Oral Preexposure Prophylaxis for HIV — Another Arrow in the Quiver?

New England Journal of Medicine (Impact Factor: 55.87). 12/2010; 363(27):2663-5. DOI: 10.1056/NEJMe1012929
Source: PubMed

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    • "Preexposure prophylaxis (PrEP) represents a promising tool for high impact prevention: recent studies have demonstrated the efficacy of daily oral antiretroviral (ARV) medications to prevent HIV acquisition in men who have sex with men (MSM) and discordant couples, although there have been discrepant findings in women [4] [5] [6]. However, PrEP's effectiveness, particularly in the populations most vulnerable to HIV infection (who may also face significant structural barriers to health systems engagement) depends on its coordinated delivery with behavioral and community-based prevention interventions [7] [8] [9] [10]. Black men who have sex with men (BMSM) face among the highest incidence of HIV infection in the US [11] [12] [13] [14]. "
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    ABSTRACT: Although HIV interventions and clinical trials increasingly report the use of mixed methods, studies have not reported on the process through which ethnographic or qualitative findings are incorporated into RCT designs. We conducted a community-based ethnography on social and structural factors that may affect the acceptance of and adherence to oral pre-exposure prophylaxis (PrEP) among Black men who have sex with men (BMSM). We then devised the treatment arm of an adherence clinical trial drawing on findings from the community-based ethnography. This article describes how ethnographic findings informed the RCT and identifies distilled themes and findings that could be included as part of an RCT. The enhanced intervention includes in-person support groups, online support groups, peer navigation, and text message reminders. By describing key process-related facilitators and barriers to conducting meaningful mixed methods research, we provide important insights for the practice of designing clinical trials for 'real-world' community settings.
    No preview · Article · Oct 2015 · Contemporary clinical trials
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    • "This low level of TSPY4 could also be visualized by agarose gel electrophoresis (white arrow). been the " Achilles' heel " of several microbicide and oral preexposure prophylaxis trials [27] [28] [29] [30]. The efficacy of a topical microbicide or contraceptive requires inhibitory concentrations of the active ingredient be present at or around the act of intercourse. "
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    ABSTRACT: Background: Developing an objective, reliable method to determine semen exposure in cervicovaginal fluids is important for accurately studying the efficacy of vaginal microbicides and contraceptives. Y-chromosome biomarkers offer better stability, sensitivity, and specificity than protein biomarkers. TSPY4 belongs to the TSPY (testis-specific protein Y-encoded) family of homologous genes on the Y-chromosome. Using a multiplex PCR amplifying TSPY4, amelogenin, and Sex-determining region in the Y chromosome (SRY), our objective was to determine whether a gene in the TSPY family was a more sensitive marker of semen exposure in cervicovaginal fluids than SRY. Study design: The multiplex polymerase chain reaction (PCR) was developed using sperm and vaginal epithelial (female) DNA. Diluted sperm DNA and mixed male/female DNA was used to determine the sensitivity of the multiplex PCR. Potential interference of TSPY4 amplification by components in cervicovaginal and seminal fluids was determined. TSPY4 and SRY amplification was also investigated in women participating in a separate IRB-approved clinical study in which cervicovaginal swab DNA was collected before semen exposure and at various time points after exposure. Results: TSPY4, SRY, and amelogenin were amplified in sperm DNA, but only amelogenin in female DNA. The limit of sperm DNA from which TSPY4 could be amplified was lower than SRY (4 pg vs 80 pg). TSPY4 could also be amplified from mixed male/female DNA. Amplification was not affected by cervicovaginal and seminal components. Using cervicovaginal swab DNA from three women before and after semen exposure, TSPY4 was detected up to 72 h post exposure while SRY detection was observed up to 24-48 h. TSPY4 was detected up to 7 days post exposure in one out of three women. Conclusions: We have demonstrated that TSPY4 is a new sensitive, and sperm-specific biomarker. The multiplex PCR incorporating this new biomarker has potential to be an objective measure for determining semen exposure in clinical trials of vaginal products such as contraceptives and HIV pre/post-exposure prophylaxis agents.
    Full-text · Article · Dec 2012 · Contraception
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    • "However, in the VOICE study, in women at high risk of acquiring HIV, 1% TDF gel arm used daily was no better than placebo. A study of daily oral TDF+ emtricitabine (FTC) in uninfected male couples reported a 44% reduction overall in HIV acquisition as compared to placebo; effectiveness was significantly affected by adherence [102, 103]. In the Partners PrEP study conducted in Kenya and Uganda among more than 1,400 HIV serodiscordant couples, the use of daily TDF or daily TDF/FTC by the uninfected partner was found to have an efficacy of 66% and 73%, respectively, compared to placebo, in reducing HIV transmission. "
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    ABSTRACT: Women living with HIV have fertility desires and intentions that are similar to those of uninfected women, and with advances in treatment most women can realistically plan to have and raise children to adulthood. Although HIV may have adverse effects on fertility, recent studies suggest that antiretroviral therapy may increase or restore fertility. Data indicate the increasing numbers of women living with HIV who are becoming pregnant, and that many pregnancies are unintended and contraception is underutilized, reflecting an unmet need for preconception care (PCC). In addition to the PCC appropriate for all women of reproductive age, women living with HIV require comprehensive, specialized care that addresses their unique needs. The goals of PCC for women living with HIV are to prevent unintended pregnancy, optimize maternal health prior to pregnancy, improve maternal and fetal outcomes in pregnancy, prevent perinatal HIV transmission, and prevent HIV transmission to an HIV-uninfected sexual partner when trying to conceive. This paper discusses the rationale for preconception counseling and care in the setting of HIV and reviews current literature relevant to the content and considerations in providing PCC for women living with HIV, with a primary focus on well-resourced settings.
    Full-text · Article · Oct 2012 · Infectious Diseases in Obstetrics and Gynecology
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