High acceptability of HIV pre-exposure prophylaxis but challenges in adherence and use: qualitative insights from a phase I trial of intermittent and daily PrEP in at-risk populations in Kenya.

This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral pre-exposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness.

"Once I begin to participate, people will run away from me": understanding stigma as a barrier to HIV vaccine research participation in Kenya.

PURPOSE: Participation of volunteers in clinical research is essential to the development of effective HIV prevention methods, including an HIV vaccine. This study expands current knowledge of stigma and discrimination related to participation in HIV vaccine research in sub-Saharan Africa by exploring the perception of stigma and discrimination as a barrier to participation in HIV vaccine research in Kenya. METHODS: Eighteen focus groups with a total of 133 participants and 82 individual interviews were conducted with a range of respondents at two centers in Nairobi, Kenya: a preventive AIDS vaccine trial center; and a preparatory clinical and epidemiological study center. Respondents included peer leaders, community advisory board members, former and current volunteers in clinical research, study staff, community leaders and community members. Data were analyzed using an iterative coding process. RESULTS: Four prominent stigma-related barriers to participation emerged among all respondent groups, across both centers: (1) volunteers are often assumed by family and community members to be HIV positive because of their participation in vaccine research; (2) HIV-related stigma is perceived as pervasive and damaging in the communities where volunteers live, thus they fear consequent stigma if people believe them to be HIV positive; (3) potential volunteers fear being tested for HIV, a prerequisite for participation, because of possible disclosure of HIV status in communities with high perceived HIV-related stigma; and (4) volunteers must carefully manage information about their participation because of misperceptions and assumptions about vaccine research volunteers. CONCLUSIONS: HIV-related stigma and discrimination influence people's decisions to join HIV-vaccine related research. Findings underscore a need for integration of stigma-reduction programming into education and outreach activities for volunteers, and the communities in which they live. This is particularly critical for trials recruiting individuals with higher HIV risk, who are often already highly stigmatized.

Conceptual framework for behavioral and social science in HIV vaccine clinical research.

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance.

Behavioral and social science in HIV vaccine clinical research: Workshop report.

In May 2009, a workshop was held in Washington DC to identify ways in which HIV vaccine clinical research could benefit from and better incorporate behavioral and social science (BSS) considerations. Seventy-one people from government, non-government, and private organizations participated, including HIV vaccine researchers, clinical trial scientists, BSS researchers, community representatives, and sponsors. This workshop elucidated the opportunities and challenges for integrating BSS in HIV vaccine research by highlighting insights gained from previous BSS research on HIV prevention and highlighting new BSS approaches and methodologies. Meeting participants identified priority areas where BSS methodologies could significantly impact HIV research and developed concrete recommendations for addressing current challenges encountered in HIV vaccine research relating to social impact, risk assessment, community engagement, informed consent, risk reduction, and special populations. These recommendations address the need for improving the accuracy of participant data; standardizing data collection to enable comparisons across studies; engaging the community at all levels; using evidenced-based counseling techniques; understanding the needs and concerns of target populations; and considering the impacts of macro-level forces and influences. The importance of establishing collaborations that can carry out these recommendations and facilitate necessary changes in thinking and practice was emphasized throughout the meeting.

Do current measurement approaches underestimate levels of unwanted childbearing? Evidence from rural India.

The validity of estimates of unintended childbearing has often been questioned, especially given their almost exclusive reliance on responses to survey questions that ask women to recall their intentions about past pregnancies. An opportunity to compare prospective and retrospective descriptions of intendedness was provided by a follow-up survey in four Indian states in 2002-2003 of rural woman originally interviewed in the 1998-99 National Family Health Survey-2. The results demonstrate a pronounced tendency for births prospectively classified as unwanted to be retrospectively described as having been wanted or mistimed. The main reason seems to be either that mothers adapt to the reality of a new birth or are reluctant to describe an existing child as having initially been unwanted. Our findings suggest that retrospective accounts of the wantedness of a birth, such as those obtained by current Demographic and Health Surveys, may lead to significant underestimates of true levels of unwanted childbearing.