Last data update: May 13, 2024. (Total: 46773 publications since 2009)
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Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya
Mugo NR , Mudhune V , Heffron R , Thomas KK , McLellan-Lemal E , Njoroge B , Peacock S , O'Connor SM , Nyagol B , Ouma E , Ridzon R , Wiener J , Isoherranen N , Erikson DW , Ouattara LA , Yousefieh N , Jacot TA , Haaland RE , Morrison SA , Haugen HS , Thurman AR , Allen SA , Baeten JM , Samandari T , Doncel GF . Front Reprod Health 2023 5 1118030 INTRODUCTION: Globally, many young women face the overlapping burden of HIV infection and unintended pregnancy. Protection against both may benefit from safe and effective multipurpose prevention technologies. METHODS: Healthy women ages 18-34 years, not pregnant, seronegative for HIV and hepatitis B surface antigen, not using hormonal contraception, and at low risk for HIV were randomized 2:2:1 to continuous use of a tenofovir/levonorgestrel (TFV/LNG), TFV, or placebo intravaginal ring (IVR). In addition to assessing genital and systemic safety, we determined TFV concentrations in plasma and cervicovaginal fluid (CVF) and LNG levels in serum using tandem liquid chromatography-mass spectrometry. We further evaluated TFV pharmacodynamics (PD) through ex vivo CVF activity against both human immunodeficiency virus (HIV)-1 and herpes simplex virus (HSV)-2, and LNG PD using cervical mucus quality markers and serum progesterone for ovulation inhibition. RESULTS: Among 312 women screened, 27 were randomized to use one of the following IVRs: TFV/LNG (n = 11); TFV-only (n = 11); or placebo (n = 5). Most screening failures were due to vaginal infections. The median days of IVR use was 68 [interquartile range (IQR), 36-90]. Adverse events (AEs) were distributed similarly among the three arms. There were two non-product related AEs graded >2. No visible genital lesions were observed. Steady state geometric mean amount (ssGMA) of vaginal TFV was comparable in the TFV/LNG and TFV IVR groups, 43,988 ng/swab (95% CI, 31,232, 61,954) and 30337 ng/swab (95% CI, 18,152, 50,702), respectively. Plasma TFV steady state geometric mean concentration (ssGMC) was <10 ng/ml for both TFV IVRs. In vitro, CVF anti-HIV-1 activity showed increased HIV inhibition over baseline following TFV-eluting IVR use, from a median of 7.1% to 84.4% in TFV/LNG, 15.0% to 89.5% in TFV-only, and -27.1% to -20.1% in placebo participants. Similarly, anti-HSV-2 activity in CVF increased >50 fold after use of TFV-containing IVRs. LNG serum ssGMC was 241 pg/ml (95% CI 185, 314) with rapid rise after TFV/LNG IVR insertion and decline 24-hours post-removal (586 pg/ml [95% CI 473, 726] and 87 pg/ml [95% CI 64, 119], respectively). CONCLUSION: TFV/LNG and TFV-only IVRs were safe and well tolerated among Kenyan women. Pharmacokinetics and markers of protection against HIV-1, HSV-2, and unintended pregnancy suggest the potential for clinical efficacy of the multipurpose TFV/LNG IVR. CLINICAL TRIAL REGISTRATION: NCT03762382 [https://clinicaltrials.gov/ct2/show/NCT03762382]. |
Acceptability of an intravaginal ring for simultaneously preventing HIV infection and pregnancy: Qualitative findings of the Kisumu combined ring study, 2019
McLellan-Lemal E , Deaton SR , Betts JE , Ondenge K , Mudhune V , O'Connor SM , Nyagol B , Thurman AR , Doncel GF , Allen SA , Heffron R , Mugo NR . Contemp Clin Trials 2022 122 106935 Multipurpose prevention technology intravaginal rings (MPT IVRs) may offer a promising solution for addressing multiple women's sexual and reproductive health needs. We describe MPT IVR acceptability perspectives and examine user experiences of 25 cisgender women aged 18-3years enrolled in a phase IIa randomized, partially blinded, placebo-controlled evaluation of tenofovir-based IVRs with and without contraceptive co-formulation. All took part in an individual, audio-recorded, semi-structured qualitative interview. A thematic analysis of transcribed interviews was completed in MaxQDA. Participants shared little or no knowledge of or experience with IVRs prior to joining the study. Four MPT IVR themes were identified: physical