CIRA Research Summary 2007 by CIRA Webmaster

2007

Community partners are often concerned that research findings are not made readily available to service providers, study participants, and others in the local community. CIRA’s Community Research Core has worked to address this issue by developing a summary of the major findings of many CIRA affiliated research projects in “user-friendly” language. This Research Summary is not meant to be comprehensive of all active and completed CIRA affiliated projects. If you would like more information on any CIRA affiliated research projects, please visit us on the Web at www.yale.edu/cira or contact CIRA at 203.764.4333.

YALE UNIVERSITY Center for Interdisciplinary Research on AIDS

CIRA Research Summary

TABLE OF CONTENTS

Community Research Partnership Program

HIV Prevention Research for Drug Users

HIV Prevention Research for Persons Living with HIV

HIV Prevention Research for Young Adults and Women

10 International Research

12 Structural and Policy Research

ABOUT CIRA

The Center for Interdisciplinary Research on AIDS (CIRA) was established in 1997 with funding from the National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) and is currently funded through a grant from the NIMH. The Center brings together scientists from 20 different disciplines in support of its mission to support the conduct of interdisciplinary research focused on the prevention of HIV infection and the reduction of the negative consequences of HIV disease in vulnerable and underserved populations nationally and abroad. There are 70 active research and training grants affiliated with CIRA and almost 60 affiliated scientists.

CIRA AND CONNECTICUT

CIRA focuses on the prevention needs of those most affected by HIV in Connecticut, including the poor, women, drug users and their partners, and communities of color. The Center unites three Connecticut research institutes: Yale University in New Haven, The Institute for Community Research (ICR) and the Hispanic Health Council (HHC), both in Hartford.

TRAINING AND DEVELOPMENT PROGRAMS

CIRAâ&#x20AC;&#x2122;s training programs include NIMH Pre-Doctoral and Post-Doctoral Fellowships to train new researchers in HIV prevention and grants from the National Institutes of Health Fogarty International Center to train fellows from Russia, China, South Africa, and Nicaragua in the conduct of HIV/AIDS prevention research. CIRA pilot project grants support HIV/AIDS pilot research and encourage new scientists to enter the field.

ABBREVIATIONS AIDS ARV CDC CIRA HAART HIV HSV IDU MSA NEP NGO NIH PLHA STD STI

Acquired Immune Deficiency Syndrome Antiretroviral Centers for Disease Control Center for Interdisciplinary Research on AIDS Highly active antiretroviral therapy Human Immunodeficiency Virus Herpes simplex virus Injection Drug User Metropolitan Statistical Area Needle exchange program Non-governmental organization National Institutes of Health Persons living with HIV/AIDS Sexually transmitted disease Sexually transmitted infection

Community Research Partnership Program This program aims to support the conduct of research by community-based organizations in collaboration with CIRA scientists, and thereby to build the research capacity of CBOs while addressing a community HIV prevention need. At the same time, the program expands the pool of CIRA researchers doing CBO research. FINDINGS Adult, Aware, and Alive, Subasree Srinivasan, M.D., with CIRA Collaborator, Lauretta Grau, Ph.D. • Evaluates the extent to which mature adults (over 50 years of age) engage in HIV-associated risk behaviors and their overall knowledge about HIV/STD risk (e.g. modes of transmission, symptoms, and prevention strategies). Assesses the attitudes of the population over 50 years of age, about being asked sexual and drug use histories by their health care providers. • Of the 125 surveys of seniors in New Haven and Bridgeport that have been conducted, 79% are female and the mean age is 67. Preliminary results of these surveys suggest behaviors that may place this population at risk for HIV infection and a need for better prevention measures. • 72% reported not having ever received any sort of HIV education or prevention materials from any healthcare or community source. • In the previous year, 24% of participants reported sexual activity; over 75% of these reported that they never used condoms. • With regards to HIV knowledge, most identified potential risk factors correctly, although 50% identified kissing or sharing a toothbrush as potential routes of transmission.

NEW RESEARCH Latinos Living with HIV/AIDS – Access to Sub-Acute Care, Martha Dale, with CIRA Collaborator, Jean Breny Bontempi, Ph.D. • Assesses traditional patterns of health care utilization for the Latino/a population at various stages of illness with HIV, what Latinos/as currently know about skilled nursing care facilities, and what local HIV care providers advise their Latino/a clients about accessing care services.

• Information will be gathered through focus groups and provider interviews. Through identification and analysis of factors contributing to the disparity of Latinos/as accessing HIV/AIDS sub-acute/skilled-nursing care, recommendations will be made on multiple levels including provider, cultural and community approaches. • Leeway views this project as a first step with the potential for broad implications relative to care for Latinos/as living with HIV/AIDS.

HIV Prevention Research for Drug Users FINDINGS Acupuncture and Coping Skills Training for Cocaine Abuse, Arthur Margolin, Ph.D. • Investigates the relative and combined clinical efficacy and costs of acupuncture and a psychosocial coping skills training as concurrent treatments for cocaine addiction. Previous studies have shown that acupuncture, a widespread treatment for addictions, is efficacious when offered concurrently with the psychosocial intervention but not when it is provided alone. • 200 cocaine-abusing methadone maintained patients were randomly assigned to four 12-week treatments: (a) acupuncture only (ACU); (b) coping skills training only (CST); (c) acupuncture plus coping skills training (ACU+CST); (d) standard methadone maintenance only (STD). Of the 191 patients who began treatment, 157 (86.4%) completed the 12-week program. • Patients in both of the CST conditions (STD+CST and STD+ACU+CST) used significantly less heroin and cocaine while in treatment than did patients assigned to STD only. • Patients assigned to STD only reported significantly more HIV risk behavior than patients assigned to STD+CST or those assigned to STD+ACU+CST. The difference between the acupuncture-only treatment condition and the two CST conditions was marginally significant, with both CST conditions reporting less HIV risk behavior than patients assigned to acupuncture only. • HIV knowledge and HIV preventive skills improved across treatment conditions, with patients in either of the CST conditions showing the greatest improvements.

CIRA 2007 RESEARCH SUMMARY

• Patients who achieved abstinence by the end of the 12week treatment phase, continued to receive their assigned treatment. At the end of six months 40 of these patients were interviewed. Although not statistically significant, perhaps due to insufficient power, patients who had received CST were least likely to have relapsed, and patients who had received acupuncture without CST were most likely to have relapsed. • Results will be applied to develop a standard for patient-totreatment matching. Counseling for Primary Care Office-Based Buprenorphine, David A. Fiellin, M.D. • Buprenorphine is an effective treatment for heroin and prescription opioid dependence. New regulations have made buprenorphine available in primary care without obligate counseling. Despite evidence demonstrating improved outcomes when drug counseling is provided along with methadone treatment in opioid treatment programs, no such evidence exists for buprenorphine treatment in primary care.

