Browsing by Author "Gray, G"

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    P14-07. Offering new prevention modalities in HIV vaccine trials: experience with male circumcision in the Phambili trial
    (BioMed Central Ltd, 2009) de Bruyn, G; Mlisana, K; Metch, B; Churchyard, G; Nchabeleng, M; Bekker, L; Roux, S; Naicker, N; Latka, M; Corey, L; Kublin, J; Gray, G
    Background: New prevention options will be added to the 'standard of prevention' offered in HIV vaccine efficacy trials as new methods prove effective. The HVTN503/Phambili trial was initiated in January 2007, shortly after results from 3 randomized controlled trials of male circumcision (MC) demonstrated that MC reduces the risk of HIV acquisition. Thus, HVTN503 investigators made plans to offer MC at no cost to enrolled male participants. Methods: All participants were informed of the benefits of MC as a component of HIV risk reduction counseling, including how and where MC could be accessed. One site offered on-site MC and the others provided referral to local services for men who requested MC. We present data on uptake of MC post-enrollment. Results: Prior to discontinuation of enrolment, 441 men joined the trial, of whom 312 (70.7%) were uncircumcised. Of these, 82 (26.3% of uncircumcised men) requested MC after enrolment. Uptake varied by site, being lower (70%) at the eThekwini site, the site with lowest baseline MC prevalence. Among 3 sites with intermediate baseline MC prevalence, uptake varied from 3.3 to 37.6%, being highest at the site providing MC on site. Uptake was similar in vaccine and placebo arms of the trial [42 (26.1%) vs. 40 (26.5%)]. There was no significant difference by arm in the timing of circumcision relative to randomization assignment being provided to participants following release of the STEP trial results [post-unblinding, vaccine 18 (42.9%) vs. placebo 13 (32.5%), p = 0.37]. Conclusion: MC, a new prevention modality, was offered as part of HIV prevention services in HVTN503. Uptake varied by provision of care model and inversely with baseline MC prevalence, but did not differ between treatment arms, and remained similar even after provision of treatment.
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    P15-13. HVTN 503(Phambili) trial discontinuation of enrolment/vaccination: the impact on trial participant attitudes to vaccine trials and scientific research
    (BioMed Central Ltd, 2009) Mark, D; Middelkoop, K; Roux, S; Gray, G; Mlisana, K; Nchabaleng, M; Churchyard, G; De Bruyn, G; Latka, M; Magagula, D; Kublin, J; Allen, M; Bekker, L; t NIAID HIV Vaccine Trials Network
    Background: The HVTN 503/Phambili trial, a phase IIB study of the Merck Ad-5 HIV vaccine, suspended enrollment and vaccinations following results of the HVTN502/STEP study. Participants were notified of their treatment allocation and continue to be followed. We investigated the impact of the suspension on trial participants' attitudes towards HIV vaccine trials and scientific research. Methods: A self-administered questionnaire investigating knowledge and attitudes utilising a five-point likert scale, was administered 12–18 months post suspension at the 4 Phambili trial sites implementing the latest protocol. Results: Of 544 participants enrolled at 4 sites, 490 completed the questionnaire. 51% understood that vaccination, and 31% that enrolment had been permanently discontinued. Although 85% knew Phambili DSMB recommendations were based on results of the STEP study, only 51% knew that the results showed more infections in the vaccine arm. Although 90% knew they should continue protecting themselves against HIV, only 33% acknowledged trialists' concerns that the vaccine may make them more susceptible to HIV. Knowledge was similar across sites. 12% had tested for HIV antibodies outside of the trial before unblinding to establish their treatment allocation. 46% felt disappointed, angry or afraid, primarily because the vaccine would not prevent HIV in their community. 79% said they would engage in less risk behaviour. 94% thought the study team had made the correct decision by unblinding them and 96% thought site-participant communication was appropriate. 91% felt they made the right decision to enrol in Phambili and 91% planned to continue attending scheduled visits. 86% support scientific research and 80% would want to participate in future HIV vaccine. Conclusion: Despite site communications, knowledge levels were low. Importantly, most knew they should continue to protect themselves against HIV. Although almost half of participants reported negative feelings, most attitudes towards trial sites, scientific research and HIV vaccine trials were positive.