Evaluation of Rapid HIV Self-Testing among MSM in High Prevalence Cities

C.1 BACKGROUND AND NEED Innovative testing strategies are needed to reduce levels of undiagnosed HIV infection and increase early access to treatment. The availability of a HIV self-test may facilitate access to testing among individuals who have never been tested due to concerns about privacy and confidentiality and may increase compliance with current CDC HIV testing recommendations for those who require regular testing due to on-going risk behavior. Rapid HIV self-tests may play an important role in efforts to reduce both HIV morbidity and mortality. Self-test HIV kits may reduce HIV incidence by helping HIV-negative persons remain free from infection (primary prevention), as well as increase early diagnoses of those who are infected (secondary prevention). Policies that guide the public-health application and use of rapid HIV self-test kits, require data on whether persons at high risk for infection will use these tests, the effectiveness of the tests for primary and secondary prevention, and the utility of the tests in promoting additional testing and linkage to HIV services of persons with preliminary positive results. Repeat testing may be particularly important for men who have sex with men (MSM) at high risk of transmitting HIV since infections in the earliest stages are associated with high viral loads and potential for transmission. MSM account for nearly half of the more than one million people living with HIV in the U.S. and they account for more than half of all new HIV infections in the U.S. each year. While MSM account for just 4 percent of the U.S. male population aged 13 and older, the rate of new HIV diagnoses among MSM in the U.S. is more than 44 times that of other men. MSM are the only risk group in the U.S. in which new HIV infections are increasing. While new infections have declined among both heterosexuals and injection drug users, the annual number of new HIV infections among MSM has been steadily increasing since the early 1990s. The exceptionally high prevalence of undiagnosed HIV infection among MSM and plausibly high transmission risks to partners who are attempting to avoid infection through HIV-negative serosorting, suggests that MSM and their partners stand to benefit the most from a rapid HIV self test. This is especially true for black and Hispanic MSM. One report suggests that young black MSM have nearly 7-times greater adjusted odds for being unaware of their HIV infection relative to young white MSM. Despite this racial disparity, young black MSM (relative to young white MSM) are equally likely to perceive themselves at low risk for infection and are nearly equally as likely to disclose being HIV-negative to new sex partners. Of black MSM with HIV who were unaware of their infection, up to 22% of their new partners reported being HIV-negative. However, of Hispanic and white MSM with HIV who were unaware of their infection, only 3% of new partners of Hispanic MSM and 4% of new partners of white MSM disclosed being HIV-negative. As of March 2011, the FDA has approved several rapid HIV tests for use at point-of-care to aid in the diagnosis of HIV. Several of these tests have received Clinical Laboratory Improvement Amendment (CLIA) waiver for use in non-clinical settings by persons without formal laboratory training and they are accurate, safe, and simple to use. Currently, OraSure Inc. has applied to the FDA for an over-the-counter (OTC) labeling of OraQuick Advance. While manufacturers that seek OTC labeling of rapid HIV tests are obligated to conduct studies to meet FDA requirements on device safety and accuracy, manufacturers will not be required to conduct studies that evaluate the public-health benefit of these tests. Thus, without CDC-supported research, data will not exist to guide the development of public-health policy and programs on the dissemination and use of OTC rapid HIV self tests when they become available. In the absence of such guidelines, CDC will not be able to take full advantage of a promising new application of rapid HIV tests for primary and secondary prevention efforts targeting persons at high risk for infection. Given the unrelenting HIV crisis among MSM and the imminent release into the market of rapid HIV self-test kits, it is necessary to evaluate the impact of providing rapid HIV self-test kits on repeat HIV testing, linkage to care, partner testing, serosorting, and HIV sexual risk behaviors among MSM to determine the potential primary and secondary prevention effectiveness of OTC rapid HIV self tests. This information will assist DHAP in developing recommendations and future research and program needs concerning self-testing for MSM to aid in identifying undiagnosed cases of HIV infection and promoting linkage to care of persons with HIV. C.2 PURPOSE/PROJECT OBJECTIVE The purpose of this contract is to assess the use and impact of rapid HIV self-testing among MSM located in up to three high HIV prevalence cities in the United States. The primary research questions to be addressed by the contractor are: 1. Does provision of self-test kits increase the frequency of HIV testing among high-risk MSM to at least three times in 12 months? 2. What proportion of persons with a preliminary positive result go on to request, be referred to, and access follow-up testing and care services (e.g., primary care provider, health department, or local AIDS service provider)? 3. Does the provision of self test kits to high-risk HIV-negative or unknown serostatus MSM increase the distribution and use of rapid HIV self-test kits to their social and sexual network affiliates? 4. Does the provision of self-test kits to HIV-positive MSM increase the distribution and use of test kits to their social and sexual network affiliates? 5. Does the provision of self-test kits change sexual behaviors among study participants (e.g. number of partners, unprotected anal intercourse, and serosorting practices)? 