“Buprenorphine is an effective treatment for heroin and prescription opioid dependence.” • Emerging evidence indicates that primary care physicians offering buprenorphine treatment will likely provide a low level of counseling services, consistent with the minimum requirements under federal regulations, due to fiscal, logistical and competency constraints. Our studies of buprenorphine in primary care demonstrate the feasibility of on-site drug counseling, great variability in buprenorphine adherence and a strong association between improved buprenorphine adherence and improved outcomes, and decreased HIV risk behavior with buprenorphine treatment. • To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing adherence, this study compares Physician Management vs. Physician Management combined with Cognitive Behavioral Therapy in 140 opioid dependent patients treated with buprenorphine in a primary care clinic. The study tests the hypothesis that the addition of Cognitive Behavioral Therapy to Physician Management will lead to decreased illicit drug use, improved buprenorphine adherence, and decreased HIV risk behaviors. • The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine. 2

C IRA 2007 RESEARCH SUMMARY

Crack Use and Related Sexual Risk in El Salvador, Julia Dickson-Gomez, Ph.D. • Both HIV/AIDS incidence and crack use have increased dramatically in El Salvador over the last decade. The research uses qualitative in-depth interviews with a purposive sample of crack smoking men and women to determine whether crack use is associated with high risk sexual behaviors, and to identify components of an HIV risk reduction intervention. A smaller sample of sex workers was also interviewed to determine differences in pathways into drug use and in HIV risk behaviors. • Interviews with sex workers indicate a high prevalence of crack use, although for this sample sex work preceded initiation of crack use. Sex workers engage in a number of high risk practices such as sex while high, sex without condoms, and sex for crack exchanges. • Among crack smoking men and women who do not consider themselves to be commercial sex workers, a majority report participating in sex for crack exchanges, or sex for money to buy crack. Additionally, some have reported that in some “trances” (sites where drugs are sold, and occasionally consumed), the exchange of sex for crack between drug sellers and drug users is very common. Crack users rarely use condoms in these exchanges. • Gang related sexual victimization includes sexual practices associated with initiation of female gang members (el brinco) in which a female initiate has to have sex with multiple gang members in succession, and the “remolque”, the gang rape of a female by members of the same or enemy gang as punishment. • 8.5% of the participants in this study voluntarily reported that they were HIV positive, a much higher rate than the 0.6% infected nationwide. Further, 79% reported that they knew at least one person who was HIV positive, had AIDS, or had died of AIDS. Only 33% of the men compared with 84% of the women had been tested for HIV. Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care Setting, David A. Fiellin, M.D. • Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and

the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of people with HIV/AIDS, or their broader impact on providers, institutions, and local systems. • This group of demonstration projects, sponsored by the Health Resources and Service Administration’s HIV/AIDS Bureau, is collaboratively coordinated by an Evaluation and Support Center managed by the New York Academy of Medicine and Yale University School of Medicine’s Section of General Internal Medicine. • Through this study, HIV-infected individuals who meet criteria for opioid dependence are enrolled by eleven model demonstration projects located in ten HIV care centers across the U.S. All eleven programs compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients receiving an alternate intervention (e.g. methadone). The program designs and comparison group interventions vary across the sites and are locally determined. Some sites have implemented randomized control designs, while others are using observational methods. • Information on patients’ drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers’ practices and attitudes towards treating drug dependent patients is being collected through interviews, surveys, and chart abstractions. • These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals. HIV Prevention in High-Risk Drug Use Sites: Project RAP (Risk Avoidance Partnership), Margaret R. Weeks, Ph.D. • The RAP project seeks to train 120 active drug users living in Hartford, CT as Peer Health Advocates (PHAs) to conduct a specifically-designed prevention intervention with their drug-using network members and sex partners. The RAP Peer-led Intervention is harm reduction and health promotion employing three components: education, demonstration (how to properly disinfect syringes with bleach, use condoms, etc.); and materials (including bleach kits for syringe disinfection, rubber tips for crack pipes, condoms, etc.).

• Community Advocacy Group meetings are held monthly to support trained PHAs to participate in health advocacy in their communities on behalf of themselves and their peers. • Evaluation of the RAP Peer-led Intervention includes: (1) baseline risk assessment of PHAs and two contact referrals (CRs, members of their drug risk networks), (2) post-training closing interview (for PHAs only), (3) a 6 month follow-up risk assessment with PHAs and CRs, and (4) ethnographic observations and interviews about in-office training sessions, partnered field sessions, daily activities regarding risk and prevention, and the diffusion of the intervention. • Preliminary results indicate that 86% of candidates who initiated the PHA training program completed the first series of in-office training sessions, and 80% completed two field training sessions with a staff partner. 50.8% of initiates completed the full training program lasting three months past the initial intensive training week. • According to encounter forms filled out by Peer Health Advocates, PHAs were more likely to deliver interventions to friends or acquaintances than to lovers or family members, particularly when staff members of the RAP project were present. • Comparisons of baseline to 6-month follow-up assessments indicated significant risk behavior reductions in all study participants (PHAs and their CRs) in rates of injection, rates of crack use, number of unprotected sexual encounters, number of sex partners, and sex for money or drugs exchanges. The percentage of participants reporting any of these behaviors also decreased significantly by the follow-up assessment. • Statistical analyses revealed an association between indicators of RAP PHA-delivered intervention and behavioral risk reductions, improved attitudes about efficacy of drug users as peer health advocates, and increased discussion among drug using network members about health issues, including HIV, STI, hepatitis, TB and prevention. Integrating Sex and Drug Related HIV Risk and Transmission, Robert Heimer, Ph.D. • A collaboration of researchers from Yale University, the Hispanic Health Council, the Biomedical Center in St. Petersburg, Russia and Imperial College, London to compare sexual and syringeborne disease transmission between populations of injection drug users and their partners in Connecticut and St. Petersburg. • Employs quantitative, qualitative and biological data to develop CIRA 2007 RESEARCH SUMMARY

