Safety and Immune Responses Following Anti-PD-1 Monoclonal Antibody Infusions in Healthy Persons With Human Immunodeficiency Virus on Antiretroviral Therapy.

Background: T cells in people with human immunodeficiency virus (HIV) demonstrate an exhausted phenotype, and HIV-specific CD4+ T cells expressing programmed cell death 1 (PD-1) are enriched for latent HIV, making antibody to PD-1 a potential strategy to target the latent reservoir. Methods: This was a phase 1/2, randomized (4:1), double-blind, placebo-controlled study in adults with suppressed HIV on antiretroviral therapy with CD4+ counts ≥350 cells/µL who received 2 infusions of cemiplimab versus placebo. The primary outcome was safety, defined as any grade 3 or higher adverse event (AE) or any immune-related AE (irAE). Changes in HIV-1-specific polyfunctional CD4+ and CD8+ T-cell responses were evaluated. Results: Five men were enrolled (median CD4+ count, 911 cells/µL; median age, 51 years); 2 received 1 dose of cemiplimab, 2 received 2 doses, and 1 received placebo. One participant had a probable irAE (thyroiditis, grade 2); another had a possible irAE (hepatitis, grade 3), both after a single low-dose (0.3 mg/kg) infusion. The Safety Monitoring Committee recommended no further enrollment or infusions. All 4 cemiplimab recipients were followed for 48 weeks. No other cemiplimab-related serious AEs, irAEs, or grade 3 or higher AEs occurred. One 2-dose recipient of cemiplimab had a 6.2-fold increase in polyfunctional, Gag-specific CD8+ T-cell frequency with supportive increases in plasma HIV RNA and decreases in total HIV DNA. Conclusions: One of 4 participants exhibited increased HIV-1-specific T-cell responses and transiently increased HIV-1 expression following 2 cemiplimab infusions. The occurrence of irAEs after a single, low dose may limit translating the promising therapeutic results of cemiplimab for cancer to immunotherapeutic and latency reversal strategies for HIV. Clinical Trials Registration. NCT03787095.

A Trauma-Informed HIV Intervention (LinkPositively) to Improve HIV Care Among Black Women Affected by Interpersonal Violence: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Black women bear a disproportionate burden of HIV, accounting for nearly 60% of new diagnoses among US women. Black women living with HIV often experience mutually reinforcing epidemics, known as syndemics, including interpersonal violence and substance use. Syndemics are associated with decreased HIV care engagement and treatment adherence and worsening HIV outcomes. Few HIV services and resources are tailored to be culturally and gender-responsive and trauma informed for Black women living with HIV. Technology-based, psychoeducational, and peer navigation programs offer promising pathways to tailored HIV support and improved HIV care outcomes. Therefore, the web-based, trauma-informed intervention LinkPositively was developed in collaboration with Black women living with HIV to promote uptake of HIV care and ancillary support services. OBJECTIVE: This study primarily determines the feasibility and acceptability of the LinkPositively intervention among Black women living with HIV affected by interpersonal violence. The secondary aim is to examine the preliminary impact of the LinkPositively intervention on retention in HIV care, antiretroviral therapy adherence, and viral suppression while evaluating the role of mechanism of change variables (eg, social support) in the associations. METHODS: The LinkPositively trial is a pilot randomized controlled trial conducted in California, United States, among 80 adult Black women living with HIV who have experienced interpersonal violence. Core components of LinkPositively include one-on-one peer navigation with phone and SMS text message check-ins; 5 weekly one-on-one video sessions to build coping and care navigation skills; and a mobile app that contains a peer support social networking platform, an educational database with healthy living and self-care tips, a GPS-enabled HIV and ancillary care resource locator, and a medication self-monitoring and reminder system. Participants are randomly assigned to the intervention (n=40) or control (Ryan White standard of care; n=40) arm, with follow-up at 3 and 6 months. At each assessment, participants complete an interviewer-administered survey and submit hair samples for the assessment of HIV medication adherence. All research staff and investigators adhere to ethical principles and guidelines for conducting research activities. Data will be analyzed using generalized estimating equations. RESULTS: Final development and testing of the LinkPositively app were completed in July 2021. As of May 2023, we have screened 97 women for eligibility. Of the 97 women screened, 27 (28%) were eligible and have been enrolled in the study. The dissemination of preliminary results will occur in 2024. CONCLUSIONS: This trial will advance HIV prevention science by harnessing technology to promote engagement in HIV care while improving social support through peers and social networking-all while being trauma informed for Black women living with HIV with experiences of interpersonal violence. If shown to be feasible and acceptable, LinkPositively has the potential to improve HIV care outcomes among Black women, a marginalized key population. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46325.

