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BACKGROUND: Doxycycline postexposure prophylaxis (PEP) has been shown to prevent sexually transmitted infections (STIs) among cisgender men and transgender women, but data from trials involving cisgender women are lacking. METHODS: We conducted a randomized, open-label trial comparing doxycycline PEP (doxycycline hyclate, 200 mg taken within 72 hours after condomless sex) with standard care among Kenyan women 18 to 30 years of age who were receiving preexposure prophylaxis against human immunodeficiency virus (HIV). The primary end point was any incident infection with Chlamydia trachomatis, Neisseria gonorrhoeae, or Treponema pallidum. Hair samples were collected quarterly for objective assessment of doxycycline use. RESULTS: A total of 449 participants underwent randomization; 224 were assigned to the doxycycline-PEP group and 225 to the standard-care group. Participants were followed quarterly over 12 months. A total of 109 incident STIs occurred (50 in the doxycycline-PEP group [25.1 per 100 person-years] and 59 in the standard-care group [29.0 per 100 person-years]), with no significant between-group difference in incidence (relative risk, 0.88; 95% confidence interval [CI], 0.60 to 1.29; P = 0.51). Among the 109 incident STIs, chlamydia accounted for 85 (78.0%) (35 in the doxycycline-PEP group and 50 in the standard-care group; relative risk, 0.73; 95% CI, 0.47 to 1.13). No serious adverse events were considered by the trial investigators to be related to doxycycline, and there were no incident HIV infections. Among 50 randomly selected participants in the doxycycline-PEP group, doxycycline was detected in 58 of 200 hair samples (29.0%). All N. gonorrhoeae-positive isolates were resistant to doxycycline. CONCLUSIONS: Among cisgender women, the incidence of STIs was not significantly lower with doxycycline PEP than with standard care. According to hair-sample analysis, the use of doxycycline PEP among those assigned to receive it was low. (Funded by the National Institutes of Health; dPEP ClinicalTrials.gov number, NCT04050540.).
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Anti-Infecciosos , Infecções por Chlamydia , Doxiciclina , Gonorreia , Profilaxia Pré-Exposição , Sífilis , Feminino , Humanos , Infecções por Chlamydia/microbiologia , Infecções por Chlamydia/prevenção & controle , Chlamydia trachomatis , Doxiciclina/administração & dosagem , Doxiciclina/efeitos adversos , Doxiciclina/análise , Doxiciclina/uso terapêutico , Infecções por HIV/prevenção & controle , Quênia/epidemiologia , Neisseria gonorrhoeae , Profilaxia Pré-Exposição/métodos , Infecções Sexualmente Transmissíveis/prevenção & controle , Sexo sem Proteção , Anti-Infecciosos/administração & dosagem , Anti-Infecciosos/efeitos adversos , Anti-Infecciosos/análise , Anti-Infecciosos/uso terapêutico , Adolescente , Adulto Jovem , Adulto , Gonorreia/microbiologia , Gonorreia/prevenção & controle , Treponema pallidum , Sífilis/microbiologia , Sífilis/prevenção & controle , Monitoramento de Medicamentos/métodos , Cabelo/químicaRESUMO
BACKGROUND: Following a decline in perinatal HIV transmission from 20% to 10% between 2010 and 2017 in Kenya, rates have since plateaued with an estimated 8% transmission rate in 2021. Between October 2016 and September 2021, Family AIDS Care & Education Services (FACES) supported HIV care and treatment services across 61 facilities in Kisumu County, Kenya with an emphasis on service strengthening for pregnant and postpartum women living with HIV to reduce perinatal HIV transmission. This included rigorous implementation of national HIV guidelines and implementation of 3 locally adapted evidence-based interventions targeted to the unique needs of women and their infants. We examined whether these person-centered program enhancements were associated with changes in perinatal HIV transmission at FACES-supported sites over time. METHODS AND FINDINGS: We conducted a repeated cross-sectional study of annually aggregated routinely collected documentation of perinatal HIV transmission risk through the end of breastfeeding at FACES-supported facilities between October 2016 and September 2021. Data included 12,599 women living with HIV with baseline antenatal care metrics, and, a separate data set of 11,879 mother-infant pairs who were followed from birth through the end of breastfeeding (overlapping with those in antenatal care 2 years prior). FACES implemented 3 interventions for pregnant and postpartum women living with HIV in 2019: (1) high-risk clinics; (2) case management; and (3) a mobile app to support treatment engagement. Our primary outcome was infant HIV acquisition by the end of breastfeeding (18 to 24 months). We compared infant HIV acquisition risk in the final year of the FACES program (2021) to the year before intervention scale-up and following implementation of the "Treat All" policy (2018). Mother-infant pair loss to follow-up was a secondary outcome. Program data were aggregated by year and site, thus in multivariable regression, we adjusted for site-level characteristics, including facility type, urban versus rural, number of women with HIV in antenatal