a mathematical model of HIV transmission throughout the two populations. Investigates through this model the expansion in each community of HIV from the injection drug use community to the general population. • The first wave of data collection was completed at the end of 2006 and preliminary data analyses have been conducted. Among the salient findings are: • HIV prevalence in the sample of 412 IDUs was 47% (194 confirmed HIV seropositives). Compared to data collected in 2002-03, the epidemic among injectors is less concentrated in just a few St. Petersburg neighborhoods. Nearly onequarter (24%) of the injectors reported never having been tested for HIV. • High incidence in the sample of drug injectors was confirmed by two measures: (1) At enrollment, 186 individuals reported having been previously tested negative for HIV, constituting a retrospective cohort. Forty-one tested positive with a total amount of person-time between last HIV test and enrollment of 250 person years. HIV incidence was estimated to be 16.3 per 100 person years (95% CI = 11.7, 21.9). (2) There were 218 respondents who were HIV-seronegative at baseline and 36 individuals were determined to be recently infected using BED assay, resulting in an estimated incidence of 27.4 per 100 person-years. • These remarkably high estimates suggest that the epidemic curve for HIV has not yet reached plateau in St. Petersburg Russia, and effective interventions (behavioral and structural) are urgently needed.

“These remarkably high estimates suggest that the epidemic curve for HIV has not yet reached plateau in St. Petersburg Russia, and effective interventions (behavioral and structural) are urgently needed.” • Hepatitis C virus infection was endemic among the injectors with prevalence >90%. • Modeling results suggest that the HIV prevalence among injectors began a steep increase in 1998 and reached 45% by 2005. Prevalence estimates from HIV testing from 1998 through 2005 are consistent with model results. • HIV-1 prevalence among MSM appears to be in excess of 20%, suggesting a second wave of the epidemic in this atrisk population.

C IRA 2007 RESEARCH SUMMARY

Project SHARRP: Criminal Justice, Race, and HIV Risk in CT Drug Users, Kim M. Blankenship, Ph.D. • Examines, through a series of interviews and surveys conducted with released prisoners with a history of drug abuse, how incarceration subsequently shapes the HIV related risks and behaviors of these individuals, and how this varies by race and gender. • Focuses on how probation and parole impacts the family relationships, social support, and economic prospects of released prisoners with a drug use history. • Data collection began in October 2005 with longitudinal qualitative interviews of 48 people on parole or probation with a history of drug use. Each respondent is interviewed three times: baseline, six months, one year. All baseline and six month follow up interviews are complete. The one year follow up interviews will be done by May 2007. • Preliminary analysis of semi-structured baseline interviews reveals: (1) Most participants have extensive histories with the criminal justice system (CJS) and these have often either disrupted stable relationships (both sexual and otherwise) or prevented such relationships from developing, (2) Histories in the CJS contribute to the socio-economic vulnerability of participants, making it difficult to find jobs and pushing them to return to the drug economy, where they can make more money, but where they are at great risk for re-incarceration, (3) Involvement with the CJS contributes to housing instability, (4) The majority of female participants describe tremendous sadness associated with loss of custody of their children, as do many men who desire to develop relationships with their children. Drugs, especially for women, are a way of coping, and (5) Participants face considerable stress due to the multiple demands of re-entry, and few have been assisted by the CJS in meeting these demands (even when they have positive experiences with their probation/parole officer). Instead, it is their own social networks (especially nondrug users) that have helped them most in re-entering the community. • The HIV related significance of these findings, as well as their implications for related structural interventions, are being explored and will be further analyzed through a cross-sectional survey of 200 individuals on parole and probation with a history of drug use planned for Spring 2007. • Interviews with CJS professionals will be undertaken during Summer 2007.

Syringe Exchange Based Hepatitis B Vaccination of IDUs, Robert Heimer, Ph.D. • Hepatitis B infection prevalence among IDUs exceeded 60% in Chicago and Bridgeport and 65% in Hartford, while vaccination rates are less than 10%. • Hepatitis C infection rates exceeded 75% in Bridgeport and 80% in Hartford. • Drug injectors can understand the project’s complicated informed consent, fully appreciating the risks and benefits for them as individuals, but are less likely to understand the primary goal of the research project. • The accelerated schedule of vaccination, giving the last vaccine dose two rather than six months after the first dose, resulted in a significantly higher rate for completing vaccination. • Although 85% of the drug injectors who received all three doses of the vaccine developed protection against HBV infection, this percentage is lower than historic controls in non-drug using population where rates of protection usually exceed 90%.

NEW RESEARCH Alcohol Associated Outcomes among HIV+/- Aging Veterans, Amy Justice, Ph.D. • The Veterans Aging Cohort Study (VACS) is an 8 site, continuing observational study of 3216 veterans with HIV and 3163 veterans without HIV. Our long-range goal is to design and implement interventions to improve survival and quality of life for HIV positive individuals. Because most individuals with HIV use alcohol, we are focused on understanding its modifiable role in determining adverse medical outcomes. • Our previous research has shown: (1) alcohol use has a temporal and dose-response association with adverse medical outcomes including adherence, viral load, symptoms, and comorbid disease, (2) alcohol related biomarkers predict decreased survival, and that even moderate alcohol use shortens survival using computer simulation, (3) HIV-positive veterans and their physicians view alcohol as a secondary problem compared to drug use, and (4) HIV providers are often unaware of hazardous consumption and are less likely to counsel patients to stop or curtail alcohol than are general medical providers.

• VACS is uniquely positioned to support and inform intervention research. Of particular importance will be the differentiation between effects of alcohol that are related to past and current use from those related to continued use which are modifiable with intervention. • This study’s goals for the next three years are (1) to utilize blood specimens and alcohol data to evaluate biomarkers for alcohol and mitochondrial toxicity and develop an Index of Alcohol Related Frailty applicable to both HIV positive and HIV negative veterans, (2) to obtain longer follow-up and more intermediate observations to characterize the roles of past and current vs. continuing alcohol use in determining adverse medical outcomes and survival, and to compare and contrast these roles by HIV status, and (3) to use longitudinal models and computer simulation to determine the threshold of alcohol consumption associated with adverse medical outcomes and to determine whether HIV positive individuals experience adverse medical outcomes at lower quantity/ frequency alcohol exposure than HIV negative controls. Evaluating the Effects of Expanded Hours for Syringe Exchange Programs in Connecticut, Robert Heimer, Ph.D. • Over 50% of HIV/AIDS cases in Connecticut can be attributed to injection drug use (IDU). One of the best means to reduce HIV transmission among drug users is to establish syringe exchange programs (SEPs) where they exchange used syringes and needles for clean ones. A recent Office of National Drug Control Policy household survey revealed that over 60% of people that use illicit drugs have full time jobs and are, therefore, not reachable by the current SEP hours of operation. • Preliminary studies suggest that the percentage of the injection drug using population being reached by SEPs in New Haven is significantly less than cities such as Chicago, which have SEPs with extended night and evening hours. • This project determines the benefit of extending evening and weekend hours at the SEPs in Connecticut and compares the impact of SEPs with these expanded hours to those that maintain the standard hours of operation. Outcomes to be compared will include number of clients served, syringes and needles exchanged per encounter, and the delivery of prevention intervention services at the SEPs. • These findings will inform tailored prevention intervention approaches for hard-to-reach injection drug users in Connecticut.