An examination of the association between forced sex history and reproductive coercion experiences among Black women attending STD clinics in Baltimore, MD, USA.

BACKGROUND: Reproductive coercion victimization (RCV) is a significant public health issue that negatively affects women's sexual and reproductive health outcomes. Less is known about reproductive coercion perpetration (RCP). Few studies have examined these phenomena among representative samples of Black women. METHODS: Retrospective data of women (n = 298) attending STD clinics in Baltimore, MD were analyzed. We calculated lifetime and 12-month prevalence reports of reproductive coercion, and reported values stratified by forced sex history. Binomial logistic regression models were used to examine the association between forced sex history and RCV, accounting for other types of violence typologies. RESULTS: Lifetime and past 12-month RCV and RCP prevalence were higher among women with forced sex experiences than their counterparts (Lifetime RCV: 46.9% versus 17.5%; past 12-month RCV: 19.4% versus 8.5%. Lifetime RCP: 24.5% versus 17%; past 12-month RCP: 13.3% versus 10.5%). Adjusted models, lifetime reproductive coercion: Women reporting forced sex had a 3.58 times higher odds of having had experienced RCV compared to women not reporting forced sex (AOR 3.58; 95% CI 2.00, 6.46). Women reporting forced sex had a 3.66 times higher odds of having ever experienced pregnancy coercion compared to their counterparts (AOR 3.66; 95% CI 1.93, 7.03) and 4.30 times higher odds of having ever experienced condom manipulation (AOR 4.30; 95% CI 2.15, 8.86). Adjusted models, past 12-month reproductive coercion: Women reporting forced sex had a 2.72 times higher odds of having had experienced past 12-month RCV compared to women not reporting forced sex (AOR 2.72; 95% CI 1.27, 5.91). Women reporting forced sex had a 3.25 times higher odds of having experienced past 12-month pregnancy coercion compared to their counterparts (AOR 3.25; 95% CI 1.38, 7.83) and 3.41 times higher odds of having experienced past 12-month condom manipulation (AOR 3.41; 95% CI 1.14, 10.98). CONCLUSIONS: Participants in our study reported high rates of RCV. Our novel exploration revealed significantly high rates of co-occurring forced sex experiences and RCV and initial prevalence report of RCP. Agencies have a unique opportunity to intervene by implementing screening protocols and referrals for supportive services. These findings may inform future intervention research efforts aimed at improving reproductive health outcomes among Black women.

"It comes altogether as one:" perceptions of analytical treatment interruptions and partner protections among racial, ethnic, sex and gender diverse HIV serodifferent couples in the United States.

