Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Phase: NA
Conditions: Hiv
Sponsor: Environment and Health Group, Inc.

 
Approved: 12/10/2020 
Expires: No Expiration Date 
Study ID: 20-ENVI-112 
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult Men 
Phase 2 
NCT04633200 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dr. Patricia Weitzman  
Environmental and Health Group  
Cambridge, Massachusetts  
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM, Phase II  
Study Protocol #2 R44 MH112221-02  
  
  
  
November 23, 2020  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

Protocol #2 R44 MH112221-02  
2  
Version: 3  
November 23, 2020  
  
  
Approved: 12/10/2020 
Expires: No Expiration Date 
Study ID: 20-ENVI-112 
Protocol #:  2R44MD009454 - 03  
Version: 1   
Date: November 23, 2020  
  
Table of Contents:  
  
Study Schema  
1.0  Background ......................................................................................................................... 3 
2.0  Rationale and Specific Aims .................................................................................................. 4 
3.0  Inclusion/Exclusion Criteria ................................................................................................... 4 
4.0  Recruitment, Enrollment and Consent Procedures ................................................................. 4 
5.0  Study Procedures ................................................................................................................. 5 
6.0  Reporting of Adverse Events or Unanticipated Problems Involving Risk to Participants or   ......... 6 
Others ............................................................................................................................. 6 
7.0  Study Withdrawal/Discontinuation ......................................................................................... 7 
8.0  Statistical Considerations ...................................................................................................... 7 
9.0  Privacy/Confidentiality Issues ................................................................................................ 7 
10.0 Follow-up and Record Retention ........................................................................................... 7 
 
  
  
  
  
  
  

Protocol #2 R44 MH112221-02  
3  
Version: 3  
November 23, 2020  
  
  
Approved: 12/10/2020 
Expires: No Expiration Date 
Study ID: 20-ENVI-112 
  
  
  
  
  
  
  
  
1.0  
Background  
In 2017, people age 13-29 represented 23% of the U.S. population, yet accounted for 41% of new 
HIV diagnoses (Avert, 2019; Ocfemia et al., 2018). Within this group, HIV rates were highest among 
young men who have sex with men (YMSM), especially minority YMSM (Avert, 2019; Ocfemia et al., 
2018). Indeed, among African American YMSM, new HIV infections increased 48% from 2006-2009 
(CDC, 2011). Latino YMSM are also at higher HIV risk compared to their non-Latino white peers, 
accounting for 25% of new HIV infections among young people (CDC, 2019a). Not surprisingly, the 
greatest increase in sex without condoms between 2005 and 2014 was among YMSM (Paz-Bailey et 
al., 2016). Clearly, there is a public health imperative to prevent new HIV infections among YMSM. 
And, because minority YMSM are at especially high risk, there is a health equity imperative to do so 
as well.  
  
Pre-exposure prophylaxis, or PrEP, is a breakthrough medication for preventing HIV. PrEP treatment 
involves a daily pill (known by the trade name Truvada). Consistent, daily adherence to PrEP reduces 
HIV risk by 92-99% (CDC, 2019b). PrEP treatment guidelines also include the use of condoms and  
HIV testing every 3 months (CDC 2017). NIH has designated preventing HIV/AIDS, including through  
PrEP, as a high-priority topic for research support using AIDS-designated funds. The CDC (2017;  
2019b) estimates at least 1 in 4 MSM are PrEP candidates. Due to the alarming rise in HIV among 
YMSM, the CDC also strongly recommends that healthcare providers reach out to this group, in 
particular, for PrEP treatment (CDC, 2012; 2019a).  
  
Moreover, the CDC (2017) recommends that all PrEP patients receive adherence support as strong 
adherence is key to PrEP effectiveness. Adhering to PrEP may be especially hard for YMSM 
because, developmentally speaking, young adults are less able to appreciate the benefits of 
consistent prevention and/or are less good at planning ahead than adults who are older (Simpson, 
2008; Steinberg 2008). Mhealth is an ideal way to reach young people due to the ubiquity of mobile 
phone ownership and use among adolescents and young adults (Taylor & Silver, 2019). Many studies 
of the impact of text messaging on medication adherence have been conducted, and results show 
that, across chronic conditions, text messages can have a positive impact (Thakkar et al., 2016). 
Partly because of this, there are now a plethora of multi-feature mobile apps to support medication 
adherence, yet very few of these apps have been clinically evaluated (Ahmed et al., 2018; Santo et 
al., 2016; 2017). Thus, the need for a PrEP mhealth adherence app for culturally-diverse YMSM 
remains urgent, which is why we are eager to move forward with Phase 2 of DOT.  
  

Protocol #2 R44 MH112221-02  
4  
Version: 3  
November 23, 2020  
  
  
Approved: 12/10/2020 
Expires: No Expiration Date 
Study ID: 20-ENVI-112 
2.0  
Rationale and Specific Aims  
The specific aim of conducting formative focus groups (or interviews) and an RCT is to develop and 
evaluate a mobile health application, DOT, to promote adherence to PrEP medication among young 
adult MSM ages 18-35.   
  
