in Aim 1, but hosted on REDCap instead of Qualtrics, with a modified 
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eligibility survey and modified Information Statement that includes a HIPAA form.  The 
procedure in Aim 2 has been the same as in Aim 1, except that study staff (Rebecca 
Giguere and Baichun Hou) have confirmed informed consent, on an individual basis 
with each Advisory Board member, and provided time for questions from the 
participant, and provided any answers to questions that have arisen.  
 
Aim 3 Information Statement. HCWs will be sent the Information Statement within an 
online survey hosted by REDCap or Qualtrics, which will include contact information 
for the Principal Investigator as well as a downloadable PDF of the Information 
Statement. The Aim 3 Information Statement describes the same components of Aim 
1 and Aim 2, except that the study procedures and study compensation are specific 
to Aim 3 procedures. 
 
In Aim 1, we conducted interviews by telephone or video through Zoom Pro. In Aim 2, 
Advisory Board participants may choose to keep their cameras off and/or to change 
their screen name, if they would like to remain more anonymous to their fellow 
Advisory Board members. In Aim 3, telephone or video through Zoom Pro will also be 
used. Written consent is the only link between the subject's identity and the research 
data, so we have requested a waiver of documentation of consent in order to remove 
the risk of a breach of confidentiality for research participants during their participation 
in all aims of the study. 
 
Aim 1 participants were compensated for their time completing hourlong interviews 
with a $50. Aim 2 Advisory Board members are being compensated $100 for 
participation in each of six to eight ~90-minute meetings over the course of nine 
months, of which two have already occurred. Aim 3 participant compensation will vary 
depending on their participation in each assessment, ranging between $90 and $190 
($50 for each in-depth interview, with a maximum participation of two interviews per 
participant, and $30 for each survey, with a maximum participation of three surveys).  
 
6) Risk/Benefit  
 
The risks are the same in Aim 1, Aim 2 and Aim 3:  
 
a) The main risk of study participation is loss of confidentiality and potential 
consequences thereof. An unintended person (e.g., family members, employers) 
could find out about a participant’s sexual identity, sexual behavior, HIV status as 
well as their stigmatized or stigmatizing behavior. Unintentional disclosure of 
sexual minority status may place participants at risks for social harm such as 
exclusion from family, job loss, harassment, and discrimination.  
 
b) Additional risk for participants includes distress when discussing issues related to 
stigma during healthcare encounters. The MSM population and other healthcare 
consumer populations who practice anal sex engage in behavior that is socially 
stigmatized and HCWs may themselves experience embarrassment with regard 
to the sexual subject matter, whether or not they engage in similar behavior. HCWs 
may also experience distress at the recognition, during assessments, that their 
own beliefs and actions could be perceived as perpetuating stigma toward their 
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clients. It is possible that participants may experience feelings of embarrassment, 
discomfort or distress when answering questions concerning sexuality, disclosure 
of sexuality or sexual behavior, experiences of stigma, and related stressful 
events.  
 
To minimize the risk of a breach of confidentiality, in addition to a waiver of 
documentation of consent: 
 
• Participants have received a downloadable PDF of their Information Statement and 
been instructed to keep any forms private, because if discovered by others, these 
might disclose their participation in the study to others.  
• Any identifying information within survey data (e.g., email address, telephone 
number) are removed from downloaded datasets and stored in a separate 
password protected file, linked only by the PTID. A list linking survey PTID and 
scheduled interview date is kept in a password protected file on OneDrive for 
Business, which holds a HIPAA Business Associate Agreement with the New York 
State Psychiatric Institute. This will be transferred to SharePoint at Einstein, upon 
approval of a data sharing agreement. 
• IP addresses are deleted immediately from any downloaded data set, after 
completing analyses for potentially duplicate respondents in online surveys.  
• Data have been deleted permanently from the online survey platforms after all data 
collection has ended.  
• MSM and healthcare consumer participants are being asked about various ways 
through which they can safely be contacted, including the option to use a 
pseudonym and an alternate email address.  
• All interviews and Advisory Board meetings have been and will continue to be 
conducted in private spaces. Interviews only include the participant(s) and the 
interviewer/research staff.  
• During interviews/Advisory Board meetings, only audio is saved. Some video 
conferencing platforms automatically record video along with audio; participants 
are forewarned of this limitation as well as of the option to rename themselves and 
to turn off their cameras; video files are deleted immediately after sessions are 
completed. File transfer of audio recordings for third-party transcription occurs 
through a secure file transfer protocol (FTP). Any identifying information recorded 
during qualitative interviews is removed during transcription. All audio-recordings 
has been and will be destroyed after final transcription and analysis.  
• All qualitative data (digital recordings, transcriptions, and data bases) and 
quantitative data is coded with PTIDs and stored in password protected files on 
HIPAA-secure servers, as appropriate.  
• All study staff have sign confidentiality pledges and are required to receive training 
on confidentiality issues.  
• The PI, primary mentor, co-mentors and advisors all must complete NIH training 
in Human Subjects Protections. New staff will be required to do the same.  
• Data summaries are written in such a way that they do not identify individuals but 
summarize findings. No individual identities will be used in any reports or 
publications. 
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• Additionally, as NIMH is funding the study, a Certificate of Confidentiality will be 
awarded, pro forma.  
 