BACKGROUND: Most HIV cure-related studies involve interrupting antiretroviral treatment to assess the efficacy of pharmacologic interventions - also known as analytical treatment interruptions (ATIs). ATIs imply the risk of passing HIV to sexual partners due to the loss of undetectable HIV status. There has been a notable lack of attention paid to perceptions of ATIs among racial, ethnic, sex and gender minorities, and HIV serodifferent couples. These populations are among those most impacted by HIV in the United States. Future HIV cure research paradigms should equitably include considerations from these groups. METHODS: From August - October 2020, we conducted in-depth interviews with 10 racial, ethnic, sex, and gender minority HIV serodifferent couples in geographically diverse regions of the United States to understand their perspectives about ATIs and partner protection measures to prevent secondary HIV transmissions because of participation in ATI studies. We used framework analysis to analyze the qualitative data. RESULTS: Of the 10 couples recruited, four identified as a gay couple, two as a gay and bisexual couple, two as a heterosexual couple, one as a gay and queer couple, and one as a queer couple. We found that HIV serodifferent couples in our study viewed ATIs as contradicting HIV treatment adherence messages. Couples expressed discomfort around ATIs in HIV cure research. They were concerned with the return of HIV detectability and worried ATIs might result in secondary HIV transmission. Participants were strongly in favor of using a range of partner protection measures during ATIs that included PrEP, HIV risk reduction counseling, and alternatives for penetrative sex practices. Couples also recommended that sex partners be consulted or involved as part of ATI trials. CONCLUSIONS: Our findings highlight new potential opportunities and strategies to mitigate risk of HIV transmission during ATIs among key groups historically under-represented in HIV cure research. Findings also underscore the relational aspects of ATI trials. We provide preliminary considerations for planning ATI trials with diverse HIV serodifferent partners. Future studies should continue to explore these issues among other types of partnerships, cultures, and socio-cultural settings.

Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States.

Frequent viral load testing is necessary during analytical treatment interruptions (ATIs) in HIV cure-directed clinical trials, though such may be burdensome and inconvenient to trial participants. We implemented a national, cross-sectional survey in the United States to examine the acceptability of a novel home-based peripheral blood collection device for HIV viral load testing. Between June and August 2021, we distributed an online survey to people with HIV (PWH) and community members, biomedical HIV cure researchers and HIV care providers. We performed descriptive analyses to summarize the results. We received 73 survey responses, with 51 from community members, 12 from biomedical HIV cure researchers and 10 from HIV care providers. Of those, 51 (70%) were cisgender men and 50 (68%) reported living with HIV. Most (>80% overall) indicated that the device would be helpful during ATI trials and they would feel comfortable using it themselves or recommending it to their patients/participants. Of the 50 PWH, 42 (84%) indicated they would use the device if they were participating in an ATI trial and 27 (54%) also expressed a willingness to use the device outside of HIV cure studies. Increasing sensitivity of viral load tests and pluri-potency of the device (CD4 count, chemistries) would augment acceptability. Survey findings provide evidence that viral load home testing would be an important adjunct to ongoing HIV cure-directed trials involving ATIs. Survey findings may help inform successful implementation and uptake of the device in the context of personalized HIV care.

Considerations for Increasing Racial, Ethnic, Gender, and Sexual Diversity in HIV Cure-Related Research with Analytical Treatment Interruptions: A Qualitative Inquiry.

Despite disproportionate incidence and prevalence of HIV among transgender individuals, cisgender women, and racial and ethnic minority groups, all remain underrepresented in HIV cure research. As HIV cure trials are scaled up, there is emerging research on ways to mitigate risks of HIV acquisition for sexual partners of analytical treatment interruption (ATI) trial participants. As such, it is imperative that HIV cure researchers consider the implications of implementing ATIs in populations that are disproportionately affected by HIV, but largely underrepresented in trials to date. In this qualitative study, we sought to derive triangulated perspectives on the social and ethical implications regarding ATIs and partner protection strategies during ATIs among under-represented populations. We conducted 21 in-depth interviews with 5 types of informants: bioethicists, community members [people living with HIV (PLWH) and their advocates], biomedical HIV cure researchers, sociobehavioral scientists, and HIV care providers. We analyzed the data using conventional content analysis and reduced the data to important considerations for implementing ATI trials in diverse communities and settings. Our study revealed the following key themes: (1) attention must be paid to gender and power dynamics in ATI trials; (2) ATI trials should be designed and implemented through the lenses of intersectionality and equity frameworks; (3) ATI trials may have both positive and negative effects on stigma for PLWH and their partners; and (4) partnership dynamics should be considered when designing ATI protocols. Our study generated actionable considerations that could be implemented in ATI trials to promote their acceptability to communities that have been underrepresented in HIV cure research to date. Research teams must invest in robust community and stakeholder engagement to define best practices. Paying attention to representation and equity will also promote better and more equitable implementation of HIV cure strategies once these become ready for rollout.

