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Funded Projects

Cohort 1 Fellows

Michelle Broaddus, PhD

Participant perspectives of risks and benefits of participating in a text message-delivered intervention for safer sex communication

Abstract
Text-messaging may offer a new effective medium of HIV prevention intervention delivery. The lack of established precedents to these innovative modalities means new ethical concerns should be considered. Privacy of participants and security of data may be of most importance to IRBs. However, denying access to these interventions may undermine principles of beneficence, and respect for persons, and may not reflect participants’ views of the potential interventions’ benefits versus risks. Aim: To survey potential participants’ perceptions of risks and benefits of participating in a sexual communication intervention delivered via text messaging compared to face-to-face. Participants: Young African American women recruited from an STI clinic. Method: Three focus groups, 100 surveys (to be collected). Results/Conclusion: Focus groups results indicate high levels comfort with a text message-based intervention, identified barriers and benefits to both modalities, and suggested ways to increase benefit of text message based intervention.

Selected Recent Publications and Presentations
Broaddus, M. R., & Dickson-Gomez, J. (2013). "Text Messaging for Sexual Communication and Safety Among African American Young Adults". Qualitative Health Research, 23(10), 1344-1353.

Broaddus, M., Marsch, L. (2013, March). "Young African-American women’s perceptions of the risks and benefits of participating in a text message-delivered sexual communication intervention". Paper presented at the national conference of the Society for Behavioral Medicine, San Francisco, CA.

Broaddus, M., DiFranceisco, W., Kelly, J., St. Lawrence, J., Amirkhanian, Y., Pearson, B., & Vann-Beets, P. (2013, March). "Social media use and sexual risk behavior among Black MSM in three cities". Poster presented at the national conference of the Society for Behavioral Medicine, San Francisco, CA.

Broaddus, M. (2013). "Participant Perspectives of Risks and Benefits of Participating in a Text-Message-delivered Intervention for Safer Sex Communication". JERHRE Special Issue (In Press).

Broaddus, M., & Marsch, L. (2013, March). Young African-American women’s perceptions of the risks and benefits of participating in a text message-delivered sexual communication intervention. Paper presented at the national conference of the Society for Behavioral Medicine, San Francisco, CA.

Broaddus, M. (2014, April). Perceived risks and benefits of participating in text message-based sexual health interventions. Poster presented at the national conference of the Society for Behavioral Medicine, Philadelphia, PA.

Broaddus, M. & Marsch L. (2014, December). Comparing risks and benefits of mobile phone text message-delivered and small group-delivered sexual health interventions among African American young women in the Midwestern U.S. Public Responsibility in Medicine and Research (PRIM&R) Conference, Special Session “Enhancing Protections for Vulnerable Populations through Research on Research Ethics” (Empirical Research Ethics Track), Oral symposium.

Broaddus, M. R. & Marsch, L. (2015). "Comparing risks and benefits of text message-delivered and small group-delivered sexual health interventions among African American young women in the Midwestern U.S." Ethics & Behavior, 25(2): 146-168. (PMCID – In Progress) 

Peter Davidson, PhD

Disjuncts in understanding: An exploration of differences in the ways drug users, researchers, and federal code understand research participation

Abstract
The research will utilize a grounded theory / situational analysis approach to explore how a specific population of young people who inject drugs understand and experience participation in epidemiologic research, and will compare these understandings with those embedded in US Federal Code regulating research with human subjects, as well as with perspectives provided by researchers and IRB members. The research is expected to offer insight into disjuncts in understanding which have the potential to inadvertently leave research participants feeling mistreated.

Selected Recent Publications and Presentations
Davidson, P., & Page, K. (2012). "Research participation as work: comparing the perspectives of researchers and economically marginalized populations". American Journal of Public Health, 102(7), 1254-1259.

Davidson, P. (In preparation). "Disjuncts in understanding: An exploration of difference in the ways drug users, researchers, and federal code understand research participation.”

Davidson, P., & Page, K. (2012). "Research participation as work: comparing the perspectives of researchers and economically marginalized populations". American Journal of Public Health, 102(7), 1254-1259.

Davidson, PJ. (2012). "Differences between the ways researchers and people who inject drugs think about research participation, and the ethical consequences of these differences". National Harm Reduction Conference, November 2012, Portland Oregon.

Jennifer Hettema, PhD

Physician attitudes and behavior towards HIV+ IDUs

Abstract
While adherence to HAART may be affected among IDUs, due to the instable lifestyle associated with drug seeking and use (Wood et al., 2008), the risk of development of antiretroviral resistance among IDUs has not been found to be higher than their non-IDU counterparts (Werb et al., 2010). Despite this, IDU status has been found effect access to care for HIV (WHO, 2006; Wood et al., 2008), with evidence that physician reluctance to prescribe HIV may play contribute to this disparity (Bassetti, 1999; Ding et al., 2005). To determine the impact of IDU status on physician prescribing behavior, a national sample of community-based HIV prescribing providers completed an online survey in which they were presented with two case vignettes describing a patient with previous adherence issues presenting for treatment and requesting reinstatement on antiretroviral medications. The vignettes were identical with the exception of the IDU status of the patient. Participants were randomly assigned to see either the IDU or non-IDU (NIDU) vignette first. To date 156 participants have consented to participate in the study and 112 of these submitted complete responses. Participants were predominately female (55.8%), White (77.9%), and practicing in Urban settings (80.5%). Participants were well distributed by state. Most participants were physicians (47.8%) or nurse practitioners (45.1%), with a smaller samples of physician assistants (7.1%). Independent samples t-tests revealed that neither IDU prescribing behavior (t(118)=-.258, p=.797) nor NIDU prescribing behavior (t(117)=-.693) differed significantly by condition (order of presentation). Consequently, conditions were collapsed for future analyses. A paired samples t-test was conducted to evaluate the impact of patient IDU status on prescribing behavior. There was a statistically significant difference between reported likelihood of prescribing for NIDU (M=3.51, SD=1.37) versus IDU patients (M=3.03, SD=1.37), t(115) = -5.03, p < .001. Attitudes towards shared decision making and concerns about adherence are both predictive of less willingness to prescribe to IDUs.

Selected Recent Publications and Presentations
Hettema, J.E., Russo, J., Fisher, C., & Cockrell, S. (April, 2013) "Disparities in prescribing behavior towards injection drug users living with HIV". Poster presented at the New Mexico Public Health Association Disparity to Equity Conference. Albuquerque, NM.

Hettema, J.E. (July 2013). "Disparities in prescribing behavior towards injection drug users living with HIV". Lecture given at the 2013 Fordham University HIV Prevention Research Ethics Training Institute.