3.0  
Inclusion/Exclusion Criteria  
Inclusion Criteria: Subjects who meet the following inclusion criteria will be considered for 
participation in formative focus groups:  
  
a) Self-identify as male  
b) Age 18-35  
c) Have sex with men   
d) Currently taking PrEP  
e) Own a smartphone  
f) Would like to participate in a focus group to provide feedback on a mobile app to support PrEP 
adherence  
  
Inclusion Criteria: Subjects who meet the following inclusion criteria will be considered for 
participation in the RCT:  
  
a) Self-identify as male  
b) Age 18-35  
c) Have sex with men   
d) Currently taking PrEP  
e) Own a smartphone and would like support for taking PrEP  
  
Exclusion criteria:  Those who meet any of the following criteria will be excluded from participation in 
formative focus groups:   
  
a) Males who do not meet the above criteria  
b) Currently use I.V. drugs  
  
Exclusion criteria:  Those who meet any of the following criteria will be excluded from participation in 
the RCT:   
  
a) Males who do not meet the above criteria  
b) Currently use I.V. drugs  
  
  
4.0  
Recruitment, Enrollment and Consent Procedures  
Formative focus groups or interviews: As per our program officer permission, formative research will 
be conducted via zoom, via zoom focus group or, in the event that we cannot schedule enough 

Protocol #2 R44 MH112221-02  
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Version: 3  
November 23, 2020  
  
  
Approved: 12/10/2020 
Expires: No Expiration Date 
Study ID: 20-ENVI-112 
people at the same time, via zoom individual interviews. Potential focus group participants will be 
recruited through Tufts, PALSS, Craigslist and UserInterviews. As done in our prior online studies 
(including the phase 1 of this study), potential participants will read the informed consent online. The 
consent will emphasize that participation is voluntary and will not in any way affect employment or 
access to any services received from any provider, agency, or clinic. If a participant has questions he 
would like answered before signing, he will be informed to contact the study investigator. Participants 
will be emailed a signed copy of the consent document.  
  
RCT: Potential RCT participants will be recruited from Userinterviews, Craigslist, and from Tufts and 
PALSS. Participants drawn from the latter two sites will be identified through referrals from Dr. 
Kogelman and Ms. Hampton-Julious and through signs posted in the respective locations. Interested 
individuals will be emailed a study link with study criteria. As in the Phase 1 evaluation of this study,, 
eligible RCT participants will complete informed consent online using Qualtrics software. The consent 
will describe procedures and potential risks. It will emphasize that participation is voluntary and will 
not in any way affect employment or access to any services received from any provider or agency or 
clinic, and that participants can discontinue involvement at any time. Participants will receive by email 
a signed copy of the consent document.  
  
5.0  
Study Procedures  
The proposed study will include 2 zoom focus groups of 6-8 individuals each (or zoom interviews with 
the same number or individuals), which will solicit feedback on text messages and the usability of the 
prototype app and be approximately 2 hours long, and a randomized control trial (RCT) to evaluate 
the effectiveness of the DOT intervention on PrEP adherence among young adult MSM on PrEP. For 
the RCT, those who meet study criteria will complete online baselines in Qualtrics, then be 
randomized by Qualtrics to either the intervention group (DOT mobile app) or the control group 
(2page document offering PrEP adherence education).  
  
Study procedures:  
Formative Focus Groups/Interviews: After signing an online informed consent form, individuals will 
meet together for a 2 hour conversation (either in a focus group or interview), during which they will 
provide feedback on new text messages and the usability of the prototype app. Focus groups will be 
audiotaped. Participants will receive a $75 Amazon gift card at the end of the focus group.  
  
RCT (both arms): Those who consent to the RCT will automatically receive a link to collect 
demographic data, e.g. age, ethnicity, education, income, and length of time on PrEP, and the 
baseline assessments. Qualtrics will then randomize participants to the intervention or control arm. 
Intervention and control participants will be offered a $20 Amazon gift card for completing baselines. 
At study completion (12 weeks), all participants will receive a text and email informing them that it is 
time to re-take baseline assessments. After completion, they will receive a $155 Amazon gift card.   
  
RCT Intervention Group: Intervention participants will receive a link to download the DOT mobile 
app from our website. During the 12-week study period, intervention participants will receive 3 types 
of messages: pill reminders, educational, and motivational (including new ones targeting stress). The 

Protocol #2 R44 MH112221-02  
6  
Version: 3  
November 23, 2020  
  
  
Approved: 12/10/2020 
Expires: No Expiration Date 
Study ID: 20-ENVI-112 
DOT app will also include a link to the DOT online community (with online community rules that each 
participant must agree to before become a part of the community) and a “GET HELP NOW” link to the 
federal crisis intervention program. We have attached the online community rules for IRB review.  
  