6. How do program participants perceive the possible uses, benefits and drawbacks of self testing and what are participant's self-testing preferences, in terms of accessing kits, cost, HIV information, and access to supportive services? The contractor shall recruit a minimum of 3,200 high-risk MSM who are HIV negative or of unknown serostatus, and a minimum of 300 HIV positive MSM (based upon self-report). (Using a binary outcome of success as having ?3 HIV tests per year and the chi-square test at the 5% significance level, we have 90% power to detect a difference between the comparison and intervention groups if the success rates in these groups are 5% and 10% respectively. We inflated the sample size to allow for a maximum 40% attrition rate). Of these men, at least 20% shall be black MSM and 15% shall be Hispanic MSM to allow for appropriate analytical comparisons. To be eligible for the study, participants must be: MSM who are age 18 and over; reside in the participating jurisdiction(s) proposed by contractor and approved by COTR; and report unprotected anal sex with more than one male partner in the past year. Recruitment of subjects shall begin approximately 18 months after award, depending on receipt of required approvals to begin research study. Recruitment of study subjects shall be completed within 9 months. An additional 14 months shall be used to complete the 12 month follow-up period for all subjects. Therefore, all research activities shall be completed within 4 years. The research study will consist of three study conditions that are based on a participant's disclosure of HIV status at time of enrollment. HIV negative and unknown status subjects shall be randomized to one of two study conditions: an intervention or comparison condition. HIV positive participants will not be randomized but assigned to a third study condition. The contractor shall recruit participants via the internet, and potentially other methods. The contractor shall develop and maintain a web-based system where interested participants will access a secure internet study specific website where screening, enrollment, consent, randomization and assessments will occur. In addition to conducting a baseline assessment, the contractor shall develop and maintain a web-based system where all participants complete follow-up assessments to be conducted at 1, 3, 6, 9, and 12 months after enrollment. The contractor shall provide participants with incentives following completion of each assessment so that the study will achieve an anticipated retention rate of 80% at each follow-up point. The contractor shall randomize the HIV-negative/unaware participants into two study arms after completing the baseline assessment. The contractor shall provide (mail or email) participants in the comparison condition with a resource page/brochure containing information on local HIV testing and other support services for MSM. The contractor shall provide participants in the intervention condition and all HIV-positive arm participants with up to 5 rapid test kits (by mail) and the resource brochure (by mail or email), upon request, at each assessment point. The contractor shall provide thethe option of requesting a kit that allows oral fluid collection or blood (finger-stick) collection. The contractor shall have a mechanism to assist person with preliminary positive results with counseling, referral, and assistance to accessing testing and care services. The contractor shall develop and maintain a web-based system where all persons who use the self-test kits can enter the result of the test and provide feedback on their experience with using the test kit. All persons who use the self-test kit, have a preliminary positive result, and contact the study counselor/referral coordinator by phone or email will be referred or if requested, provided assistance with linkage to local services by the contactor to a local site for appropriate follow-up testing and care services. The study also includes a qualitative component to better understand how participants used the test kits, attitudes about self-testing, perceived benefits and drawbacks of self-testing, unintended consequences, and preferences for future program implementation. Five focus groups will be conducted in each participating city (k=15) with a total of approximately 50 men per city. Participants assigned to the intervention arm will be invited to indicate their interest in participating in a focus group discussion after completing the 12 month survey. After a sufficient number of potential focus group participants have been accrued, study staff will randomly select a sample to follow-up to ascertain interest and availability. Contractor staff shallshall travel, as needed to each study city to conduct and record the face-to-face focus groups. Other mechanisms for convening participants (e.g., online focus groups, conference calls or online chats) can be discussed. The contractor shall implement a mechanism to ensure focus group participation. The contractorshall record and transcribe discussions, enter the data into a qualitative software analysis program, and conduct analysis. A written summary of the qualitative findings, the analytic database, transcripts, and audio-recordings shall be supplied to CDC by the Contractor.. Specific objectives of the contract include the following: 1. Obtain and confirm required Institutional Review Board (IRB) and Office of management and Budget (OMB) approvals. 2. Design, develop and implement a secure study website to include a participant recruitment interface. 3. Develop and implement internet capable screening, enrollment, and consent procedures. 4. Develop and implement a web-based data collection system for all quantitative data activities (surveys and test results from self-test kits). 5. Develop and implement a participant tracking system which securely houses participant contact information (e.g., names, email address, mailing address, phone number), and automates reminder email notifications. 6. Develop and implement a confidential rapid HIV self-test kit and delivery system according to study protocol. 7. For persons testing preliminary positive, develop and implement a counseling, referral and linkage system protocol that includes supplemental testing. 8. Develop and implement a system to routinely monitor the progress of the accrual of study participants and make adjustments as necessary. 9. Conduct focus groups. 10. Produce interim and final progress reports. 11. Create and deliver semi-annual data sets and final data sets. Create and deliver a final report of the qualitative findings. C.3 SCOPE OF WORK The contractor will implement a three condition research study using a protocol developed by the contractor and approved by CDC. The study will assess the impact of providing rapid HIV self-test kits to MSM, coupled with phone-based counseling and referral to local testing and care services. Research activities shall be conducted in at least one, and up to three of the top 10 US jurisdictions with the highest HIV prevalence rates among MSM. In this study, CDC will not be engaged in counducting research activities and CDC staff will not have access to personal identifiable information. Therefore, CDC IRB will not be obtained. This study will identify and quantify the use of the HIV self-test kits, changes in sexual behaviors, changes in HIV testing practices, and the use of phone-based counseling, supplemental testing and linkage to care. The contractor shall produce a final report and final dataset to be submitted to CDC at the end of the contract.