Hettema, J.E., Russo, J.M., & Fisher, C.B. (August, 2013). "Disparities in Prescribing Behavior Towards Injection Drug Users". Poster to be presented at the American Psychological Association Annual Convention. Honolulu, HI.

Hettema, J.E., Russo, J.M., & Fisher, C.B. (November, 2013). "Disparities in prescribing behavior towards injection drug users living with HIV". Oral presentation as part of the symposium titled Enhancing the Responsible Conduct of HIV Treatment and Prevention in Community Contexts moderated by Celia Fisher. American Public Health Association Annual Meeting: Boston, MA.

Kristin Kostick, PhD

Exploring participant experiences in a peer-delivered HIV intervention with IV drug users

Abstract
The goal of this project is to use qualitative methodologies to explore the role of communication between research staff and patients involved in a peer-delivered HIV risk and harm reduction program for intravenous (IV) drug users in Hartford, CT. Peer-delivered interventions among drug users have come under close scrutiny by ethics researchers because of their potential to inadvertently and negatively impact patient rehabilitation efforts due to continued exposure to and engagement with drug-using social networks in conjunction with peer-delivered intervention strategies. This study aims to explore whether enhanced communication of patient concerns and experiences with research staff may help to reduce the potential for inadvertent maleficence in peer-delivered drug treatment interventions.

Selected Recent Publications and Presentations
Kostick, K., et al. (2014). "Participant and Staff Experiences in a Peer-Delivered HIV Intervention with Injection Drug Users". Journal of Empirical Research on Human Research Ethics, 9(1), 6-18.

Kostick, K. (March 2013). Denver. "Participant and Staff Experiences in a Peer-Delivered HIV Intervention with Injection Drug Users". Society for Applied Anthropology Meeting.

Purnima Madhivanan, MBBS, MPH, PhD

Ethical issues in the deliver of prevention of mother-to-child transmission of HIV interventions in South India

Abstract
Background: GOI recently changed guidelines for HIV testing from “opt-out” testing to routine HIV testing of all pregnant women receiving antenatal care.

Participants: This qualitative study examined the experiences and perceptions of recently delivered women undergoing HIV testing during ANC and healthcare workers who conduct HIV testing and counseling in government and private hospitals in Mysore, Karnataka, India.

Methods: 2 FGD carried out among recently delivered HIV-negative women who underwent HIV testing to explore women’s experiences with pre-test counseling; informed consent; and HIV testing during their antenatal care. In addition, a FGD with healthcare workers involved with HIV testing was carried out to assess KAP around HIV testing of pregnant women.

Results: Only six of the 15 women recalled being informed about the purpose of routine HIV testing. A large majority of the women (11) said that only their doctor informed them that they had to get an HIV test if they wished to deliver at the hospital. Only 3of the 15 women said they recalled signing a consent form for testing but a majority (8) said they had been given forms that they were told to sign. The seven HCW attending the FGD had sufficient knowledge about HIV testing and PMTCT. While they said that they kept confidentiality about women’s HIV test results, many admitted that other hospital employees might occasionally find out about a women’s HIV status. In addition, several expressed derogatory and stigmatizing remarks about “uneducated rural women” who did not comprehend HIV counseling or understand the reasons for giving consent.

Conclusions: Women are poorly informed about the risks and reasons for routine antenatal HIV testing. Healthcare workers should be further trained on confidentiality and informed consent in addition to sensitizing them about the need for non-stigmatizing HIV care and testing.

Selected Recent Publications and Presentations
Madhivanan, P., et al. (2014). "HIV testing among Pregnant Women Living with HIV in India: Are Private Providers Routinely Violating Women’s Human Rights?" BMC International Health and Human Rights, 14(7).

Madhivanan, P., et al. (2012). "Ethical issues in the delivery of prevention of mother-to-child transmission of HIV interventions in Mysore, South India". 4th National Bioethics Conference, December 5-8, 2012, Hyderabad, India.

Cynthia Pearson, PhD

Human subject research training for community researchers: A Pacific Northwest Native American cultural prospective

Abstract
This RETI mentored research project will develop a model to adapt and augment the Collaborative Institutional Training Initiative (CITI) human subject certification training curriculum. The model will describe the steps taken to adapt a CITI module to be culturally-responsive and user friendly for rural American Indian (AI) community researchers from Pacific Northwest tribal communities. An expert panel of AI academic and community researchers will prioritize focus areas; adapt and augment components from 1 to 2 CITI Social and Behavioral Sciences modules, highlighting cultural relevance (i.e. sovereignty), priorities and values. The Aims are: 1) in collaboration with Pacific Northwest tribal partners, define the process to produce a culturally relevant CITI human subject certification curriculum module; and 2) produce and evaluate the validity of the culturally-adapted module among 40 tribal members who: a) are 18 years or older; 2) have never taken the CITI training; 3) currently collaborate with an academic research partner or are interested in research; and, 4) reside on a reservation. Improving human subject training usability and cultural relevance for community partners will enhance HIV prevention research ethics practices.

Selected Recent Publications and Presentations
Pearson C.R, Parker, M., Fisher C., Moreno, C. (2014). "Capacity Building from the Inside Out: A Randomized Control Trial on Adapting the CITI Ethics Certification Training Course for American Indian Community Researchers Journal of Empirical Research on Human Research Ethics". Journal of Empirical Research on Human Research Ethics, 9(1), 46-57.

Pearson C.R, Walters K.L, Simoni J.M, Beltran, R., Nelson, K.M. "A cautionary tale: Risk reduction strategies among urban American Indian/Alaskan Native men who have sex with men". (Feb. 2013) AIDS Education and Prevention, Volume 25 (1):25-37; PMID 23387949

Pearson, C.R. “Enhancing the Responsible Conduct of HIV Prevention Research across Culturally and Globally Diverse Populations” Submitted Ethics SPIG: Oral presentation APHA Conference November 2-6 2013, Boston, MA.

Pearson, C.R. & Parker, M. “Are the CITI Certification Modules Adequate to Ensure Human Subjects Protections in Community Based Participatory Research? A Case Example from Indian Country” Oral presentation, Public Responsibility in medicine and Research PRIMR 2013, Advancing Ethical Research Conference November 7-9 Boston MA Oral presentation.

Pearson, C.R., Cassels, S., *Whitefoot, P., Symposium presentation “HIV risk and protective factors in place and space: Partnering among American Indian and Alaskan Native young adults” U.S. Conference on AIDS 2013, September 8-11, 2013, in New Orleans.