care each year, and the proportion among them under 25 years of age. Between October 2016 and September 2021, 81,172 pregnant women received HIV testing at the initiation of antenatal care, among whom 12,599 (15.5%) were living with HIV, with little variation in HIV prevalence over time. The risk of infant HIV acquisition by 24 months of age declined from 4.9% (101/2,072) in 2018 to 2.2% (48/2,156) in 2021 (adjusted risk difference -2.6% [95% confidence interval (CI): -3.7, -1.6]; p < 0.001). Loss to follow-up declined from 9.9% (253/2,556) in 2018 to 2.5% (59/2,393) in 2021 (risk difference -7.5% [95% CI: -8.8, -6.2]; p < 0.001). During the same period, UNAIDS estimated rates of perinatal transmission in the broader Nyanza region and in Kenya as a whole did not decline. The main limitation of this study is that we lacked a comparable control group. CONCLUSIONS: These findings suggest that implementation of person-centered interventions was associated with significant declines in perinatal HIV transmission and loss to follow-up of pregnant and postpartum women.
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Understanding the levels of power that adolescent girls and young women exercise in their sexual and reproductive lives is imperative to inform interventions to help them meet their goals. We implemented an adapted version of the Sexual and Reproductive Health Empowerment (SRE) Scale for Adolescents and Young Adults among 500 adolescent girls and young women aged 15-20 in Kisumu, Kenya. We used confirmatory factor analysis (CFA) to assess factor structure, and logistic regression to examine construct validity through the relationship between empowerment scores and ability to mitigate risk of undesired pregnancy through consistent contraceptive use. Participants had a mean age of 17.5, and most were students (61 percent), were currently partnered (94 percent), and reported having sex in the past 3 months (70 percent). The final, 26-item CFA model had acceptable fit. All subscales had Cronbach's alpha scores >0.7, and all items had rotated factor loadings >0.5, indicating good internal consistency and robust factor-variable associations. The total SRE-Kenya (SRE-K) score was associated with increased odds of the consistent method used in the past three months (adjusted odds ratio: 1.98, 95 percent CI: 1.29-3.10). The SRE-K scale is a newly adapted and valid measure of sexual and reproductive empowerment specific to adolescent girls and young women in an East African setting.
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Empoderamento , Comportamento Sexual , Humanos , Adolescente , Feminino , Quênia , Adulto Jovem , Análise Fatorial , Comportamento Contraceptivo/psicologia , Inquéritos e Questionários/normas , Reprodutibilidade dos Testes , Saúde Reprodutiva , GravidezRESUMO
BACKGROUND: Mobile health (mHealth) has become an increasingly popular strategy to improve healthcare delivery and health outcomes. Communicating results and health education via text may facilitate program planning and promote better engagement in care for women undergoing human papillomavirus (HPV) screening. We sought to develop and evaluate an mHealth strategy with enhanced text messaging to improve follow-up throughout the cervical cancer screening cascade. METHODS: Women aged 25-65 participated in HPV testing in six community health campaigns (CHCs) in western Kenya as part of a single arm of a cluster-randomized trial. Women received their HPV results via text message, phone call, or home visit. Those who opted for text in the first four communities received "standard" texts. After completing the fourth CHC, we conducted two semi-structured focus group discussions with women to develop an "enhanced" text strategy, including modifying the content, number, and timing of texts, for the subsequent two communities. We compared the overall receipt of results and follow-up for treatment evaluation among women in standard and enhanced text groups. RESULTS: Among 2368 women who were screened in the first four communities, 566 (23.9%) received results via text, 1170 (49.4%) via phone call, and 632 (26.7%) via home visit. In the communities where enhanced text notification was offered, 264 of the 935 screened women (28.2%) opted for text, 474 (51.2%) opted for phone call, and 192 (20.5%) for home visit. Among 555 women (16.8%) who tested HPV-positive, 257 (46.3%) accessed treatment, with no difference in treatment uptake between the standard text group (48/90, 53.3%) and the enhanced text group (22/41, 53.7%). More women in the enhanced text group had prior cervical cancer screening (25.8% vs. 18.4%; p < 0.05) and reported living with HIV (32.6% vs. 20.2%; p < 0.001) than those in the standard text group. CONCLUSIONS: Modifying the content and number of texts as an enhanced text messaging strategy was not sufficient to increase follow-up in an HPV-based cervical cancer screening program in western Kenya. A one-size approach to mHealth delivery does not meet the needs of all women in this region. More comprehensive programs are needed to improve linkage to care to further reduce structural and logistical barriers to cervical cancer treatment.