CIRA 2007 RESEARCH SUMMARY

Interventions for HIV-positive Drug Abusers, S. Kelly Avants, Ph.D. • The goals of this project are: (1) Intervention development: Develop interventions specifically targeting inner-city HIVpositive injection drug users to (a) reduce high risk behavior, (b) increase medication adherence, and (c) improve quality of life. (2) Intervention evaluation: Rigorously evaluate these interventions in randomized clinical trials that include cost analyses to ensure that these interventions are cost effective as well as clinically efficacious. (3) Technology transfer: Bring research findings to clinical practice by ensuring timely dissemination of efficacious and cost-effective treatments to community-based programs. Technology transfer includes publishing and disseminating treatment protocols in ready-touse manuals, and designing and implementing comprehensive training programs for front-line clinical staff using state-ofthe-art technology in electronic and print communications. • Two manual-guided psychotherapeutic interventions specifically for HIV-positive drug users have been developed, evaluated, and disseminated. Both are available free-of-charge at www.3-S.us. The first intervention - the Holistic Health Recovery Program (HHRP+) - is a group intervention tailored to the special needs of HIV-positive drug users, and addresses the influence of cognitive impairment on sustaining drug use and other behaviors that contribute to the spread of HIV and to non-adherence to medical regimens. Following findings of efficacy of HHRP+ in a randomized clinical trial with HIV positive injection drug users, the CDC selected HHRP+ as one of 12 evidence-based interventions for inclusion in its Diffusion of Effective Behavioral Interventions (DEBI) project. As a CDC DEBI project, community based organizations (CBOs) nation-wide have received training in the delivery of HHRP+.

“Two manual-guided psychotherapeutic interventions specifically for HIV-positive drug users have been developed, evaluated, and disseminated. Both are available free-ofcharge at www.3-S.us.” • The second manual-guided intervention - Spiritual Self Schema (3-S+) therapy - is a faith-based cognitive behavioral intervention for people of all faiths that focuses on increasing motivation for abstinence, HIV prevention, and medication adherence by integrating cognitive self-schema theory with Buddhist principles and practices. Dissemination of the intervention is ongoing and includes the following: (1) therapy manuals and client workbooks are available for free 6

C IRA 2007 RESEARCH SUMMARY

download at the Training link of the 3-S Web site (www.3S.us). (2) 3-day workshops have been developed and are delivered to CBOs, upon request, across the country. (3) A 17-hour video training program in the delivery of 3-S+ therapy was developed, and is also available free-of-charge upon request. To date, over 300 DVD training sets have been provided to clinicians, researchers, clergy, and educators, nationally and internationally. • 3-S+ therapy manuals have recently been translated into Spanish and will be available on the Web site for free download in late Spring 2007. There are also plans to evaluate the Spanish version in a clinical setting in the coming year. Longitudinal Study of the RAP Peer Intervention for HIV, Margaret R. Weeks, Ph.D. • This 3-year study assesses the long-term behavioral effects of a peer-implemented HIV prevention program on trained active drug users and the drug-using contacts to whom they provide intervention, diffusion of the intervention and its effects through drug-user social networks and into drug use sites in Hartford, CT, and sustainability of peer-led HIV prevention interventions. • This is a continuation of the (RAP) project (R01 DA13356) to test this theoretically driven peer intervention program regarding its effectiveness in reducing HIV risks and drugrelated harm among the trained Peer Health Advocates (PHAs), their network Contact Referrals (CRs), and the Hartford drugusing community. • The aims of the proposed continuation study are to assess: (1) long-term effects of the RAP PHA training program and the process of delivering the peer-led intervention on PHAs’ HIV risk reduction attitudes and behaviors, (2) long-term effects of the RAP PHA delivered peer-led intervention on CRs’ HIV risk reduction attitudes and behaviors, (3) the diffusion of the RAP peer-led intervention components (materials, messages), effects (risk/harm reduction practices), and delivery process (peers helping peers) through networks of drug users in Hartford, and (4) the sustainability of the RAP peer-led intervention (materials/messages, risk reduction practices, peer-delivery process), and factors needed to sustain it over time. • Qualitative and quantitative methods will include: (1) a repeat follow-up survey interview with PHAs who initiated the training (n=129; 90 after attrition), their initial CRs who we interviewed at the start of the study (n=258, 155 after attrition), and at least one new CR from PHAs’ current drugusing social networks (n=90); this survey (total n=335) will

be conducted at approximately 2 - 2 1/2 years post intake for PHAs and original CRs, (2) continued ethnographic observations of drug use sites and Community Advocacy Group meetings of PHAs, and in-depth interviews of PHAs, CRs, and other drug users regarding the intervention, its provision and effects, and its diffusion and sustainability, and (3) a repeat communitywide survey conducted with PHAs, CRs, and other drug users in Hartford, using the same methods as the communitywide survey of the original RAP study (n=700). Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence, Lynn E. Sullivan, M.D. • Non-injection (oral prescription and intranasal/inhalational heroin) opioid dependence is on the rise, and sex-related HIV risk behaviors (non-condom use, multiple partners) are prevalent in this patient population. The availability of buprenorphine, a new medication that is effective in treating opioid dependence, through physicians’ offices, creates the additional opportunity for physicians to target these sex-related HIV risk behaviors through counseling interventions. The prevalence of these behaviors in these patients is not known and interventions specifically targeted at counseling for sexual risk behaviors delivered to patients receiving buprenorphine treatment have not been refined. • This project, funded by the Robert Wood Johnson Foundation, will determine the prevalence of specific sexual risk behaviors and evaluate the efficacy and costs of counseling interventions focused on reducing these sex-related HIV risk behaviors in non-injecting opioid dependent patients entering treatment with office-based buprenorphine. • 115 non-injecting opioid dependent patients enrolling in officebased buprenorphine treatment will be randomly assigned to one of two 14-week counseling interventions: (1) Standard HIV Counseling and Testing (educational), or (2) Enhanced HIV Counseling and Testing (interactive risk-reduction strategy). • Patients will be assessed for both opioid abstinence and for reduction in sex-related HIV risk behaviors. • A cost-effectiveness analysis will be conducted to evaluate the costs associated with both of the two counseling interventions. Substance Abuse, HIV and HCV Treatments to Improve Health Outcomes in Drug Users, R. Douglas Bruce, M.D. • Patients with substance use disorders are disproportionately affected by infectious diseases, particularly HCV and HIV. It is