Walters, K.L., LaMarr, J., Levy, R. L., Pearson, C.R., Maresca, T., Mohammed, S.A., Simoni, J.M., Evans-Campbell, T., Fredriksen-Goldsen, K., Fryberg, S., Jobe, J.B., (2012) “Project həli?dxw: The Development and Evaluation Design of a Tribally Based Cardiovascular Disease Prevention Intervention for American Indian Families.” The Journal of Primary Prevention: Aug; 33(4):197-207. PMID: 22965622; PMC3505854

Evans-Campbell, T., Walters K., Pearson, C.R., C. Campbell, Indian Boarding School, Substance Use, And Mental Health Among Two-Spirit urban American Indian/Alaska Natives (2012). The American Journal of Drug and Alcohol Abuse. Sept 38 (5): 421-7. PMID:22931076

Rao, D., Chen, W-T., Pearson, C., Simoni, J., Fredriksen-Goldsen, K., Nelson, K., Zhao, H., Zhang, F. "Social Support Mediates the Relationship between HIV Stigma and Depression/Quality of Life among People Living with HIV in Beijing, China". (2012) Int J STD AIDS (23) 481-484. PMID: 22844001; PMC3408622

Hicks, S., Duran, B., Wallerstein, N., Avila, M., Belone, L., Lucero, J., Magarati, M., Mainer, E., Martin, D., Muhammad, Oetzel, J., Pearson, C., Sahota, Simonds, V. and Sussman, A., "Evaluating Community-Based Participatory Research (CBPR) to Improve Community-Partnered Science and Community Health". (2012) Progress in Community Health Partnerships: Research, Education, and Action. Fall 6 (3): 289-99 PMID: 22982842

Sandoval, J., Lucero, J., Oetzel, J., Avila, M., Belone, L., Mau M., Pearson C., Tafoya G., Duran B., Iglesias Rios L., Wallerstein N. (2012) "Process and outcome constructs for evaluating community based participatory research". Health Education Research. 27 (4), 680-690. PMID: 21940460; PMC3396879

Nelson KM, Simoni JM, Pearson CR, Walters KL. (2011) ‘‘'I've had unsafe sex so many times why bother being safe now?': The role of cognitions in sexual risk among American Indian/Alaska Native men who have sex with men". Annals of Behavioral Medicine Dec 42(3):370-80 PMID:21887585; PMC3272360

Elizabeth Reed, MPH, ScD

Perceptions of HIV prevention research participation among women working as sex workers in Andhra Pradesh, India

Abstract
The proposed project aims to explore qualitatively the perspectives of female sex workers (FSW) in Rajahmundry, Andhra Pradesh (India) regarding their participation in HIV research studies, with primary focus on ethical issues in research. FSW face multiple burdens due to various contextual challenges in their lives, as well as high levels of stigma and related discrimination. Thus, efforts are needed to ensure that research is being conducted in a way that is most ethical, and specifically considers the multitude of unique factors relevant to women working as sex workers in this high HIV prevalence region of India. Findings will inform the implementation of future HIV prevention research efforts in this context, determine whether revisions to research ethics protocols are needed as well as to guide such changes, and have implications for work conducted in similar settings.

Selected Recent Publications and Presentations
Reed, E. (2014) "Confidentiality, Privacy, & Respect: Perspectives of Female Sex Workers Participating in HIV Prevention Research in Andhra Pradesh, India". Journal of Empirical Research on Human Research Ethics, 9(1), 19-28.

Reed, E. (In Review). "Informed Consent and Motivations to Participate in HIV Research among Female Sex Workers in Andhra Pradesh, India": The Myth of Voluntariness.

Reed, E. (2013). Confidentiality, Privacy, & Respect: Perspectives of Female Sex Workers Participating in HIV Prevention Research in Andhra Pradesh, India, APHA, Boston, MA.

Reed, E. (2012). "Perceptions of HIV Prevention Research Participation among Women Working as Sex Workers in Andhra Pradesh, India"; International Conference on AIDS, Washington, DC.

Lianne Urada, PhD, MSW, LCSW

Social and structural constraints on disclosure and informed consent with female sex workers and their managers in the Philippines

Abstract
Aim: This project explored the experiences of female sex workers (FSWs) working in night clubs, karaoke bars, and spa/saunas in the Philippines in participating in behavioral HIV prevention research, including their process of consent to research, their knowledge of research ethics, barriers to disclosure of sensitive topics, and the necessary conditions for their involvement in HIV research prevention interventions.

Participants: 7 former interviewers participated in a focus group, and 20 FSWs and 10 establishment managers were interviewed individually as key informants about the research process. Method: This qualitative research used semi-structured interview guides for the individual interviews, focus group, and community advisory board meetings, and ethnographic approaches.

Results: Emergent themes include FSW issues with trust of the research and interviewer, intrusiveness of survey questions, problems seeing any changes made as a result of the research, and feeling forced by government to do surveys. FSWs expressed desire to actively participate in intervention design and implementation and to learn new skills and obtain job training to learn other ways to earn money. Both FSW and managers expressed dissatisfaction with government support: having to pay for clinic health exams, and managers expressed problems with the government’s ability to intervene around police raids and bribes.

Conclusion: This project has the potential to improve HIV prevention research practices with FSWs by 1) foregrounding ethical issues by addressing barriers to respect, trust, and/or disclosure stemming from risks in the structural environment or micro-level social aspects of the research process and 2) developing a more transparent and participatory approach to HIV prevention research that engages participants/ FSWs in the research process in order to reduce perceived and actual risks to participants.

Selected Recent Publications and Presentations
Urada, L.A., Simmons, J. (2014) "Social and structural constraints on disclosure and informed consent for HIV survey research with female sex workers and their managers in the Philippines". Journal of Empirical Research on Human Research Ethics, 9(1), 29-40.

Urada, L.A., Simmons, J. (2014) "A collaborative methodology for investigating the ethical conduct of female sex workers in the Philippines". Journal of Empirical Research on Human Research Ethics, 9(1), 41-45.

Urada, L.A., Strathdee, S.A., Morisky, D.E., Schilling, R.F., Pimentel-Simbulan, N., Estacio Jr, L.R. & Raj, A. (2013). "Sex work and its associations with alcohol and methamphetamine use among female bar and spa workers in the Philippines". Asia-Pacific Journal of Public Health. Online Jan. 22, 2013.

Urada, L.A., Morisky, D.E., Hernandez, L.I., & Strathdee, S.A. (2013). "Social and structural factors associated with consistent condom use among female entertainment workers trading sex in the Philippines". AIDS and Behavior, 17(2), 523-535.

Urada, L.A., Raj, A., Cheng, D.M., Quinn, E., Bridden, C., Blokhina, E.A., Krupitsky, E., Samet, J.H. (in press). "History of intimate partner violence is associated with sex work but not STI among HIV-positive female drinkers in Russia". International Journal of STD/AIDS.