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Infecções por Papillomavirus , Envio de Mensagens de Texto , Neoplasias do Colo do Útero , Feminino , Humanos , Crioterapia , Detecção Precoce de Câncer/métodos , Quênia , Infecções por Papillomavirus/diagnóstico , Estudos Prospectivos , Neoplasias do Colo do Útero/prevenção & controle , Adulto , Pessoa de Meia-Idade , IdosoRESUMO
BACKGROUND: Adolescents account for 15% of new HIV cases in Kenya. HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are highly effective prevention tools, but uptake is low among adolescents, particularly in resource-limited settings. We assessed awareness and acceptability of PrEP and PEP among Kenyan adolescents. METHOD: Focus group discussions were conducted with 120 adolescent boys and girls ages 15 to 19 in Kisumu. Data were analyzed using the Framework Approach. RESULTS: Adolescent participants often had not heard of or could not differentiate between PrEP and PEP. They also confused these HIV prevention tools with emergency contraceptives. Taking a daily pill to prevent HIV was perceived as analogous to taking a pill to treat HIV. Boys were aware of and willing to consider using PrEP and PEP due to their dislike for using condoms. Adolescents identified insufficient information, cost, and uncomfortableness speaking with healthcare workers about their HIV prevention needs due to sexuality stigma as barriers to using PrEP and PEP. CONCLUSION: Low awareness and poor understanding of PrEP and PEP among adolescents reveal the need for increased education and sensitization about these HIV prevention options. Expanding access to sexual and reproductive health services that are tailored to the needs of adolescents and staffed with non-judgmental providers could help reduce sexuality stigma as a barrier to accessing care. New HIV prevention approaches such as long-acting injectables or implants, on-demand regimens, and multipurpose prevention technologies may encourage increased uptake of PrEP and PEP by adolescents.
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BACKGROUND: The Covid-19 pandemic led to an unprecedented impact on many sectors globally including research. We assessed the impact of the Covid-19 pandemic on the research portfolio, and on the approval turnaround time for research protocols submitted to the Scientific and Ethics Review Unit (SERU), at the Kenya Medical Research Institute (KEMRI). METHODS: We compared research protocols submitted between October 01, 2019 and March 31, 2020 (Period 1), to those submitted between April 1 and September 30, 2020 (Period 2). A document review tool was used to extract data from the 198 research protocols reviewed and approved over the two periods. RESULTS: In the two periods under review, the single largest percentage of protocols (89/198, 45.4%) involved infectious and parasitic diseases, and the single largest percentage of study designs was cross-sectional (75/198, 38%). Before the pandemic, the median time taken to review KEMRI-linked protocols was 87 days and for non-KEMRI linked protocols it was 121 days. During the pandemic, approval turnaround time dropped for both KEMRI and non-KEMRI protocols to 66 days and 92 days, respectively, due to the streamlined processes at the KEMRI SERU. CONCLUSION: The research portfolio was minimally affected by the pandemic. The adoption of email submission, and faster-than-usual processing and review protocols during the pandemic reduced the approval turnaround time.