challenging to bridge the gap between the disparate disciplines of substance abuse and infectious diseases. • This study, as part of Dr. Bruce’s K-award, conducts an analysis of the treatment outcomes of HCV treatment among prisoners using a retrospective analytic approach. • Seeks to develop and evaluate novel strategies for the treatment of HCV infection among opiod-dependent patients within a drug treatment program. • Intervention development will occur with both methadone (MMT) and buprenorphine (BMT) maintenance treatment. Among these, the adherence to therapy intervention will compare onsite or co-location of HCV services with HCV services provided off-site from the drug treatment program. • Data used from this study will provide an effect estimate that will be used for an R01 submission to conduct a randomized controlled trial.

HIV Prevention Research for Persons Living with HIV FINDINGS

Understanding the Social and Psychological Context of Acute Infection, Paul D. Cleary, Ph.D., Robert Dubrow, M.D., Ph.D. • Acute HIV infection, the earliest stage of HIV disease characterized by very high viral loads, is generally a period in which the infected individual continues to engage in high risk behaviors. Recent studies indicate that up to one-half of HIV transmission may occur during acute infection. • CIRA is contributing to a one-year, multi-center feasibility/ pilot study coordinated by the National Institute of Mental Health to better understand the social and psychological context of acute HIV infection. • The study will develop methods for identifying and recruiting individuals with acute HIV infection so that how they experience acute HIV infection and their sexual behavior, substance use and psychological state can be assessed. • The data collection phase of the study at CIRA was completed in January 2007 and will be completed at other centers by May 2007. CIRA used three mechanisms to identify cases of acute HIV infection: (1) In collaboration with the Hill Health Center HIV/AIDS Division, we screened for acute HIV infection at the South Central Rehabilitation Center (an inpatient alcohol and opiate detoxification facility) and the Grant Street Partnership (an intermediate care substance abuse CIRA 2007 RESEARCH SUMMARY

program), (2) In collaboration with the State of Connecticut Department of Public Health and the City of New Haven Health Department, we screened for acute HIV infection at the New Haven Health Department STD Clinic, and (3) We received referrals of suspected cases of acute HIV infection from the Yale-New Haven Hospital Emergency Department and other clinical sites. • The CIRA site screened 589 persons for acute HIV infection and identified three cases (two by screening and one by clinical referral). Two of these cases were recruited into the study. Through February 2007, 24 cases of acute HIV infection had been recruited into the study across all study sites. At all study sites, identifying cases of acute HIV infection was more difficult than anticipated.

“The CIRA site screened 589 persons for acute HIV infection and identified three cases.” • Researchers are in the process of summarizing the lessons learned. Nevertheless, this is one of the first behavioral studies of acute HIV infection, and we expect to learn much about its behavioral aspects, particularly from the in-depth qualitative interviews.

NEW RESEARCH Intervention for HIV+ Adults with Childhood Sexual Abuse, Nathan Hansen, Ph.D. • This project aims to develop and pilot test an intervention for HIV-positive adult survivors of childhood sexual abuse (CSA) who are sexually active and exhibit psychiatric distress related to trauma. • The widespread prevalence of CSA among HIV+ adults is concerning, as CSA has been linked to poor mental health, substance abuse, HIV risk behavior, and poor treatment adherence and outcome. • The training objectives are to develop the PI’s expertise in: (1) developing culturally sensitive empirically supported mental health treatments for trauma and CSA, (2) integrating HIVprevention strategies into mental health treatments for trauma and CSA, and (3) learning advanced quantitative data analytic skills for longitudinal data and outcome analysis. • The primary goals of the proposed project are to: (1) develop a 16 session individual cognitive-behavioral intervention for HIV+ adults with a history of CSA based on self- trauma 8

C IRA 2007 RESEARCH SUMMARY

theory and tailored to meet the needs of those living with HIV, (2) pilot test this intervention with a sample of 80 participants, 40 who will be randomized into an initial treatment condition followed by a four-month follow-up, and 40 who will be randomized into a four-month waitlist condition followed by treatment with the study intervention, and (3) evaluate the intervention’s ability to reduce distress and HIV transmission risk behavior, and collect estimates of effect size for future research. • This project will result in an intervention that integrates HIV-prevention strategies into mental health treatment for HIV-positive adults who have experienced CSA, a group with elevated risk for HIV-transmission behavior, that can be evaluated in a randomized, controlled intervention trial. The award will also support the PI’s long-term goal of integrating HIV-prevention strategies into the mental health care of vulnerable populations, such as survivors of trauma. Pilot Intervention Research: Brief Care-based HIV Prevention for Newly Diagnosed Men, Kathleen J. Sikkema, Ph.D. • Recent increases in HIV diagnoses, sexually transmitted infections, and risk behavior indicate that there is a need to identify effective prevention services integrated within the HIV primary care and treatment settings to reduce transmission risk behavior among HIV positive individuals. For two reasons, this is particularly the case for those newly diagnosed with HIV infection. First, this event provides a window of opportunity, as the time immediately after an HIV diagnosis is a critical period for risk reduction, especially for men. Second, HIV infected persons are most infectious and thus most likely to transmit the infection to others when they are recently infected. • The purpose of this project would be to conduct an evaluation of a Brief Risk Reduction (BRR) pilot prevention program among newly diagnosed HIV-infected men who have sex with men (MSM) and receive care at the Callen-Lorde Community Health Center in New York City. Our goal would be to determine the feasibility of this program, provided within the care and treatment setting, to reduce sexual transmission risk behavior of newly diagnosed HIV-positive MSM. • The program will be implemented by HIV clinic counselors and follow an initial physician visit. The program content will be focused on developing a tailored plan for transmission risk reduction, including sexual and substance use behavior, coping with the new diagnosis, decision making regarding disclosure, and enhancing motivation for health care. • If successful, this program will integrate risk reduction within

the context of personalized, relevant medical treatment, enhance the uptake of health-protective information and behavior change, and allow for preventive interventions to be normative in the care setting.