Ethics of HIV cure research: an unfinished agenda.

BACKGROUND: The pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research. METHODS: We conducted a scoping review of the growing HIV cure research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing. DISCUSSION: Despite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation). CONCLUSION: HIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time.

Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19.

The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.

Impact of dedicated women's outreach workers (WOWs) on recruitment of women in ACTG clinical studies.

BACKGROUND: Despite efforts by the AIDS Clinical Trials Group (ACTG) to enroll representative numbers of diverse women, participation in ACTG studies in the United States remains largely white and male. To address this gap in women's participation in ACTG research, a one-year pilot study of dedicated women's outreach workers (WOWs) was proposed. OBJECTIVES: included demonstrating that targeted recruitment efforts can expand community awareness of ACTG research and ensuring successful enrollment of women at the respective clinical research sites. METHODS: The pilot study was conducted at two U.S. sites (Rutgers New Jersey Medical School and Emory Ponce de Leon Center in Atlanta, Georgia). The WOWs worked with site personnel to identify and reach out to women living with HIV and/or Hepatitis B or C at their respective sites and encourage them to join a clinical trial registry for those interested in participating in future clinical trials. RESULTS: The Rutgers WOW approached 127 potential participants (of whom 100 joined the WOW registry) and screened 35 participants for open ACTG studies. The Emory WOW approached 120 participants, enrolling 86 into the WOW registry, and screened 51 potential participants for open ACTG studies during the WOW's tenure. The majority of women screened at both sites were women of color. CONCLUSIONS: The WOW study team identified several lessons learned that can inform future efforts to engage women living with HIV in clinical research. First, success in engaging women is proportional to level of funding and institutional support. Second, there is a need for a more gender-inclusive scientific agenda as women are more likely to participate if studies address topics of interest to them. Third, meaningful engagement is a two-way street.

Ethical and practical considerations for mitigating risks to sexual partners during analytical treatment interruptions in HIV cure-related research.

BACKGROUND: Background: Analytical treatment interruptions (ATIs) in HIV cure-related research can result in trial participants becoming viremic with HIV, placing HIV-negative sexual partners at elevated risk of acquiring HIV. OBJECTIVE: Objective:Our study aimed to generate ethical and practical considerations for designing and implementing appropriate risk mitigation strategies to reduce unintended HIV transmission events during ATIs. METHODS: Methods: We conducted 21 in-depth interviews with five types of informants: bioethicists, community members, biomedical HIV cure researchers, socio-behavioral scientists/epidemiologists, and HIV care providers. We used conventional content analysis to analyze the data and generate considerations. RESULTS: Results: Key findings include: 1) Ethical permissibility of ATI trials depends on due diligence and informed consent to mitigate risks to participants and their sexual partners; 2) Participants should receive adequate support and/or counseling if they choose to disclose ATI participation to their partners; 3) Measures to protect sexual partners of trial participants from HIV transmission during ATIs should include referral to and/or provision of pre-exposure prophylaxis, as well as other available means of preventing HIV transmission; 4) There is uncertainty regarding the appropriate management of emerging sexually transmitted infections during ATI trials and possible protection measures for multiple and/or anonymous partners of ATI trial participants. CONCLUSION: Conclusion: While there is no way to completely eliminate the risk of HIV transmission to sexual partners during ATIs, HIV cure trialists and sponsors should consider the ethical concerns related to the sexual partners of ATI participants. Doing so is essential to ensuring the welfare of participants, their partners and the trustworthiness of research.

Reasons People Living with HIV Might Prefer Oral Daily Antiretroviral Therapy, Long-Acting Formulations, or Future HIV Remission Options.

