Lisa A. Eaton, Ph.D. - US grants

DESCRIPTION (provided by applicant): Men who have sex with men continue to make up a majority of incident HIV infections. Despite alarmingly high rates of HIV infection, there are few effective interventions to prevent HIV transmission among these men. This five year study, proposed by a New/Early Stage Investigator, consists of a randomized controlled trial to test a behavioral intervention designed to reduce risks for HIV/AIDS posed by sexual partner selection strategies, specifically serosorting, among at-risk HIV negative men who have sex with men in Atlanta, GA. Serosorting - limiting unprotected sexual partners to those of the same HIV status- has emerged as a risk reduction strategy with little input from public health agencies. It is commonly practiced among men who have sex with men to avoid HIV infection. However, engaging in serosorting is a predictor of HIV transmission rather than a reliable form of prevention. Serosorting is ineffective due to several factors, including: multiple flaws in the ability to be certain of own or partner's HIV statuses, the failure of routine HIV tests to detect acute HIV infection, elevated infectiousness due to acute HIV infection, and increased risk for contracting other STIs that can facilitate HIV transmission. We are therefore proposing to test a brief, single-session, Conflict Theory of Decision Making based intervention for use in public health settings. This project uses a novel theory of informed decision making to guide an intervention designed for use in routine services, i.e., HIV post-test counseling. An intervention to address the needs of men who test HIV negative fits well with current efforts to scale up HIV testing, also referred to as seek, test and treat. The proposed research builds on the strengths of a pilot tested, behavioral intervention for addressing serosorting among men who have sex with men. Following screening, informed consent, baseline assessments, and HIV testing (we predict 70 men will test HIV positive), 600 HIV- negative participants will be randomly assigned to receive one of two intervention arms: (a) a serosorting, partner selection intervention, or (b) a time-match, CDC based, post-HIV test counseling, standard-of-care. Participants will be followed over 12-months and assessments will include measures of serosorting beliefs, decisional balance, knowledge of acute HIV infection, HIV status disclosure, and biological (incident STI) and behavioral outcomes (sexual behaviors). This study will test the hypotheses that a brief, single session, serosorting intervention will result in less risk-related serosorting beliefs, greater knowledge/awareness of HIV transmission risk taking, increased HIV status disclosure, reductions in number of sex partners, unprotected sex acts, and incident STIs among intervention participants more so than the control group participants. Moreover, we will test the hypothesis that the intervention will be cost saving when tested in cost-effectiveness analyses. If shown effective, the intervention model will be ready for immediate dissemination to HIV testing services. Effective and novel strategies for reducing risk taking among men who have sex with men are urgently needed to reduce the disproportionate rate of incident HIV infections among this highest risk group.

This application requests support to conduct structural and stigma-focused interventions to increase HIV and STI testing uptake among Black men who have sex with men (BMSM). Our research proposal is focused on this population due to the alarmingly high rates of HIV/STI among BMSM? this group has experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and current estimates demonstrate that although BMSM make up only 0.2% of the population they make up 22% of new HIV infections. In our own work we have documented a 5.1% annual HIV incidence and a 35% HIV prevalence among BMSM. We are failing to engage BMSM at all points of the HIV care continuum including the seek and test components. The CDC recommends that individuals at substantial risk for HIV be tested for HIV/STI every three to six months; however, this goal is not being achieved and, therefore, a new approach to engaging BMSM is needed. To address these shortcomings and based on preliminary studies, we are proposing a 2 x 2 factorial design to evaluate a model that is aimed at increasing HIV/STI testing uptake among BMSM. We will test a stigma-focused intervention as stigma is a known deterrent to HIV/STI testing, yet little has been done to address this factor; and, we will evaluate HIV/STI test counseling delivered online (in conjunction with at-home HIV/STI test kits) as this delivery of testing may remove key barriers to reaching BMSM in need of HIV/STI related care services. Specific Aim 1: Assess HIV/STI testing uptake at scheduled HIV/STI test counseling appointments during the 12 month follow-up period. 500 BMSM who are HIV negative/unknown status, and report condomless anal intercourse with a male partner in past year and infrequent HIV/STI testing (?1 HIV/STI test in past year) will be randomly assigned to one of four conditions: (a) receive CDC-based risk reduction counseling and scheduled for in-office HIV/STI test counseling appointments, (b) receive HIV stigma-enhanced intervention and scheduled for in-office HIV/STI test counseling appointments, (c) receive CDC-based risk reduction counseling and scheduled for online, via video calling, HIV/STI test counseling appointments, or (d) receive HIV stigma-enhanced intervention and scheduled for online, via video calling, HIV/STI test counseling appointments. Specific Aim 2: Evaluate mediating (key theoretical stigma variables) factors collected via assessments at 3, 6, and 12 month follow-ups. Specific Aim 3: Conduct an economic evaluation to determine the costs of the office-based and online-based HIV/STI test delivery formats from both a community-based payer perspective and a comprehensive societal perspective that includes all costs. Our project has the potential to exert a sustained and powerful impact not only on approaches to engaging BMSM, but to improving HIV/STI testing uptake which will likely improve multiple health outcomes among BMSM. If effective, our approach to improving HIV/STI testing uptake would be available for dissemination immediately and would fit within resource limited settings such as community based organizations and health departments.

