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BackgroundFollowing 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 findingsWe 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.ConclusionsThese 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.

Introduction Healthcare providers are required to support people living with HIV (PLHIV) to quit tobacco use for improved health outcomes, but it is unclear to what extent they adhere to these requirements. We examined HIV care providers and PLHIV’s perceptions of support, and barriers, to providing tobacco cessation.Methods This qualitative investigation was part of a larger study seeking to integrate tobacco cessation into HIV care in Western Kenya (NCT05351606). We conducted 22 key informant interviews with HIV care providers and managers and four focus group discussions (n=28) with PLHIV. The interviews and discussions were audio-recorded, and audio files were transcribed and, when necessary, translated into English for coding and analysis.Results PLHIV rarely disclose or are screened for tobacco use unless a complaint or clinical finding prompts a provider. Despite PLHIV wanting to receive support to quit tobacco use, they feared negative reactions from their providers if they disclosed their tobacco use status. Providers cited several system-related barriers to screening for and providing cessation support for PLHIV, including workload pressure, lack of job aids, tobacco use screening not included as a performance indicator and lack of adequate counselling skills to address tobacco use.Conclusions PLHIV are not routinely screened for tobacco use despite their knowledge of the negative impact of tobacco use on overall health outcomes and desire to quit. System-related barriers hinder providers from providing cessation support. Providers should be trained and equipped with additional skills and resources to integrate tobacco cessation support into routine HIV care.

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.

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.

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.

Methods We applied an iterative, four-phased HCD process in Kenya that included: (1) systematic review of extant knowledge, (2) prioritisation of design challenges, (3) a co-creation workshop and (4) translation tables to pair insights with trial intervention adaptations. The co-creation workshop was co-led by youth facilitators employing participatory activities to inform intervention adaptations. Iterative data analysis included rapid thematic analysis of visualised workshop outputs and notes using affinity mapping and dialogue to identify key themes. We conducted a survey to assess workshop acceptability among participants.Results Twenty-two participants engaged in the 4-day workshop. Co-creation activities yielded recommendations for improving planned interventions (eg, message frequency and content; strategies to engage hard-to-reach participants), critical principles to employ across interventions (eg, personalisation, AYA empowerment) and identification of unanticipated AYA HIV treatment priorities (eg, drug holidays, transition from adolescent to adult services). We revised intervention content, peer navigator training materials and study inclusion criteria in response to findings. The youth-led HCD workshop was highly acceptable to participants.Conclusions Research employing HCD among youth can improve interventions preimplementation through empathy, youth-led inquiry and real-time problem solving. Peer navigation may be most influential in improving retention when engagement with young people is based on mutual trust, respect, privacy and extends beyond HIV-specific support. Identifying opportunities for personalisation and adaptation within intervention delivery is important for AYAs. Patient engagement interventions that target young people should prioritise improved transition between youth and adult services, youth HIV status disclosure, AYA empowerment and healthcare worker responsiveness in interactions and episodic adherence interruptions.

Non-disclosure of human immunodeficiency virus (HIV) status can hinder optimal health outcomes for people living with HIV (PLHIV). We sought to explore experiences with and correlates of disclosure among PLHIV participating in a study of population mobility. Survey data were collected from 1081 PLHIV from 2015-16 in 12 communities in Kenya and Uganda participating in a test-and-treat trial (SEARCH, NCT#01864603). Pooled and sex-stratified multiple logistic regression models examined associations of disclosure with risk behaviors controlling for covariates and community clustering. At baseline, 91.0% (n = 984) of PLHIV had disclosed their serostatus. Amongst those who had never disclosed, 31% feared abandonment (47.4% men vs. 15.0% women; p = 0.005). Non-disclosure was associated with no condom use in the past 6 months (aOR = 2.44; 95%CI, 1.40-4.25) and with lower odds of receiving care (aOR = 0.8; 95%CI, 0.04-0.17). Unmarried versus married men had higher odds of non- disclosure (aOR = 4.65, 95%CI, 1.32-16.35) and no condom use in the past 6 months (aOR = 4.80, 95%CI, 1.74-13.20), as well as lower odds of receiving HIV care (aOR = 0.15; 95%CI, 0.04-50 0.49). Unmarried versus married women had higher odds of non-disclosure (aOR = 3.14, 95%CI, 1.47-6.73) and lower odds of receiving HIV care if they had never disclosed (aOR = 0.05, 95%CI, 0.02-0.14). Findings highlight gender differences in barriers to HIV disclosure, use of condoms, and engagement in HIV care. Interventions focused on differing disclosure support needs for women and men are needed and may help facilitate better care engagement for men and women and improve condom use in men.

Climate change is associated with adverse mental and emotional health outcomes. Social and economic factors are well-known drivers of mental health, yet comparatively few studies examine the social and economic pathways through which climate change affects mental health. There is additionally a lack of research on climate change and mental health in sub-Saharan Africa. This qualitative study aimed to identify potential social and economic pathways through which climate change impacts mental and emotional wellbeing, focusing on a vulnerable population of Kenyan smallholder farmers living with HIV. We conducted in-depth, semi-structured interviews with forty participants to explore their experience of climate change. We used a thematic analytical approach. We find that among our study population of Kenyan smallholder farmers living with HIV, climate change is significantly affecting mental and emotional wellbeing. Respondents universally report some level of climate impact on emotional health including high degrees of stress; fear and concern about the future; and sadness, worry, and anxiety from losing one's home, farm, occupation, or ability to support their family. Climate-related economic insecurity is a main driver of emotional distress. Widespread economic insecurity disrupts systems of communal and family support, which is an additional driver of worsening mental and emotional health. Our study finds that individual adaptive strategies used by farmers in the face of economic and social volatility can deepen economic insecurity and are likely insufficient to protect mental health. Finally, we find that agricultural policies can worsen economic insecurity and other mental health risk factors. Our proposed conceptual model of economic and social pathways relevant for mental health can inform future studies of vulnerable populations and inform health system and policy responses to protect health in a changing climate.

IntroductionEffective use of oral HIV pre-exposure prophylaxis (PrEP) has been lower among African adolescent girls and young women (AGYW) than among older women, young men who have sex with men, and serodiscordant heterosexual couples in the region. Efforts to build PrEP support have centered around peers and male partners, but the family may also play an important role. This qualitative study aimed to describe family influence on PrEP use among AGYW in in three African cities.MethodsPOWER (Prevention Options for Women Evaluation Research) was a PrEP demonstration project among 2550 AGYW (16-25 years old) in Johannesburg and Cape Town, South Africa and Kisumu, Kenya conducted from 2017 to 2020. In-depth interviews and focus group discussions were conducted with 136 AGYW participants to explore their PrEP views and experiences, including awareness and interest in PrEP; barriers and facilitators to uptake and use; the influence of family, peers, intimate partners, and community; and the key types of support for their PrEP use. Transcripts were coded and analysed thematically.ResultsThe decision to initiate PrEP was associated with fear and anxiety linked to anticipated stigma from family members, and with family's lived HIV experience. Family disclosure, especially to mothers, was important to participants, as most lived with their families and considered it essential for them to obtain their mother's approval to use PrEP. Most family members, particularly mothers, provided instrumental, emotional, informational and appraisal support to participants using PrEP, including reminders, encouragement, and problem-solving. Participants reported that family members with insufficient information about PrEP safety and efficacy and who voiced concerns were a substantial barrier to their use. However, they often became supportive after receiving more PrEP information.ConclusionFamilies, particularly mothers, can play an important role in supporting PrEP use. PrEP programmes should leverage family support to help with PrEP persistence by providing basic information to families about PrEP safety and efficacy. AGYW using PrEP should be encouraged to selectively disclose PrEP use to build support and counseled on how to disclose and address family concerns.

