Publications by authors named "Baeten J"

Background: Direct measurement of tenofovir (TFV) in urine could be an objective measure to monitor adherence to preexposure prophylaxis (PrEP) or TFV-based antiretroviral therapy (ART).

Methods: We conducted a 3-arm randomized, pharmacokinetic study of tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg among adults living with human immunodeficiency virus. Participants were randomized to receive controlled TDF/FTC dosing as (1) "perfect" adherence (daily); (2) "moderate" adherence (4 doses/week); or (3) "low" adherence (2 doses/week).

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Patients can be exposed to leachables derived from pharmaceutical manufacturing systems, packages, and/or medical devices during a clinical therapy. These leachables can adversely decrease the therapy's effectiveness and/or adversely impact patient safety. Thus, extracts or drug products are chromatographically screened to discover, identify, and quantify organic extractables or leachables.

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Objectives: To evaluate pharmacokinetics and pharmacogenetics of contraceptive implant progestin concentrations in HIV-positive women initiating efavirenz (EFV)-containing or nevirapine (NVP)-containing antiretroviral therapy (ART).

Design: We analyzed stored samples from women self-reporting implant use in the Partners PrEP Study.

Methods: Plasma samples collected every 6 months were analyzed for levonorgestrel and etonogestrel concentrations.

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Objective: Observational studies have associated use of intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM) with increased risk of HIV-1 acquisition, but limited data are available to assess HIV-1 risk for alternate contraceptive methods.

Methods: Within a randomized trial of the dapivirine vaginal ring for HIV-1 prevention, we assessed HIV-1 incidence by contraceptive method. We limited analyses to participants from South African sites and to women who used DMPA-IM, the alternative injectable norethisterone enanthate, implants, or copper intrauterine devices (IUDs).

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Background: The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya.

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Purpose Of Review: This review summarizes key HIV prevention strategies in the 2020 toolkit and discusses opportunities to maximize the public health impact of these prevention interventions at a population level.

Recent Findings: HIV prevention has relied on counseling, HIV testing, and condom distribution for the past three decades. Recent exciting work has provided evidence on effective HIV prevention interventions, including antiretroviral therapy for HIV prevention, expanding preexposure prophylaxis modalities, and voluntary medical male circumcision which all reduce individual-level HIV risk.

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Background: Among HIV serodiscordant couples, most conception involves condomless sex and may confer a period with increased HIV transmission risk if HIV viral load is not suppressed and other precautions are not used. Safer conception strategies enable HIV serodiscordant couples to attain their pregnancy goals while markedly reducing this risk. We explored the perceptions and beliefs held by HIV serodiscordant couples and health care providers concerning pregnancy among HIV serodiscordant couples in Kenya and gathered their thoughts about how these might influence use of safer conception methods.

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Substances leached from materials used in pharmaceutical manufacturing systems, packages, and/or medical devices can be administered to a patient as part of a clinical therapy. These leachables can have an undesirable effect on the effectiveness of the therapy and/or patient safety. Thus, relevant samples such as material extracts or drug products are chromatographically screened for foreign organic impurities, where screening is the analytical process of discovering, identifying, and quantifying these unspecified foreign impurities.

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Background: In 2016, the Kenyan Ministry of Health (MOH) released guidelines that recommend preexposure prophylaxis (PrEP) for persons with substantial ongoing HIV risk, including those in HIV serodiscordant partnerships. Estimates of the costs of delivering PrEP within Kenyan public health facilities are needed for planning for PrEP scale up.

Methods: We estimated the incremental annual costs of providing PrEP to HIV uninfected partners as a time-limited "bridge" until the infected partner is virally suppressed on ART within HIV serodiscordant couples as part of routine clinic care in Thika, Kenya.

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Controlled pharmacokinetic (PK) studies in United States populations have defined categories of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) for various pre-exposure prophylaxis (PrEP) adherence targets. It is unknown how these categories perform in other populations. Therefore, we evaluated the sensitivity and specificity of these PK-derived categories compared to daily medication electronic adherence monitoring (MEMS) data among East African men and women using daily PrEP.