Hiller, S. P., Urada, L. A., Lozada, R., Syvertsen, J., Ojeda, V. D. (in press). "Social support and recovery among Mexican female sex workers who inject drugs". Journal of Substance Abuse Treatment.

Davtyan, M., Munoz, K., Urada, L., & Brown, B. (2013). "Transactional Sex: A Client’s Perspective from Peru". Electronic Journal of Human Sexuality, 16.

Urada, L.A., Goldenberg, S. M., Shannon, K., & Strathdee, S.A. (in press). Sex Work. In Baumeister, J., Ward, L. M., George, W., & Pfaus, J. (Eds.), APA Handbook of Sexuality. Washington, D.C.: American Psychological Association.

Urada, L.A., Strathdee, S.A., Morisky, D.E., Schilling, R.F., Pimentel-Simbulan, N., Estacio Jr, L.R. & Raj, A. (January, 2013). "Sex work and its associations with alcohol and methamphetamine use among female bar and spa workers in the Philippines". Society for Social Work and Research Annual Conference, San Diego, CA.

Urada, L.A. (February, 2013). Disempowerment and engagement: Sex workers and female bar/spa workers in the Philippines. Panel on “Sexual health and empowerment of female sex workers in several countries” with Brown, B., Yarborough, D., & Swendenman, D. UC Global Health Day, UC Global Health Institute, Riverside, CA.

Urada, L.A., Goldenberg, S. M., Shannon, K., & Strathdee, S.A. (August, 2013). Sex Work. Panel on “Sexuality and social issues: Current advances and directions for the future” with Tolman, D., McClelland S. & Hernandez, K. American Psychological Association Convention, Honolulu, HI.

Urada, L.A. & Simmons, J. (November, 2013). Social and structural constraints on disclosure and informed consent with female sex workers and their managers in the Philippines. Panel on “Enhancing the responsible conduct of HIV prevention research across culturally and globally diverse populations” with Fisher C., Reed E., & Pearson C. American Public Health Association Annual Meeting and Exposition, Boston, MA.

Urada, L.A., Morisky, D.E., Pimentel-Simbulan, N., Silverman, J.G., & Strathdee, S.A. (2012). "Condom negotiations among female sex workers in the Philippines": Environmental Influences. PLoS ONE 7(3):1-9, doi: 10.1371/journal.pone.0033282. Epub 2012 Mar 20.

Urada, L.A., Malow, R.M., Santos, N.C., Morisky, D.E. (2012). "Age differences among female sex workers in the Philippines: Sexual risk negotiations and perceived manager advice". AIDS Research and Treatment, doi: 10.1155/2012/812635. Epub 2012 Jul 17.

Cohort 2 Fellows

Tania Basta, PhD, MPH

Consent Preparedness for Home-Based HIV Testing Research in Rural Appalachia

Abstract
Background: HIV rates are low in Appalachia, however individuals are engaging in high risk behaviors. Very few individuals get tested for HIV due to low HIV-related knowledge, high HIV-related stigma, and lack of access to testing sites. Home HIV testing kits will be available in October 2012 at Walmart, which will increase access for many rural individuals.

Specific Aims

  1. Assess the knowledge and attitudinal factors that facilitate and hinder participation in HIV/STI prevention research among rural individuals living in Appalachia.
  2. Assess the effects of a brief educational intervention on the understanding of HIV acquisition, transmission and health effects, and the purpose, nature, risks and benefits, confidentiality protections, and voluntary nature of HIV/STI prevention research among rural individuals living in Appalachia.
  3. Assess the effects of a brief educational intervention on attitudes toward participation in HIV/STI prevention research among rural individuals living in Appalachia.

Study Population: The participants in this study will be residents of rural Appalachian counties in Ohio, West Virginia and Kentucky. Participants must be 18 years of age or older, live in a rural Appalachian county, do not have an HIV diagnosis, and speak fluent English.

Research Design: This study will be a mixed-methods study (focus groups, survey, and intervention) and will occur three phases.

Selected Recent Publications and Presentations
Basta, T. (2013, November). "Factors influencing HIV testing among individuals living in rural Appalachia". In 141st APHA Annual Meeting (November 2-November 6, 2013). APHA.
*Winner of the APHA Excellence in Abstract Submission among All Presentations Award.

Bansah, A. K., Holben, D. H., & Basta, T. (2013). "Food Insecurity is Associated with Household Utility Insecurity among Individuals Living with HIV/AIDS in Rural Appalachia". Journal of Hunger & Environmental Nutrition, 8(2), 242-255.

Morrone, M., & Basta, T. B. (2013). "Public opinion, local pollution havens, and environmental justice: a case study of a community visioning project in Appalachian Ohio". Community Development, (ahead-of-print), 1-14.

Darlington, K. A., Basta, T., & Obregon, R. (2012). "Cross-generational relationships in rural Jamaica". Vulnerable Children and Youth Studies, 7(2), 128-138.

Morrone, M., Basta, T. B., & Somerville, J. (2012). "Framing the national nuclear legacy at the local level: Implications for the future of federal facilities". Energy Policy, 43, 145-152.

Vance, R. A., Basta, T. B., Bute, J. J., & Denham, S. A. (2012). "Identifying The Health Needs In Rural Appalachian Ohio: Outcomes Of A Rural Community-Academic Partnership". American Journal of Health Sciences (AJHS), 3(2), 115-124.

Brandon Brown, PhD, MPH

Voluntary study participation in a clinical trial of HPV vaccine with Peruvian FSWs

Abstract
Research Questions: What do FSW participants understand about participation in a clinical trial, including study specifics, risks, benefits, and voluntariness? What are the effects of income, incentive types and amounts, and health care availability on voluntary participation in clinical trials with a certain level of risk? Can an incentive be excessive?

Background: People should have voluntary choice to participate in a study. Informed consent may allow free choice, but measures to help ensure this during and after consent to gauge continued voluntariness and understanding of study participation are lacking. Understanding of acceptable/excessive incentive types and amounts is lacking, and study integrity may be brought into play if subjects falsify eligibility

Specific Aims:

  1. Determine what FSWs understand/perceive about participating in a clinical trial, including study specifics, risks, benefits, and voluntariness;
  2. Explore mediating effects of income, incentive types/amounts, and health care availability on voluntary participation of FSWs in clinical trials; and
  3. Examine the issue of undue inducement in research, and if incentives and benefits are viewed as separate items. Study Population: 40 FSWs in Peru previously in HPV vaccine trial. Research Design: FG with 6-10 FSWs per group, 1-2 hours, separated by income (brothel vs. street). Demographic info collected by survey.