wellbeing, method reliability, personal management, and societal endorsement. Commonly cited of concern, but less described as being experienced, were physical discomforts (e.g., painful insertion/removal; inability to carry out daily activities/chores; foreign body sensation; expulsion; sexual interference, or debilitating side effects). Uncertainty regarding efficacy influenced perspectives about intended prevention benefits. Personal choices in managing reproduction and sexual behaviors had to be congruent with sociocultural values and norms for acceptance beyond the individual user level. Participants viewed broader community acceptance as likely to be mixed given community opposition to the use of modern family planning methods. They also shared concerns that IVR use could lead to infertility, especially among nulliparous women, or that it would encourage premarital sex or high-risk sexual behaviors among adolescent and young women. While a MPT IVR may not be suitable for all women, first-hand testimonials could help influence collective receptivity. Additional community acceptability research is needed. Clinical Trial Registration The study is registered at ClinicalTrials.gov under the identifier NCT03762382. |
Genital microbiota of women using a 90 day tenofovir or tenofovir and levonorgestrel intravaginal ring in a placebo controlled randomized safety trial in Kenya.
Dabee S , Mugo N , Mudhune V , McLellan-Lemal E , Peacock S , O'Connor S , Njoroge B , Nyagol B , Thurman AR , Ouma E , Ridzon R , Wiener J , Haugen HS , Gasper M , Feng C , Allen SA , Doncel GF , Jaspan HB , Heffron R . Sci Rep 2022 12 (1) 12040 In a phase-IIa trial, we investigated the influence of 90 days continuous-delivery tenofovir (TFV) intravaginal rings (IVRs) with/without levonorgestrel (LNG) on the genital microbiota of Kenyan women. Eligible women (n = 27; 18-34 years; negative for HIV, sexually transmitted infections, and Amsel-bacterial vaginosis) were randomized 2:2:1 to use of IVRs containing TFV, TFV/LNG, or placebo. Using vaginal wall and IVR swabs at IVR insertion and removal, the genital microbial composition was determined using 16S rRNA gene sequencing. The presence of Candida spp. was determined using qPCR. The vaginal total bacterial burden appeared to decrease with TFV and TFV/LNG IVR use (log(10)0.57 and log(10)0.27 decrease respectively; p > 0.05). The TFV/LNG IVR was more 'stabilizing': 50% of the participants' microbiota community state types remained unchanged and 50% shifted towards higher Lactobacillus abundance. Specifically, TFV/LNG IVR use was accompanied by increased abundances of Lactobacillus gasseri/hominis/johnsonii/taiwanensis (16.3-fold) and L. fermentum/reuteri/vaginalis (7.0-fold; all p < 0.01). A significant shift in the overall microbial α-diversity or β-diversity was not observed for either IVR, and IVR use did not influence Candida spp. prevalence. TFV/LNG and TFV IVRs did not adversely affect the genital microbiota and are safe to use. Our findings support further studies assessing their efficacy in preventing HIV/HSV-2 and unintended pregnancies. |
High prevalence of sexually transmitted infections among women screened for a contraceptive intravaginal ring study, Kisumu, Kenya, 2014
Oliver VO , Otieno G , Gvetadze R , Desai MA , Makanga M , Akelo V , Gust DA , Nyagol B , McLellan-Lemal E . Int J STD AIDS 2018 29 (14) 956462418782810 We assessed prevalence and correlates of bacterial vaginosis (BV) and sexually transmitted infections (STIs) including herpes simplex virus type 2 (HSV-2), gonorrhoea (GC), syphilis (SYP), Chlamydia (CT) and HIV among Kenyan women aged 18-34 years who were screened for a contraceptive intravaginal ring study. Women provided demographic, behavioural and medical information, and underwent medical evaluation, including a pelvic exam. We computed crude and adjusted prevalence ratio (aPR) and 95% confidence interval (CI) using log-binomial regression. Of 463 women screened, 457 provided laboratory specimens and were included in the analysis. The median age was 25 years, interquartile range (21-28), and 68.5% had completed primary or lower education. Overall, 