Publications by authors named "Nelly R Mugo"

Background: Increased risk of HIV acquisition during pregnancy and lactation among women is evident, necessitating their inclusion in the evaluation of new HIV prevention interventions. Pregnant and postpartum women specifically face challenges with oral PrEP associated with stigma, and the burden of using other tablets. Long-acting products may address challenges related to oral PrEP, however, there is limited data on product-specific preferences and acceptability among pregnant and lactating women.

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Objective: Human papillomavirus (HPV) vaccines and DNA testing roll out in resource-constrained settings. We evaluated the natural history of HPV infections in African women to contribute to normative guidance.

Methods: Women aged 16 to 35 years were enrolled from 3 sites in South Africa and Kenya and followed quarterly for 18 months.

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: Human Papillomavirus (HPV) is the primary cause of cervical cancer. Single-dose HPV vaccination can effectively prevent high-risk HPV infection that causes cervical cancer and accelerate progress toward achieving cervical cancer elimination goals. We modelled the potential impact of adopting single-dose HPV vaccination strategies on health and economic outcomes in Kenya, where a two-dose schedule is the current standard.

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Background: The World Health Organization recommends a single-dose human papillomavirus (HPV) vaccination schedule for girls and boys to accelerate progress toward cervical cancer elimination. We applied the Theoretical Framework of Acceptability (TFA) within the context of HPV vaccination to assess the acceptability of a single-dose schedule among health-care professionals in Kenya.

Methods: A REDCap survey was developed using relevant Theoretical Framework of Acceptability domains and validated with health-care professionals.

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Background: In Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services.

Methods: We conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.

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Article Synopsis
  • The study investigated the accuracy of HIV point-of-care testing among African women using various contraceptive methods, focusing on the occurrence of true and false positive results.
  • Out of 48,234 visits by 7,730 women, true positive results were found in only 0.9% of cases, while false positives occurred in 0.2%, necessitating additional confirmatory testing.
  • The findings emphasize the need for confirmatory tests, as not all HIV infections presented typical laboratory results, particularly in populations with low HIV prevalence and repeat testing.
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Purpose Of Review: This review summarizes differentiated service delivery (DSD) models for HIV treatment and prevention that have been adapted for maintaining continuity of services during the COVID-19 pandemic and proposes strategies for sustaining their benefits now and during future disruptions.

Recent Findings: The COVID-19 pandemic resulted in an overburdened and disrupted health system, forcing countries to adopt and/or scale up DSD models for HIV services. While initially implemented as emergency measures, these models evolved and were refined over time to fit recipient needs ensuring continued HIV treatment and prevention services with minimal health system impact.

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Article Synopsis
  • A pilot trial was conducted to evaluate the effectiveness of a new urine assay for monitoring adherence to tenofovir-based PrEP, comparing standard counselling with counselling based on urine test results over a 12-month period.
  • The study enrolled 100 women and found that those receiving urine-test counselling had significantly lower rates of long-term non-adherence to PrEP, with only 21% showing undetectable tenofovir levels compared to 37% in the standard care group.
  • Overall, 72% of women in the urine-test counselling group had detectable tenofovir in urine at the end of the study, indicating improved short-term adherence relative to 45% in the standard care group.*
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Background: Oral pre-exposure prophylaxis (PrEP) using co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is a potent HIV prevention method for men and women, with its efficacy highly dependent on adherence. A pivotal HIV efficacy study combined with a directly observed pharmacological study defined the thresholds for HIV protection in men who have sex with men (MSM), which are the keys to PrEP promotion and development of new PrEP agents. For African women at risk for HIV and belonging to a priority group considered due to disproportionately high incident HIV infections, the variable adherence in PrEP clinical trials and the limited pharmacologic data have resulted in a lack of clarity about the PrEP adherence required for HIV protection.

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Real-time electronic adherence monitoring involves "smart" pill boxes that record and monitor openings as a proxy for pill taking and may be useful in understanding and supporting PrEP use; however, acceptability and/or feasibility for PrEP users is uncertain. We sought to understand the experiences of using a real-time electronic adherence monitor for PrEP delivery among young women in Kisumu and Thika, Kenya. We used the Wisepill device to monitor PrEP use among 18-24-year-old women for two years.

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Non-neutralizing functions of antibodies, including phagocytosis, may play a role in (CT) infection, but these functions have not been studied and assays are lacking. We utilized a flow-cytometry-based assay to determine whether serum samples from a well-characterized cohort of CT-infected and naïve control individuals enhanced phagocytosis via Fc-receptor-expressing THP-1 cells, and whether this activity correlated with antibody titers. Fc-receptor-mediated phagocytosis was detected only in CT+ donors.

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Introduction: Delivery of oral pre-exposure prophylaxis (PrEP) is being scaled up in Africa, but clinic-level barriers including lengthy clinic visits may threaten client continuation on PrEP.

Methods: Between January 2020 and January 2022, we conducted a quasi-experimental evaluation of differentiated direct-to-pharmacy PrEP refill visits at four public health HIV clinics in Kenya. Two clinics implemented the intervention package, which included direct-to-pharmacy for PrEP refill, client HIV self-testing (HIVST), client navigator, and pharmacist-led rapid risk assessment and dispensing.