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Academias e Institutos , COVID-19 , Pesquisa , Pesquisa/estatística & dados numéricos , Protocolos Clínicos , Tempo , Quênia , Academias e Institutos/estatística & dados numéricosRESUMO
Introduction: Despite increasing global commitment to meeting the family planning needs of adolescent girls and young women (AGYW), there is limited research on how they prioritize contraceptive method and service delivery characteristics. In this qualitative study, we examine the specific elements that drive the contraceptive choices of Kenyan AGYW, and apply our findings to the development of attributes and levels for a discrete choice experiment (DCE). Methods: Our four-stage approach included data collection, data reduction, removing inappropriate attributes, and optimizing wording. Between June-October 2021, we conducted in-depth interviews with 30 sexually-active 15-24 year-old AGYW in Kisumu county, Kenya who were non-pregnant and desired to delay pregnancy. Interviews focused on priorities for contraceptive attributes, how AGYW make trade-offs between among these attributes, and the influences of preferences on contraceptive choice. Translated transcripts were qualitatively coded and analyzed with a constant comparative approach to identify key concepts. We developed and iteratively revised a list of attributes and levels, and pre-tested draft DCE choice tasks using cognitive interviews with an additional 15 AGYW to optimize comprehension and relevance. Results: In-depth interview participants' median age was 18, 70% were current students, and 93% had a primary sexual partner. AGYW named a variety of priorities and preferences related to choosing and accessing contraceptive methods, which we distilled into six key themes: side effects; effectiveness; user control; privacy; source of services; and cost. Bleeding pattern was top of mind for participants; amenorrhea was generally considered an intolerable side effect. Many participants felt more strongly about privacy than effectiveness, though some prioritized duration of use and minimizing chance of pregnancy above other contraceptive characteristics. Most AGYW preferred a clinic setting for access, as they desired contraceptive counseling from a provider, but pharmacies were considered preferable for reasons of privacy. We selected, refined, and pre-tested 7 DCE attributes, each with 2-4 levels. Conclusions: Identifying AGYW preferences for contraceptive method and service delivery characteristics is essential to developing innovative strategies to meet their unique SRH needs. DCE methods may provide valuable quantitative perspectives to guide and tailor contraceptive counseling and service delivery interventions for AGYW who want to use contraception.
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Objective: To determine the safety, tolerance, and adherence to self-administered intravaginal 5% fluorouracil (5FU) cream as adjuvant therapy following cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) treatment among women living with HIV (WLWH) in Kenya. Methods: A Phase I Pilot trial was performed among 12 WLWH in Kenya, aged 18-49 years between March 2023-February 2024 (ClinicalTrial.gov NCT05362955). Participants self-administered 2g of 5FU intravaginally every other week for eight applications. Safety was assessed using a standardized grading scale, and adherence was evaluated using self-report, inspection of used applicators, and weighing of the study drug. Results: The mean age and CD4 count were 43.9 years and 781 cells/mm3, respectively. Seven (58%) had an 8th-grade education or less. All 12 reported at least one grade I adverse event (AE), 1 (8%) reported a grade 2 AE, no grade 3 or 4 AEs were reported. Increased vaginal discharge (n=9, 75%) and irritation (n=5, 42%), with a mean duration of 3.2 and 2.8 days, respectively, were the most commonly reported AEs. Provider-observed AEs included grade 1 cervical erythema and superficial abrasions. All participants tolerated all eight 5FU doses, and 96% adherence was demonstrated. Conclusion: Self-administered 5FU following CIN2/3 treatment among WLWH in Kisumu, Kenya, was safe, tolerable, and associated with high adherence. Randomized trials are needed to investigate whether adjuvant 5FU can improve treatment outcomes or serve as primary cervical precancer treatment in sub-Saharan Africa. A self-administered therapy may be transformative in increasing access to treatment and, hence, secondary prevention of cervical cancer.
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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. Half of the participants were randomized to also receive SMS adherence reminders (daily or as needed for missed doses). We assessed acceptability quantitatively and qualitatively according to the four constructs of Unified Theory of Acceptance and Use of Technology (UTAUT): performance expectancy, effort expectancy, social influence, and facilitating conditions. We assessed feasibility by monitor functionality during periods of PrEP use. We analyzed quantitative data descriptively and compared by site and over time; qualitative data were analyzed inductively and deductively. The median age was 21 years (IQR 19-22), median education was 12 years (IQR 10-13), 182 (53%) had disclosed PrEP use, and 55 (16%) reported recent intimate partner violence. Most participants reported high levels of usefulness and high interest in using the monitor with few problems or worries reported throughout follow-up. Feasibility was high overall with some differences by site (96% functional monitor days in Kisumu vs 88% in Thika). Few monitors were reported lost (N = 29; 8%) or dysfunctional (N = 11; 3%). In qualitative interviews, electronic monitoring was perceived as useful because it supported privacy, confidentiality, easy storage, and PrEP adherence. Effort was generally considered low. Participants expressed some concern for stigma from monitor and/or PrEP use. Facilitating conditions involved the monitor size, color, and battery life. Overall, real-time electronic adherence monitoring was a highly acceptable and feasible approach to understand PrEP adherence among young women in a sub-Saharan African setting.