To minimize the risk of discomfort participants have been informed that their 
participation in this study is voluntary and reminded that they do not have to answer 
any questions that they do not want to answer, that they are free to refuse to 
participate or leave the study at any time. Information Statements highlight the 
potential risk of disclosure of sexual minority status, sexual behavior, HIV status, and 
involvement in stigmatized or stigmatizing behavior, and its consequences due to 
participation in the study.  
 
This study has not been designed for the direct benefit of the participants. However, 
there are several ways in which participants may derive benefit. First, participants may 
benefit from disclosing their perceptions of stigma that occurs during healthcare 
encounters. Participants might feel relief in discussing a topic which is rarely 
discussed with another person. Participants may indirectly benefit by providing 
information that may contribute to knowledge about intervention development to 
improve the quality of care and engagement of MSM.  
 
7) Data Analysis 
 
Only univariate statistics are planned for quantitative data from Aim 1 and Aim 2. Aim 
3 will involve both univariate statistics as well as inferential statistics. 
 
The primary outcome of Aim 1 is qualitative, to identify a set of techniques and 
mechanisms that could mitigate anal sex stigma during clinical encounters between 
HCWs and MSM and that would be acceptable, feasible and appropriate for both 
HCWs and MSM populations. We conducted rapid qualitative analysis, using 
debriefing forms after each interview and then templates to extract constructs from 
our qualitative inquiry guide. These were then added to a spreadsheet that also 
contained survey responses, and then a matrix analysis was conducted to establish 
themes for barriers, facilitators, techniques and mechanisms of action. 
 
The primary outcome of Aim 2 is to elicit feedback from the Advisory Board and to 
develop the intervention. Data analysis involves taking notes based on each Advisory 
Board meeting and then consulting within the research team to revise plans for 
intervention development based on the Advisory Board’s recommendations. 
 
The primary outcomes of Aim 3 are both qualitative and quantitative, to assess 
implementation outcomes as well as preliminary effects of the intervention among 
healthcare workers. As in Aim 1, for Aim 3 we will conduct rapid qualitative analysis, 
using debriefing forms after each interview and then templates to extract constructs 
from our qualitative inquiry guide. These will then be added to a spreadsheet that also 
contains survey responses, and then a matrix analysis will conducted to establish 
themes. For quantitative data, we will assess implementation outcomes using 
descriptive statistics and assess changes in mechanisms of action, behavior and 
quality of care using paired t-tests.  
 
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8) Data quality control and database management. 
 
For Aim 1 and Aim 2, quantitative data have been collected via online surveys, 
downloaded and imported into SPSS and then stored on SharePoint in password-
protected files. Audio files are downloaded and stored on OneDrive for Business along 
with transcripts, all in password protected files. The Principal Investigator conducts 
data quality control and checking and editing quantitative data. In Aim 2, data has 
been been stored in REDCap and managed on a daily basis by the study’s research 
coordinator, Baichun Hou, with oversight by the PI. All data are stored only on 
password protected, HIPAA-secure websites. Aim 3 will continue the same data 
collection and storage procedures as Aim 2. 
 
Aim 1 and Aim 2 data are currently stored in SharePoint and REDCap at Einstein, 
where Aim 3 data will also be stored. Data for Aim 3 may also be stored in Qualtrics 
at Einstein. 
 
9) Data Safety Monitoring 
This study is scheduled for review by the Performance and Safety Monitoring Board of 
the HIV Center for Clinical and Behavioral Studies at New York State Psychiatric 
Institute and Columbia University. The most recent review was on November 11, 2022 
and there were no concerns regarding the performance, monitoring and safety of the 
study and recommended the continuation of the study as planned. 
 
10) References: None 
  
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