Kathleen M. MacQueen

Codebook Development for Team-Based Qualitative Analysis

One of the key elements in qualitative data analysis is the systematic coding of text (Strauss and Corbin 1990:57%60; Miles and Huberman 1994:56). Codes are the building blocks for theory or model building and the foundation on which the analyst’s arguments rest. Implicitly or explicitly, they embody the assumptions underlying the analysis. Given the context of the interdisciplinary nature of research at the Centers for Disease Control and Prevention (CDC), we have sought to develop explicit guidelines for all aspects of qualitative data analysis, including codebook development.

Beyond the Qualitative Interview: Data Preparation and Transcription

The increased use of qualitative research, especially its application in multisite studies, requires robust data collection techniques and the documentation of research procedures. The inappropriate or inadequate preparation of transcripts from audio or digital recordings can delay or negatively affect the analysis process. Although no universal transcription format is adequate for all types of qualitative data collection approaches, settings, or theoretical frameworks, there are some practical considerations that can help researchers systematically organize and analyze textual data.

Alcohol use and high-risk sexual behavior among men who have sex with men: the effects of consumption level and partner type.

Alcohol use may increase HIV sexual risk behavior, although findings have varied across study populations and methods. Using event-level data from 1,712 seronegative men who have sex with men, the authors tested the hypothesis that social context would moderate the effect of alcohol consumption on unprotected anal sex (UAS). For encounters involving a primary partner, rates of UAS did not vary as a function of alcohol use. However, consumption of 4 or more drinks tripled the likelihood of UAS for episodes involving a nonprimary partner. Thus, the effects of alcohol vary according to the context in which it is used. Interventions to reduce substance-related risk should be tailored to the demands of maintaining sexual safety with nonprimary partners.

Willingness to volunteer in future preventive HIV vaccine trials: Issues and perspectives from three U.S. communities

Summary: This study examined perceived risks, benefits, and desired information related to willingness to volunteer in preventive HIV vaccine trials. Sample: Purposive sampling was used to select 90 participants among injecting drug users (Philadelphia, PA, U.S.A.); gay men (San Francisco, CA, U.S.A.); and black Americans (Durham, NC, U.S.A.). Methods: A qualitative interview guide elicited perceived benefits, risks, and desired information relating to trial participation. Themes were developed from the transcribed texts and from freelists. Results: Stated willingness to volunteer in a preventive HIV vaccine trial was similar across the three communities. Eight perceived benefits were reported, including self‐benefits, altruism, and stopping the spread of AIDS. Seven perceived risks were reported, including negative side effects and vaccine safety issues, contracting HIV from the vaccine, and social stigmatization. Participants voiced the desire for eight types of information about issues relating to trust and confidentiality in the research process, health complications and later assistance, and vaccine trial methodology. Conclusions: In this study, many benefits as well as risks of preventive HIV vaccine trial participation were cited. Scientists conducting preventive HIV vaccine trials need to address community perceptions of risks and provide information about the research if trial enrollment is to be diverse and successful.

Changes in sexual risk behavior among participants in a PrEP HIV prevention trial.

Background: One of the concerns raised regarding the introduction of any new HIV-prevention measure, such as PrEP, is the potential for risk disinhibition or sexual risk compensation. The oral tenofovir HIV prevention trial has been the subject of international discussion in this regard. Methods: This article maps the changes in sexual risk behavior among women participating in the oral tenofovir HIV prevention trial in Ghana. Content-driven, thematic analysis was carried out on qualitative data obtained from in-depth interviews with study participants. Growth curve analysis was the primary method used to document trends over time in self-reported sexual behavior collected monthly. Results: Overall, the study found that sexual risk behavior did not increase during the trial. Number of sexual partners and rate of unprotected sex acts decreased across the 12-month period of study enrollment. Certain subgroups of women, however, exhibited different growth curves. Data indicate that the HIV prevention counseling associated with the trial was effective. Conclusions: Counseling during the trial was effective. Different types of counseling and messaging may be needed for different subgroups within a population. These findings also have implications for required sample sizes for future HIV prevention trials where seroconversion is the main outcome.