HIV Prevention Research for Young Adults and Women FINDINGS

Female Condom Use in High-Risk Women as Predictor of Microbicide Readiness, Margaret R. Weeks, Ph.D. • Studies social and contextual factors that affect high-risk women’s potential willingness to use female-controlled vaginal microbicides for HIV/STI prevention, including cultural beliefs, peer norms, and prior experiences. • Conducts an in-depth exploration of the parallels between potential use and perceived value/effectiveness of the female condom and vaginal microbicides among high-risk women, including barriers to adoption of the female condom as a woman-controlled option for HIV/STI prevention. • Preliminary results indicate the following: Barriers to female condom use are similar to those found with male condom use (e.g. negotiating use, condoms as a sign of distrust, etc.) and also included: lack of information, limited access, difficulty inserting it the first time, and hearing negative things about it from partners or peers; some of these barriers were removed just through participating in the study. • Female condom use was low at the beginning of the trial with only 32% of participants having ever used it. Those who had tried it used it between one and three times. • With adequate instruction, women and men at high-risk of HIV infection will try and continue to use the female condom with various types of partners (primary, casual, paying/paid). • After trying them, 64% of the men and women said they would “definitely recommend” the female condoms to friends. • Positive attitudes towards the female condom increased with repeated use.

NEW RESEARCH Coping with Pediatric HIV/AIDS in South Africa: Needs Assessment and Development of a Child Focused Psychosocial Intervention, Alexandra Boeving, Ph.D.

• Given the staggering consequences of the HIV/AIDS epidemic for children, pediatric psychosocial assessment and intervention efforts are greatly needed in Sub-Saharan Africa. As more HIV+ children gain access to life-saving antiretroviral medication, it is essential to conjointly attend to improving the children’s quality of life and ameliorating psychological distress. • This study aims to address the current deficit in the literature with regard to psychosocial functioning in the context of pediatric HIV/AIDS in southern Africa. The project will be conducted in collaboration with colleagues at the University of Pretoria-Kalafong Hospital. • The specific aims of the proposed research are to: (1) conduct a psychosocial needs assessment of the underserved pediatric HIV/AIDS population in a large urban public hospital, (2) compare the functioning of these children to community and affected (HIV+ mother) samples, (3) document contextual (family and community) factors in meeting the children’s psychosocial needs, and (4) assess the relationships between physiological, psychological, and educational functioning. • The project team will be interdisciplinary, drawing upon the expertise of psychologists, nurses, social workers, and pediatric physicians. • Over the year long study duration, 100 caregiver-child dyads will be recruited for participation in the needs assessment. Planned analyses are aimed to inform the development of a contextually specific family coping intervention targeted to address the needs of HIV+ children. Integrating Prenatal Care to Reduce HIV/STDs Among Teens: A Translational Study, Jeannette R. Ickovics, Ph.D. • The long-term objective of this study is to reduce risk for HIV and other STDs during and after pregnancy among adolescents and young women (aged 14-19) receiving prenatal care in 14 Community Health Centers (CHCs) serving predominantly Black and Latina communities in the New York City Metropolitan area. • Evaluates an innovative model of group prenatal care that integrates HIV prevention (Centering Pregnancy Plus, CP+) and has already yielded favorable biological and behavioral outcomes in a large NIMH-sponsored randomized controlled efficacy trial. • Specific aims are to: (1) Translate an efficacious HIV prevention intervention to 14 CHCs; (2) Test the effectiveness CIRA 2007 RESEARCH SUMMARY

of this intervention by (a) examining behavioral and biological outcomes via prospective measurement throughout the prenatal period and up to one year postpartum (N=1400), and (b) identifying potential mechanisms of the effects of group prenatal care, using Bronfenbrenner’s Ecological Systems Theory as a guiding framework; and (3) Conduct a rigorous process evaluation to identify factors that influence the uptake, fidelity, and sustainability of this intervention. • Using a clustered randomized controlled design, CHCs will be randomly assigned to group care or individual standard of care. We hypothesize that CP+ will be effectively translated to CHCs, and that it will result in significant reductions in HIV-related risk behaviors, significantly lower rates of STDs and repeat pregnancies, as well as improvements in perinatal outcomes. While extensive resources have been devoted to efficacy trials, fewer resources have been devoted to identify the effectiveness of programs implemented in “real world” settings, such as CHCs, where one in ten women — including many at highest risk for HIV/STDs — receive prenatal care. • This represents an important advance in interdisciplinary HIV prevention research for adolescent women: integrating a theoretically-driven and empirically-validated program for HIV/STD prevention into prenatal care is a promising way to provide sustainable care and disease prevention in a culturally-tailored setting. These underserved patients and the clinicians who care for them represent the ideal beneficiaries of translating clinical research into clinical practice for the reduction of risk and transmission of HIV and other STDs, as well as the elimination of health disparities. HIV/STD Risk among Young Expectant Fathers: Relationship Attachment & Transition, Trace Kershaw, Ph.D. • Men are understudied in the area of sexual risk and maternalchild health. The role men play in the health and sexual decisions of young couples transitioning to parenthood has not been fully explored. The inclusion of men in prevention research is essential to understanding the interpersonal context in which decisions are made about sexual behavior, personal health, and family functioning. • Using the guiding framework of attachment theory, we will examine HIV/STI risk behavior, relationship quality, and parenting functioning for young expectant fathers and their pregnant adolescent partners from pregnancy to parenthood. Since much of sexual risk occurs in the context of romantic relationships, it is essential to understand how each member of a romantic dyad influences sexual risk behavior, and how 10

C IRA 2007 RESEARCH SUMMARY

changes in relationships during important life transitions (e.g. parenthood) influence behavioral and biological outcomes associated with HIV/STD risk. • We will examine these issues in a multi-site longitudinal study of young expectant fathers and their pregnant adolescent partners (n=300 dyads) to be conducted in health clinics in Connecticut. Data will be collected through Audio Computer Assisted Self-Interview (ACASI) and semi-annual STD testing. Both members of the dyad will be assessed at three time points regardless of relationship status: during 3rd trimester of pregnancy, 6 months postpartum, and 12 months postpartum. Therefore, we can assess sexual risk behavior within couples and across new partnerships for both young men and women. • The results of this study can promote theoretical development and provide empirical information to enhance current and future interventions to prevent HIV, and other STDs for both young men and women. In addition, results will inform couple-based interventions that focus on relationship maintenance and family strengthening as well as HIV prevention during times of stress and transition.

