Views and Experiences of Mucosal Sampling in HIV Clinical Research among Kenyan Volunteers

HIV transmission predominantly occurs across mucosal surfaces. Efforts to find an effective and efficacious HIV vaccine, requires understanding the various mechanisms of sexual HIV transmission including immune responses to various HIV vaccine candidates along the mucosal pathways.  In this paper, we describe the experiences of health volunteers in three Phase 1 HIV vaccines trials and an observation study that comprised of high- risk and low risk healthy participants with regard to the collection of rectal, cervical and seminal mucosal samples. The paper emanates from a study that examined the views and experiences of volunteers in participating in HIV clinical research, at the KAVI-Institute of Clinical Research, Nairobi, Kenya. The study followed a mixed methods phenomenological research approach with a dominant qualitative strand. In the first phase, quantitative data was collected via a survey questionnaire involving 116 volunteers that helped identify 28 volunteers for the qualitative phase.  Quantitative data were analyzed using SPPS while qualitative data was transcribed verbatim, thematic themes identified for coding and entered into Atlas ti for analysis. Participants had a mean age of 28.5 ± 5.7 years (range 20–51 years). There were more males (n =85) than females (n= 31). In general, volunteers expressed mixed reactions towards the collection and use of mucosal samples. Both none-consenting and consenting volunteers cited invasiveness of their privacy.Also reported were experiences of physical and psychological discomforts, with men terming the collection of semen via masturbation as unnatural and contravening individuals’ religious and cultural beliefs. The findings reveal a knowledge gap among community members with use of mucosal samples and modes of collection

Factors Associated with Sexual Violence against Men Who Have Sex with Men and Transgendered Individuals in Karnataka, India

There is a lack of information on sexual violence (SV) among men who have sex with men and transgendered individuals (MSM-T) in southern India. As SV has been associated with HIV vulnerability, this study examined health related behaviours and practices associated with SV among MSM-T.Data were from cross-sectional surveys from four districts in Karnataka, India.Multivariable logistic regression models were constructed to examine factors related to SV. Multivariable negative binomial regression models examined the association between physician visits and SV.A total of 543 MSM-T were included in the study. Prevalence of SV was 18% in the past year. HIV prevalence among those reporting SV was 20%, compared to 12% among those not reporting SV (p = .104). In multivariable models, and among sex workers, those reporting SV were more likely to report anal sex with 5+ casual sex partners in the past week (AOR: 4.1; 95%CI: 1.2-14.3, p = .029). Increased physician visits among those reporting SV was reported only for those involved in sex work (ARR: 1.7; 95%CI: 1.1-2.7, p = .012).These results demonstrate high levels of SV among MSM-T populations, highlighting the importance of integrating interventions to reduce violence as part of HIV prevention programs and health services

How Informed is Informed Consent? Experiences of Research Participants at the KAVI-Institute of Clinical Research, Kenya

Introduction: Informed consent (IC) is a key yardstick for the ethical and legal conduct of clinical research involving human subjects. However, the extent to which it meets its obligations in low-income settings remains under-examined. This study explored the views and experiences of informed consent among research participants at the KAVI-Institute for Clinical Research, Nairobi, Kenya.Materials and Methods: A mixed-methods study was conducted between March and June 2014. Participants were drawn from six selected KAVI-ICR studies. Data collection involved a survey questionnaire with 164 participants and in-depth interviews with 44 participants purposively selected from the survey questionnaire respondents. Descriptive statistics via SPSS and thematic analysis via Atlas Ti were used, for quantitative and qualitative data analysis respectively.Results:  The majority of participants had learnt about the KAVI studies from friends (41%) and community mobilisers/ peer educators (47%). The information relayed by these relations regarding participation had led some participants to reach their decisions before undergoing the informed consent process. All participants reported attending information meetings, passed the assessment of understanding tests, and autonomously gave their written consent. Incomplete understanding of research concepts such as randomization and associated terminologies, placebo, and vaccine-induced positivity were expressed.Conclusion: Beyond understanding the information received before enrolment, participants’ decisions are shaped by individual and community factors as well as trust relations with trial staff and own friends. There is, therefore, a need for innovative approaches to implementing and evaluating informed consent in low-resource settings

Frontline Health Service Providers' Perspectives on HIV Vaccine Trials among Female Sex Workers and Men Who Have Sex with Men in Karnataka, South India.

Little qualitative research is available on the role of frontline health service providers (FHSPs) in the implementation of clinical trials, particularly in developing countries. This paper presents findings from a qualitative study about the perspectives of FHSPs on future HIV vaccine trials involving female sex workers (FSWs) and men who have sex with men (MSM) in three districts of Karnataka, India. In particular, we explore FHSPs' knowledge of and views on clinical trials in general, and examine their potential willingness to play a role if such trials were introduced or implemented in the region.A field team of four researchers from Karnataka-two of whom self-identified with FSW or MSM communities ("community researchers") and two with backgrounds in social work-conducted in-depth interviews with FHSPs. Including community researchers in the study helped to build rapport with FSW and MSM participants and facilitate in-depth discussions. A coding scheme for transcribed and translated data was developed using a framework analysis approach. Data was then analysed thematically using a combination of a priori and emergent codes.Over half of FHSPs demonstrated limited knowledge or understanding of clinical trials. Despite reported skepticism around the testing of HIV vaccines in developing countries and concerns around potential side effects, most FHSPs strongly advocated for the implementation of HIV vaccine clinical trials in Karnataka. Further, most FHSPs expressed their willingness to be involved in future HIV vaccine clinical trials in varying capacities.Given that FHSPs are often directly involved in the promotion of health and well-being of FSWs and MSM, they are well-positioned to play leadership, ethical, and communicative roles in future HIV vaccine trials. However, our findings reveal a lack of awareness of clinical trials among FHSP participants, suggesting an important area for capacity building and staff development before viable and ethical clinical trials can be set up in the region