Measuring empowerment is critical to understanding the level of control adolescents and young adults (AYA) have over their sexual and reproductive health (SRH) behaviors, and could provide a key window into addressing their unique SRH needs. We adapted the Sexual and Reproductive Empowerment (SRE) scale for AYA for use in an East African context. This multi-method qualitative study sampled 15-23 year-old female adolescents and young adults in Kisumu, Kenya. We conducted in-depth interviews (n = 30) and analyzed transcripts with an inductive, constant comparison approach. Empowerment domains were integrated with Kabeer's (1999) framework in a conceptual model, which we referenced to revise the original and develop new scale items. Items underwent expert review, and were condensed and translated through team-based consensus-building. We evaluated content validity in cognitive interviews (n = 25), during which item phrasing and word choice were revised to generate an adapted SRE scale. Participants (n = 55) had a median age of 18 (range 16-23), and 75% were under 19 years. We categorize three types of adaptations to the SRE scale: new item generation, item revision, and translation/linguistic considerations. We developed nine new items reflecting AYA's experiences and new domains of empowerment that emerged from the data; new domains relate to self-efficacy in accessing sexual and reproductive health care, and how material needs are met. All items were revised and translated to echo concepts and language relevant to participants, navigating the multilingualism common in many African countries. Centering the voices of female Kenyan AYA, this study provides insight into measuring the latent construct of adolescent sexual and reproductive empowerment in an East African setting, and supports the adapted SRE scale's content validity for Kenya. We detail our multi-method, theory-driven approach, contributing to limited methods guidance for measure adaptation across contexts and among diverse adolescent populations.

BackgroundAntiretroviral therapy (ART) assures major gains in health outcomes among people living with HIV, however, this benefit may not be realized by all due to care interruptions. Mobile populations comprise a subgroup that is likely to have sub-optimal care engagement, resulting in discontinuation of ART. We sought to evaluate the barriers to care engagement among highly mobile individuals living with HIV and explore options aimed at improving engagement in care for this group.MethodsQualitative in-depth interviews were conducted in 2020 among a purposive sample of twelve persons living with HIV and eight health care providers in western Kenya, within a mixed methods study of mobility in communities participating in the SEARCH trial (NCT01864603). We explored the barriers to care engagement among mobile individuals living with HIV and explored different options aimed at enhancing care engagement. These included options such as a coded card containing treatment details, alternative drug packaging to conceal drug identity, longer refills to cover travel period, wrist bands with data storage capability to enable data transfer and "warm handoff" by providers to new clinics upon transfer. Data were inductively analyzed to understand the barriers and acceptability of potential interventions to address them.ResultsStigma and lack of disclosure, rigid work schedules, and unpredictability of travel were major barriers to care engagement for highly mobile individuals living with HIV. Additionally, lack of flexibility in clinic schedules and poor provider attitude were identified as health-system-associated barriers to care engagement. Options that enhance flexibility, convenience and access to care were viewed as the most effective means of addressing the barriers to care by both patients and providers. The most preferred option was a coded card with treatment details followed by alternative drug packaging to conceal drug identity due to stigma and longer refills to cover travel periods.ConclusionHighly mobile individuals living with HIV desire responsive, flexible, convenient and patient-centered care delivery models to enhance care engagement. They embraced simple health delivery improvements such as coded cards, alternative drug packaging and longer refills to address challenges of mobility.

Summary: Background: Cervical cancer incidence is high in Kenya due to HIV and limited access to cancer prevention services. Human papillomavirus (HPV) has been shown to increase HIV acquisition; however, the potential impact of HPV vaccination on HIV is unknown. We modeled the health impact of HPV vaccination in the context of the HIV epidemiology in Kenya. Methods: Using a validated compartmental transmission model of HIV and HPV set in Kenya, we evaluated five scenarios of nonavalent HPV vaccination: single-age-vaccination of 10-year-old girls at 90% coverage; multi-age-cohort (MAC) vaccination of 10-14-year-old girls at 90% coverage; MAC plus moderate-coverage (50%) catch-up vaccination of 15-24-year-old women; MAC plus high-coverage (80%) catch-up of 15-24-year-old women; and MAC plus catch-up of 15-44-year-old women at 80% coverage (HPV-FASTER). We compared cervical cancer incidence, HIV prevalence, and cumulative cervical cancer and HIV cases averted after 50 years to a baseline scenario without vaccination. In all scenarios, we assumed the UNAIDS 90-90-90 goal for HIV treatment is attained by 2030. Findings: In 2021, model-estimated cervical cancer incidence is 44/100,000 and HIV prevalence among women is 6·5%. In 2070, projected cancer incidence declines to 27/100,000 and HIV prevalence reaches 0·3% without vaccination. With single-age-vaccination, cancer incidence in 2070 is reduced by 68%, averting 64,529 cumulative cancer cases. MAC vaccination reduces cancer incidence by 75%, averting 206,115 cancer cases. Moderate and high-coverage catch-up and HPV-FASTER reduce cancer incidence by 80%, 82%, and 84%, averting 254,930, 278,690, and 326,968 cancer cases, respectively. In all scenarios, HIV prevalence in 2070 is reduced by a relative 8-11%, with 15,609-34,981 HIV cases averted after 50 years. Interpretation: HPV vaccination can substantially reduce cervical cancer incidence in Kenya in the next 50 years, particularly if women up to age 24 are vaccinated. HIV treatment scale-up can also alleviate cervical cancer burden. However, HPV vaccination has modest additional impact on HIV when antiretroviral therapy coverage is high. Funding: National Institutes of Health, Bill and Melinda Gates Foundation

Summary: Background: Universal testing and treatment for HIV has shown promise as an approach to reduce mortality and lower HIV incidence. Evidence on the economic effects of this approach on individuals and households in low-resource settings is scarce. We aimed to examine the effect of universal HIV testing and treatment on a range of economic outcomes. Methods: We collected data in household surveys done over a 3-year period in a sample of HIV-positive and HIV-negative adults participating in a cluster-randomised trial of universal HIV testing and treatment in 32 rural communities in Kenya and Uganda. Communities of approximately 10 000 people were pair-matched on the basis of geographical and population characteristics, with the best-matching 16 pairs randomly assigned (1:1) to intervention or control groups. Participants in intervention communities received annual HIV and multidisease testing, universal antiretroviral therapy (ART) eligibility, and patient-centred care. Participants in control communities received baseline testing and medical care according to national guidelines. We analysed employment and health-care utilisation outcomes for working-age adults (age 18–65 years) and education outcomes for school-age children (6–17 years) using data from 3 years after the intervention. This trial is now complete, and is registered with ClinicalTrials.gov, NCT01864603. Findings: Between July 9, 2013, and June 15, 2017, we collected survey data on 8198 working-age adults and 6755 school-age children. Compared with adults living with HIV in control communities, adults living with HIV in intervention communities were more likely to be employed (difference 9·7% [95% CI 2·1 to 18·3]), less likely to seek health care (–10·3% [–22·0 to 0·1]), and less likely to spend money on health care (–12·7% [–22·4 to 0·6]) 3 years after the intervention. We found no significant differences in outcomes between HIV-negative adults in intervention and control communities. Among children in households with HIV-positive adults, the intervention led to a 7·3% (95% CI 1·0 to 15·1) increase in primary school completion after 3 years in intervention communities compared with control communities. Interpretation: Universal HIV testing and treatment improved employment outcomes and other indicators of socioeconomic wellbeing for HIV-positive adults and children in their households, but had no effect on HIV-negative adults. Our findings suggest that the considerable investments needed to expand ART access might have substantial short-term and long-term economic returns. Funding: National Institutes of Health.