Selected Recent Publications and Presentations
Brown, B., Blas, M. M., Heidari, O., Carcamo, C., & Halsey, N. A. (2013). "Reported changes in sexual behavior and human papillomavirus knowledge in Peruvian female sex workers following participation in a human papillomavirus vaccine trial". International journal of STD & AIDS, 24(7), 531-535.

Davtyan, M., Munoz, K., Urada, L., & Brown, B. (2013). "Transactional Sex: A Client’s Perspective from Peru". Electronic Journal of Human Sexuality, 16.

Nureña, C. R., Brown, B., Galea, J. T., Sánchez, H., & Blas, M. M. (2013). "HPV and Genital Warts among Peruvian Men Who Have Sex with Men and Transgender People": Knowledge, Attitudes and Treatment Experiences. PloS one, 8(3), e58684.

Shroff, N., Brown, B., Kinsler, J., Cabral, A., & Blas, M. M. (2013). "Barriers and Facilitators in the Recruitment and Retention of Peruvian Female Sex Workers in a Randomized HPV Vaccine Trial". Journal of Vaccines and Vaccinations, 4(198), 2.

Brown, B., Davtyan, M., Galea, J., Chow, E., Leon, S., & Klausner, J. D. (2012). "The Role of Human Papillomavirus in Human Immunodeficiency Virus Acquisition in Men who Have Sex with Men: A Review of the Literature". Viruses, 4(12), 3851-3858.

Brenda Curtis, PhD

Online Recruiting for HIV Research: Ethical Issues and Concerns for Investigators and IRBs

Abstract
Research Question: What ethical dilemmas have arisen during the design and conduct of HIV prevention research that used Internet recruitment?
Background: Institutional Review Boards (IRBs) are facing major challenges in the research environment due to changes in how investigators recruit human subjects.
Specific Aims: To examine the ethical challenges investigators and IRBs have encountered in developing adequate human subjects protections for recruitment procedures for HIV prevention. To provide examples of how these dilemmas were resolved by investigators and IRBs.
Study Population: PHS Funded Principal Investigators and IRB chairs at academic institutions.
Research Design: Semi-structured phone interviews will be conducted with 15 IRB Chairs/Directors and 15 HIV prevention principal investigators.

Selected Recent Publications and Presentations
Curtis, B. (2014). "Social networking and online recruiting for HIV research: ethical challenges". Journal of Empirical Research on Human Research Ethics, 9(1), 58-70.

Conducted a workshop using data obtained from this research project at the PRIM&R 2013 Advancing Ethical Research (AER) Conference in Boston. Presented at PRIM&R 2013.

Shira Goldenberg, PhD

Barriers and Facilitators to Participation in HIV Research: Female Sex Workers’ Perspectives

Abstract
Background: Research with female sex workers (FSWs) is critical to inform prevention; few data on barriers and facilitators to participation.

Specific Aims:

  1. Investigate perceived barriers and facilitators to participation.
  2. Develop recommendations to enhance FSWs’ participation.

Study Population: FSWs ≥18 years old in Tecun Uman/Xela.

Research Design: 3-5 focus groups + follow-up interviews (min. n=5). IMPACT: Development of interventions to address barriers & facilitators and enhanced ethical practices in sex work research.

Selected Recent Publications and Presentations
Goldenberg, S. M., Engstrom, D., Rolon, M. L., Silverman, J. G., & Strathdee, S. A. (2013). Sex Workers Perspectives on Strategies to Reduce Sexual Exploitation and HIV Risk: A Qualitative Study in Tijuana, Mexico. PloS one,8(8), e72982.

Goldenberg, S. M., Chettiar, J., Simo, A., Silverman, J. G., Strathdee, S. A., Montaner, J., & Shannon, K. (2013). "Early sex work initiation independently elevates odds of HIV infection and police arrest among adult sex workers in a Canadian setting". Journal of Acquired Immune Deficiency Syndromes (1999).

Collins, S. P., Goldenberg, S. M., Burke, N. J., Bojorquez-Chapela, I., Silverman, J. G., & Strathdee, S. A. (2013). "Situating HIV risk in the lives of formerly trafficked female sex workers on the Mexico–US border". AIDS Care, 25(4), 459-465.

Knight, R., Shoveller, J. A., Oliffe, J. L., Gilbert, M., & Goldenberg, S. (2013). "Heteronormativity hurts everyone: Experiences of young men and clinicians with sexually transmitted infection/HIV testing in British Columbia, Canada". Health, 17(5), 441-459.

Goldenberg, S. M., Strathdee, S. A., Perez-Rosales, M. D., & Sued, O. (2012). "Mobility and HIV in Central America and Mexico: A critical review". Journal of Immigrant and Minority Health, 14(1), 48-64.

Goldenberg, S. M., Rangel, G., Vera, A., Patterson, T. L., Abramovitz, D., Silverman, J. G., ... & Strathdee, S. A. (2012). "Exploring the impact of underage sex work among female sex workers in two Mexico–US border cities". AIDS and Behavior, 16(4), 969-981.

Thomas Guadamuz, PhD, MHS

Barriers and facilitators to YMSM participating in HIV-related research studies in Thailand: Perspectives of parents and teens

Abstract
Research Question: What are the barriers and facilitators to YMSM (under 18 years) participating in HIV-related research studies in Thailand?

Background: Young men who have sex with men (YMSM) continue to bear the burden of new HIV infections in Southeast Asia. Currently, there are very few studies that include YMSM under 18 years. Reasons for not including YMSM in research studies include the requirements of parental consent from IRBs. This resents a problem because many YMSM have not disclosed their sexual activities or sexual orientation identities to their parents.

Specific Aims: To examine the barriers and facilitators related to the participation of YMSM in HIV-related research studies from the perspectives of parents and teens.

Study Population: Using purposive sampling, 6 groups of parents and YMSM will be recruited: (1) Parents of sons, (2) parents of gender non-conforming YMSM, (3) parents of “out”/disclosed YMSM, (4) “out” /disclosed YMSM (15-17 years), (5) “not out” YMSM (18-20 years), (6) street-based YMSM.

Research Design: Qualitative research methods: Focus group discussions and semi-structured in-depth interviews (5-8 persons per group above and 1-2 persons per FGD will be asked to participate in in-depth interviews). A total sample size of 50 is expected. Social and cultural values and related issues specific to the Thai context will be explored in detail. IMPACT: To reduce the barriers of adolescent participation in sexuality-related research in Thailand.