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Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Humanos , Feminino , Adulto Jovem , Adulto , Adolescente , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Profilaxia Pré-Exposição/métodos , Quênia , Estudos de Viabilidade , Fármacos Anti-HIV/uso terapêutico , Adesão à Medicação , EletrônicaRESUMO
Research increasingly involves cross-cultural work with non-English-speaking populations, necessitating translation and cultural validation of research tools. This paper describes the process of translating and criterion validation of the Client Diagnostic Questionnaire (CDQ) for use in a multisite study in Kenya and Uganda. The English CDQ was translated into Swahili, Dholuo (Kenya) and Runyankole/Rukiga (Uganda) by expert translators. The translated documents underwent face validation by a bilingual committee, who resolved unclear statements, agreed on final translations and reviewed back translations to English. A diagnostic interview by a mental health specialist was used for criterion validation, and Kappa statistics assessed the strength of agreement between non-specialist scores and mental health professionals' diagnoses. Achieving semantic equivalence between translations was a challenge. Validation analysis was done with 30 participants at each site (median age 32.3 years (IQR = (26.5, 36.3)); 58 (64.4%) female). The sensitivity was 86.7%, specificity 64.4%, positive predictive value 70.9% and negative predictive value 82.9%. Diagnostic accuracy by the non-specialist was 75.6%. Agreement was substantial for major depressive episode and positive alcohol (past 6 months) and alcohol abuse (past 30 days). Agreement was moderate for other depressive disorders, panic disorder and psychosis screen; fair for generalized anxiety, drug abuse (past 6 months) and Post Traumatic Stress Disorder (PTSD); and poor for drug abuse (past 30 days). Variability of agreement between sites was seen for drug use (past 6 months) and PTSD. Our study successfully adapted the CDQ for use among people living with HIV in East Africa. We established that trained non-specialists can use the CDQ to screen for common mental health and substance use disorders with reasonable accuracy. Its use has the potential to increase case identification, improve linkage to mental healthcare, and improve outcomes. We recommend further studies to establish the psychometric properties of the translated tool.
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Background: Consistent engagement in HIV treatment is needed for healthy outcomes, yet substantial loss-to-follow up persists, leading to increased morbidity, mortality and onward transmission risk. Although conditional cash transfers (CCTs) address structural barriers, recent findings suggest that incentive effects are time-limited, with cessation resulting in HIV care engagement deterioration. We explored incentive experiences, perceptions, and effects after cessation to investigate potential mechanisms of this observation. Methods: This qualitative study was nested within a larger trial, AdaPT-R (NCT02338739), focused on HIV care engagement in western Kenya. A subset of participants were purposively sampled from AdaPT-R participants: adults with HIV who had recently started ART, received CCTs for one year, completed one year of follow-up without missing a clinic visit, and were randomized to either continue or discontinue CCTs for one more year of follow-up. In-depth interviews were conducted by an experienced qualitative researcher using a semi-structed guide within a month of randomization. Interviews were conducted in the participants' preferred language (Dholuo, Kiswahili, English). Data on patient characteristics, randomization dates, and clinic visit dates to determine care lapses were extracted from the AdaPT-R database. A codebook was developed deductively based on the guide and inductively refined based on initial transcripts. Transcripts were coded using Dedoose software, and thematic saturation was identified. Results: Of 38 participants, 15 (39%) continued receiving incentives, while 23 (61%) were discontinued from receiving incentives. Half were female (N = 19), median age was 30 years (range: 19-48), and about three-quarters were married or living with partners. Both groups expressed high intrinsic motivation to engage in care, prioritized clinic attendance regardless of CCTs and felt the incentives expanded their decision-making options. Despite high motivation, some participants reported that cessation of the CCTs affected their ability to access care, especially those with constrained financial situations. Participants also expressed concerns that incentives might foster dependency. Conclusions: This study helps us better understand the durability of financial incentives for HIV care engagement, including when incentives end. Together with the quantitative findings in the parent AdaPT-R study, these results support the idea that careful consideration be exercised when implementing incentives for sustainable engagement effects.
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Antiretroviral therapy for children living with HIV (CLHIV) under 3 years of age commonly includes lopinavir/ritonavir (LPV/r). However, the original liquid LPV/r formulation has taste and cold storage difficulties. To address these challenges, LPV/r oral pellets have been developed. These pellets can be mixed with milk or food for administration and do not require refrigeration. We developed the population pharmacokinetic (PK) model and assessed drug exposure of LPV/r oral pellets administered twice daily to CLHIV per World Health Organization (WHO) weight bands. The PK analysis included Kenyan and Ugandan children participating in the LIVING studies (NCT02346487) receiving LPV/r pellets (40/10 mg) and ABC/3TC (60/30 mg) dispersible tablets. Population PK models were developed for lopinavir (LPV) and ritonavir (RTV) to evaluate the impact of RTV on the oral clearance (CL/F) of LPV. The data obtained from the study were analyzed using nonlinear mixed-effects modeling approach. Data from 514 children, comprising a total of 2,998 plasma concentrations of LPV/r were included in the analysis. The LPV and RTV concentrations were accurately represented by a one-compartment model with first-order absorption (incorporating a lag-time) and elimination. Body weight influenced LPV and RTV PK parameters. The impact of RTV concentrations on the CL/F of LPV was characterized using a maximum effect model. Simulation-predicted target LPV exposures were achieved in children with this pellet formulation across the WHO weight bands. The LPV/r pellets dosed in accordance with WHO weight bands provide adequate LPV exposures in Kenyan and Ugandan children weighing 3.0 to 24.9 kg.