IntroductionAgriculture is the primary source of income and household food for >75% of rural Kenyans, including people living with HIV (PLHIV), making agricultural yields an important factor in food security and nutrition. Previous studies have shown the interconnectedness of food insecurity, malnutrition, and poor HIV health by elucidating that having one of these conditions increases the likelihood and severity of having another. However, few studies have explored the linkages between agricultural practices, food security and nutrition for PLHIV, or how agricultural livelihood interventions may affect these domains. This study aimed to examine the mechanisms through which an agricultural livelihood intervention can positively or negatively affect agricultural practices, food security, and nutrition for PLHIV.MethodsFrom July 2012-August 2013, we interviewed participants with HIV on antiretroviral therapy (ART) enrolled in a pilot randomized controlled trial (RCT) of an agricultural livelihood and finance intervention to understand the mechanisms through which the intervention may have affected HIV health outcomes. The intervention included agricultural and finance training and a microfinance loan to purchase the MoneyMaker hip pump, a human-powered water pump, seeds, and other farming implements. A purposive sample of 45 intervention and a random subset of 9 control participants were interviewed at 12-month endline visit with a subset of 31 intervention participants interviewed longitudinally at both the 3- and 12-month visits. Transcripts were double coded using an inductive-deductive approach and analyzed for impacts of the intervention on agricultural practices, food security, and nutrition using analytic reports for each key theme.ResultsAll intervention participants described improvements in agricultural practices and yields attributed to the intervention while many also described improvements in income; these changes in turn contributed to improved HIV health, including suppressed viral loads, and a few people noted improved immunologic parameters. Key mechanisms included the knowledge gained from agricultural training which led to improved yields and access to new markets. The use of the irrigation pump was also identified as an additional, lesser important mechanism. All intervention participants reported sustained improvements in food security and nutrition through increased yields and income from the sale of excess crops used to purchase food, and diversification of fresh fruits and vegetables consumed through agricultural production. This led to self-reported weight gain which was a nutritional mechanism towards improved health.ConclusionsAgricultural and finance interventions that improve farming practices could lead to improved health outcomes through the pathways of improved food security, income, and diversified diet. The results from this study helped the team to enhance the intervention prior to implementation of the larger cluster RCT (cRCT). By understanding how agricultural livelihood interventions act upon pathways towards improved health, policy options can be developed and implemented to include components that are needed to achieve sustainable outcomes.Trial registrationClinicalTrials.gov NCT01548599.

Novel "differentiated service delivery" models for HIV treatment that reduce clinic visit frequency, minimize waiting time, and deliver treatment in the community promise retention improvement for HIV treatment in Sub-Saharan Africa. Quantitative assessments of differentiated service delivery (DSD) feature most preferred by patient populations do not widely exist but could inform selection and prioritization of different DSD models. We used a discrete choice experiment (DCE) to elicit patient preferences of HIV treatment services and how they differ across DSD models. We surveyed 18+year-olds, enrolled in HIV care for ≥6 months between February-March, 2019 at four facilities in Kisumu County, Kenya. DCE offered patients a series of comparisons between three treatment models, each varying across seven attributes: ART refill location, quantity of dispensed ART at each refill, medication pick-up hours, type of adherence support, clinical visit frequency, staff attitude, and professional cadre of person providing ART refills. We used hierarchical Bayesian model to estimate attribute importance and relative desirability of care characteristics, latent class analysis (LCA) for groups of preferences and mixed logit model for willingness to trade analysis. Of 242 patients, 128 (53.8%) were females and 150 (62.8%) lived in rural areas. Patients placed greatest importance on ART refill location [19.5% (95% CI 18.4, 10.6) and adherence support [19.5% (95% CI 18.17, 20.3)], followed by staff attitude [16.1% (95% CI 15.1, 17.2)]. In the mixed logit, patients preferred nice attitude of staff (coefficient = 1.60), refill ART health center (Coeff = 1.58) and individual adherence support (Coeff = 1.54), 3 or 6 months for ART refill (Coeff = 0.95 and 0.80, respectively) and pharmacists (instead of lay health workers) providing ART refill (Coeff = 0.64). No differences were observed by gender or urbanicity. LCA revealed two distinct groups (59.5% vs. 40.5%). Participants preferred 3 to 6-month refill interval or clinic visit spacing, which DSD offers stable patients. While DSD has encouraged community ART group options, our results suggest strong preferences for ART refills from health-centers or pharmacists over lay-caregivers or community members. These preferences held across gender&urban/rural subpopulations.

Summary: Background: Successful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya. Methods: As part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010. Findings: After the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25–39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2–39·5, p

BackgroundHypertension treatment reduces morbidity and mortality yet has not been broadly implemented in many low-resource settings, including sub-Saharan Africa (SSA). We hypothesized that a patient-centered integrated chronic disease model that included hypertension treatment and leveraged the HIV care system would reduce mortality among adults with uncontrolled hypertension in rural Kenya and Uganda.Methods and findingsThis is a secondary analysis of the SEARCH trial (NCT:01864603), in which 32 communities underwent baseline population-based multidisease testing, including hypertension screening, and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Patient-centered care included on-site introduction to clinic staff at screening, nursing triage to expedite visits, reduced visit frequency, flexible clinic hours, and a welcoming clinic environment. The analytic population included nonpregnant adults (≥18 years) with baseline uncontrolled hypertension (blood pressure ≥140/90 mm Hg). The primary outcome was 3-year all-cause mortality with comprehensive population-level assessment. Secondary outcomes included hypertension control assessed at a population level at year 3 (defined per country guidelines as at least 1 blood pressure measure ConclusionsIn this cluster randomized comparison where both arms received population-level hypertension screening, implementation of a patient-centered hypertension care model was associated with a 21% reduction in all-cause mortality and a 22% improvement in hypertension control compared to standard care among adults with baseline uncontrolled hypertension. Patient-centered chronic care programs for HIV can be leveraged to reduce the overall burden of cardiovascular mortality in SSA.Trial registrationClinicalTrials.gov NCT01864603.

BackgroundOral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but data are limited on HIV incidence among PrEP users in generalized epidemic settings, particularly outside of selected risk groups. We performed a population-based PrEP study in rural Kenya and Uganda and sought to evaluate both changes in HIV incidence and clinical and virologic outcomes following seroconversion on PrEP.Methods and findingsDuring population-level HIV testing of individuals ≥15 years in 16 communities in the Sustainable East Africa Research in Community Health (SEARCH) study (NCT01864603), we offered universal access to PrEP with enhanced counseling for persons at elevated HIV risk (based on serodifferent partnership, machine learning-based risk score, or self-identified HIV risk). We offered rapid or same-day PrEP initiation and flexible service delivery with follow-up visits at facilities or community-based sites at 4, 12, and every 12 weeks up to week 144. Among participants with incident HIV infection after PrEP initiation, we offered same-day antiretroviral therapy (ART) initiation and analyzed HIV RNA, tenofovir hair concentrations, drug resistance, and viral suppression (ConclusionsPopulation-level offer of PrEP with rapid start and flexible service delivery was associated with 74% lower HIV incidence among PrEP initiators compared to matched recent controls prior to PrEP availability. HIV infections were significantly lower among women who started PrEP. Universal HIV testing with linkage to treatment and prevention, including PrEP, is a promising approach to accelerate reductions in new infections in generalized epidemic settings.Trial registrationClinicalTrials.gov NCT01864603.