RCT Control Group: Control participants will be emailed a 2-page written PrEP patient education 
based on PrEP patient information on the CDC website, emphasizing the importance of daily 
adherence, use of condoms, and 3-month HIV testing while on PrEP.   
  
6.0  
Reporting of Adverse Events or Unanticipated Problems Involving Risk to Participants  
or Others  
We do not consider the time demand on participants to be a serious risk because the informed 
consent procedures make it very clear that they can terminate their participation at any time. To 
address the potential risk of participant discomfort or embarrassment due to participation in the RCT 
or focus group study, we will emphasize in our informed consent that participation is completely 
voluntary. We will also state that, despite protections, there remains a risk of privacy loss for all study 
participants, and individuals uncomfortable with this risk should not participate in the study. Any 
adverse events will be reported to the IRB, and any suspension of the project by the IRB will be 
communicated to NIH.  
  
Focus groups risk: We consider the risks to focus group participants to be minimal. There is a minor 
risk that other members of the focus group will know that a given participant is taking PrEP to prevent 
HIV. We will be clear in consenting that such a risk exists.   
  
RCT risk: We consider the risks to RCT participants to be minimal. Participants will complete 
questions at baseline and 12 weeks focusing on PrEP adherence, PrEP knowledge, PrEP 
selfefficacy, PrEP treatment guidelines, and stress burden. We see the content of these questions as 
posing minimal risk to participants overall. No participants experienced distress in Phase I when 
asked similar questions.   
  
There is additional risk to RCT intervention participants that someone will see their text messages 
and realize that the participant is taking PrEP. Provisions against this risk will be outlined in the 
informed consent, and include measures such as: 1) disguising the app as DOT, which does not 
reveal the app’s purpose; 2) separate app login for accessing educational and motivational texts; 3) 
disguising such texts as “daily fitness news” or “notifications”; and 4) the option to select surrogate 
language for pill reminders. In the RCT informed consent, we will also advise participants randomly 
assigned to the intervention group who have concerns about privacy that they should only log in to 
the app when they are alone, and delete any texts they would not wish others to view. We will relate 
to participants that while there is inherent risk to moving data, state-of-the-art and HIPAA-compliant 
security protections are in place for any data in transit. Specifics about the length of data storage 
according to Massachusetts state law, as well as security protections for data storage, are detailed in 
the RCT informed consent as per the NIH project officer’s request.  
  

Protocol #2 R44 MH112221-02  
7  
Version: 3  
November 23, 2020  
  
  
Approved: 12/10/2020 
Expires: No Expiration Date 
Study ID: 20-ENVI-112 
We will point out that RCT participants assigned to the control group face the risk that someone may 
view the PrEP education materials emailed to them as part of the study. If this concerns them, they 
should destroy the materials after reading them or move them to a secure place. We provide 
recommendations to participants about securing these documents in the informed consent as per the 
NIH project officer’s request.  
  
Despite all the security safeguards and precautions, we will point in the RCT informed consent that 
there is still a risk of privacy loss and that participants should not participate if they are concerned 
about the risk.  
  
7.0  
Study Withdrawal/Discontinuation  
We will emphasize in our informed consent that participation is completely voluntary and that 
participants can excuse themselves from the study at any time with no negative repercussions.  
  
8.0  
Statistical Considerations  
The sample size of 110 for the RCT is based on our Phase 1 pretest results and an a priori power 
analysis for a multiple regression with 4 predictors of PrEP adherence, which was conducted to 
determine a sample size with a power of at least 90% with a two-sided alpha level of .05. The desired 
minimum sample size was 92 participants (Rosner, 2010). In the event of 20% attrition, we added 
20% additional participants to the sample, and set 110 as the total sample size. Therefore, even if the 
study encounters diminished recruitment or greater post-recruitment attrition, it should still be possible 
to detect moderate effects.  
  
9.0  
Privacy/Confidentiality Issues  
The research study will be monitored by the research team and the Pearl IRB. All study staff (PI, 
project manager, research assistant, consultants) will have completed human subjects training. 
Although the RCT study will be implemented online, the team will nevertheless review RCT data 
collected via Qualtrics for accuracy and safety. All data collected will have patient identifiers removed. 
No reports or papers based on the project will use any individual level data or include participant 
names or identifying information.    
  
All study procedures (formative and RCT) will be reviewed by Pearl IRB. Only aggregate level 
deidentified data will be transferred between sites and/or aggregated on-site, with any data stored on 
secure servers and transmitted via secure protocols, encrypted email, password-protected media, 
and other appropriate protections.  
  
10.0 Follow-up and Record Retention  
Informed consent documents and a master list linking the participants' names to their number will be 
kept in a password-protected computer, separate from other study documents. Only the PI and study 
staff have access to these data. All participant data gathered via the HIPAA-compliant Qualtrics 
platform will be removed from Qualtrics at study conclusion and stored in a secure, encrypted drive 
on an EHG computer. These measures are outlined in the RCT informed consent.