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iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5

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Letter from iPrEx Protocol Chair Together we have reached the next major milestone for iPrEx: the database on all 2,499 iPrEx participants has been cleaned and prepared for the next major review. This milestone was reached on time, and with the expected outstanding quality. This is a major achievement involving hundreds of thousands of pieces of data. Brian Postle, the iPrEx data manager at the data management center, DF/Net, reports that they have received a total of 640,000 pages of data so far. More than 7,000 faxes were received weekly. Each of these forms is transcribed into digital form, checked twice, and then checked again for completeness and consistency. If issues are found, an inquiry is sent to the clinical study site where the data was gathered. These questions are then addressed by the site, which either corrects the form or explains why the information is already correct. Like an elite athlete, the data has been kept in good shape at all times. However, before a blinded data review, the database is put through intensive additional checking to verify that everything is ready for analysis. Over the past 6 months, those who manage our iPrEx data having been working overtime -- like Olympic athletes who know the world will watch their every move. We are particularly proud of David Glidden, the head of the iPrEx data team and our protocol statistician at UCSF. Dave provided clear and calm guidance and relentless motivation to the rest of the team, including Vanessa McMahan (the study coordinator at Gladstone), Brian Postle (the data manager at DF/Net), Albert Liu (the iPrEx Medical Officer at the San Francisco Department of Public Health) and the nearly one hundred data managers and laboratory personnel who worked tirelessly to get the data ready. None of us knows what the data will show. During these times of anticipation, we are heartened to know that all of the information gathered through this study is in excellent shape. Whether we find a new way to fight HIV remains to be seen, but we are confident that our work is in top shape and we are ready.

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iPrEx iPrExUPDATE UPDATE••3rd 3rdQUARTER QUARTER2010 2010••NUMBER NUMBER55

Dear iPrEx Family Glidden McMahan Postle Liu

Robert M Grant, MD, MPH Protocol chair, iPrEx


Data Management:

The Big Picture Brian Postle

DF/Net Research, Inc

As we enter the final phase of the iPrEx study, it is hard to believe that more than three years have passed since the first participant was enrolled in the Global iPrEx study, on July 10, 2007. Since iPrEx began, more than 640,000 data sheets, called Case Report Forms (CRFs), have been transmitted by fax to the data management center, DF/ Net, based in Seattle, Washington, in the United States. Here, the information is reviewed and queried for omissions, correction or clarification in a process called quality control (QC.) After the QC process, the queries are sent back to the study sites where the forms are corrected and faxed back to DF/Net. To say the least, the data collection and QC process require a lot of our time and attention. Fortunately, due to excellent work at the site level the vast majority of the data received from the sites is clean upon arrival. Overall, the average iPrEx QC rate for all study sites is relatively low: about 8 QC notes (or queries) generated for every 100 CRFs received. This demonstrates the great attention to detail shown by the iPrEx data managers.

Each ream contains 500 sheets of paper. Tami is standing next to 15,000 sheets of paper. We call this one “Tami” unit.

We have received 43 Tami units... over 640,000 CRFs!

Over the past several months we all have put a considerable amount of time and energy into reviewing forms that are considered a priority for the upcoming next major review of the study. Now, this review process is complete. Thanks to extraordinary team efforts, we can all feel satisfied that we have providing the statisticians with the cleanest data possible. Part of what makes this team effort so successful is the high level of communication between the study sites, the Coordinating Center, and DF/ Net. I would personally like to thank all of the site data managers for their responsiveness; it is a pleasure to work with all of you. iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5

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An Investigator’s Perspective

Principal Investigator, Fundacion Ecuatoriana Equidad

Data Quality Control

One of the Main

Challenges Orlando Montoya Fundacion Ecuatoriana Equidad’s ongoing efforts to ensure the effective and efficient management of all Global iPrEx data generated at our site were led by the Principal Investigator and executed by the Data Management Coordinator and his team. Everyone at Equidad, however, played an important role in ensuring the quality of our data. The first step in ensuring that we meet the standards demanded by the Data Management Center was ensuring that everyone here understood that generating high quality data is not just the responsibility of the Data Management Unit, but of all of us. Everybody had to be careful when recording data on the forms, be an active part in the quality control chain and always be willing to address and solve data queries in a timely fashion.