Selected Recent Publications and Presentations
Guadamuz, T. E., Friedman, M. S., Marshal, M. P., Herrick, A. L., Lim, S. H., Wei, C., & Stall, R. (2013). "Health, Sexual Health, and Syndemics: Toward a Better Approach to STI and HIV Preventive Interventions for Men Who Have Sex with Men (MSM) in the United States". In The New Public Health and STD/HIV Prevention (pp. 251-272). Springer New York.

Guadamuz, T. E., Lim, S. H., Marshal, M. P., Friedman, M. S., Stall, R. D., & Silvestre, A. J. (2012). "Sexual, Behavioral, and Quality of Life Characteristics of Healthy Weight, Overweight, and Obese Gay and Bisexual Men: Findings from a Prospective Cohort Study". Archives of sexual behavior, 41(2), 385-389.

Herrick, A. L., Lim, S. H., Plankey, M. W., Chmiel, J. S., Guadamuz, T. T., Kao, U., ... & Stall, R. (2013). "Adversity and syndemic production among men participating in the Multicenter AIDS Cohort Study: a life-course approach". American Journal of Public Health, 103(1), 79-85.

Wei, C., Lim, S. H., Guadamuz, T. E., & Koe, S. (2013). "Virtual Versus Physical Spaces: Which Facilitates Greater HIV Risk Taking Among Men Who Have Sex with Men in East and South-East Asia?". AIDS and Behavior, 1-8.

Lim, S. H., Guadamuz, T. E., Wei, C., Chan, R., & Koe, S. (2012). "Factors associated with unprotected receptive anal intercourse with internal ejaculation among men who have sex with men in a large internet sample from Asia". AIDS and Behavior, 16(7), 1979-1987.

Wei, C., Guadamuz, T. E., Lim, S. H., Huang, Y., & Koe, S. (2012). "Patterns and levels of illicit drug use among men who have sex with men in Asia". Drug and Alcohol Dependence, 120(1), 246-249.

Wei, C., Lim, S. H., Guadamuz, T. E., & Koe, S. (2012). "HIV disclosure and sexual transmission behaviors among an Internet sample of HIV-positive men who have sex with men in Asia: Implications for prevention with positives". AIDS and Behavior, 16(7), 1970-1978.

Wei, C., Guadamuz, T. E., Lim, S. H., & Koe, S. (2012). "Sexual transmission behaviors and serodiscordant partnerships among HIV-positive men who have sex with men in Asia". Sexually Transmitted Diseases, 39(4), 312.

Charmaine Thokoane

Knowledge of rights to sexual reproductive health services among 12-18 year olds in Hammanskraal

Abstract
Intervention Program Questions:

  • What are the attitudes of youth regarding their rights to access sexual and reproductive health services?
  • What is the knowledge that the youth has regarding their rights to sexual and reproductive health services?
  • What are the attitudes of the health workers that create a barrier for the youth in accessing sexual and reproductive health services?
Study Population: 40 young people (12-18 year olds) out of school and in-school recruited at local NGO’s and through referrals by other youth. Health care workers recruited from hospital and clinics.

Evaluation Design:

  • Youth: Pre-study circle intervention questionnaire, study circle, post-study circle questionnaire.
  • Health Care Workers: In depth interviews, pre-intervention interview, training on working with young people, post intervention interview.

Kristen Underhill, JD, PhD

Exploring IRB Responses to Participant Complaints: Processes, Values, and Resources

Abstract
Research Question: How do IRBs respond to participant complaints arising out of general clinical research and PrEP effectiveness studies?

Background: Participants in clinical research are advised to contact IRBs with questions or complaints, but little scholarship has examined IRBs’ procedures for responding.

Specific Aims: To use qualitative methods to explore

  1. How IRBs may address risk of side effects, HIV infection, secondary resistance, and post-trial access when approving PrEP effectiveness protocols.
  2. Procedures that IRBs currently use to respond to participant complaints.
  3. How IRBs may apply dispute resolution procedures to complaints in PrEP trials.
  4. What guidance or training IRBs may need to guide these processes.
Study Population: IRB chairs, directors, and possible IRB-related legal personnel from IRBs that review PrEP clinical trials.

Research Design: Individual semi-structured qualitative interviews, triangulated with documentation of IRB policies or procedures.

Selected Recent Publications and Presentations
Underhill, K. (2014). "Legal and ethical values in the resolution of research-related disputes: how can IRBs respond?". Journal of Empirical Research on Human Research Ethics, 9(1), 71-82.

Underhill, K. (2013). "Study designs for identifying risk compensation behavior among users of biomedical HIV prevention technologies: Balancing methodological rigor and research ethics". Social Science & Medicine.

Underhill, K. (2013). "Risk-Taking and Rulemaking: Addressing Risk Compensation Behavior Through FDA Regulation of Prescription Drugs". Yale J. on Reg., 30, 377-475.

Underhill, K. (2013). "Transferring Behavioral Interventions for Global Health: Intellectual Property Barriers, Information Constraints, and Possible Solutions". Yale Journal of Health Policy, Law, and Ethics, 10(2), 3.

Underhill, K. (2012). "Paying for prevention: challenges to health insurance coverage for biomedical HIV prevention in the United States". Am. JL and Med.,38, 607-751.

Cohort 3 Fellows

Stella Njuguna, B Pharm, MPH

Post-trial access of Truvada® amongst HIV-1 discordant couples enrolled in the PrEP study in Kisumu, Kenya
Introduction: In Kenya, 44% of married/cohabiting HIV infected persons have an HIV uninfected partner and this population contributes significantly to the incidence HIV infections in the country. Given the high risk of transmission in this population, novel HIV prevention strategies are critical in decreasing the incidence of HIV infection. Recent studies have shown that TRUVADA is efficient in preventing HIV infections in most at risk populations. However, TRUVADA has not been availed to the HIV discordant couples who were enrolled in the Pre-Exposure Prophylaxis (PrEP) study in Kisumu, Kenya. This is a critical ethical issue embodied in the principle of distributive justice that needs to be addressed.

General Objective: to describe the attitudes regarding post-trial benefits amongst a random sample of serodiscordant couples enrolled in the PrEP study in Kisumu, Kenya.

Method: This is a mixed method cross sectional study where qualitative and quantitative data will be collected. Focus group discussions (FGD) conducted by an experienced moderator will explore views and probe for information regarding post-trial access to Truvada from former PrEP study participants. We will conduct four FGDs of a random sample of HIV-1 discordant couples. Each FGD will be gender and age specific and be composed of eight to ten HIV-negative women and men. In-depth interviews will also be conducted for the principal investigators of the study to explore the attitudes, opinions and feelings about PTA. FGD guides and interview scripts will be piloted tested prior use. Each FGD and interview will be audio recorded and later transcribed and translated for analysis. Field notes will also be taken during the FGDs and interview sessions. Finally, a brief questionnaire will be administered to participants to capture their socio-economic demographics and trial experience. Informed consent will be sought from study participants’ prior data collection.