A growing body of research is beginning to elucidate reasons people living with HIV (PLWHIV) might prefer oral daily antiretroviral treatment (ART) compared with emerging long-acting ART (LA-ART) or HIV remission strategies under investigation. Our objective is to provide qualitative insights into the reasons why PLWHIV might prefer one of these HIV control therapies over others. From May to August 2018, we implemented a semistructured cross-sectional survey of PLWHIV in the United States to better understand patient preferences around various HIV treatment and remission options. Using free text, respondents were asked to explain why they preferred one HIV control option over the other two. We analyzed responses to the open-ended survey questions on reasons for preferring oral daily ART versus LA-ART versus HIV remission strategies using conventional content analysis. The results showed that PLWHIV preferred oral daily ART because of its familiarity and known safety and efficacy profile, whereas those who preferred LA-ART would value the convenience it offers. Finally, HIV remission strategies would be preferred to avoid taking ART altogether. The qualitative results provide insights into reasons why PLWHIV in the United States might prefer oral daily ART versus novel therapies. More importantly, they provide information to better align HIV virological control strategies with end-user perspectives. To make informed choices around evolving HIV therapeutics, PLWHIV and HIV care providers would benefit from decision tools to better assess options and trade-offs. More research is needed on how best to effectively support PLWHIV and HIV care providers in shared decision-making.

Participant Perspectives in an HIV Cure-Related Trial Conducted Exclusively in Women in the United States: Results from AIDS Clinical Trials Group 5366.

Women remain underrepresented in HIV research. The AIDS Clinical Trials Group (ACTG) 5366 study was the first HIV cure-related trial conducted exclusively in women. Our multidisciplinary team integrated participant-centered reports into the ACTG 5366 protocol to elicit their perspectives. We nested mixed-methods surveys at the enrollment and final study visits to assess ACTG 5366 participants' perceptions and experiences. Of 31 participants enrolled in the ACTG 5366, 29 study agreed to complete the entry questionnaire and 27 completed the exit survey. The majority of study participants were nonwhite. We identified societal and personal motivators for participation, understanding of risks and benefits, and minor misconceptions among some trial participants. Stigma was pervasive for several women who joined the study, and served as a motivator for study participation. Reimbursements to defray costs of study participation were reported to facilitate involvement in the trial by about one-third of participants. Almost all respondents reported positive experiences participating in the ACTG 5366 trial. The ACTG 5366 study showed that it is possible to recruit and retain women in HIV cure-related research and to embed participant-centered outcomes at strategic time points during the study. The findings could help in the design, implementation, recruitment, and retention of women in HIV cure-related research and highlight the value of assessing psychosocial factors in HIV cure-related research participation.

Increasing the use of research in population health policies and programs: a rapid review.

BACKGROUND AND OBJECTIVES: Although the body of literature on factors that impede and enhance the use of research in policy making continues to expand, there is limited evidence about strategies that are effective at fostering the use of research in population health policy and programs. Building on previous reviews, we reviewed the published literature to identify and assess papers describing intervention studies that had outcome measures relating to research use. STUDY TYPE: Rapid review. METHODS: We searched four academic databases and Google Scholar to identify papers published between 2009 and 2015. Our focus was on strategies relevant to population health policy and program delivery. For studies that tested strategies to increase the use of research, we extracted details about the intervention, participants, study sites and methods, and primary and other outcomes. RESULTS: We identified 14 articles reporting on 13 intervention studies. The studies were relatively weak methodologically and together provide few indications of effect. Only one study used an experimental design and one other used pre-/post-test design; the remaining studies were characterised by an absence of control groups, small sample sizes, and self-report data. Of the 13 studies: four intervention studies were related to the theme 'relevant, useful, accessible research'; five studies (described in six papers) tested strategies that facilitated interaction between researchers and research users; three studies assessed strategies aimed at enhancing the capacity of organisations to use research; and one intervention study was related to the theme 'funding research infrastructure and research projects'. CONCLUSION: The level of evidence for the effectiveness of strategies to improve the use of research in policy making is low, and there remains a need for well-designed empirical studies that evaluate interventions. In the absence of strong evidence, efforts to enhance research use should be tailored to organisational needs and may incorporate capability development, improved access to targeted research summaries and syntheses, and greater interaction and collaboration with researchers.