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iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5

This challenging process required ongoing training and strong teamwork that was coordinated and supported by a committee consisting of the Data Management Coordinator, the Investigator of Record, the Medical Coordinator and the Pharmacy and Lab Directors. Addressing the queries identified by the Data Management Center required a constant emphasis on quality control and quality assurance. We could not have kept up with the data demands of this study, however, without the invaluable support of the data teams at INMENSA and Impacta, the Study Coordinator at Gladstone and DF/Net. Without their support we could not have achieved our goals regarding quality control and assurance in the study. And we’re not done yet!

The Data Management Unit, located at the Lima’s INMENSA study clinic and commonly know as DCT (Data Crazy Team), is comprised of Mylena, Carla, Maria, Alex and Rosemery in quality assurance and control, and Wendy working in the clinic charts archive.


Experiences with the Management of Data of iPrEx in Lima:

or How to be part of the Data Management Center

and not Die Trying…

The iPrEx study started at INMENSA back in June of 2007. Since then, the DCT has QCed (data management lingo for performing “quality control”) 23,324 screening and enrollment case report forms (CRF.) Follow-up monthly visits have generated the revision of 17,000 CRFs and 500 clinical charts for about 34 visits for each participant. In all, the team has checked 21,094 Informed Consent Forms (ICFs) for consistency and 100% of the data have been QCed. The list of forms and tools that data managers use at the site level give you some idea of how carefully every participant record is scrutinized to ensure that all data in the Global iPrEx study are completely accurate. (They may also make you glad that you’re not a data manager!) At the site level, data managers use these tools to guarantee data quality control:

• • • • •

Internal QA / QC, which are conducted after each study visit and in the screening and enrollment phase. Chart review tools: in- house developed tools to conduct QC/QA activities in 100% of CRFs and medical charts. Error tracking logs, to identify and track any CRFs errors. Monitoring reports: generated by the study sponsor. Others: datafax and transmission reports and Queries and QC resolutions reports.

In addition, the data management team continually reviews the following for all Global iPrEx participants:

•• •• •• • •• •• ••

Informed consent form and process Participant education Test of understanding of the protocol Eligibility criteria HIV prevention counseling Lab results follow up and procedures Concomitant medications, vaccines, prohibited medications Missed visits and follow-up Protocol endpoint verification AE / SAE reporting follow-up Adherence report Study product administration / Dosing Verification of consistency between pharmacy records and clinical chart

Correction procedures:

The team manages the QC and QA, CRF transcription and CRF correction procedures

Data cleaning To prepare for the primary analysis of iPrEx data (the analysis of all data collected through May 1, 2010) the team has been working for the last three months cleaning the data and solving queries in a coordinated way with DF/Net and the study statistician. With all these numbers moving around, the quality of communication and collaboration between the data management team and the clinic staff is particularly important to ensuring that everything is done and checked and rechecked for complete accuracy. We are fortunate to all work together in a very collaborative and participative environment that has as its top priority ensuring that all of the data produced in the iPrEx study is the best it can be. The Data Management Center at INMENSA is like a fine timepiece, working together to improve the health and wellbeing of study participants through research, prevention and treatment of disease. And thanks to their outstanding efforts, the Global iPrEx clock keeps ticking! iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5

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From the Frontlines

Voices from the San Francisco iPrEx Team

iPrEx inspires, invigorates, and challenges staff in many ways. Global iPrEx Update asked the iPrEx team at San Francisco Department of Public Health (SFDPH) to share their impressions of what it is like to work on this groundbreaking study:

Kerry (Clinician): I remember the early days when people didn’t have ART and the advances that were made thanks to the help of volunteers. The contribution of our volunteers at this stage in the epidemic is just as crucial. We ask a lot of them. They are amazing. Liz (Clinician): It is enlightening to learn how iPrEx affects participants’ lives. Hearing about their challenges and successes is inspiring; I feel like I’ve accompanied them on a journey. Hailey (Coordinator): I’m behind the scenes, but it is life- and world-changing work we are doing. I am proud to be a part of it.