IntroductionOral pre-exposure prophylaxis (PrEP) is increasingly being implemented in sub-Saharan Africa. Adolescent girls and young women (AGYW) in Kenya contribute more than half of all new infections among young people aged 15-24 years, highlighting the need for evidence on the cost of PrEP in real-world implementation to inform the budget impact, cost-effectiveness, and financial sustainability of PrEP programs.MethodsWe estimated the cost of delivering PrEP to AGYW enrolled in a PrEP implementation study in two family planning clinics in Kisumu county, located in western Kenya. We derived total annual costs and the average cost per client-month of PrEP by input type (variable or fixed) and visit type (initiation or follow-up). We estimated all costs as implemented in the study, and under implementation by the Kenyan Ministry of Health (MoH), both at the program volume observed and if the facilities were delivering PrEP at full capacity (scaled-MoH).ResultsFor the costing period between March 2018 and March 2019, 615 HIV-negative women contributed 1,128 (502 initiation and 626 follow-up) visits. The average cost per client-month of PrEP dispensed per study protocol and per the MoH scenario was $28.92 and $14.52, respectively. If the MoH scaled the program so that facilities could see PrEP clients at capacity, the average cost per client-month of PrEP was $10.88. Medication costs accounted for the largest proportion of the total annual costs (48% in MoH scenario and 65% in the scaled-MoH scenario).ConclusionsUsing data from a PrEP implementation program, we found that the cost per client-month of PrEP dispensed is reduced by 62% if PrEP delivery at the two clinics is scaled up by the MoH. Our findings are valuable for informing local resource allocation and budgetary cost projections for scale-up of PrEP delivery to AGYW. Additionally, previous cost-effectiveness studies have been limited by the use of fixed assumptions of the cost of PrEP per person-month. Our study provides cost estimates from practical data which will better inform cost-effectiveness and budget impact analyses.

BackgroundHIV-positive women suffer a high burden of mental disorders due in part to gender-based violence (GBV). Comorbid depression and posttraumatic stress disorder (PTSD) are typical psychiatric consequences of GBV. Despite attention to the HIV-GBV syndemic, few HIV clinics offer formal mental healthcare. This problem is acute in sub-Saharan Africa, where the world's majority of HIV-positive women live and prevalence of GBV is high.Methods and findingsWe conducted a randomized controlled trial at an HIV clinic in Kisumu, Kenya. GBV-affected HIV-positive women with both major depressive disorder (MDD) and PTSD were randomized to 12 sessions of interpersonal psychotherapy (IPT) plus treatment as usual (TAU) or Wait List+TAU. Nonspecialists were trained to deliver IPT inside the clinic. After 3 months, participants were reassessed, and those assigned to Wait List+TAU were given IPT. The primary outcomes were diagnosis of MDD and PTSD (Mini International Neuropsychiatric Interview) at 3 months. Secondary outcomes included symptom measures of depression and PTSD, intimate partner violence (IPV), and disability. A total of 256 participants enrolled between May 2015 and July 2016. At baseline, the mean age of the women in this study was 37 years; 61% reported physical IPV in the past week; 91% reported 2 or more lifetime traumatic events and monthly income was 18USD. Multilevel mixed-effects logistic regression showed that participants randomized to IPT+TAU had lower odds of MDD (odds ratio [OR] 0.26, 95% CI [0.11 to 0.60], p = 0.002) and lower odds of PTSD (OR 0.35, [0.14 to 0.86], p = 0.02) than controls. IPT+TAU participants had lower odds of MDD-PTSD comorbidity than controls (OR 0.36, 95% CI [0.15 to 0.90], p = 0.03). Linear mixed models were used to assess secondary outcomes: IPT+TAU participants had reduced disability (-6.9 [-12.2, -1.5], p = 0.01), and nonsignificantly reduced work absenteeism (-3.35 [-6.83, 0.14], p = 0.06); partnered IPT+TAU participants had a reduction of IPV (-2.79 [-5.42, -0.16], p = 0.04). Gains were maintained across 6-month follow-up. Treatment group differences were observed only at month 3, the time point at which the groups differed in IPT status (before cross over). Study limitations included 35% attrition inclusive of follow-up assessments, generalizability to populations not in HIV care, and data not collected on TAU resources accessed.ConclusionsIPT for MDD and PTSD delivered by nonspecialists in the context of HIV care yielded significant improvements in HIV-positive women's mental health, functioning, and GBV (IPV) exposure, compared to controls.Trial registrationClinical Trials Identifier NCT02320799.

BackgroundExisting social relationships are a potential source of "social capital" that can enhance support for sustained retention in HIV care. A previous pilot study of a social network-based 'microclinic' intervention, including group health education and facilitated HIV status disclosure, reduced disengagement from HIV care. We conducted a pragmatic randomized trial to evaluate microclinic effectiveness.MethodsIn nine rural health facilities in western Kenya, we randomized HIV-positive adults with a recent missed clinic visit to either participation in a microclinic or usual care (NCT02474992). We collected visit data at all clinics where participants accessed care and evaluated intervention effect on disengagement from care (≥90-day absence from care after a missed visit) and the proportion of time patients were adherent to clinic visits ('time-in-care'). We also evaluated changes in social support, HIV status disclosure, and HIV-associated stigma.ResultsOf 350 eligible patients, 304 (87%) enrolled, with 154 randomized to intervention and 150 to control. Over one year of follow-up, disengagement from care was similar in intervention and control (18% vs 17%, hazard ratio 1.03, 95% CI 0.61-1.75), as was time-in-care (risk difference -2.8%, 95% CI -10.0% to +4.5%). The intervention improved social support for attending clinic appointments (+0.4 units on 5-point scale, 95% CI 0.08-0.63), HIV status disclosure to close social supports (+0.3 persons, 95% CI 0.2-0.5), and reduced stigma (-0.3 units on 5-point scale, 95% CI -0.40 to -0.17).ConclusionsThe data from our pragmatic randomized trial in rural western Kenya are compatible with the null hypothesis of no difference in HIV care engagement between those who participated in a microclinic intervention and those who did not, despite improvements in proposed intervention mechanisms of action. However, some benefit or harm cannot be ruled out because the confidence intervals were wide. Results differ from a prior quasi-experimental pilot study, highlighting important implementation considerations when evaluating complex social interventions for HIV care.Trial registrationClinical trial number: NCT02474992.

BackgroundAdditional progress towards HIV epidemic control requires understanding who remains at risk of HIV infection in the context of high uptake of universal testing and treatment (UTT). We sought to characterize seroconverters and risk factors in the SEARCH UTT trial (NCT01864603), which achieved high uptake of universal HIV testing and ART coverage in 32 communities of adults (≥15 years) in rural Uganda and Kenya.MethodsIn a pooled cohort of 117,114 individuals with baseline HIV negative test results, we described those who seroconverted within 3 years, calculated gender-specific HIV incidence rates, evaluated adjusted risk ratios (aRR) for seroconversion using multivariable targeted maximum likelihood estimation, and assessed potential infection sources based on self-report.ResultsOf 704 seroconverters, 63% were women. Young (15-24 years) men comprised a larger proportion of seroconverters in Western Uganda (18%) than Eastern Uganda (6%) or Kenya (10%). After adjustment for other risk factors, men who were mobile [≥1 month of prior year living outside community] (aRR:1.68; 95%CI:1.09,2.60) or who HIV tested at home vs. health fair (aRR:2.44; 95%CI:1.89,3.23) were more likely to seroconvert. Women who were aged ≤24 years (aRR:1.91; 95%CI:1.27,2.90), mobile (aRR:1.49; 95%CI:1.04,2.11), or reported a prior HIV test (aRR:1.34; 95%CI:1.06,1.70), or alcohol use (aRR:2.07; 95%CI:1.34,3.22) were more likely to seroconvert. Among survey responders (N = 607, 86%), suspected infection source was more likely for women than men to be ≥10 years older (28% versus 8%) or a spouse (51% vs. 31%) and less likely to be transactional sex (10% versus 16%).ConclusionIn the context of universal testing and treatment, additional strategies tailored to regional variability are needed to address HIV infection risks of young women, alcohol users, mobile populations, and those engaged in transactional sex to further reduce HIV incidence rates.

