20 research outputs found

    Recruitment of female sex workers in HIV prevention trials: Can efficacy endpoints be reached more efficiently?

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    Background/Setting: Randomized controlled trials (RCTs) of HIV biomedical prevention interventions often enroll participants with varying levels of HIV exposure, including people never exposed to HIV. We assessed whether enrolling larger proportion of participants with consistently high exposure to HIV, such as female sex workers (FSWs), might reduce trial duration and improve the accuracy of product efficacy estimates in future HIV prevention trials. Methods: We used an individual-based stochastic model to simulate event-driven RCTs of an HIV prevention intervention providing 80% reduction in susceptibility per act under different proportions of FSW enrolled. A 5% annual dropout rate was assumed for both FSW and non-FSW in our main scenario, but rates of up to 50% for FSW were also explored. Results: Enrolling 20% and 50% FSW reduced the mediansimulated trial duration from 30 months with 0% FSW enrolled to 22 months and 17 months, respectively. Estimated efficacy increased from 71% for RCTs without FSW to 74% and 76% for RCTs with 20% and 50% FSW enrolled, respectively. Increasing the FSW dropout rate to 50% increased the duration of RCTs by 1-2 months on average and preserved the gain in estimated efficacy. Conclusions: Despite the potential logistical challenges of recruiting and retaining FSW, trialists should revisit the idea of enrolling FSW in settings where HIV incidence among FSW is higher than among non-FSW. Our analysis suggests that enrolling FSW would increase HIV incidence, reduce trial duration, and improve efficacy estimates, even if the annual dropout rate among FSW participants is high

    Understanding patient acceptance and refusal of HIV testing in the emergency department

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    <p>ABSTRACT</p> <p>Background</p> <p>Despite high rates of patient satisfaction with emergency department (ED) HIV testing, acceptance varies widely. It is thought that patients who decline may be at higher risk for HIV infection, thus we sought to better understand patient acceptance and refusal of ED HIV testing.</p> <p>Methods</p> <p>In-depth interviews with fifty ED patients (28 accepters and 22 decliners of HIV testing) in three ED HIV testing programs that serve vulnerable urban populations in northern California.</p> <p>Results</p> <p>Many factors influenced the decision to accept ED HIV testing, including curiosity, reassurance of negative status, convenience, and opportunity. Similarly, a number of factors influenced the decision to decline HIV testing, including having been tested recently, the perception of being at low risk for HIV infection due to monogamy, abstinence or condom use, and wanting to focus on the medical reason for the ED visit. Both accepters and decliners viewed ED HIV testing favorably and nearly all participants felt comfortable with the testing experience, including the absence of counseling. While many participants who declined an ED HIV test had logical reasons, some participants also made clear that they would prefer not to know their HIV status rather than face psychosocial consequences such as loss of trust in a relationship or disclosure of status in hospital or public health records.</p> <p>Conclusions</p> <p>Testing for HIV in the ED as for any other health problem reduces barriers to testing for some but not all patients. Patients who decline ED HIV testing may have rational reasons, but there are some patients who avoid HIV testing because of psychosocial ramifications. While ED HIV testing is generally acceptable, more targeted approaches to testing are necessary for this subgroup.</p

    HIV Treatment as Prevention: Debate and Commentary-Will Early Infection Compromise Treatment-as-Prevention Strategies?

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    Universal HIV testing and immediate antiretroviral therapy for infected individuals has been proposed as a way of reducing the transmission of HIV and thereby bringing the HIV epidemic under control. It is unclear whether transmission during early HIV infection—before individuals are likely to have been diagnosed with HIV and started on antiretroviral therapy—will compromise the effectiveness of treatment as prevention. This article presents two opposing viewpoints by Powers, Miller, and Cohen, and Williams and Dye, followed by a commentary by Fraser

    Participant Experiences and Facilitators and Barriers to Pill Use Among Men Who Have Sex with Men in the iPrEx Pre-Exposure Prophylaxis Trial in San Francisco

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    In 2010, the iPrEx study demonstrated efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) in reducing HIV acquisition among men who have sex with men. Adherence to study product was critical for PrEP efficacy, and varied considerably, with FTC/TDF detection rates highest in the United States. We conducted a qualitative study to gain insights into the experiences of iPrEx participants in San Francisco (SF) where there was high confirmed adherence, to understand individual and contextual factors influencing study product use in this community. In 2009 and 2011, we conducted focus groups and in-depth interviews in 36 and 16 SF iPrEx participants, respectively. Qualitative analyses indicate that participants joined the study out of altruism. They had a clear understanding of study product use, and pill taking was facilitated by establishing or building on an existing routine. Participants valued healthcare provided by the study and relationships with staff, whom they perceived as nonjudgmental, and found client-centered counseling to be an important part of the PrEP package. This facilitated pill taking and accurate reporting of missed doses. Adherence barriers included changes in routine, side effects/intercurrent illnesses, and stress. Future PrEP adherence interventions should leverage existing routines and establish client-centered relationships/ environments to support pill taking and promote accurate reporting

    Does ART prevent HIV transmission among MSM?

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    OBJECTIVE: To review the evidence for antiretroviral 'treatment as prevention' for HIV transmission among MSM. METHODS: We reviewed studies that assess the biological plausibility that virally suppressive antiretroviral therapy (ART) reduces HIV infectiousness via anal intercourse and the epidemiologic evidence of whether ART has played a role in attenuating HIV incidence among MSM. RESULTS: Although ART treatment among MSM is likely to provide some preventive benefit, it is unknown whether it will reduce HIV infectiousness via anal intercourse to the same extent as via penile-vaginal intercourse. Additional research is needed on the pharmacokinetic properties of specific antiretroviral agents in the gastrointestinal tract. Estimates of risk behaviors and the incidence of HIV among MSM before and after the introduction and expansion of ART suggest that the population-level protective benefits of ART may be attenuated by a number of factors, most notably, continuing or increasing frequency of condomless anal intercourse and incidence of other sexually transmitted infections (STIs). Additional studies are needed on the impact of ART on HIV sexual risk behaviors and transmission among MSM outside of developed countries in North America, western Europe, and Australia. CONCLUSION: The benefits of treatment as prevention for MSM are highly plausible, but not certain. In the face of these unknowns, treatment guidelines for earlier ART initiation should be considered within a combination prevention strategy that includes earlier diagnosis, expanded STI treatment, and structural and behavioral interventions
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