Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jan 9, 2015
Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare wh... more Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare whole-body bone mineral content (BMC) of newborns exposed versus not exposed to tenofovir in utero. We enrolled participants from April 2011 to June 2013 at 14 US clinical sites. Singleton infants of women with HIV infection who took tenofovir in late pregnancy (tenofovir-exposed) or no tenofovir during pregnancy (tenofovir-unexposed) were enrolled during late pregnancy or within 72 hours of birth. Infants born before 36 weeks gestation or with confirmed HIV infection were excluded. Whole-body BMC was measured in the first month of life and compared between the tenofovir-exposed and tenofovir-unexposed newborns, unadjusted and adjusted for covariates. Seventy-four tenofovir-exposed and 69 tenofovir-unexposed infants had evaluable BMC measurements. Tenofovir-exposed mothers were more likely to be married (31% vs. 22%, P=0.04) and use boosted protease inhibitors (84% vs. 62%, P=.004). Teno...
Background: We reviewed and examined various financial incentives used in HIV prevention studies,... more Background: We reviewed and examined various financial incentives used in HIV prevention studies, and outlines important ethical considerations to using financial incentives in HIV prevention research. Methods: We searched PubMed using the terms “HIV”, “prevention”, and “incentive” for articles published between January 2009 and January 2013. Manuscripts were excluded if they were not written in English, not involving humans, and were not clinical trials. Results: Of the 84 manuscripts selected for review, 49 studies were conducted in the US, 13 were conducted in Africa, 17 in Asia, 3 in the Caribbean, 1 in Europe, and 1 in South America. Sample sizes ranged from 37 to 12,590. Of the 49 studies that offered financial incentives, the amount given ranged from $2.00 to $60.00 USD. We found a significant variety of monetary and non-monetary incentives used in HIV prevention studies. Several questions arose considering the ethical standards of using incentives. Conclusion: Incentives can...
The HIV epidemic in Latin America is concentrated among men who have sex with men (MSM) and trans... more The HIV epidemic in Latin America is concentrated among men who have sex with men (MSM) and transgender women (TGW) with transmission predominately occurring during unprotected anal intercourse. This mode of transmission is also responsible for other sexually transmitted infections (STIs) such as herpes simplex, chlamydia and gonorrhoea, human papillomavirus (HPV)/genital warts and syphilis. Studies assessing the prevalence of HIV and HPV among MSM have not addressed the role of genital warts and HPV-related diseases in the acquisition of HIV infection. Community-based testing programmes are a potentially important way to remove barriers including stigma for individuals to learn about their STI status. The prospective cohort study will recruit 600 MSM/TGW at a community centre in Lima, Peru, named Epicentro. Half of the participants will have a history of or have current anogenital warts (AGW), and the other half will have no history of AGW. We will measure the prevalence and acquis...
Aims: This qualitative study examined Peruvian female sex workers’ (FSWs) evaluation of social an... more Aims: This qualitative study examined Peruvian female sex workers’ (FSWs) evaluation of social and health risks/benefits, informed consent, incentives, fair treatment, and post-trial care following their participation in an HPV vaccine phase IV clinical trial (GIRASOL), in which all participants received quadrivalent HPV vaccine. Methods: Sixteen FSWs aged 23-29 years from Lima, Peru who previously enrolled in the GIRASOL trial were administered semi-structured interviews to assess perceptions of study participation. Interviews were conducted in Spanish, audio-recorded, transcribed, and translated into English. Transcripts were coded in Atlas.ti using open and axial coding. Codes were collapsed, combined, and developed into concepts and representative quotes. Results: Broad themes emerging from content analysis included respect, privacy, absence of stigma, access to healthcare, and abandonment. Most participants reported staff treated them with empathy, fairness, and dignity, that p...
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jan 9, 2015
Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare wh... more Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare whole-body bone mineral content (BMC) of newborns exposed versus not exposed to tenofovir in utero. We enrolled participants from April 2011 to June 2013 at 14 US clinical sites. Singleton infants of women with HIV infection who took tenofovir in late pregnancy (tenofovir-exposed) or no tenofovir during pregnancy (tenofovir-unexposed) were enrolled during late pregnancy or within 72 hours of birth. Infants born before 36 weeks gestation or with confirmed HIV infection were excluded. Whole-body BMC was measured in the first month of life and compared between the tenofovir-exposed and tenofovir-unexposed newborns, unadjusted and adjusted for covariates. Seventy-four tenofovir-exposed and 69 tenofovir-unexposed infants had evaluable BMC measurements. Tenofovir-exposed mothers were more likely to be married (31% vs. 22%, P=0.04) and use boosted protease inhibitors (84% vs. 62%, P=.004). Teno...
Background: We reviewed and examined various financial incentives used in HIV prevention studies,... more Background: We reviewed and examined various financial incentives used in HIV prevention studies, and outlines important ethical considerations to using financial incentives in HIV prevention research. Methods: We searched PubMed using the terms “HIV”, “prevention”, and “incentive” for articles published between January 2009 and January 2013. Manuscripts were excluded if they were not written in English, not involving humans, and were not clinical trials. Results: Of the 84 manuscripts selected for review, 49 studies were conducted in the US, 13 were conducted in Africa, 17 in Asia, 3 in the Caribbean, 1 in Europe, and 1 in South America. Sample sizes ranged from 37 to 12,590. Of the 49 studies that offered financial incentives, the amount given ranged from $2.00 to $60.00 USD. We found a significant variety of monetary and non-monetary incentives used in HIV prevention studies. Several questions arose considering the ethical standards of using incentives. Conclusion: Incentives can...
The HIV epidemic in Latin America is concentrated among men who have sex with men (MSM) and trans... more The HIV epidemic in Latin America is concentrated among men who have sex with men (MSM) and transgender women (TGW) with transmission predominately occurring during unprotected anal intercourse. This mode of transmission is also responsible for other sexually transmitted infections (STIs) such as herpes simplex, chlamydia and gonorrhoea, human papillomavirus (HPV)/genital warts and syphilis. Studies assessing the prevalence of HIV and HPV among MSM have not addressed the role of genital warts and HPV-related diseases in the acquisition of HIV infection. Community-based testing programmes are a potentially important way to remove barriers including stigma for individuals to learn about their STI status. The prospective cohort study will recruit 600 MSM/TGW at a community centre in Lima, Peru, named Epicentro. Half of the participants will have a history of or have current anogenital warts (AGW), and the other half will have no history of AGW. We will measure the prevalence and acquis...
Aims: This qualitative study examined Peruvian female sex workers’ (FSWs) evaluation of social an... more Aims: This qualitative study examined Peruvian female sex workers’ (FSWs) evaluation of social and health risks/benefits, informed consent, incentives, fair treatment, and post-trial care following their participation in an HPV vaccine phase IV clinical trial (GIRASOL), in which all participants received quadrivalent HPV vaccine. Methods: Sixteen FSWs aged 23-29 years from Lima, Peru who previously enrolled in the GIRASOL trial were administered semi-structured interviews to assess perceptions of study participation. Interviews were conducted in Spanish, audio-recorded, transcribed, and translated into English. Transcripts were coded in Atlas.ti using open and axial coding. Codes were collapsed, combined, and developed into concepts and representative quotes. Results: Broad themes emerging from content analysis included respect, privacy, absence of stigma, access to healthcare, and abandonment. Most participants reported staff treated them with empathy, fairness, and dignity, that p...
Uploads