HIV-related stigma is a frequently cited barrier to HIV testing and care engagement. A nuanced understanding of HIV-related stigma is critical for developing stigma-reduction interventions to optimize HIV-related outcomes. This qualitative study documented HIV-related stigma across eight communities in east Africa during the baseline year of a large HIV test-and-treat trial (SEARCH, NCT: 01864603), prior to implementation of widespread community HIV testing campaigns and efforts to link individuals with HIV to care and treatment. Findings revealed experiences of enacted, internalized and anticipated stigma that were highly gendered, and more pronounced in communities with lower HIV prevalence; women, overwhelmingly, both held and were targets of stigmatizing attitudes about HIV. Past experiences with enacted stigma included acts of segregation, verbal discrimination, physical violence, humiliation and rejection. Narratives among women, in particular, revealed acute internalized stigma including feelings of worthlessness, shame, embarrassment, and these resulted in anxiety and depression, including suicidality among a small number of women. Anticipated stigma included fears of marital dissolution, verbal and physical abuse, gossip and public ridicule. Anticipated stigma was especially salient for women who held internalized stigma and who had experienced enacted stigma from their partners. Anticipated stigma led to care avoidance, care-seeking at remote facilities, and hiding of HIV medications. Interventions aimed at reducing individual and community-level forms of stigma may be needed to improve the lives of PLHIV and fully realize the promise of test-and-treat strategies.

IntroductionTo improve retention on HIV treatment in Africa, public health programs are promoting a family of innovations to service delivery-referred to as "differentiated service delivery" (DSD) models-which seek to better meet the needs of both systems and patients by reducing unnecessary encounters, expanding access, and incorporating peers and patients in patient care. Data on the relative desirability of different models to target populations, which is currently sparse, can help guide prioritization of specific models during scale-up.MethodsWe conducted a discrete choice experiment to assess patient preferences for various characteristics of treatment services. Clinically stable people living with HIV were recruited from an HIV clinic in Kisumu, Kenya. We selected seven attributes of DSD models drawn from literature review and previous qualitative work. We created a balanced and orthogonal design to identify main term effects. A total of ten choice tasks were solicited per respondent. We calculated relative utility (RU) for each attribute level, a numerical representation of the strength of patient preference. Data were analyzed using a Hierarchical Bayesian model via Sawtooth Software.ResultsOne hundred and four respondents (37.5% men, 41.1 years mean age) preferred receiving care at a health facility, compared with home-delivery or a community meeting point (RU = 69.3, -16.2, and -53.1, respectively; p << 0.05); receiving those services from clinicians and pharmacists-as opposed to lay health workers or peers (RU = 21.5, 5.9, -24.5; p < 0.05); and preferred an individual support system over a group support system (RU = 15.0 and 4.2; p < 0.05). Likewise, patients strongly preferred longer intervals between both clinical reviews (RU = 40.1 and -50.7 for 6- and 1-month spacing, respectively; p < 0.05) and between ART collections (RU = 33.6 and -49.5 for 6- and1-month spacing, respectively; p < 0.05).ConclusionAlthough health systems find community- and peer-based DSD models attractive, clinically stable patients expressed a preference for facility-based care as long as clinical visits were extended to biannual. These data suggest that multi-month scripting and fast-track models best align with patient preferences, an insight which can help prioritize use of different DSD models in the region.

Abstract Background Factors influencing fertility desires among HIV-infected individuals remain poorly understood. With new recommendations for universal HIV treatment and increasing antiretroviral therapy (ART) access, we sought to evaluate how access to early ART influences fertility desires among HIV-infected ART-naïve women. Methods Semi-structured in-depth interviews were conducted with a select subgroup of 20 HIV-infected ART-naïve women attending one of 13 HIV facilities in western Kenya between July and August 2014 who would soon newly become eligible to initiate ART based on the latest national policy recommendations. The interviews covered four major themes: 1) definitions of family and children’s role in community; 2) personal, interpersonal, institutional, and societal factors influencing fertility desires; 3) influence of HIV-positive status on fertility desires; and 4) influence of future ART initiation on fertility desires. An iterative process of reading transcripts, applying inductive codes, and comparing and contrasting codes was used to identify convergent and divergent themes. Results The women indicated their HIV-positive status did influence—largely negatively—their fertility desires. Furthermore, initiating ART and anticipating improved health status did not necessarily translate to increased fertility desires. Instead, individual factors, such as age, parity, current health status, financial resources and number of surviving or HIV-infected children, played a crucial role in decisions about future fertility. In addition, societal influences, such as community norms and health providers’ expectations of their fertility desires, played an equally important role in determining fertility desires. Conclusions Initiating ART may not be the leading factor influencing fertility desires among previously ART-naïve HIV-infected women. Instead, individual and societal factors appear to be the major determinants of fertility desires among these women.

BackgroundApproximately one in every five adolescent girls in Kenya has either had a live birth or is pregnant with her first child. There is an urgent need to understand the language and symbols used to represent adolescent pregnancy, if the current trend in adolescent pregnancy is to be reversed. Agreement on the definition of a societal problem is an important precursor to a social issue's political prioritization and priority setting.MethodsWe apply the Public Arenas Model to appraise the environments, definitions, competition dynamics, principles of selection and current actors involved in problem-solving and prioritizing adolescent pregnancy as a policy issue. Using a focused ethnographic approach, we undertook semi-structured interviews with 14 members of adolescent sexual reproductive health networks at the national level and conducted thematic analysis of the interviews.FindingsWe found that existing definitions center around adolescent pregnancy as a "disease" that needs prevention and treatment, socially deviant behaviour that requires individual agency, and a national social concern that drains public resources and therefore needs to be regulated. These competing definitions contribute to the rarity of the topic achieving traction within the political agenda and contribute to conflicting solutions, such as lowering the legal age of consenting to sex, while limiting access to contraceptive information and services to minors.ConclusionThis paper provides a timely theoretical approach to draw attention to the different competing definitions and subsequent divergent interpretations of the problem of adolescent pregnancy in Kenya. Adolescent reproductive health stakeholders need to be familiar with the existing definitions and deliberately reframe this important social problem for better political prioritization and resource allocation. We recommend a definition of adolescent pregnancy that cuts across different arenas, and leverages already existing dominant and concurrent social and economic issues that are already on the agenda table.

BackgroundTimely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention.Methods and findingsIn a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range [IQR] 23-30), median gestational age was 30 weeks (IQR 28-34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk [aRR] 1.03; 95% CI 0.97-1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97-1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention.ConclusionsIn this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates.Trial registrationClinicalTrials.gov Trial Number NCT02350140.