Willingness of injection drug users to participate in an HIV vaccine efficacy trial in Bangkok, Thailand

We assessed willingness to participate in an HIV recombinant gp120 bivalent subtypes B/E candidate vaccine efficacy trial among 193 injection drug users (IDUs) attending drug treatment clinics in Bangkok, Thailand. IDUs previously enrolled in a prospective cohort study were invited to group sessions describing a potential trial, then completed questionnaires assessing comprehension and willingness to participate. A week later, they completed a follow-up questionnaire that again assessed comprehension and willingness to participate, as well as barriers to and positive motives for participation, with whom (if anyone) they talked about the information, and whether others thought participation was a good, bad, or neutral idea. At baseline, 51% were definitely willing to participate, and at follow-up 54%; only 3% were not willing to participate at either time. Comprehension was high at baseline and improved at follow-up. Participants who viewed altruism, regular HIV tests, and family support for participation as important were more willing to volunteer. Frequency of incarceration and concerns about the length of the trial, possible vaccine-induced accelerated disease progression, and lack of family support were negatively associated with willingness. Overall, IDUs comprehended the information needed to make a fully informed decision about participating in an rgp120 vaccine efficacy trial and expressed a high level of willingness to participate in such a trial.

Evaluating community engagement in global health research: the need for metrics

BackgroundCommunity engagement in research has gained momentum as an approach to improving research, to helping ensure that community concerns are taken into account, and to informing ethical decision-making when research is conducted in contexts of vulnerability. However, guidelines and scholarship regarding community engagement are arguably unsettled, making it difficult to implement and evaluate.DiscussionWe describe normative guidelines on community engagement that have been offered by national and international bodies in the context of HIV-related research, which set the stage for similar work in other health related research. Next, we review the scholarly literature regarding community engagement, outlining the diverse ethical goals ascribed to it. We then discuss practical guidelines that have been issued regarding community engagement. There is a lack of consensus regarding the ethical goals and approaches for community engagement, and an associated lack of indicators and metrics for evaluating success in achieving stated goals. To address these gaps we outline a framework for developing indicators for evaluating the contribution of community engagement to ethical goals in health research.SummaryThere is a critical need to enhance efforts in evaluating community engagement to ensure that the work on the ground reflects the intentions expressed in the guidelines, and to investigate the contribution of specific community engagement practices for making research responsive to community needs and concerns. Evaluation mechanisms should be built into community engagement practices to guide best practices in community engagement and their replication across diverse health research settings.

Feasibility and suitability of targeting young gay men for HIV vaccine efficacy trials

We evaluated factors affecting the feasibility of including young high-risk HIV-negative gay and bisexual men in preventive HIV vaccine trials using data from the U.S. Centers for Disease Control and Prevention Collaborative HIV Seroincidence Study. Of 2189 men enrolled in this study, 17% were <25 years of age. HIV seroincidence was 4.2/100 person-years (95% confidence interval [CI], 2.6-7.0) in young men compared with 2.0/100 person-years (95% CI, 1.4-2.6) for older men. Compared with men 25 and older, young men were more likely to report several high-risk behaviors, to perceive themselves to be at risk for HIV infection, and to report that their risk behavior might be increased by participation in an HIV vaccine trial. The majority of both young men (69%) and older men (74%) expressed willingness in participate in HIV vaccine trials. Young men were less likely to answer questions about vaccine concepts correctly and were more likely to be lost to follow-up. Young gay and bisexual men are important candidates for future HIV vaccine trials, but they may need targeted approaches to recruitment, retention, education about trial concepts prior to enrollment, and behavioral interventions during the trial.

AIDS awareness among a cohort of young Thai men: Exposure to information, level of knowledge, and perception of risk

Structured interviews and focus group discussions were conducted among 834 young Thai men drafted into military service by random lottery in northern Thailand. Level of AIDS risk, exposure to AIDS information, level of knowledge about AIDS, and perception of risk for acquiring HIV and AIDS were assessed at baseline and six months after induction into the Army in 1991. General fear of AIDS was high, yet personal perception of risk for acquiring HIV was low, even for those at enhanced behavioural risk of infection with HIV. Multivariate PATH analysis shows that exposure to information about AIDS significantly reduced risk taking from baseline to follow-up, but only by first affecting personal risk perception. Focus group discussions revealed that risk perception for acquiring AIDS was low due to never knowing a person with AIDS, because prostitutes had health certificates for STD, and since many believed that AIDS could be cured or prevented with folk medicines. Implications and recommendations for intervention programmes are discussed.

Ethical Challenges in International HIV Prevention Research

Members of an HIV-prevention research network were asked to describe ethical challenges faced in their work. Major themes included acceptable standards of care for participants, defining research of relevance to host countries, reducing risks related to stigma, designing research that meets local needs without contributing to an inadequate status quo, and ensuring informed consent for complex research with potentially vulnerable participants. The challenges are interrelated and highlight the need for innovative, practical strategies to be incorporated into the planning, design, and conduct of HIV prevention trials. Research in applied ethics to support decision-making about HIV prevention research is needed, along with ethics training, mechanisms to support community-wide benefit from research, and expanded dialog on the ethics surrounding HIV prevention and public health research.