Tim (Counseling Supervisor): Many men who have sex with men are educated about HIV and sometimes use that information to take calculated risks. One of the biggest counseling challenges is helping participants better understand their perceptions of risk. Alfonso (Research Associate): I’m grateful to be challenged by participants about the relevance of our studies. They want to end the epidemic - their participation proves their support. I’m proud to be part of this community. Jeff (Research Associate): Our study participants brave barriers and fears to help their community. I witness their selfless dedication. It’s a pleasure to work with such amazing people.

Quinto

Community Engagement in HIV Prevention Trials: Health = Quality of Life Julio Gilvonio, MD What does it mean to improve someone’s quality of life? Quinto Piso, a program of Lima’s INMENSA study site, believes the process involves addressing an individual’s needs for peace, freedom, justice, equity and tolerance. Is that just talk? I don’t think so…especially when we consider a clinical trial like iPrEx. Our challenge is to reduce risky behaviors that lead to the acquisition of HIV in the gay, trans and bisexual (GTB) population. We do it by providing HIV prevention education, delivering condoms and involving the larger community. That has been our mission for the past two years. We work to enhance our participants’ quality of life in order to help them participate more fully in the study, come to their study visits and use the study medication. Here are just a few of the ways Quinto Piso 6

iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5

is involved in building that better quality of life for our participants: Physical and mental health: Quinto Piso provides psychological, general medicine and legal support services. These services enhance the relationship between the participant and the study clinic, and thus, the study. Improving work opportunities: Quinto Piso participants enhance their work skills and opportunities through handson programs that include occupational workshops, programs on funding a small enterprise and participating successfully in the labor market, and other programs. Last year, more than 300 clinical trial participants also participated in Quinto Piso workshops designed to enhance their employability in computer services,

massage, beauty services, baking, silkscreening and many other fields. Using free time and managing stress: Stress is a big issue for study participants across Global iPrEx. To help relieve stress, build community and improve quality of life, between April and November 2009, Quinto Piso organized five volleyball schools in different neighborhoods in Lima. Of the 300 GTB community participants, nearly half were iPrEx study participants. Other Quinto Piso workshops included photography, a dancing school (their first performance took place at the V Latin American Forum of HIV/AIDS in November 2009) and a theater club that had two performances of a collective creation entitled “Entono Gay”. Moving forward, Quinto Piso is now organizing a soccer contest.


Christina (Program Assistant): Being involved in this study makes me view people I pass on the street through a different lens. You never know who is helping change the face of HIV, one visit at a time. Al (Co-Principal Investigator): It has been great working with iPrEx staff from around the world, sharing the common goal of finding new ways to prevent HIV. I’m excited that we’re in the final phase of the study and thank our wonderful study volunteers and staff for their dedication! Susan (Principal Investigator): I am so impressed with the way volunteers and study staff from four continents have joined together to answer this critical HIV prevention question for MSM throughout the world. I am very proud to be a part of this global effort.

Piso Managing stigma and discrimination: Since March 2009, Quinto Piso has organized an entertainment/education activity every Friday that addresses stigma and discrimination through community forums, video clubs and talk shows. More than 700 participants have attended these activities. Topics include stigma and discrimination, blind dates, human rights, diversity, clinical trials, homophobia, gay pride and many others. What are we looking to do with all of these activities? Provide information, promote behavior change, improve health and help ensure that Quinto Piso plays a positive role in enhancing the quality of life for our study participants and for Lima’s larger GTB community.

s w Ne e h t rom

f

Lima

y d u t S es Sit

Lima, INMENSA

Lima’s Gay Pride Parade took place on Sunday, July 10th and iPrEx was there with a double-decker bus loaded with the Drags and the I Boys as well as staff of the INMENSA’s Community Involvement Unit. More than 200 volunteers, participants and members of the Quinto Piso Community Center were part of this parade. Educational materials and rainbow flags were distributed by peer educators. All told, Lima’s Gay Pride Parade attracted more than 4000 participants and took place along the most important avenues of the city, with joy, color and dignity.