BackgroundFemale positive/male negative HIV-serodiscordant couples express a desire for children and may engage in condomless sex to become pregnant. Current guidelines recommend antiretroviral treatment in HIV-serodiscordant couples, yet HIV RNA viral suppression may not be routinely assessed or guaranteed and pre-exposure prophylaxis may not be readily available. Therefore, options for becoming pregnant while limiting HIV transmission should be offered and accessible to HIV-affected couples desiring children.MethodsA prospective pilot study of female positive/male negative HIV-serodiscordant couples desiring children was conducted to evaluate the acceptability, feasibility, and effectiveness of timed vaginal insemination. Eligible women were 18-34 years with regular menses. Prior to timed vaginal insemination, couples were observed for two months, and tested and treated for sexually transmitted infections. Timed vaginal insemination was performed for up to six menstrual cycles. A fertility evaluation and HIV RNA viral load assessment was offered to couples who did not become pregnant.FindingsForty female positive/male negative HIV-serodiscordant couples were enrolled; 17 (42.5%) exited prior to timed vaginal insemination. Twenty-three couples (57.5%) were introduced to timed vaginal insemination; eight (34.8%) achieved pregnancy, and six live births resulted without a case of HIV transmission. Seven couples completed a fertility evaluation. Four women had no demonstrable tubal patency bilaterally; one male partner had decreased sperm motility. Five women had unilateral/bilateral tubal patency; and seven women had an HIV RNA viral load (≥ 400 copies/mL).ConclusionTimed vaginal insemination is an acceptable, feasible, and effective method for attempting pregnancy. Given the desire for children and inadequate viral suppression, interventions to support safely becoming pregnant should be integrated into HIV prevention programs.

INTRODUCTION:Global efforts to end HIV by 2030 focus on reducing and eventually eliminating new infections in priority populations. Identifying these populations and characterizing their vulnerability factors helps in guiding investment of scarce HIV prevention resources to achieve maximum impact. We sought to establish HIV prevalence, spatial distribution and risk factors for HIV infection in the Kenyan fishing communities of Lake Victoria. METHODS:We conducted a cross-sectional survey of 2637 people from all the 308 fish-landing beaches on the Kenyan shore of Lake Victoria. The number of participants enrolled at each beach were weighted based on the size of the beach, determined by the number of functional registered boats. We used simple random sampling to select those to be approached for study participation. Consenting participants were privately interviewed about their socio-economic and demographic characteristics and sexual behavior, and were invited for HIV test using the Kenya rapid HIV testing protocol. We used descriptive statistics and multivariate logistic and linear regression for analysis. RESULTS:We found high HIV prevalence of 32% with significant differences between men (29%) and women (38%). Among men, having an HIV negative sexual partner, being circumcised, increasing number of condom protected sex acts in the preceding month, being younger and being a resident of Homa Bay, Kisumu, Siaya and Busia counties compared to Migori County reduced the risk of HIV infection. For women, being married, having more children with the current spouse, having an HIV negative sexual partner and being a resident of Busia compared to Migori County reduced the risk of HIV infection. We also found that longer distance from the beaches to the nearest public health facilities was associated with increasing cumulative HIV prevalence at the beaches. CONCLUSION:Fishing communities have high HIV prevalence and may greatly benefit from interventions such as wider ART coverage, couple HIV risk reduction counseling, PrEP use for HIV negative partner at substantial continuous risk, alongside other HIV prevention services that the Kenyan government is currently rolling out. This will additionally require adequate plans to synchronize the provision of these services with the population's routine schedules for all these options to be reasonably accessible to them.

BackgroundPrevious research indicates clinical outcomes among HIV-infected men in sub-Saharan Africa are sub-optimal. The SEARCH test and treat trial (NCT01864603) intervention included antiretroviral care delivery designed to address known barriers to HIV-care among men by decreasing clinic visit frequency and providing flexible, patient-centered care with retention support. We sought to understand facilitators and barriers to retention in care in this universal treatment setting through quantitative and qualitative data analysis.MethodsWe used a convergent mixed methods study design to evaluate retention in HIV care among adults (age > = 15) during the first year of the SEARCH (NCT01864603) test and treat trial. Cox proportional hazards regression was used to evaluate predictors of retention in care. Longitudinal qualitative data from n = 190 in-depth interviews with HIV-positive individuals and health care providers were analyzed to identify facilitators and barriers to HIV care engagement.ResultsThere were 1,863 men and 3,820 women who linked to care following baseline testing. Retention in care was 89.7% (95% CI 87.0-91.8%) among men and 89.0% (86.8-90.9%) among women at one year. In both men and women older age was associated with higher rates of retention in care at one year. Additionally, among men higher CD4+ at ART initiation and decreased time between testing and ART initiation was associated with higher rates of retention. Maintaining physical health, a patient-centered treatment environment, supportive partnerships, few negative consequences to disclosure, and the ability to seek care in facilities outside of their community of residence were found to promote retention in care.ConclusionsFeatures of the ART delivery system in the SEARCH intervention and social and structural advantages emerged as facilitators to retention in HIV care among men. Messaging around the health benefits of early ART start, decreasing logistical barriers to HIV care, support of flexible treatment environments, and accelerated linkage to care, are important to men's success in ART treatment programs. Men already benefit from increased social support following disclosure of their HIV-status. Future efforts to shift gender norms towards greater equity are a potential strategy to support high levels of engagement in care for both men and women.

BACKGROUND:Despite substantial progress, gaps in the HIV care cascade remain large: globally, while about 36.7 million people were living with HIV in 2015, 11.9 million of these individuals did not know their HIV status, 12.7 million were in need of antiretroviral therapy (ART) and 13.0 million were not virally suppressed. We sought to deepen understanding of the barriers to care engagement at three critical steps of the care cascade proposed to make greatest impact for attaining the UNAIDS 90-90-90 targets aimed at shutting down the HIV epidemic. METHODS:Analyses were conducted among HIV-infected adults in rural East Africa. Qualitative data were collected using in-depth interviews among 63 individuals participating in an ongoing test-and treat trial (NCT01864683) in its baseline year (July 2013-June 2014). Audio recordings were transcribed, translated into English, and coded using Atlas.ti software. Data were analyzed using a thematic framework for explaining barriers to care engagement that drew upon both theory and prior empirical research in similar settings. RESULTS:Multiple barriers to engagement in care were observed. HIV-related stigma across dimensions of anticipated, internalized and enacted stigma manifested in denial and fears of disclosure, and influenced lapses in care engagement across multiple steps in the cascade. Poverty (lack of food and transport), lack of social support, work interference, prior negative experiences with health services, drug side effects, and treatment fatigue also negatively affected ART adherence and viral suppression. Gender differences were observed, with work interference and denial disproportionately affecting men compared to women. CONCLUSION:Multiple barriers to HIV care engagement still pervade rural sub-Saharan settings threatening the realization of the UNAIDS 90-90-90 targets. To control the epidemic, efforts need to be accelerated to combat stigma. Patient economic empowerment, innovative drug formulations, as well as more patient-responsive health systems, may help overcome barriers to engagement in care.