72.2% tested positive for any STI or BV. Point prevalence was 55.6, 38.5, 3.9, 2.0, 4.6, and 14.7% for HSV-2, BV, GC, SYP, CT, and HIV, respectively. Co-infection with HSV-2, BV, and HIV occurred in 28 (6.1%) participants. Having >/=1 STI/BV was associated with younger age at first sex (</=13 versus 17-19 years, aPR=1.27, 95% CI 1.07-1.51), history of exchange sex (aPR = 2.05, 95% CI 1.07-3.92), sexual intercourse in the past seven days (aPR = 1.17, 95% CI 1.01-1.36), and older age (30-34 versus 18-24 years, aPR = 1.26, 95% CI 1.06-1.48). STI/BV diagnosis was less likely for women reporting one lifetime sexual partner compared to women with >/=4 lifetime sexual partners (aPR = 0.70, 95% CI 0.54-0.92). Combination prevention approaches (biomedical, behavioural, social, and structural) tailored to women with diverse risk profiles may help mitigate STI/BV prevalence in this setting. |
Contraceptive vaginal ring experiences among women and men in Kisumu, Kenya: A qualitative study
McLellan-Lemal E , Ondeng'e K , Gust DA , Desai M , Otieno FO , Madiega PA , Nyagol B , Makanga EM . Front Womens Health 2017 2 (1) BACKGROUND: Future HIV prevention options for women will likely include Antiretroviral (ARV)-based intravaginal rings. Valuable insights may be gained by examining user experiences with a similar licensed technology, a contraceptive ring, especially in settings where this technology may not be currently available. METHODS: In-depth interviews with 24 females enrolled in a trial assessing acceptability and use of a contraceptive ring, and 20 male sexual partners were conducted September 2014-April 2015. Elements of ethnography and phenomenological anthropology were used to collect, analyze, interpret, and describe ring users' experiences. Thematic analysis was completed in MaxQDA-10. RESULTS: Experiences with the contraceptive ring reflected a broader Family Planning (FP) paradigm that centered around three themes: latitudes and drawbacks of FP (being free); an FP method needs to be compatible with a woman's body (feeling normal); and dealing with fertility control uncertainties (how well does it really work). FP intentions and disclosure practices were influenced by partner support, socioeconomic factors, religion, cultural beliefs, and societal norms, including female sexuality. A user-friendly FP design was emphasized. Non-suppression of menstruation was favored by most. Unease with vaginal insertion as well as ring placement issues (slippage, expulsion) created initial challenges requiring clinician assistance and practice for some participants. While minor side-effects were described, concerns centered on ring efficacy, negative effect on a woman's sexual desire, and future fertility issues. CONCLUSIONS: Awareness of the multiple contexts in ring users' experience may inform the development, education, and promotion approaches for future ARV rings. |
Factors associated with psychological distress among young women in Kisumu, Kenya
Gust DA , Gvetadze R , Furtado M , Makanga M , Akelo V , Ondenge K , Nyagol B , McLellan-Lemal E . Int J Womens Health 2017 9 255-264 BACKGROUND: Attention to mental health issues is growing globally. In many countries, including Kenya, however, assessment of psychological distress, especially in rural areas, is limited. METHODS: We analyzed data from young women screened for a longitudinal contraceptive ring study in Kisumu, Kenya. Multivariable regression analysis was used to assess factors associated with recent moderate and high psychological distress, as measured by the Kessler (K-6) psychological distress scale. RESULTS: Among the 461 women screened, most (58.4%) were categorized as having moderate psychological distress, 20.8% were categorized as having low or no psychological distress, and 20.8% were categorized as having high psychological distress. Moderate psychological distress (vs low/no) was significantly more likely among women who reported a history of forced sex and were concerned about recent food insecurity. High (vs low/no) psychological distress was significantly more likely among women who reported a history of forced sex, who were concerned