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Fármacos Anti-HIV , Infecções por HIV , Inibidores da Protease de HIV , Humanos , Criança , Lopinavir/farmacocinética , Ritonavir/farmacocinética , Quênia , Infecções por HIV/tratamento farmacológico , Simulação por ComputadorRESUMO
OBJECTIVE: To evaluate the impact of an agricultural livelihood intervention on gender role conflict and sexual relationship power among people with HIV (PWH) in western Kenya. DESIGN: Study participants were enrolled in Shamba Maisha , a cluster randomized controlled trial of an agricultural intervention conducted among PWH across 16 health facilities during 2016-2020. Intervention participants received a water pump, seeds, and agricultural and financial training; control participants received standard of HIV care. METHODS: We assessed men's views on masculinity and gender roles via the validated gender role conflict score (GRCS; range 18-78, higher = greater gender role conflict). We measured gender power imbalances among women via the validated Sexual Relationship Power Scale (SRPS), which combines subscales of relationship control and decision-making dominance (range 1-4, higher = female holds more power). We compared changes over the study period by arm using longitudinal multilevel difference-in-difference linear regression models accounting for clustering of facilities using the intention-to-treat cohort. RESULTS: We enrolled 720 participants (366 intervention, 354 control); 2-year retention was 94%. Median age was 40 and approximately 55% of participants were female. Among men, after 24-months the decrease in GRCS scores was 4.3 points greater in the intervention than the control arm ( P â<â0.001). Among women, the intervention resulted in 0.25 points greater increase in the SRPS compared to the control arm ( P â<â0.001). CONCLUSIONS: Shamba Maisha resulted in less gender role conflict in men and greater sexual relationship power for women. Agricultural livelihood interventions may be a powerful tool to improve gender power imbalances, which may subsequently mitigate poverty and food insecurity.
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Papel de Gênero , Infecções por HIV , Masculino , Humanos , Feminino , Adulto , Comportamento Sexual , Pobreza , QuêniaRESUMO
Introduction: HIV self-testing (HIVST) is highly sensitive and specific, addresses known barriers to HIV testing (such as stigma), and is recommended by the World Health Organization as a testing option for the delivery of HIV pre-exposure prophylaxis (PrEP). Nevertheless, HIVST remains underutilized as a diagnostic tool in community-based, differentiated HIV service delivery models, possibly due to concerns about result misinterpretation, which could lead to inadvertent onward transmission of HIV, delays in antiretroviral therapy (ART) initiation, and incorrect initiation on PrEP. Ensuring that HIVST results are accurately interpreted for correct clinical decisions will be critical to maximizing HIVST's potential. Early evidence from a few small pilot studies suggests that artificial intelligence (AI) computer vision and machine learning could potentially assist with this task. As part of a broader study that task-shifted HIV testing to a new setting and cadre of healthcare provider (pharmaceutical technologists at private pharmacies) in Kenya, we sought to understand how well AI technology performed at interpreting HIVST results. Methods: At 20 private pharmacies in Kisumu, Kenya, we offered free blood-based HIVST to clients ≥18 years purchasing products indicative of sexual activity (e.g., condoms). Trained pharmacy providers assisted clients with HIVST (as needed), photographed the completed HIVST, and uploaded the photo to a web-based platform. In real time, each self-test was interpreted independently by the (1) client and (2) pharmacy provider, with the HIVST images subsequently interpreted by (3) an AI algorithm (trained on lab-captured images of HIVST results) and (4) an expert panel of three HIVST readers. Using the expert panel's determination as the ground truth, we calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for HIVST result interpretation for the AI algorithm as well as for pharmacy clients and providers, for comparison. Results: From March to June 2022, we screened 1,691 pharmacy clients and enrolled 1,500 in the study. All clients completed HIVST. Among 854 clients whose HIVST images were of sufficient quality to be interpretable by the AI algorithm, 63% (540/854) were female, median age was 26 years (interquartile range: 22-31), and 39% (335/855) reported casual sexual partners. The expert panel identified 94.9% (808/854) of HIVST images as HIV-negative, 5.1% (44/854) as HIV-positive, and 0.2% (2/854) as indeterminant. The AI algorithm demonstrated perfect sensitivity (100%), perfect NPV (100%), and 98.8% specificity, and 81.5% PPV (81.5%) due to seven false-positive results. By comparison, pharmacy clients and providers demonstrated lower sensitivity (93.2% and 97.7% respectively) and NPV (99.6% and 99.9% respectively) but perfect specificity (100%) and perfect PPV (100%). Conclusions: AI computer vision technology shows promise as a tool for providing additional quality assurance of HIV testing, particularly for catching Type II error (false-negative test interpretations) committed by human end-users. We discuss possible use cases for this technology to support differentiated HIV service delivery and identify areas for future research that is needed to assess the potential impacts-both positive and negative-of deploying this technology in real-world HIV service delivery settings.