ObjectiveText messages significantly improve uptake of infant HIV testing in clinical trial contexts. Women who were excluded from a randomized trial in Kenya were followed to create a comparison between women who were enrolled and did not receive the study SMS intervention and women who were screened but not enrolled.DesignParallel-cohort randomized controlled trial analysis.MethodsWe compared time to infant HIV testing between women in three groups: the Trial SMS group, the Trial Control group, and the Comparison Cohort comprised of women who were screened but not enrolled.ResultsOf the 1,115 women screened, 388 (35%) were eligible for trial enrollment, and were randomized to receive either intervention text messages (Trial SMS; N = 195) or continue usual care (Trial Control; N = 193). Among 727 women not enrolled in the study (Comparison Cohort), we obtained infant HIV testing data from clinic records for 510 (70%). The cumulative probability of infant HIV testing was highest in the Trial SMS group (92.0%; 95% CI 87.5-95.3), followed by the Trial Control group (85.1%; 95% CI 79.5-89.8), and lowest among women in the Comparison Cohort (43.4%; 95% CI 39.2-47.8).ConclusionsBoth the Trial SMS group and the Trial Control group were significantly more likely to have their infants tested for HIV compared to the Comparison Cohort, providing evidence of a "clinical trial effect." This analysis suggests that SMS interventions should be implemented as an adjunct to consistent and engaged delivery of basic health services.

BACKGROUND:The role of migration in the spread of HIV in sub-Saharan Africa is well-documented. Yet migration and HIV research have often focused on HIV risks to male migrants and their partners, or migrants overall, often failing to measure the risks to women via their direct involvement in migration. Inconsistent measures of mobility, gender biases in those measures, and limited data sources for sex-specific population-based estimates of mobility have contributed to a paucity of research on the HIV prevention and care needs of migrant and highly mobile women. This study addresses an urgent need for novel methods for developing probability-based, systematic samples of highly mobile women, focusing on a population of female traders operating out of one of the largest open air markets in East Africa. Our method involves three stages: 1.) identification and mapping of all market stall locations using Global Positioning System (GPS) coordinates; 2.) using female market vendor stall GPS coordinates to build the sampling frame using replicates; and 3.) using maps and GPS data for recruitment of study participants. RESULTS:The location of 6,390 vendor stalls were mapped using GPS. Of these, 4,064 stalls occupied by women (63.6%) were used to draw four replicates of 128 stalls each, and a fifth replicate of 15 pre-selected random alternates for a total of 527 stalls assigned to one of five replicates. Staff visited 323 stalls from the first three replicates and from these successfully recruited 306 female vendors into the study for a participation rate of 94.7%. Mobilization strategies and involving traders association representatives in participant recruitment were critical to the study's success. CONCLUSION:The study's high participation rate suggests that this geospatial sampling method holds promise for development of probability-based samples in other settings that serve as transport hubs for highly mobile populations.

OBJECTIVES:To determine if integration of family planning (FP) and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices) and decreased pregnancy rates. DESIGN:Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration) sites and oversaw integrated services at the original intervention (early integration) sites. SETTING:Eighteen health facilities in Kenya. SUBJECTS:Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2. INTERVENTION:"One-stop shop" approach to integrating FP and HIV services. MAIN OUTCOME MEASURES:Use of more effective contraceptive methods and incident pregnancy across two years of follow-up. RESULTS:Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR) = 1.39 (1.19-1.63). Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%). Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87). CONCLUSIONS:Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model. TRIAL REGISTRATION:ClinicalTrials.gov NCT01001507.

Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings.Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP.Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of 5% per year.

INTRODUCTION:The World Health Organization now recommends antiretroviral therapy (ART) initiation for all HIV-infected individuals regardless of CD4 cell count or disease status. Understanding the facilitators and barriers to initiation of and adherence to ART is essential to successful scale-up of "universal" ART. METHODS:To investigate facilitators and barriers to ART initiation, we conducted 44 in-depth individual or couple interviews with 63 participants (33 participants with HIV and 30 without HIV) already enrolled in a prospective implementation study of oral antiretroviral-based prevention in Kisumu, Kenya between August and September 2014. A semi-structured interview guided discussions on: 1) perceived advantages and disadvantages of ART; 2) reasons for accepting or declining ART initiation; and 3) influence of prevention of transmission to partner or infant influencing ART use. Transcripts from the interviews were iteratively analyzed using inductive content analysis. RESULTS:HIV-infected participants indicated that living a healthier life, preventing HIV transmission to others, and appearing "normal" or "healthy" again facilitated their initiation of ART. While appearing "normal" allowed these individuals to interact with their communities without stigmatization, they also perceived community opposition to their initiating ART, because appearing "normal" again prevented community members from easily identifying infected individuals in their community. Denial of diagnosis, disclosure stigma, perceived side-effects, and challenges in obtaining refills were additional barriers to ART initiation. CONCLUSIONS:Community perceptions play an important role in both facilitating and inhibiting ART initiation. Perceived stigma, including perceived community opposition to widespread ART use, is an important barrier to ART initiation. Addressing such barriers, while capitalizing on facilitators, to ART initiation should be central to universal ART scale-up efforts.

Losses to follow-up (LTFU) remain an important programmatic challenge. While numerous patient-level factors have been associated with LTFU, less is known about facility-level factors. Data from the East African International epidemiologic Databases to Evaluate AIDS (EA-IeDEA) Consortium was used to identify facility-level factors associated with LTFU in Kenya, Tanzania and Uganda. Patients were defined as LTFU if they had no visit within 12 months of the study endpoint for pre-ART patients or 6 months for patients on ART. Adjusting for patient factors, shared frailty proportional hazard models were used to identify the facility-level factors associated with LTFU for the pre- and post-ART periods. Data from 77,362 patients and 29 facilities were analyzed. Median age at enrolment was 36.0 years (Interquartile Range: 30.1, 43.1), 63.9% were women and 58.3% initiated ART. Rates (95% Confidence Interval) of LTFU were 25.1 (24.7-25.6) and 16.7 (16.3-17.2) per 100 person-years in the pre-ART and post-ART periods, respectively. Facility-level factors associated with increased LTFU included secondary-level care, HIV RNA PCR turnaround time >14 days, and no onsite availability of CD4 testing. Increased LTFU was also observed when no nutritional supplements were provided (pre-ART only), when TB patients were treated within the HIV program (pre-ART only), and when the facility was open ≤4 mornings per week (ART only). Our findings suggest that facility-based strategies such as point of care laboratory testing and separate clinic spaces for TB patients may improve retention.

Introduction HIV infection is frequently transmitted within stable couple partnerships. In order to prevent HIV acquisition in HIV‐negative couples, as well as improve coping in couples with an HIV‐positive diagnosis, it has been suggested that interventions be aimed at strengthening couple relationships, in addition to addressing individual behaviours. However, little is known about factors that influence relationships to impact joint decision‐making related to HIV. Methods We conducted qualitative in‐depth interviews with 40 pregnant women and 40 male partners in southwestern Kenya, an area of high HIV prevalence. Drawing from the interdependence model of communal coping and health behaviour change, we employed thematic analysis methods to analyze interview transcripts in Dedoose software with the aim of identifying key relationship factors that could contribute to the development of a couples‐based intervention to improve health outcomes for pregnant women and their male partners. Results In accordance with the interdependence model, we found that couples with greater relationship‐centred motivations described jointly engaging in more health‐enhancing behaviours, such as couples HIV testing, disclosure of HIV status, and cooperation to improve medication and clinic appointment adherence. These couples often had predisposing factors such as stronger communication skills and shared children, and were less likely to face potential challenges such as polygamous marriages, wife inheritance, living separately, or financial difficulties. For HIV‐negative couples, joint decision‐making helped them face the health threat of acquiring HIV together. For couples with an HIV‐positive diagnosis, communal coping helped reduce risk of interspousal transmission and improve long‐term health prospects. Conversely, participants felt that self‐centred motivations led to more concurrent sexual partnerships, reduced relationship satisfaction, and mistrust. Couples who lacked interdependence were more likely to mention experiencing violence or relationship dissolution, or having difficulty coping with HIV‐related stigma. Conclusions We found that interdependence theory may provide key insights into health‐related attitudes and behaviours adopted by pregnant couples. Interventions that invest in strengthening relationships, such as couple counselling during pregnancy, may improve adoption of beneficial HIV‐related health behaviours. Future research should explore adaptation of existing evidence‐based couple counselling interventions to local contexts, in order to address modifiable relationship characteristics that can increase interdependence and improve HIV‐related health outcomes.