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Article Synopsis
  • - The KEN SHE trial demonstrated over 97% efficacy for a single-dose HPV vaccine against HPV16 and HPV18 infections in Kenyan women over 36 months.
  • - The DoRIS trial involved 930 Tanzanian girls aged 9-14, examining antibody responses from one, two, or three doses of either 2-valent (Cervarix) or 9-valent (Gardasil-9) vaccines, finding comparable or higher antibody levels at 24 months compared to the KEN SHE participants.
  • - Results indicated that a single dose of either HPV vaccine effectively induced immune responses in young girls, suggesting it may be sufficient for protection, similar to the responses seen in older women who had received a single
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Cervical cancer burden is high where prophylactic vaccination and screening coverage are low. We demonstrated in a multicenter randomized, double-blind, controlled trial that single-dose human papillomavirus (HPV) vaccination had high vaccine efficacy (VE) against persistent infection at 18 months in Kenyan women. Here, we report findings of this trial through 3 years of follow-up.

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Background: Cervical cancer is the leading cause of cancer-related deaths among Kenyan women. Persistent infection with high-risk oncogenic Human papillomavirus (HPV) genotypes is a necessary cause of cervical cancer. HPV vaccines are safe, durable, and efficacious in preventing incident HPV infections.

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Background: Adolescent girls and young women (AGYW) have a high incidence of unplanned pregnancies, especially in low-resource settings. AGYW assess the overlapping risks of pregnancy, contraception, and STIs as they navigate relationships. Few studies have examined how AGYW consider the comparative risks of their decisions around sexual and reproductive health in this context or how risk perception influences contraceptive use.

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Background: Bacterial vaginosis is a risk factor for sexually transmitted infections, including HIV. Adult African women have a high prevalence of bacterial vaginosis, but it is not known when first bacterial vaginosis occurs.

Objective: This study aimed to describe bacterial vaginosis in younger African women, before and after first sex, and to determine the incidence of bacterial vaginosis and significant correlates of bacterial vaginosis incidence and recurrence.

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Article Synopsis
  • Many young women globally experience the dual challenges of HIV and unintended pregnancies, highlighting the need for multipurpose prevention technologies.
  • A study involving 312 healthy women aged 18-34 randomized participants to use either a tenofovir/levonorgestrel (TFV/LNG), TFV-only, or placebo intravaginal ring to assess safety and effectiveness.
  • Results showed that both TFV IVR groups demonstrated significant increases in HIV inhibition in cervicovaginal fluid, with no serious adverse effects linked to the products, indicating their potential as safe prevention methods.
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Background: An important cervical cancer prevention strategy in low- and middle-income countries (LMICs) has been single-visit screen-and-treat (SV-SAT) approach, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. While SV-SAT with VIA and cryotherapy have established efficacy, its population level coverage and impact on reducing cervical cancer burden remains low. In Kenya, the estimated cervical cancer screening uptake among women aged 30-49 is 16% and up to 70% of screen-positive women do not receive treatment.

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Understanding PrEP adherence is key in the formulation of HIV prevention strategies; however, measurement of adherence can be challenging. We compared multiple adherence measures in a two-year study of young Kenyan women at high risk of HIV acquisition. Among 289 participants, concordance between electronic adherence monitoring (EAM) and tenofovir diphosphate (TFV-DP) in dried blood spots ranged from 57 to 72% depending on selected thresholds.

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Importance: Daily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients.

Objective: To evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits.

Design, Setting, And Participants: This randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya.

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Article Synopsis
  • - The study assessed IUD insertion outcomes by newly trained clinicians at 12 sites in Africa, noting a 5.46% failure rate and a 0.27% perforation rate, particularly higher among breastfeeding women postpartum.
  • - Results showed that of 2582 women, 493 experienced expulsions, with lower risk in women over 24 and potential higher risk in nulliparous women; however, breastfeeding did not significantly impact expulsion rates.
  • - The findings suggest that effective training and ongoing support for new providers can lead to successful IUD insertions in resource-limited settings, aligning with existing literature on safety and efficacy.
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Purpose: Adolescent girls and young women (AGYW) are disproportionately affected by STIs. Observation of life course events can describe behavioral and biological factors associated with STI risk.

Methods: Sexually inexperienced AGYW aged 16-20 years in Kenya were followed for five years.

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Background: Adolescent girls and young women (AGYW) are at high risk of sexually transmitted infections (STIs). It is unknown whether beginning to have sexual intercourse results in changes to immune mediators in the cervicovaginal tract that contribute to this risk.

Methods: We collected cervicovaginal lavages from Kenyan AGYW in the months before and after first penile-vaginal sexual intercourse and measured the concentrations of 20 immune mediators.

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Article Synopsis
  • Hormonal changes during the menstrual cycle influence immune responses in the cervicovaginal area, with varying concentrations of immune mediators like cytokines and immunoglobulins across different phases.
  • A systematic review and meta-analysis of studies revealed that many immune mediators have lower concentrations in the luteal phase compared to the follicular phase, with only a few, like IL-1α and HBD-2, showing elevated levels during luteal phase.
  • The research compiled data from over 39,000 measurements, indicating a moderate to high strength of evidence for these immunological shifts throughout the menstrual cycle, highlighting a need for more comprehensive understanding due to previous inconsistent study results.
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