Data Analysis: to ensure data quality field notes and transcripts will be used for data analysis. FGDs and interviews will be recorded and the audio files will be transcribed and translated into English. The transcripts from the in-depth interviews and FGDs will be coded by two analysts. This will be done by identifying themes and organizing them into the categories based on the tenets of grounded theory. Quantitative data will be analyzed using descriptive statistics.

Expected Application: Limited data exists on individual views regarding PTA therefore the findings from this study will provide guidance in the implementation of PrEP services.

Nicole Overstreet, PhD

Ethical Considerations in HIV Research: Examining the Role of Intersectional Stigma

Background: African American women living with HIV who have experienced intimate partner violence (IPV) may experience multiple forms of stigma and discrimination related to their HIV status, experiences of IPV, race, and gender. Despite these experiences of intersectional stigma, few studies have explored whether living with multiple marginalized social identities elicits ethical concerns when participating in HIV research.

Specific Aims: The current study examines

  1. Women’s perceptions of risks and benefits of participating in HIV research;
  2. Whether women’s experiences of stigma and discrimination are associated with negative emotional reactions to research participation;
  3. Whether experiences of stigma are associated with participant distress when answering sensitive questions regarding HIV and IPV.

Study Population: HIV-positive African American women in the Baltimore area.

Research Design: Quantitative survey assessing perceptions of participation in HIV research.

Alexis Roth, PhD, MPH

Ethical considerations for mHealth research with persons who inject drugs

"mHealth” research refers to an emerging discipline that leverages the increasingly sophisticated capabilities of mobile communications technology for both measurement and intervention in health behavior research. mHealth is a new but growing field, it’s been approximately 5 years since the first mHealth randomized controlled trial, thus, a set of commonly agreed upon ethical standards for the use of these tools has yet to be established. Improving our understanding of the benefits and harms associated with involvement in mHealth studies, as well as concerns participants might have about privacy and data security, will be critical if mHealth research is to move forward. This project aims to draw upon participant perspectives to investigate ethical considerations for conducting one type of mHealth research, event-level monitoring of drug use via digital diaries entered on smartphones, to establish best-practice guidelines for researchers interested in using mHealth tools with drug using populations.

Darpun Sachdev, MD

Fair Access to effective Interventions in Research trials (FAIR study): A qualitative study

Determining the standard prevention in HIV‐related clinical trials has been a controversial and enduring ethical dilemma, as increasing levels of care for trial participants also increases the time and cost necessary to carry out a trial. HIV prevention trials must weigh the need for rigorously‐designed trials that enable sound scientific results with the obligation to provide appropriate benefits to trial participants. The FAIR study (Fair Access to effective Interventions in Research trials) is a qualitative three part study to understand the biostatistical, ethical and scientific considerations in determining if, when and how to incorporate a new prevention modality as part of the standard of prevention in biomedical prevention trials. To address this complex issue we will conduct semi‐structured interviews with biostatisticians to understand current and innovative clinical trial design approaches to address changing standards of care in HIV prevention. Next, we will interview bioethicists to understand how the ethical “threshold” to include a new standard of prevention is reached and what the ethical considerations are when implementing a new modality into an existing trial. Finally, we will interview principal investigators from vaccine, PrEP and microbicide trials to understand the scientific and practical implications of including new prevention modalities as part of the standard of care in clinical trials.

  • Aim 1: Understand the biostatistical implications of incorporating new prevention modalities as part of the standard of prevention in biomedical HIV prevention trials.

  • Aim 2: Understand the bioethical perspectives that guide the decision that an ethical “threshold” is reached and a moral obligation has been triggered to include a new prevention modality in a biomedical prevention trial.

  • Aim 3: Understand how principal investigators approach the ethical and practical challenges of conducting biomedical prevention trials in a constantly evolving landscape of prevention modalities.

  • Potential impact: To our knowledge, this would be the first study to systematically and critically analyze biostatistical, ethical and clinical perspectives on the tension of providing the best possible standard of care versus a ‘good enough’ package. These data will provide crucial information on how to address standard of care dilemmas and ethically design future multinational combination prevention trials.

Andrew Spieldenner, PhD

Ethical consideration of HIV and Pre-Exposure Prophylaxis (PrEP) recruitment materials for African American and Latino men who have sex with men (MSM)

HIV vaccine and PrEP trials are ongoing foci of HIV prevention efforts in the United States. Due to the disproportionate impact of HIV/AIDS on the population, African American and Latino MSM are primary concerns of these research initiatives. While recruitment efforts continue, there has been little review and analysis of the recruitment materials. While efficacy is one concern, ethical considerations are an integral issue in HIV vaccine and PrEP trials, including in recruitment efforts. This project will conduct a content analysis of HIV vaccine and PrEP trials conducted in the United States in order to see how messages and ethical concerns are communicated to African American and Latino MSM.

Sean Young, PhD

Ethics and Social Networking for HIV Research

In a number of studies, we have discovered ways that social networking technologies can be used for HIV prevention research. However, little work has been done to identify and to address potential ethical issues pertaining to participants’ experiences in these studies. It is important that we re-contact past participants to find out about their experiences in order to understand the ethical issues associated with social networking for HIV prevention research and how to design future studies that take into account these ethical challenges. Therefore, we propose a study to survey men who have sex with men (MSM) in Peru (greater Lima area) and Los Angeles (LA) who were participants in our prior studies on ethical-related issues based on their experiences in the HOPE studies, a social networking-based HIV prevention intervention in Los Angeles and Peru. The specific aims are to:

  1. Identify ethical-related concerns related to the recruitment process
    Hypothesis: We are able to contact participants to identify ethical-related concerns related to the recruitment process.

  2. Identify positive and negative deviations from expectations related to the consent process
    Hypothesis: Education level might impact the understanding of the consent material and the expectations of the intervention.

  3. Assess intervention and follow-up-related benefits and harms
    Information on benefits and harms during recruitment, intervention, and post-intervention will be collected.

Cohort 4 Fellows

Erin Bonar, PhD

Emerging Adults’ Risk-Benefit Experiences with Using mHealth Technologies for Research on Drug Use and Sexual Behaviors

Goals: To understand perceptions of risks and benefits experienced by emerging adults who complete text message assessments of alcohol use, drug use, and sexual behavior in order to inform ethical procedures for future research using mHealth with this population.

Population: 18-25 year-olds from an urban, low resource community who report using drugs and engaging in sexual risk behavior.