about recent food insecurity, and who self-reported a sexually transmitted infection. CONCLUSION: To reduce psychological distress, a focus on prevention as well as care methods is needed. Girls need a path toward a healthy and productive adulthood with a focus on education, which would help them gain skills to avoid forced sex. Women would benefit from easy access to social services and supports that would help them with basic needs like food security among other things. A holistic or ecological approach to services that would address mental, educational, social, health, and economic issues may have the highest chance of having a long-term positive impact on public health. |
Residual hormone levels in used contraceptive rings as a measurement of adherence to vaginal ring use
Haaland RE , Holder A , Evans-Strickfaden T , Nyagol B , Makanga M , Oyaro B , Humwa F , Williams T , McLellan-Lemal E , Desai M , Huey MJ . Contraception 2017 95 (6) 602-604 OBJECTIVE: This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials. STUDY DESIGN: Residual etonogestrel and ethinyl estradiol levels from used NuvaRings(R) of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing(R) as their contraceptive choice. RESULTS: Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones. CONCLUSION: Residual vaginal ring drug levels could help assess adherence in clinical trials. |
Assessment of traditional and improved stove use on household air pollution and personal exposures in rural western Kenya
Yip F , Christensen B , Sircar K , Naeher L , Bruce N , Pennise D , Lozier M , Pilishvili T , Loo Farrar J , Stanistreet D , Nyagol R , Muoki J , de Beer L , Sage M , Kapil V . Environ Int 2016 99 185-191 BACKGROUND: Over 40% of the world's population relies on solid fuels for heating and cooking. Use of improved biomass cookstoves (ICS) has the potential to reduce household air pollution (HAP). OBJECTIVES: As part of an evaluation to identify ICS for use in Kenya, we collected indoor air and personal air samples to assess differences between traditional cookstoves (TCS) and ICS. METHODS: We conducted a cross-over study in 2012 in two Kenyan villages; up to six different ICS were installed in 45 households during six two-week periods. Forty-eight hour kitchen measurements of fine particulate matter (PM2.5) and carbon monoxide (CO) were collected for the TCS and ICS. Concurrent personal CO measurements were conducted on the mother and one child in each household. We performed descriptive analysis and compared paired measurements between baseline (TCS only) and each ICS. RESULTS: The geometric mean of 48-hour baseline PM2.5 and CO concentrations in the kitchen was 586mug/m3 (95% CI: 460, 747) and 4.9ppm (95% CI: 4.3, 5.5), respectively. For each ICS, the geometric mean kitchen air pollutant concentration was lower than the TCS: median reductions were 38.8% (95% CI: 29.5, 45.2) for PM2.5 and 27.1% (95% CI: 17.4, 40.3) for CO, with statistically significant relationships for four ICS. We also observed a reduction in personal exposures to CO with ICS use. CONCLUSIONS: We observed a reduction in mean 48-hour PM2.5 and CO concentrations compared to the TCS; however, concentrations for both pollutants were still consistently higher than WHO air quality guidelines. Our findings illustrate that ICS tested in real-world settings can reduce exposures to HAP, but implementation of cleaner fuels and related stove technologies may also be necessary to optimize public health benefits. |
Effectiveness of six improved cookstoves in reducing household air pollution and their acceptability in rural western Kenya