Guayaquil, Equidad

Let’s clean the data!!! This was our commitment and challenge. How did we do it? Teamwork was the foundation. Every team member is very important in this phase of the study -- not only to the local team, but all those who supported us from abroad as well. Some helped coordinating the steps to follow, other with operations and other with motivation; words such as “thank you for your work” and “congratulations” were the fuel for the engine. Congratulations to each and every one of the iPrEx sites!!! iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5

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Boston, Fenway

Boston Pride 2010 Fenway Health Rock with Pride! Boston Pride is a big citywide event that is held the second Saturday of each June. Thousands of people pour into the city of the Puritans and the Boston Tea Party, to celebrate the LGBT community and its straight allies. This year’s Boston Pride boasted the largest Fenway Health contingent ever. Fenway Health designed and operated 2 floats and our marchers included dozens of staff, friends of Fenway and study participants. The day began at 7 am with a brunch and float decorating party. Pictured are Recruitment and Retention Specialist Sochet Pheoun (3rd from the left) with a Fenway volunteer and The Sisters of Perpetual Indulgence®, a leading-edge order of queer nuns who believe all people have a right to express their unique joy and beauty and use humor and irreverent wit to expose the forces of bigotry, complacency and guilt that chain the human spirit. They are also a lot of fun to march with! Upcoming Fenway participant retention efforts will include regular study updates, movie gift cards, a reception to honor our participants and a Community Research Forum when the Global iPrEx study results are released.

Boston

g n i Comtudy ue of xt iss date: e n e in th l iPrEx Up Globa

s iPrExsults re

Rio de Janeiro 8

iPrEx UPDATE • 3rd QUARTER 2010 • NUMBER 5

Chiang Mai, RIHES

Greeting to the iPrEx team! This August our participants will stop the study drug. We have talked to many participants, they said that participating in the study was a great experience for them and they were really proud of being part of this study. For this occasion, Piman center gave “Piman iPrEx” coffee mugs as a souvenir for all participants to thank them for being in our study.

San Francisco, SFDPH

There has been quite a flurry of activity at SFDPH recently! Late last year we brought together participants to meet one another and discuss their experiences of pill-taking in the study. We started off 2010 with a Research Section appreciation party in January for volunteers across studies. In March the site launched a new optional multimedia storytelling project called “Eye on Life,” in which participants speak about HIV and their communities. SFDPH also hosted a public screening of the iPrEx documentary “Voices of Hope” on June 2 - the event was a smashing success!

San Francisco

Chiang Mai São Paulo, USP The last months were marked by the announcement that the study medication would be discontinued starting in August. One last adherence strategy (to taking study medication) adopted by our center is the use of pill cases, which is ongoing, and showing positive results. Since the announcement of the coming termination of this phase of the study, it became necessary to work on building the relationship established between the study team and the volunteers, since some of them felt disheartened with the possibility of losing contact with the study team, that they so value. There also were reactions of anxiety in relation to the knowledge of the possible study results and to which study arm they were assigned (active medication or placebo). With regards to retention, the possibility of having Psychological Support outside of the study visits proved to be an effective strategy that was very well taken and currently 25% of our active volunteers benefit from this service. The invitation to participate in the sub studies: hair and urine started on August 16th and until now all of the participants consulted have shown a willingness to collaborate.

3rd quarter 2010 • Number 5 Visit the Global iPrEx website:

www.globaliprex.net Editors: Mark Aurigemma and Pedro Goicochea Design: Miguel Bernal iPrEx is sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health (NIH) and co-funded by the Bill & Melinda Gates Foundation. Study medication is donated by Gilead Sciences. This study is under the United States Food and Drug Administration (FDA) investigational new drug (IND) number 71,859.


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