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  • This was a two year longitudinal observational cohort study, implemented in 2009 at KAVI-Institute of Clinical Research (KAVI-ICR). KAVI-ICR consists of two sites, both in Nairobi. One is located at the Kenyatta National Hospital (KNH) and the other at a small clinic in Kangemi. Kangemi is located on the Western part of Nairobi County and is an informal settlement consisting of people of both medium and low socio-economic classes. The study was designed to recruit both adult male and female participants into a cohort to serve as a pool of volunteers, from which participants would be drawn into future studies (observational studies or clinical trials). Participants who rolled over to another study were replaced. While the study commenced in 2009 at the KNH KAVI-ICR site, recruitment at Kangemi KAVI-ICR site commenced in the year 2010. It was aimed at creating a pool of participants for an anticipated phase I HIV vaccine clinical trial that was to start in the year 2011. Participants were HIV negative male and female adults aged 18–45 years and willing to give informed consent. Current or past participants in clinical trials were excluded from participation. Peer leaders from the community were identified and trained on the study. These peer leaders then mobilized potential study participants from local communities, institutions, markets, and churches. They informed the potential participants about the study in the field, and then assembled them for initial study information group sessions delivered by KAVI-ICR staff (community mobilizers). Thereafter, the community mobilizers referred interested participants to the Kangemi KAVI-ICR research site for detailed study information seminars. This was followed by individualized informed consent sessions by study nurse counsellors; where participants’ questions or concerns regarding the study were addressed. On average, each participant had 3 individualized sessions before signing the consent to join the study. Consent and screening for eligibility: We administered an assessment-of-understanding (AOU) of consent information to assess participant’s comprehension of the study before signing the study consent. Only two attempts of assessment-of-understanding were permitted. Those who passed this test by correctly answering at least 8/10 questions were offered the study consent form to sign. Thereafter, we used a structured questionnaire (S1 Appendix) to obtain socio-demographic data, self-reported health status, medical history, HIV risk assessment, and reasons for volunteering to participate in the study. Information regarding willingness to join a future/hypothetical HIV vaccine clinical trial was also collected. Details of what a HIV vaccine clinical trial entailed were not part of the information given in this study. A study nurse counsellor performed pre and post- HIV test counselling then HIV-testing using rapid test kits [17]. Participants who tested HIV positive were not enrolled but referred for further management at a health facility of their choice. About 10mls of blood was drawn from eligible participants for storage. Follow-up visits were scheduled every six months. At every visit, nurse counsellors performed HIV test using rapid test kits after pre and post- test counselling. Recruitment and consent of participants into a recruiting HIV vaccine clinical trial: Starting from February 2011, participants who had expressed willingness to participate in a future HIV vaccine clinical trial were contacted via telephone calls by the study coordinator to come for information regarding a recruiting phase I HIV vaccine trial (IAVI Protocol B003) [18], which required enrolment of 40 participants. Participants who came in were given information about the HIV vaccine clinical trial and their consent to participate was subsequently sought. Clinical trial registry name and registration number: The HIV vaccine trial clinical trial was registered on the National Institute of Health U.S. National Library of Medicine ClinicalTrials.gov. Registry name: Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults. ClinicalTrials.gov identifier: NCT01215149. The Kenyatta National Hospital-University of Nairobi Ethics and Research Committee (KNH-UON ERC) approved the study, and we obtained written informed consent from each participant. At each study visit, participants were reimbursed for their time and effort. SPSS statistics for windows (version 17.0, Chicago, USA) was used for analysis. Descriptive statistics such as frequencies, percentages, mean and standard deviation was used to describe the participant characteristics and occurrences of motivators across various volunteer demographics. Chi-square test was used to compare demographics and sexual risk behaviour of participants who consented to join an HIV vaccine clinical trial with demographics of those who declined. Results are presented in form of text, tables and figures.
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