Procedures: At follow-up assessments, participants will complete tablet based surveys assessing domains of risks and benefits experienced during participation in a daily text message survey study. Relevance to HIV Prevention Research: mHealth is increasingly used in HIV prevention and substance use research, particularly with young people who are at high risk. The data can inform the appropriate delivery of informed consent and confidentiality protections in this type of research and will also be informative to IRBs that must make decisions about the risk level and perceived benefits of this type of research.

Faith Fletcher, PhD

Perceptions of Barriers and Benefits to Adolescent Participation in Pre-exposure Prophylaxis (PrEP) Clinical Trials among African American Women and Their Adolescent Daughters

Introduction
African American female youth are disproportionately impacted by STIs and HIV. Factors that may increase young women’s vulnerability to STIs and HIV acquisition include a lack of awareness regarding safe sexual practices, cultural and gender incapacity to insist on male partner condom use, biological development, psychosexual maturation, and socio-cultural factors. Thus, innovative methods are needed to thwart the negative effects of STIs, including HIV. One potential biomedical method to reduce HIV acquisition among uninfected populations is Pre-Exposure Prophylaxis (PrEP). PrEP is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk. Despite studies demonstrating PrEP effectiveness with high risk populations, none of these studies have included adequate representation of youth, particularly African American female youth. General Objective: Given the disproportionate rates of STIs and HIV among African American female youth in general and their under-representation in PrEP clinical trials, the overall goal of this study is to assess perceptions of barriers and benefits to adolescent participation in PrEP clinical trials among African American women and their adolescent daughters. Methods: To understand perceptions of adolescent participation in PrEP clinical trials, For Our Daughters research study will be conducted. For Our Daughters presents a hypothetical PrEP clinical trial to African American women and their adolescent daughters followed by a series of focus group questions in Phase I and a cross-sectional survey administered in Phase II. Utilizing a convenience sample, women and daughters will be recruited from a two-armed randomized controlled trial (IMARA). Scientific Translation: Limited data exists on perceptions related to adolescent PrEP research study participation among African American women and their adolescent daughters. Therefore, study findings will inform future study design and participant protection procedures specific to African American female youth for PrEP clinical trials.

Julia Lechuga, PhD

Risks, Benefits and Sustained Change Associated with Participating in a Social Network Based Community-Level HIV Risk Reduction Intervention for Crack Users: Participant Perspectives

There is limited research on the effectiveness of social network-based community-level HIV risk reduction behavioral interventions in non-injection drug users and the risks and benefits encountered. In addition, there is a dearth of research on participants’ expectations and motivations to participate. The purpose of the study will be to retrospectively assess the research experiences of crack users who took part in such an intervention. The goal will be to shed light on the motivations to participate, perceived drawbacks of participation, and behavior change intentions and perceived sustainability of behavior change. Participants will be recruited from a study currently evaluating the effectiveness of such intervention with crack users in San Salvador. We will conduct 80 quantitative surveys immediately post intervention and 20 in-depth interviews at one month post intervention. Findings will inform the development of guidelines to inform IRB decision-making regarding the risk/benefit ratio of participation in such interventions.

Abby Rudolph, PhD

Ethical Considerations for the Collection of Geographic Data for HIV Prevention Research among Illicit Drug Users

GIS methods are used to identify health service deserts, evaluate associations between proximity to health services and their use, and link contextual factors with individual-level data. Current methods for collecting geographic information range from interviewer-administered surveys to geographical momentary assessments, which combine ecological momentary assessments with time-stamped GPS data. However, technological advancements for data collection have outpaced the development of ethical standards and guidance, particularly for research involving populations engaged in illicit and/or stigmatizing behaviors. The major goals of this project are to 1) describe the privacy and confidentiality concerns associated with different approaches used to collect geographic information from drug using populations in HIV-prevention and substance-use research and 2) assess how these concerns may influence the validity of participant responses.

Arunansu Talukdar, MD, PhD

Voluntariness of Consent to Research of Women participated at a clinic based HIV intervention trial in Kolkata, India

A core ethical principal in research is voluntary participation. Voluntariness is ensured through the informed consent process, in which research participants receive detailed information about study procedures, risks, and benefits; are informed of their rights as research participants; and are given the opportunity to decide – without penalty or coercion – whether or not to participate in a research study. Unfortunately, there are at least two potentially significant barriers to this process, many of which are apparent in the developing world. First, literacy levels (both reading levels and levels of scientific literacy required to understand the research process) are often low among resource-limited groups, thus raising questions regarding the capacity of potential research participants to understand the informed consent process.

Second, cultural barriers might impact the ability of an individual to provide informed consent. For example, the informed consent process assumes that an individual makes the decision of whether or not to participate in a research project. However, in many cultures important decisions are made by other family or community members, or are made collectively. While these decision-making processes reflect community norms, they are in direct conflict with the autonomy of potential research participants that is embedded in the informed consent process. These potential barriers to informed consent can be seen in the patient population at Medical College & Hospital, Kolkata, which is located in Kolkata, India. This hospital operates a large clinic for HIV+ patients, where clinical care (including antiretroviral medication, ART) is provided free of charge. Within the hospital, medical and social science research is regularly conducted, overseen by local and state internal review boards. A research project will be conducted soon on trial of cognitive behavior therapy (CBT) for non-ART adherent patients at ART centre in collaboration with Psychiatry department. Patients who enroll in this research project will first complete an informed consent process. This proposed study will assess the degree of voluntariness of this informed consent process prior to the initiation of CBT. A community advisory board will provide input on measures and research design. Semi-structured interviews will be conducted with 60 Bengali-speaking women who have provided informed consent but not yet begun therapy. Findings will be reviewed by focus groups of women, men and link workers to help contextualize results and make recommendations to improve the informed consent process for future research studies.

Thespina (Nina) Yamanis, PhD

Exploring the ethics of a social network intervention to reduce HIV risk among young, Tanzanian men

This study examines the ethics of involving social networks in HIV prevention interventions. Network interventions often train leaders to model health behaviors to members of their networks. Limited attention has been paid to ethical concerns associated with this approach, including: voluntariness (leaders may influence members’ decisions to participate); beneficence at the network level (network characteristics may change in harmful ways); and beneficence at the individual level (members may experience stigma and mistrust). We will explore these concerns during an ongoing HIV prevention trial (R01MH098690) with young men in Tanzania who socialize in networks known as “camps”. 60 camps with 1278 individuals are enrolled. Health leaders at 30 intervention camps deliver HIV prevention messages to members. I will quantitatively describe network changes from baseline to midpoint and use mixed methods to describe members’ perceptions of the intervention’s benefits and harms. The results will guide those interested in network-related HIV prevention research.