International Research FINDINGS

NIMH Collaborative HIV/STD Prevention Trial (Russia), Nadia Abdala, Ph.D. • The NIMH Collaborative HIV/STD Prevention Trial is a twoarm randomized, community-level trial being conducted in five countries: China, India, Peru, Russia, and Zimbabwe. It is the first international test of a community-level prevention program and is based on the theory of diffusion of innovation utilizing Community Public Opinion Leaders (C-POLs). In this intervention model, popular opinion leaders within a high-risk population are systematically identified, recruited, trained, and engaged to communicate risk reduction messages to friends and acquaintances also in the target population. • Dr. Nadia Abdala is responsible for the biological evaluation component of the study, including establishment of a highquality STD laboratory in Russia and oversight of biological QA/QC procedures. Biological samples, taken at all assessment points, were tested for Chlamydia trachomatis, Neisseria gonorrhea, herpes simplex type 2, syphilis, trichomonas (females only), and HIV-1. • The intervention started in Fall 2002 and continued

through the end of 2005. The first and second part of the baseline assessment were conducted in the Falls of 2002 and 2003, with the recruitment of 922 and 1296 subjects, respectively. Intervention activities in control venues were conducted in 2006. • A pre-baseline study to determine the prevalence of HIV and STDs in the study population undertaken in the Fall (between September and December) of 2001 showed that 1,100 subjects studied had an overall STD prevalence ranging between 0.1 to 8%, depending on the pathogen. • Baseline results are currently under analysis and preliminary data indicate STD prevalences between 0 and 6.8%. Study data will be analyzed and published once interventions are completed in all study sites. • The results of this trial should provide the first documentation and evaluation of the portability and adaptability of interventions cross-nationally and cross-culturally and is being designed and implemented to be realistic and feasible for replication and dissemination. Microbicide/Female Condom Acceptability for Sex Workers in China, Margaret R. Weeks, Ph.D. • This supplemental study will be conducted by an international research team from the Institute for Community Research in Hartford, CT, in collaboration with Dr. Susu Liao from the Department of Epidemiology, Peking Union Medical College (PUMC), in Beijing, China, to work in three mid-sized towns in Hainan and Guangxi Provinces, targeting female sex workers at high risk of HIV/STDs. • Examines readiness for and acceptability of microbicide prevention methods and the female condom among Chinese female sex workers at high risk of contracting or transmitting HIV through unprotected sex in three southern Chinese rural and semi-urban towns. • Identifies contextual factors in the southern Chinese setting that affect acceptability of microbicides/female condoms, including ethnic/cultural beliefs, peer norms, personal risk context (prostitution, migration, abusive partners), economic conditions, social settings, partners and partner relationships, and concern for reproduction. • Assesses conditions under which high-risk Chinese female sex workers will be willing and/or able to use a vaginal microbicide (in a gel form) for HIV prevention during their regular sexual activity with their primary, casual, and/or paying sex partners.

• Assesses conditions under which high-risk Chinese female sex workers will be willing and/or able to use a female condom for HIV prevention during their regular sexual activity with their primary, casual, and/or paying sex partners. • Establishes an international research collaboration, infrastructure, and foundation for conducting a larger study of microbicide and female condom acceptability and adoption for HIV/STD prevention among female sex workers in these three towns in southern China.

“Establishes an international research collaboration, infrastructure, and foundation for conducting a larger study of microbicide and female condom acceptability and adoption for HIV/STD prevention among female sex workers in these three towns in southern China.”

NEW RESEARCH Access to ARV Therapy and Stigma: The Perceived Magnitude, Impact, and Implications of Stigma for HIV/AIDS Prevention Interventions among Women in Kenya, Erica Dawson, Ph.D. • This project studies the nature and degree of AIDS-related stigma and its potential impact on certain preventive behaviors among women in Kenya perceived to have HIV/AIDS. The aim is to recommend stigma-reduction strategies. • The research team is particularly interested in whether making HIV anti-retroviral (ARV) therapy available to women mitigates the physical, psychological, and social consequences of AIDS stigma. Quantitative data collected from clinic participants will allow analyses of the ways in which women’s experiences of stigma are distinct from men’s; the relationship between women’s demographic characteristics and their experiences of stigma; and the degree to which fear of stigmatization is claimed as a factor in women’s decisions whether or not to seek voluntary testing, to disclose serostatus, and to refrain from breastfeeding. • The results of this study will inform the understanding of the challenges and daily discriminations women face as a result of AIDS stigma in this community, as well as the impact of stigma on these preventive behaviors. Finally, the researchers hope that a demonstration of the hypothesized ability of ARV therapy to reduce stigma will increase public determination to make ARV therapy widely accessible in Kenya.

CIRA 2007 RESEARCH SUMMARY

Raising the Voice of the African Decade of Disabled Persons, Nora Ellen Groce, Ph.D. • Currently there is little to no HIV/AIDS awareness and prevention information designed in formats that meet the needs of adolescents and young adults with disabilities. Blatant discrimination occurs when these individuals are excluded from accessing this vital information. The development of prevention material and training is urgently needed to reach the multifaceted goals behind the African Decade of Disabled Persons and programs set forth by the international community. • Specific goals of this project involve working with the Tanzanian based organization, DOLASED (Disabled Organization for Legal Affairs and Social Economic Development), to facilitate trainings for emerging leaders both within the disability community and amongst HIV/ AIDS outreach workers. While focusing on disability-specific human rights issues, these trainings will develop high quality, accessible disability rights and HIV/AIDS awareness and prevention materials that address the particular needs of adolescents and young adults with disabilities in Africa. • This project will be conducted in Tanzania and Mozambique with the goal of creating a model for training emerging leaders in the disability field and to raise HIV/AIDS awareness and prevention that can be sustained and replicated throughout Africa. Mozambique is selected because of its high HIV/AIDS incidence and because it has received less attention and resources than the English-speaking countries within the region. Tanzania is selected because of its high HIV/AIDS incidence and because of leadership potential.