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Objectives: A recent study of HIV serodiscordant couples found that depot medroxyprogesterone acetate (DMPA) and oral contraceptive pills (OCPs) were associated with increased HIV risk in the presence, but not in the absence, of bacterial vaginosis. We assessed whether bacterial vaginosis is an effect modifier of the association between hormonal contraception and HIV seroconversion in female sex workers (FSWs) in Mombasa, Kenya.

Design: Prospective cohort study.

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Purpose: Currently available oral cancer screening adjuncts have not enhanced clinical screening methods because of high false positives and negatives, highlighting the need for a molecularly specific technique for accurate screening of suspicious oral lesions. The purpose of this study was to evaluate the in vivo screening accuracy of an oral lesion identification system that evaluates aberrant glycosylation patterns using a fluorescently labeled lectin (wheat germ agglutinin and fluorescein isothiocyanate [WGA-FITC]).

Materials And Methods: The authors designed and implemented a prospective cohort study at 3 institutions composed of patients with and without suspicious oral lesions.

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Background: Some HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospective qualitative assessments that did not use a standardized approach.

Methods: We administered a measure of PM called PREMIS, during Microbicide Trials Network 020-A Study to Prevent Infection with a Ring for Extended Use, a large, multicenter, placebo-controlled, phase III trial evaluating the safety and efficacy of a dapivirine vaginal ring among women at risk for HIV infection in Malawi, South Africa, Uganda, and Zimbabwe.

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Background: HIV serodiscordant couples are at heightened risk of HIV transmission when attempting to conceive, yet reproductive goals can outweigh concerns about HIV exposure. Safer conception strategies support fertility desires while minimizing HIV transmission risk and novel mHealth tools can optimize their use. The objective of this analysis is to examine the feasibility and usability of short message service (SMS) messages and a mobile application to support safer conception for HIV serodiscordant couples.

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Introduction: Safer conception strategies minimize HIV risk during condomless sex to become pregnant. Gaps remain in understanding the acceptability, feasibility and choices HIV-serodiscordant couples make when multiple safer conception options are available.

Methods: We conducted a pilot study of a comprehensive safer conception package for HIV-serodiscordant couples with immediate fertility desires in Kenya from March 2016 to April 2018.

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Background: Providing HIV self-tests to women for distribution to male partners may provide a unique opportunity to increase male partner and couples testing among women in HIV high-burden settings.

Methods: Between November 2017 and June 2018, we offered self-tests for at-home couples or partner HIV testing to HIV-uninfected women seeking routine maternal and child health and family planning services at eight facilities in Kisumu, Kenya. Women accepting self-tests were offered at least two self-tests (OraQuick) to take to their partner(s) with instructions on use.

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Background: Pharmacologic adherence measures were critical to the interpretation of the tenofovir (TFV)-disoproxil-fumarate/emtricitabine (TDF/FTC) PrEP trials. These measures are being incorporated into PrEP demonstration projects, but currently-available metrics in plasma, cells, hair or urine involve expensive and time-intensive mass-spectrometry (MS)-based methods. No point-of-care method to assess PrEP adherence in real-time has yet been implemented.

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To catalyse national scale up of PrEP for HIV serodiscordant couples in public health facilities in Kenya, the Partners Scale-Up Project, using a two-day case-based interactive curriculum, trained health care providers working in 24 high volume facilities in central and western Kenya on PrEP service delivery. Using a standardised test with questions about PrEP and antiretroviral-based HIV prevention we assessed gain in knowledge and confidence gain by comparing pre-and post-training test scores. We explored experiences of the training through key informant interviews after clinics started delivering PrEP.

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Introduction: Women in regions with high HIV prevalence are at high risk of HIV acquisition during pregnancy and postpartum, and acute maternal HIV contributes a substantial proportion of infant HIV infections. Pre-exposure prophylaxis (PrEP) could prevent HIV during pregnancy/postpartum; however, identifying women who would most benefit from PrEP in this period is challenging. Women may not perceive risk, may not know partner HIV status and partners may have external partners during this period.

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Background: In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Africa, we assessed whether worries about ring use changed over time and were associated with adherence.

Methods: Participants (N = 2585) were surveyed at baseline and follow-up about worries regarding daily ring use. First, they answered a question about general worries and then responded to 15 items covering specific worries.

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