This pragmatic adaptive clinical trial will test the effects of a Stigma-Motivational-Decision intervention designed to increase HIV treatment engagement, retention, and medication adherence for substance using adolescents and young adults (AYA) living with HIV who are not in clinical care. The intervention uses a uniquely unified counseling approach at multiple points along the HIV continuum of care. In a first step, we will use multiple modes of outreach including social media, passive media, clinic records, and chain referrals to seek and identify HIV positive AYA (age 16 to 25) who are out of HIV care. In Step 2, HIV positive AYA who are out of HIV care and substance using will be enrolled in a phone-delivered counseling intervention to address substance use, HIV stigmas, medical care-related concerns, structural barriers, and other challenges to engaging youth in HIV care. Counseling will be provided weekly until the time participants are engaged in care, with a maximum of 12 sessions (up 3-months). We will therefore determine the number of theory-based phone intervention sessions needed (minimally effective dose) for care engagement and the associated costs. Once engaged in care, Step 3 will conduct a randomized trial to test the comparative effects and cost effectiveness of interactive text messaging with opportunities for ongoing supportive problem solving versus text message reminders to sustain long-term retention in care and medication adherence. HIV positive AYA are likely to drop out of care because of known challenges such as substance use, social barriers such as stigma, and concerns regarding treatment. Our 3-step study will use a single theory-based approach to determine the number of phone-delivered Stigma-Motivational-Decision counseling intervention sessions necessary to achieve engagement or re-engagement in HIV care, and will test the effects of a low-cost approach to sustaining long-term retention in care and medication adherence. Participants will be out of care at baseline and counseled with up to 12 weekly phone-delivered intervention sessions until they confirm engagement in HIV care. The study will determine the minimally effective counseling dose needed to engage substance using HIV positive AYA in care. Once participants attend HIV medical appointments, they will be randomized to either: (a) 15-months of ongoing weekly mobile phone text message check-ins with the opportunity for brief problem-focused phone support or (b) weekly text message reminders. The study will test the effects of the counseling and text messaging interventions on maintaining HIV care retention, medication adherence, and HIV viral suppression over 18-months. The primary endpoint in this trial is HIV RNA suppression. We will perform economic evaluations to determine the cost-effectiveness of the engagement-retention-adherence intervention. The proposed pragmatic adaptive trial will therefore determine the minimally effective dose of counseling and the effects of a low-burden retention/adherence intervention to maintain retention in care and avoid relapse to non-adherence for AYA living with HIV.