Structural and Policy Research FINDINGS

Project Parivartan: Structural Interventions and HIV Prevention among Sex Workers, their Clients, and Injection Drug Users in India, Kim M. Blankenship, Ph.D. • Project Parivartan, meaning “long-term change,” is supported by the Bill and Melinda Gates Foundation’s Avahan India AIDS Initiative to conduct research on implementing structural interventions among sex workers, their clients, and injection drug users in six Indian states with the highest HIV prevalence: Andhra Pradesh, Karnataka, Tamil Nadu, Maharashtra, Manipur, and Nagaland. • The project supports CARE India and other Avahan 12

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partners by systematically documenting and analyzing the implementation of community led structural interventions (CLSI) – which involve mobilized communities initiating and directing structural interventions – and providing methodological tools and frameworks for their continued documentation and analysis. • To date, more than 200 interviews have been conducted. Although there is much more work to be done, preliminary findings indicate that the intervention has: (1) Increased sex workers’ awareness of HIV and other sexually transmitted infections, (2) Increased sex worker knowledge and use of condoms, and (3) Contributed to sex workers’ sense of pride and of unity with other sex workers, as well as the level of respect and recognition they receive from family members and the broader community. • Also, according to sex workers, some problems with police harassment seem to have declined. At the same time, their increased visibility and self-confidence has led to targeted harassment and their arrest when they do not “show respect.” Arrests to fulfill police quotas appear to continue as well.

“Also, according to sex workers, some problems with police harassment seem to have declined. At the same time, their increased visibility and self-confidence has led to targeted harassment and their arrest when they do not “show respect.” Arrests to fulfill police quotas appear to continue as well.” • Field observations of and interviews related to the intervention implementation indicate a series of ongoing challenges, including: (1) conflicts between principles of harm reduction and rehabilitation, (2) rivalries among and within groups of sex workers, (3) need to reinforce “bottom up” police advocacy activities with “top down” approaches, (4) sex worker lack of experience in running organizations, and (5) hierarchy among sex workers created by different levels of involvement in the intervention. • In April 2006, in order to corroborate these and other preliminary results from interviews and observations, Parivartan implemented a large-scale survey of 813 sex workers. The survey will be repeated in 2007 to assess further the impact of the intervention on sex workers’ lives and the structural factors that put them at risk. The survey uses an innovative network-based recruiting method called Respondent Driven Sampling (RDS). • In addition to Parivartan’s focused work in Rajahmundry, team members also conduct site visits with other Avahan grantees to

observe the implementation of CLSI in other contexts. Several such site visits have been completed, and others are planned, in order to identify strategies that can increase the likelihood of successfully implementing CLSI, and the conditions under which these strategies will be more or less successful. Ultimately, this information can be used by others, in India or elsewhere, to replicate CLSI with various populations in different contexts.

NEW RESEARCH Guidelines for HIV/AIDS Interventions for People who are Deaf, Blind and Intellectually Disabled, Nora Ellen Groce, Ph.D. • The WHO is increasingly aware of the negative impact of HIV/AIDS on women and men with disabilities. Seeking to raise awareness of national HIV/AIDS prevention, care, support and treatment program personnel about the impact of the HIV/AIDS epidemic on individuals with disabilities they commissioned Dr. Groce to prepare a series of three information publications or guides. • These guides are based on scientifically valid information, but are simple, straightforward and user-friendly. They will be made available through WHO, UNAIDS and other UN agency websites and in hard copies. They will be made available in major language versions, including Braille. They will target various policy makers and practitioners working with subgroups within the HIV/AIDS community (women, adolescents, people living with HIV/AIDS, etc). The guides will be issued as joint publications of UNAIDS and WHO to help ensure that mainstream HIV/AIDS personnel worldwide pay increased attention to issues related to HIV/AIDS and people with disabilities within their own national programs. • They are to be prepared in conjunction with the two sets of Guides on HIV/AIDS in preparation by Dr. Groce for the WHO’s sister agency the International Labor Organization. • Specifically, for the WHO component of the project, Dr. Groce will be preparing guides on “What You Need to Know about HIV/AIDS” for three specific groups and their families: (1) individuals who are blind, (2) individuals who are deaf, and (3) individuals who are intellectually disabled.

condom-usage, testing, disclosure with partners). Explores the hypothesis that prevention behavior is reduced among religiously-involved sexually-active individuals because the performance of this religious identity conflicts with acceptance of an at-risk status. • Examines how religious identity and its interaction with these risk behaviors differs between African-American and white faith communities. • Sociologist Averil Clarke is conducting ethnographic research in two different church communities around the moral evaluation of sex, stigmatization, health risk, and identity. The Impact of Compliance with the WTO Trade Related Aspects of Intellectual Property (TRIPS) Agreement on Access to HIV/AIDS Medicines in India and Other Low and Middle Income Countries, Amy Kapczynski, M.A., M.Phil., J.D. • India is the largest supplier of generic medicines by volume in the world, and is responsible for a significant percentage of antiretroviral HIV/AIDS medicines (ARVs) currently in use in low- and middle-income (LMI) countries. • There has therefore been much concern about the impact of India’s new patent law on ARV prices and availability in India and around the world. India’s law also incorporates some novel elements designed to help minimize the public health impact of patents. The World Trade Organization’s intellectual property agreement is known as TRIPS. If successful, these innovations could provide much-needed models for other developing countries in search of TRIPS-compliant patent laws that do not compromise public health. • Project studies the implementation of the new patent law, including the legal framework introduced, the political economy of the shift, and the likely effects on access to ARVs in India and on the countries to which it exports. • Conducts two in-country assessments, approximately one year apart, to obtain a dynamic picture of the effects of the new law. • Assesses the impact of TRIPS on access to medicines in a key source country for generic medicines, and to extrapolate from this example lessons about the impact of trade-related intellectual property laws on people living with HIV/AIDS.

Playing Safe: Religious Identity in the Performance of Health and Risk, Averil Clarke, Ph.D.

• Investigates how a conservative religious identity requiring a chaste and heterosexual self-presentation affects health and sexual risk and interacts with HIV prevention behaviors (i.e. CIRA 2007 RESEARCH SUMMARY

YA L E U N I V E RSITY Center for Interdisciplinary Research on AIDS

135 College Street, Suite 200 New Haven, CT 06510-2483 Phone: 203.764.4333 Fax: 203.764.4353 Web: www.yale.edu/cira

This work has been supported by the Center for Interdisciplinary Research on AIDS (CIRA), through its grant No. P30 MH62294 from the National Institute of Mental Health, Paul D. Cleary, Ph.D., Principal Investigator.

Director Deputy Director Associate Director Center Coordinator

Paul D. Cleary, Ph.D. Jeannette R. Ickovics, Ph. D. Kim M. Blankenship, Ph.D. Gai Pollard

Prepared by CIRAâ&#x20AC;&#x2122;s Community Research Core Director Margaret R. Weeks, Ph.D. Assistant Director Leif Mitchell, B.A.