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Infecções por HIV , HIV , Humanos , Feminino , Adulto , Masculino , Autoteste , Inteligência Artificial , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Teste de HIV , ComputadoresRESUMO
Understanding risk perception and risk-taking among youth can inform targeted prevention efforts. Using a health beliefs model-informed framework, we analysed 8 semi-structured, gender-specific focus group discussions with 93 youth 15-24 years old (48% male, 52% female), drawn from the SEARCH trial in rural Kenya and Uganda in 2017-2018, coinciding with the widespread introduction of PrEP. Highly connected social networks and widespread uptake of antiretrovirals shaped youth HIV risk perception. Amid conflicting information about HIV prevention methods, youth felt exposed to multiple HIV risk factors like the high prevalence of HIV, belief that people with HIV(PWH) purposefully infect others, dislike of condoms, and doubts about PrEP efficacy. Young women also reported minimal sexual autonomy in the context of economic disadvantages, the ubiquity of intergenerational and transactional sex, and peer pressure from other women to have many boyfriends. Young men likewise reported vulnerability to intergenerational sex, but also adopted a sexual conquest mentality. Comprehensive sexuality education and economic empowerment, through credible and trusted sources, may moderate risk-taking. Messaging should leverage youth's social networks to spread fact-based, gender- and age-appropriate information. PrEP should be offered alongside other reproductive health services to address both pregnancy concerns and reduce HIV risk.
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Background: Greater social capital is associated with positive health outcomes and better HIV management. The ways by which social capital may influence household water insecurity (HHWI), a critical determinant of health among persons living with HIV, remain underexplored. Further, despite the importance of reliable water access and use for health and agricultural productivity, few studies have described the strategies smallholder farmers living with HIV use to manage water insecurity. Objective: We qualitatively explored how an agricultural intervention (provision of a treadle pump for irrigation) influenced HHWI coping strategies through its impacts on social capital among smallholder farmers living with HIV in western Kenya. Method: In 2018, we purposively recruited participants from the Shamba Maisha study, a randomized agricultural intervention (NCT02815579) that provided irrigation pumps to improve treatment outcomes and food security among smallholder farmers living with HIV in western Kenya (nâ¯=â¯42). Participants shared their experiences with water insecurity through go-along and photo-elicitation interviews. Data were thematically analyzed using inductively developed codes. Results: Participants described diverse strategies for coping with agricultural water insecurity. Dimensions of social capital such as feelings of belonging, connectedness, and trust influenced the use of the treadle water pump and other water access behaviors. For instance, participants reported borrowing or sharing water pumps with friends and neighbors if they felt they had a good rapport. In addition, participants indicated a willingness to engage in collective activities, such as supporting the operation of the irrigation pump during planting, when they felt sufficiently connected to a larger group. Overall, individuals in the intervention arm described greater social cohesion, reciprocity, and community connectedness than those in the control arm. Conclusion: The impact of an agricultural intervention on water access and use was described as being modified by social capital among female smallholder farmers living with HIV. Findings suggest that social capital may create an enabling environment for implementing strategies that improve the management and reduce the burden of HIV. Measuring these strategies and their associations with HIV outcomes may strengthen our understanding of resilience among female smallholder farmers living with HIV. The development of a coping strategies index and its use in a longitudinal study could help to identify pathways through which social capital influences health and the effectiveness of livelihood interventions.