Contextualizing willingness to participate: recommendations for engagement, recruitment & enrolment of Kenyan MSM in future HIV prevention trials

Abstract Background The HIV epidemic among men who have sex with men (MSM) continues to expand globally. The addition of an efficacious, prophylactic vaccine to combination prevention offers immense hope, particularly in low- and middle- income countries which bear the greatest global impact. However, in these settings, there is a paucity of vaccine preparedness studies that specifically pertain to MSM. Our study is the first vaccine preparedness study among MSM and female sex workers (FSWs) in Kenya. In this paper, we explore willingness of Kenyan MSM to participate in HIV vaccine efficacy trials. In addition to individual and socio-cultural motivators and barriers that influence willingness to participate (WTP), we explore the associations or linkages that participants draw between their experiences with or knowledge of medical research both generally and within the context of HIV/AIDS, their perceptions of a future HIV vaccine and their willingness to participate in HIV vaccine trials. Methods Using a social network-based approach, we employed snowball sampling to recruit MSM into the study from Kisumu, Mombasa, and Nairobi. A field team consisting of seven community researchers conducted in-depth interviews with a total of 70 study participants. A coding scheme for transcribed and translated data was developed and the data was then analysed thematically. Results Most participants felt that an HIV vaccine would bring a number of benefits to self, as well as to MSM communities, including quelling personal fears related to HIV acquisition and reducing/eliminating stigma and discrimination shouldered by their community. Willingness to participate in HIV vaccine efficacy trials was highly motivated by various forms of altruism. Specific researcher responsibilities centred on safe-guarding the rights and well-being of participants were also found to govern WTP, as were reflections on the acceptability of a future preventive HIV vaccine. Conclusion Strategies for engagement of communities and recruitment of trial volunteers for HIV vaccine efficacy trials should not only be grounded in and informed by investigations into individual and socio-cultural factors that impact WTP, but also by explorations of participants’ existing experiences with or knowledge of medical research as well as attitudes and acceptance towards a future HIV vaccine

Beyond biomedical and comorbidity approaches: Exploring associations between affinity group membership, health and health seeking behaviour among MSM/MSW in Nairobi, Kenya

We explored general health and psychosocial characteristics among male sex workers and other men who have sex with men in Nairobi, Kenya. A total of 595 MSM/MSW were recruited into the study. We assessed group differences among those who self-reported HIV positive (SR-HIVP) and those who self-reported HIV negative (SR-HIVN) and by affinity group membership. Quality of life among SR-HIVP participants was significantly worse compared to SR-HIVN participants. Independent of HIV status and affinity group membership, participants reported high levels of hazardous alcohol use, harmful substance use, recent trauma and childhood abuse. The overall sample exhibited higher prevalence of moderate to severe depressive symptoms compared to the general population. Quality of life among participants who did not report affinity group membership (AGN) was significantly worse compared to participants who reported affinity group membership (AGP). AGN participants also reported significantly lower levels of social support. Membership in affinity groups was found to influence health seeking behaviour. Our findings suggest that we need to expand the mainstay biomedical and comorbidity focused research currently associated with MSM/MSW. Moreover, there are benefits to being part of MSM/MSW organisations and these organisations can potentially play a vital role in the health and well-being of MSM/MSW

High prevalence of vaccine‐preventable anal human papillomavirus infections is associated with HIV infection among gay, bisexual, and men who have sex with men in Nairobi, Kenya

Abstract Background Human papillomavirus (HPV) infection is associated with anal cancers and is more prevalent in gay, bisexual, and men who have sex with men (gbMSM), partly due to their vulnerability to HIV infection. Baseline HPV genotype distributions and risk factors can inform the design of next‐generation HPV vaccines to prevent anal cancer. Methods A cross‐sectional study was conducted among gbMSM receiving care at a HIV/STI clinic in Nairobi, Kenya. Anal swabs were genotyped using a Luminex microsphere array. Multiple logistic regression methods were used to identify risk factors for four HPV outcomes (any HPV, any HR‐HPV, and 4‐ and 9‐valent vaccine‐preventable HPVs). Results Among 115 gbMSM, 51 (44.3%) were HIV‐infected. Overall HPV prevalence was 51.3%; 84.3% among gbMSM living with HIV and 24.6% among gbMSM without HIV (p < 0.001). One‐third (32.2%) had HR‐HPV and the most prevalent vaccine‐preventable HR‐HPV genotypes were 16, 35, 45, and 58. HPV‐18 was uncommon (n = 2). The 9‐valent Gardasil vaccine would have prevented 61.0% of HPV types observed in this population. In multivariate analyses, HIV status was the only significant risk factor for any HPV (adjusted odds ratio [aOR]:23.0, 95% confidence interval [95% CI]: 7.3–86.0, p < 0.001) and for HR‐HPV (aOR: 8.9, 95% CI: 2.8–36.0, p < 0.001). Similar findings were obtained for vaccine‐preventable HPVs. Being married to a woman significantly increased the odds of having HR‐HPV infections (aOR: 8.1, 95% CI: 1.6–52.0, p = 0.016). Conclusions GbMSM living with HIV in Kenya are at higher risk of anal HPV infections including genotypes that are preventable with available vaccines. Our findings support the need for a targeted HPV vaccination campaign in this population