Pilishvili T , Loo JD , Schrag S , Stanistreet D , Christensen B , Yip F , Nyagol R , Quick R , Sage M , Bruce N . PLoS One 2016 11 (11) e0165529 BACKGROUND: Household air pollution (HAP) from biomass fuel burning is linked to poor health outcomes. Improved biomass cookstoves (ICS) have the potential to improve HAP. OBJECTIVES: A pre-/post- intervention study assessed the impact of six ICS on indoor air quality and acceptability of ICS to local users in rural Western Kenya. METHODS: We measured mean personal and kitchen level concentrations of particulate matter <2.5mum in diameter (PM2.5, mug/m3) and carbon monoxide (CO, ppm) during the 48-hour period of each ICS use in 45 households. We compared these levels to those observed with traditional 3-stone fire (TSF) use. We assessed ICS acceptability through interviews and focus groups. We evaluated association of stove type, fuel use, and factors related to cooking practices with mean kitchen PM2.5 and CO using multivariable regression. RESULTS: Stove type, exclusive ICS use (vs. concurrent TSF use), and the amount of fuel used were independently associated with kitchen PM2.5 and CO levels. Reductions (95%CI) in mean PM2.5 compared to TSF, ranged by ICS from 11.9% (-2.8-24.5) to 42.3% (32.3-50.8). Reductions in kitchen CO compared to TSF, ranged by ICS from -5.8% (-21.9-8.2) to 34.5% (23.2-44.1). Mean kitchen PM2.5 ranged from 319mug/m3 to 518mug/m3 by ICS. Women thought ICS were easy to use, more efficient, produced less smoke, and cooked faster, compared to TSF. Women also reported limitations for each ICS. CONCLUSIONS: We documented reductions in HAP from ICS compared to TSF. The PM2.5 levels with ICS use were still considerably higher than WHO indoor air quality guidelines. Achieving maximal potential of ICS requires adherence to more exclusive use and addressing user reported ICS limitations. |
Evaluating four measures of water quality in clay pots and plastic safe storage containers in Kenya
Murphy JL , Ayers TL , Knee J , Oremo J , Odhiambo A , Faith SH , Nyagol RO , Stauber CE , Lantagne DS , Quick RE . Water Res 2016 104 312-319 Household water treatment with chlorine can improve microbiological quality and reduce diarrhea. Chlorination is typically assessed using free chlorine residual (FCR), with a lower acceptable limit of 0.2 mg/L, however, accurate measurement of FCR is challenging with turbid water. To compare potential measures of adherence to treatment and water quality, we chlorinated recently-collected water in rural Kenyan households and measured total chlorine residual (TCR), FCR, oxidation reduction potential (ORP), and E. coli concentration over 72 h in clay and plastic containers. Results showed that 1) ORP served as a useful proxy for chlorination in plastic containers up to 24 h; 2) most stored water samples disinfected by chlorination remained significantly less contaminated than source water for up to 72 h, even in the absence of FCR; 3) TCR may be a useful proxy indicator of microbiologic water quality because it confirms previous chlorination and is associated with a lower risk of E. coli contamination compared to untreated source water; and 4) chlorination is more effective in plastic than clay containers presumably because of lower chlorine demand in plastic. |
Characteristics of women screened for a contraceptive intravaginal ring study in Kisumu, Kenya, 2014
McLellan-Lemal E , Gust DA , Gvetadze R , Furtado M , Otieno FO , Desai M , Zeh C , Samandari T , Nyagol B , Makanga EM . Res J Womens Health 2016 3 (1) BACKGROUND: HIV antiretroviral-based intravaginal rings with and without co-formulated contraception hold promise for increasing HIV prevention options for women. Acceptance of and ability to correctly and consistently use this technology may create challenges for future ring-based microbicide trials in settings where this technology has not been introduced. We examined baseline factors associated with enrolling in a contraceptive intravaginal ring study in Kisumu, Kenya and describe notional acceptability (willingness to switch to a contraceptive ring based solely on information received about it). METHODS: Demographic, psychosocial, and behavioral eligibility screening of women 18-34 years was undertaken. Testing for pregnancy, HIV, and other sexually transmitted infections (STIs) was also conducted. We compared enrollment status across groups of categorical predictors using prevalence ratios (PR) and 95% confidence interval (CI) estimates obtained from a log-binomial regression model. RESULTS: Out of 692 women pre-screened April to November 2014, 463 completed screening, and 302 women were enrolled. Approximately 97% of pre-screened women