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BACKGROUND: In Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators. METHODS: The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored. DISCUSSION: We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Feminino , Adolescente , Infecções por HIV/prevenção & controle , Profilaxia Pré-Exposição/métodos , Quênia , Adulto Jovem , Fármacos Anti-HIV/administração & dosagem , Adesão à Medicação , Resultado do Tratamento , Fatores de Tempo , Estudos Multicêntricos como Assunto , Serviços Comunitários de FarmáciaRESUMO
INTRODUCTION: Young women in sub-Saharan Africa are a priority population for HIV prevention, yet challenges with adherence and persistence to HIV pre-exposure prophylaxis (PrEP) are common. This study involved the development and pilot testing of My Way-a novel delivery system for PrEP and co-packaged sexual health services. METHODS: My Way was developed in Kisumu, Kenya through a user-centred design process (2020). The intervention involves peer-delivery and support for HIV testing and PrEP use, self-collected vaginal swabs for sexually transmitted infection (STI) testing, pregnancy testing, oral contraceptive pills, self-injectable medroxyprogesterone and/or condoms. My Way was assessed among 16- to 24-year-old sexually active women in a randomized controlled trial versus standard of care (SoC; 2021-2022). Use of PrEP and other sexual health services were tracked at 1, 3 and 6 months for feasibility. Acceptability was determined by questionnaire. The effect of the intervention on tenofovir diphosphate (TFV-DP) levels was assessed by chi-square test (primary outcome); other predictors were explored with regression analysis. RESULTS: Among 150 women, the median age was 22 years and the median number of sexual partners was 2. Moderate/severe depression was common (60%). In the intervention arm, peers made 88% (198/225) of possible kit deliveries (177 with PrEP) and 49 STIs were diagnosed. In the SoC arm, 24% (55/225) of expected clinic visits occurred (53 with PrEP); no STI testing was performed. TVF-DP was detected in 16 participants at 6 months: 16% (12/75) in the intervention arm versus 5% (4/75) in the SoC arm (p = 0.03). Persistence among those with ongoing HIV prevention needs (i.e. prevention-effective persistence) was 18% (12/67) versus 7% (4/56; p = 0.08). No women acquired HIV. The intervention was significantly associated with detectable TFV-DP (OR 3.5, 1.1-11.4; p = 0.04); moderate/severe depression trended towards an association with TFV-DP (OR 0.2, 0.03-1.6; p = 0.13). CONCLUSIONS: My Way is a promising delivery system for PrEP and other sexual health services among young women in Western Kenya. We found high feasibility and acceptability. PrEP use was modest, but higher with My Way compared to SoC. Long-acting PrEP formulations may overcome important barriers to PrEP use and should be explored in combination with the My Way delivery model.
Assuntos
Adenina/análogos & derivados , Fármacos Anti-HIV , Infecções por HIV , Organofosfatos , Profilaxia Pré-Exposição , Saúde Sexual , Infecções Sexualmente Transmissíveis , Humanos , Feminino , Adulto Jovem , Adulto , Adolescente , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Quênia/epidemiologia , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/prevenção & controleRESUMO
OBJECTIVE: HIV stigma undermines antiretroviral treatment (ART) adherence and viral suppression. Livelihood interventions may target drivers of negative attitudes towards people with HIV (PWH) by improving their health and strengthening their economic contributions. We examined the effects of a multisectoral agricultural livelihood intervention on HIV stigma among PWH in western Kenya. DESIGN: Sixteen health facilities were randomly allocated (1â:â1) to intervention or control arms in Shamba Maisha , a cluster randomized controlled trial that aimed to improve HIV-related health through behavioral, mental health, and nutritional pathways. METHODS: The intervention included a farming loan and agricultural and financial training. Participants had access to farmland and surface water and were at least 18âyears old, on ART for more than 6 months, and moderately-to-severely food insecure. We measured internalized, anticipated, and enacted HIV stigma semiannually over 2 years using validated scales. In blinded intent-to-treat analyses, we compared changes in scores over 24âmonths by study arm, using longitudinal multilevel difference-in-differences linear regression models that accounted for clustering. RESULTS: Of 720 enrolled participants (354 intervention), 55% were women, and the median age was 40âyears [interquartile range 34-47âyears]. Two-year retention was 94%. Compared with the control arm, the intervention resulted in significant decreases ( P â<â0.001) of 0.42 points [95% confidence interval (CI) -0.52 to -0.31) in internalized stigma, 0.43 points (95% CI -0.51 to -0.34) in anticipated stigma, and 0.13 points (95% CI -0.16 to -0.09) in enacted stigma over 24âmonths. CONCLUSION: The agricultural livelihood intervention reduced HIV stigma among PWH. Poverty-reduction approaches may be a novel strategy for reducing HIV stigma.