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Empowering With PrEP (E-PrEP), a Peer-Led Social Media–Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial

Background Young black and Latinx, gay, bisexual, and other men who have sex with men (YBLGBM, aged 18-29 years) have among the highest rates of new HIV infections in the United States and are not consistently reached by existing prevention interventions. Preexposure prophylaxis (PrEP), an oral antiretroviral regimen taken daily by HIV-uninfected individuals to prevent HIV acquisition, is highly efficacious in reducing HIV acquisition and could help stop the HIV epidemic in YBLGBM. Use of social media (eg, Facebook, Twitter, online dating sites) is ubiquitous among young people, providing an efficient avenue to engage YBLGBM to facilitate PrEP adoption. Objective Our overall goal was to develop and pilot test a theoretically grounded, social media–based, peer-led intervention to increase PrEP uptake in YBLGBM. We used diffusion of innovation and information-motivation-behavioral skills frameworks to (1) identify potential factors associated with interest in and adoption of PrEP among YBLGBM; (2) develop Empowering with PrEP (E-PrEP), a social media–based, peer-led intervention to increase PrEP uptake in YBLGBM; and (3) pilot test the feasibility and acceptability of E-PrEP, and determine its preliminary efficacy for increasing adoption of PrEP by YBLGBM. We describe the development and protocol for E-PrEP. Methods Using a participatory research approach, we partnered with YBLGBM intervention development partners to develop a social media–based behavioral intervention to facilitate PrEP uptake, which involved an online messaging campaign disseminated by YBLGBM peer leaders to their existing online networks. We designed the 6-week campaign to provide education about PrEP, increase motivation to use PrEP, and facilitate access to PrEP. We then conducted a cluster-randomized trial of E-PrEP compared with an attention-matched general health control condition (E-Health) among YBLGBM aged 18 to 29 years to assess E-PrEP’s feasibility, acceptability, preliminary efficacy for increasing self-reported intention to use PrEP, PrEP uptake, and impact on knowledge and attitudes about PrEP at 12-week follow-up (6 weeks after the end of the online campaign). Results From October 2016 to March 2017, we developed, pretested, and refined E-PrEP with 6 YBLGBM intervention development partners. From May to June 2017, we recruited, enrolled, and randomly assigned 10 peer leaders (n=5 for each condition). The 10 peer leaders then recruited and enrolled 152 participants from their existing online networks (range 3-33 per peer leader), during June and July 2017. Intervention follow-up was completed after 12 weeks, in November 2017, with analyses underway. Conclusions We hypothesize that, compared with E-Health, participants randomly assigned to E-PrEP will be more likely to express intention to use PrEP and greater PrEP uptake, and will also show changes in potential mediators of PrEP uptake (knowledge, attitudes, stigma, and access). A Web-based biobehavioral intervention model such as E-PrEP could be rapidly scaled even with limited resources and have significant population-level impact. Trial Registration ClinicalTrials.gov NCT03213366; https://clinicaltrials.gov/ct2/show/NCT03213366 (Archived by WebCite at http://www.webcitation.org/71onSdcXY) Registered Report Identifier RR1-10.2196/11375

1 K23 MH106387-01 2 BSPH PATEL, V PUBLIC HEALTH RELEVANCE: Young men who have sex with men of color (YMCSM) in the U.S. experience the highest rates of new HIV infections, with existing prevention interventions failing to reach most of this hard to reach population. Pre-exposure prophylaxis (PrEP), an oral antiretroviral medication taken daily by HIV-uninfected individuals, has shown efficacy in preventing HIV. At the same time, increasingly widespread use of social media (e.g. Facebook, online dating sites) by young people, including YMCSM, provides an efficient avenue to identify and reach large populations of high-risk individuals to rapidly disseminate information about effective HIV prevention tools. This study will use a community based participatory research approach to identify factors impacting PrEP adoption and then design and implement a social media-based peer-led intervention to enhance uptake of this new biomedical innovation for HIV prevention. Study results have the potential to influence PrEP dissemination and help reduce disparities in access to PrEP for hard to reach at-risk populations. Overall Impact: This is an excellent career award application proposing training and research conducted by a junior, highly promising physician scientist. The training is well structured and should allow the candidate to reach the needed level of technical competency. There are proper provisions for training on the responsible conduct of research with humans. The research component entails a randomized control trial using a Facebook delivered application to increase PrEP uptake in young men of color who have sex with men. The research is significant, innovative, and valid. Overall, the application is very strong and should allow an excellent candidate to progress towards independence.