Biomedical HIV prevention tools are very promising, but are not sufficiently reaching those in greatest need. This R34 application requests support to develop a novel, unified model to address PrEP interest, uptake, and adherence among Black men who have sex with men (BMSM). BMSM have experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and the CDC estimates that half of BMSM will be diagnosed with HIV in their lifetime. In our current (non-overlapping) work, we have documented an exceedingly high 5.1% annual HIV incidence rate and 35% HIV prevalence rate among BMSM (R01MH094230, N=549). Although Pre-Exposure Prophylaxis (PrEP) is highly effective for preventing HIV, there is urgent need to improve efforts to deliver PrEP, in particular, for BMSM at-risk for HIV. Current strategies to increase PrEP interest, uptake, and adherence are not adequate and there are formidable barriers (e.g., stigma surrounding PrEP use, and adherence and retention concerns) to sufficient coverage of PrEP that must be addressed. Without considerable and targeted change to our current approach to PrEP delivery, we will fail to adequately provide PrEP to those in greatest need. In our PrEP focused preliminary studies with BMSM, we have identified two primary areas in need of critical focus and intervention ? (1) stigma related to PrEP use, and (2) medication cognitions such as the perceived costs and benefits of taking PrEP, both of which can impede PrEP interest, uptake, and adherence. To address these areas we are proposing to develop an intervention model grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Our proposed study includes: Specific Aim 1: Conduct elicitation research with BMSM, community advisers, and expert consultants to design an empirically-based PrEP enhancement intervention for use in targeted service delivery settings. Specific Aim 2: PrEP messaging and intervention content will be assessed by a community advisory panel, and intervention feasibility and acceptability will be completed by conducting a pre-pilot test of the intervention procedures. Specific Aim 3: Conduct a pilot test that compares the PrEP enhancement intervention (N=100), including on-demand interactive text messaging, to a contact matched PrEP information only and sexual risk counseling control intervention (N=50) at 2, 4, and 6 month follow-ups on PrEP uptake, adherence, and persistence in order to establish preliminary intervention efficacy. Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV. Low-resource burden, easily implemented, and effective social/behavioral interventions are urgently needed if the full benefits of PrEP are to be realized. If effective and disseminated, this intervention would meet current prevention needs and its potential impact on HIV infections averted could be substantial.

This application is in response to PAS-18-915 HIV/AIDS High Priority Drug Abuse Research. HIV incidence among Black men who have sex with men (BMSM) in the southeastern United States is one of the highest in the world. Our research team has conducted studies with BMSM in Atlanta that have demonstrated 35% HIV prevalence and over 5% annual HIV incidence. Although PrEP is highly effective for preventing HIV transmission, it is not reaching BMSM. The failures in our ability to engage BMSM in PrEP use are highly problematic given the alarming rates of HIV transmission among this group. In our most recent work with BMSM in Atlanta, we found that only 4% (n=19/474) of BMSM are currently taking PrEP even though 90% (n=428/474) are aware of PrEP. Of particular concern is the impact of substance use as a barrier in PrEP linkage, uptake, adherence, and persistence. Substance use is common among BMSM in our study, with 43% (n=204/474) reporting recent substance use. And, critically, in our most recent longitudinal study with BMSM, substance users were more than twice as likely than non-substance users to test HIV positive, 7% (n=15/205) vs. 2% (n=4/244) at baseline testing, and an additional 7% (n=13/190) vs 3% (n=8/240) at study follow up one year later. Further complicating PrEP use is the potential impact of COVID- 19 on health care access, health care infrastructure, and sex behavior. The need to better understand PrEP use in the context of our new health care landscape is critical to making advances in PrEP use. At this point, assessing how substance use impacts PrEP use is challenging because PrEP implementation is so low among this group. The proposed research aims to provide substance using BMSM with evidence-based PrEP engagement counseling to address barriers to accessing PrEP (not for intervention testing, but for facilitating PrEP use) and to assess the multiple forms and paths of stigma and substance use as they relate to PrEP linkage, uptake, adherence, and persistence. We propose using the HIV Stigma Framework as a conceptual model for investigating the intersecting pathways of stigma drivers and stigma mechanisms as they relate to PrEP use among substance using BMSM. Aim 1: Enroll a prospective cohort of N=500 BMSM who test HIV negative and test substance use positive on toxicology testing, and provide evidence-based PrEP engagement counseling to facilitate access to PrEP care. Aim 2: Conduct psychosocial and health care access assessments every 2-months for 18-months, and conduct HIV/STI testing and dried blood spot testing for TFV-DP every 3-months for 18-months. Aim 3: Using data collected from Aims 1 and 2, model stigma pathways of advancing and reverting along the PrEP cascade (i.e., linkage, uptake, adherence, persistence), with these pathways mediated by health care access and moderated by substance use. Achieving the aims will provide critical insight for translating and adapting interventions to enhance potency and durability for individuals at exceedingly elevated risk for HIV.