The Prevention Research Support Program: supporting innovation in research, translation and capability building.

OBJECTIVES: The Prevention Research Support Program (PRSP) is a New South Wales (NSW) Ministry of Health funding scheme. The scheme aims to build capability, and strengthen prevention and early intervention research that is important to the NSW public health system (NSW Health) and that leads to improved health and reduced health inequities for the people of NSW. This paper describes how PRSP funding has supported recipients to produce high-quality, policy-relevant research, and increase the impact of research on policy and practice. Type of program: The PRSP is a competitive funding program that supports NSW research organisations that conduct prevention and early intervention research that aligns with NSW Health priorities. The objectives of the PRSP are to: increase high-quality and internationally recognised prevention research in NSW; support the generation of research evidence that addresses NSW Health prevention priorities, including cross-government priorities; encourage the adoption of research evidence in relevant policies, programs and services in NSW; and build the prevention research capability of NSW Health staff and the NSW Health system. METHODS: Funding recipients provide information about their research, translation and capability building achievements in their funding applications and submit annual progress reports. Data from these sources were aggregated to illustrate trends in indicators of research excellence over time. Prior to the most recent call for applications, the program was reviewed. The review included consultations with funding recipients, policy and practice partners, and key funding stakeholders. Stakeholders' perceptions of the benefits and challenges associated with the PRSP were drawn from the consultation data. RESULTS: PRSP funding recipients demonstrate considerable increases over time on several indicators of research excellence, including peer-reviewed journal publications, grant income, and research students supervised. Recipients use a range of strategies to ensure dialogue with health system partners, and report research impacts at the local, state, national and international levels. PRSP funding also supports the development of research capability. LESSONS LEARNT: The PRSP is a unique scheme that is highly valued by both funding recipients and health system stakeholders. The continuity of funding provided under the scheme enables recipients to adopt a strategic approach to their research and develop innovative strategies to support its conduct and use.

Increasing the use of evidence in health policy: practice and views of policy makers and researchers.

BACKGROUND: Better communication is often suggested as fundamental to increasing the use of research evidence in policy, but little is known about how researchers and policy makers work together or about barriers to exchange. This study explored the views and practice of policy makers and researchers regarding the use of evidence in policy, including: (i) current use of research to inform policy; (ii) dissemination of and access to research findings for policy; (iii) communication and exchange between researchers and policy makers; and (iv) incentives for increasing the use of research in policy. METHODS: Separate but similar interview schedules were developed for policy makers and researchers. Senior policy makers from NSW Health and senior researchers from public health and health service research groups in NSW were invited to participate. Consenting participants were interviewed by an independent research company. RESULTS: Thirty eight policy makers (79% response rate) and 41 researchers (82% response rate) completed interviews. Policy makers reported rarely using research to inform policy agendas or to evaluate the impact of policy; research was used more commonly to inform policy content. Most researchers reported that their research had informed local policy, mainly by increasing awareness of an issue. Policy makers reported difficulty in accessing useful research syntheses, and only a third of researchers reported developing targeted strategies to inform policy makers of their findings. Both policy makers and researchers wanted more exchange and saw this as important for increasing the use of research evidence in policy; however, both groups reported a high level of involvement by policy makers in research. CONCLUSION: Policy makers and researchers recognise the potential of research to contribute to policy and are making significant attempts to integrate research into the policy process. These findings suggest four strategies to assist in increasing the use of research in policy: making research findings more accessible to policy makers; increasing opportunities for interaction between policy makers and researchers; addressing structural barriers such as research receptivity in policy agencies and a lack of incentives for academics to link with policy; and increasing the relevance of research to policy.