Strengths
The application describes the project as the first to try to induce PrEP uptake in this population, particularly using social media. This is significant and innovative.
The plan is well structured, moving from qualitative community input to develop the program.
The materials presented with the application seem well developed and indicate that the candidate has taken many important preparatory steps that should ensure success of the project.
Addressing the needs of the target population in a scientifically valid, innovative way is highly significant.

Weaknesses
There is a need to specify the techniques/modules of the intervention to ensure they are likely to effectively promote behavior change.

Strengths
The mentoring team is excellent. Dr. Arnsten and Dr. Golub have expertise in medicine and social psychology, respectively. Both are highly accomplished, successful in receiving funding, and very competent mentors.
There is a supporting team with expertise in social media and data analysis, which should allow the candidate to have adequate mentoring in the different areas concerning the application.

Strengths
The environment is excellent, has already supported Dr. Patel in his work.
The combination of clinical settings and academic units should provide the ideal environment for the training and research components of this application. Overall Impact: The candidate seeks to become an independent clinical investigator with expertise in social media based interventions that are developed through CBPR processes. The candidate has great depth of experience across fields -medicine, CBPR methods, community organizingand demonstrates a high degree of commitment, although his publication record is limited. The mentor team and career development plans are also very strong and highly conducive to the candidate's success. The research plan is clear and highly innovative. This candidate should be expected to contribute much to the field. fie

CRITIQUE 2:
Young minority MSM are a highly significant population in need of HIV prevention services.
The investigator's prior research with social media interventions is a clear strength of the study.
The steps in the research plan are well thought out.
The use of diffusion of innovations theory is innovative in this context, and has demonstrated efficacy in other non-PrEP strategies.

Weaknesses
The selection of intentions to use PrEP is not ideal for providing support to a large R01 trial. It is unclear which barriers the investigator believes will prevent MSM who "intend" to use PrEP from actually using it.

Strengths
The candidate has very strong letters of support from experts in all of the necessary fields: clinical, statistics, intervention development, PrEP, HIV risk behavior research, research ethics, and technology based health research.

Weaknesses
None noted

Strengths
The research and training environment at Einstein / Montefiore is superb. The institution has made a strong commitment to the candidate, assuring at least 80% time devoted to research regardless of the decision on this award.

Weaknesses
None noted. Overall Impact: This K-23 (Career Development Award) application from an Assistant Professor of General Internal Medicine aims to enhance the skills needed to become an independent investigator in bio-behavioral HIV interventions for MSM and Transgender populations. The applicant is very well qualified and has demonstrated commitment in bio-behavioral HIV intervention for MSM, and is focused on becoming an independent investigator. The application provides a strong mentorship plan, a schedule of classes and seminars, and a multi-phased developmental and pilot research project grounded in behavioral theory. The specific milestones for evaluation of the candidate's education and skills development are weak.

Strengths
The research project addresses significant and innovative questions and is guided by an appropriate theoretical model. The study is generally clearly and adequately articulated, and strong.
The PI will address MSM populations which are at high risk and not well understood.
The PI is addressing new HIV prevention techniques such as use of PrEP.
The PI is examining the use of social media as an HIV prevention tool.
The PI is examining D.O.I. theory The PI is learning skills in CBPR

Strengths
The PI proposes mentorship from excellent mentors. The mentors provide letters of strong support for the career development.

Weaknesses
None noted

18-21 included
The environment is strong as is the institutional commitment to the applicant

Strengths
Vertebrate Animals:

Budget and Period of Support:
Recommend as Requested: NIH has modified its policy regarding the receipt of resubmissions (amended applications). See Guide Notice NOT-OD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-074.html. The impact/priority score is calculated after discussion of an application by averaging the overall scores (1-9) given by all voting reviewers on the committee and multiplying by 10. The criterion scores are submitted prior to the meeting by the individual reviewers assigned to an application, and are not discussed specifically at the review meeting or calculated into the overall impact score. Some applications also receive a percentile ranking. For details on the review process, see http://grants.nih.gov/grants/peer_review_process.htm#scoring. Consultants are required to absent themselves from the room during the review of any application if their presence would constitute or appear to constitute a conflict of interest.