were willing to switch from their current contraceptive method to use the intravaginal ring exclusively for the 6-month intervention period. Pregnancy, HIV, and STI prevalence were 1.7%, 14.5%, and 70.4% respectively for the 463 women screened. Women 18-24 (PR=1.47, CI 1.15-1.88) were more likely to be enrolled than those 30-34 years of age, as were married/cohabitating women (PR=1.62, CI 1.22-2.16) compared to those separated, divorced, or widowed. In adjusted analyses, sexual debut at less than 17 years of age, one lifetime sexual partner, abnormal vaginal bleeding in the past 12 months, condomless vaginal or anal sex in the past 3 months, and not having a sexual partner of unknown HIV status in the past 3 months were predictive of enrollment. CONCLUSION: High notional acceptability suggests feasibility for contraceptive intravaginal ring use. Factors associated with ring use initiation and 6-month use will need to be assessed. |
Use of temperature sensors to determine exclusivity of improved stove use and associated household air pollution reductions in Kenya
Lozier MJ , Sircar K , Christensen B , Pillarisetti A , Pennise D , Bruce N , Stanistreet D , Naeher L , Pilishvili T , Farrar JL , Sage M , Nyagol R , Muoki J , Wofchuck T , Yip F . Environ Sci Technol 2016 50 (8) 4564-71 Household air pollution (HAP) contributes to 3.5-4 million annual deaths globally. Recent interventions using improved cookstoves (ICS) to reduce HAP have incorporated temperature sensors as stove use monitors (SUMs) to assess stove use. We deployed SUMs in an effectiveness study of 6 ICSs in 45 Kenyan rural homes. Stove were installed sequentially for 2 weeks and kitchen air monitoring was conducted for 48 h during each 2-week period. We placed SUMs on the ICSs and traditional cookstoves (TCS), and the continuous temperature data were analyzed using an algorithm to examine the number of cooking events, days of exclusive use of ICS, and how stove use patterns affect HAP. Stacking, defined as using both a TCS and an ICS in the same day, occurred on 40% of the study days, and exclusive use of the ICS occurred on 25% of study days. When researchers were not present, ICS use declined, which can have implications for long-term stove adoption in these communities. Continued use of TCSs was also associated with higher HAP levels. SUMs are a valuable tool for characterizing stove use and provide additional information to interpret HAP levels measured during ICS intervention studies. |
User perspectives of characteristics of improved cookstoves from a field evaluation in Western Kenya
Loo JD , Hyseni L , Ouda R , Koske S , Nyagol R , Sadumah I , Bashin M , Sage M , Bruce N , Pilishvili T , Stanistreet D . Int J Environ Res Public Health 2016 13 (2) 167 Over half of the world's population uses biomass fuels; these households cook on open fires indoors, increasing their risk of adverse health effects due to household air pollution (HAP) from biomass combustion. This study evaluated six improved cookstoves (ICS) for effectiveness and acceptability in a rural community in Western Kenya. This paper describes women's views on each ICS compared to the traditional three-stone fire. Views on stove characteristics, fuel consumption, health effects and acceptability were assessed through structured interviews and focus group discussions. Data were coded and analyzed using a thematic approach. In total, 262 interviews and 11 focus groups were conducted from 43 women. Overall, women preferred the ICS over the traditional three-stone fire for various reasons including ease of use, efficiency, fuel efficiency and perceived reduction in smoke and improved health. However, there were clear preferences for specific ICS with almost half of women preferring a Philips stove. Despite acceptance and use of ICS, women used multiple stoves to meet their daily needs. Qualitative studies are essential to field evaluations to provide insight into user perspectives and acceptability of ICS and to inform research and development of technologies that are both effective in reducing HAP and practical in use. |
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