Introduction Since 2015, the World Health Organization recommends pre‐exposure prophylaxis (PrEP) for all persons at substantial risk for HIV, including HIV‐uninfected partners in serodiscordant relationships in resource‐limited settings. As PrEP moves from clinical trials to real‐world use, understanding facilitators of and barriers to PrEP initiation and adherence is critical to successful PrEP implementation and rollout. Methods We conducted 44 in‐depth individual or couple interviews with 63 participants (30 without HIV and 33 with HIV) enrolled in the Partners Demonstration Project in Kisumu, Kenya, between August and September 2014. The semi‐structured interviews discussed the following: 1) perceived advantages and disadvantages of antiretroviral therapy (ART)/PrEP; 2) reasons for accepting or declining ART/PrEP and 3) influence of prevention of transmission to partner or infant on ART/PrEP use. Transcripts from the interviews were iteratively analyzed using inductive content analysis. Results Our study identified three key factors that may facilitate initiation of PrEP in this population. First, participants using PrEP felt reduced stress and increased trust in their HIV serodiscordant relationships. Second, greater community‐wide knowledge of PrEP was thought to likely increase PrEP acceptance. Third, greater education and counselling by providers on PrEP use was also considered to likely increase the adoption of PrEP. We also identified three key barriers to initiation of and adherence to PrEP. First, most participants who declined PrEP expressed doubts about the relative additional effectiveness of PrEP in combination with other prevention tools. Second, perceived stigma related to PrEP use was an important barrier to PrEP initiation. Third, many struggled with overcoming perceived side effects or logistical challenges of taking daily PrEP, particularly when they themselves were not ill. Conclusions Leveraging the facilitators and overcoming barriers to PrEP uptake may enhance the successful rollout of PrEP among HIV serodiscordant couples in Kenya and other areas in sub‐Saharan Africa, thereby reducing sexual transmission of HIV. Further research focused on how best to provide counselling on combination HIV prevention tools in the context of PrEP use is a crucial next step to delivering PrEP.

During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

Despite their perceived vulnerability to HIV, East African street youth have been neglected in HIV prevention research. We examined HIV seroprevalence and correlates of HIV infection in a sample of male street youth in Kisumu, Kenya.We enrolled a street-recruited sample of 13-21 year old street youth. Participants completed a survey followed by voluntary HIV counseling and testing. Survey items included demographics, homelessness history, survival activities, sexual behavior and substance use. We examined the relationship between predictor variables, markers of coercion and marginalization and HIV.The sample included 296 males. Survival activities included garbage picking (55%), helping market vendors (55%), begging (17%), and working as porters (46%) or domestic workers (4%). Forty-nine percent of participants reported at least weekly use of alcohol and 32% marijuana. Forty-six percent of participants reported lifetime inhalation of glue and 8% fuel. Seventy-nine percent of participants reported lifetime vaginal sex, 6% reported lifetime insertive anal sex and 8% reported lifetime receptive anal sex. Twelve (4.1%; 95% CI: 2.3-7.0) participants tested positive for HIV. Of those, all had been on the street for at least one year and all had engaged in vaginal sex. Occupations placing youth at particular risk of coercion by adults, including helping market vendors (prevalence ratio (PR) = 8.8; 95% CI: 1.2-67.5) and working as domestic workers (PR = 4.6; 95% CI: 1.1-19.0), were associated with HIV infection. Both insertive anal sex (PR = 10.2; 95% CI: 3.6-29.4) and receptive anal sex (PR = 3.9; 95% CI: 1.1-13.4) were associated with HIV infection. Drug use, begging, and garbage picking were not associated with HIV infection.Although HIV prevalence in our sample of street youth is comparable to that of similarly-aged male youth in Nyanza Province, our findings highlight behavioral factors associated with HIV infection that offer opportunities for targeted prevention among street youth in East Africa.

The clinical effects and potential benefits of nutrition supplementation interventions for persons living with HIV remain largely unreported, despite awareness of the multifaceted relationship between HIV infection and nutrition. We therefore examined descriptive characteristics and nutritional outcomes of the Food by Prescription (FBP) nutrition supplementation program in Nyanza Province, Kenya.Demographic, health, and anthropometric data were gathered from a retrospective cohort of 1,017 non-pregnant adult patients who enrolled into the FBP program at a Family AIDS Care and Education Services (FACES) site in Nyanza Province between July 2009 and July 2011. Our primary outcome was FBP treatment success defined as attainment of BMI>20, and we used Cox proportional hazards to assess socio-demographic and clinical correlates of FBP treatment success.Mean body mass index was 16.4 upon enrollment into the FBP program. On average, FBP clients gained 2.01 kg in weight and 0.73 kg/m2 in BMI over follow-up (mean 100 days), with the greatest gains among the most severely undernourished (BMI 20, though 44.5% achieved a BMI increase ≥0.5. Greater BMI at baseline, younger age, male gender, and not requiring highly active antiretroviral therapy (HAART) were associated with a higher rate of attainment of BMI>20.This study reports significant gains in weight and BMI among patients enrolled in the FBP program, though only a minority of patients achieved stated programmatic goals of BMI>20. Future research should include well-designed prospective studies that examine retention, exit reasons, mortality outcomes, and long-term sustainability of nutrition supplementation programs for persons living with HIV.

Maternal attendance at postnatal clinic visits and timely diagnosis of infant HIV infection are important steps for prevention of mother-to-child transmission (PMTCT) of HIV. We aimed to use theory-informed methods to develop text messages targeted at facilitating these steps.We conducted five focus group discussions with health workers and women attending antenatal, postnatal, and PMTCT clinics to explore aspects of women's engagement in postnatal HIV care and infant testing. Discussion topics were informed by constructs of the Health Belief Model (HBM) and prior empirical research. Qualitative data were coded and analyzed according to the construct of the HBM to which they related. Themes were extracted and used to draft intervention messages. We carried out two stages of further messaging development: messages were presented in a follow-up focus group in order to develop optimal phrasing in local languages. We then further refined the messages, pretested them in individual cognitive interviews with selected health workers, and finalized the messages for the intervention.Findings indicated that brief, personalized, caring, polite, encouraging, and educational text messages would facilitate women bringing their children to clinic after delivery, suggesting that text messages may serve as an important "cue to action." Participants emphasized that messages should not mention HIV due to fear of HIV testing and disclosure. Participants also noted that text messages could capitalize on women's motivation to attend clinic for childhood immunizations.Applying a multi-stage content development approach to crafting text messages--informed by behavioral theory--resulted in message content that was consistent across different focus groups. This approach could help answer "why" and "how" text messaging may be a useful tool to support maternal and child health. We are evaluating the effect of these messages on improving postpartum PMTCT retention and infant HIV testing in a randomized trial.

Mobility has long been associated with high HIV prevalence. We sought to assess sex differences in the relationship between mobility and risk for HIV infection among married couples in the fishing communities.We conducted 1090 gender-matched interviews and rapid HIV testing with 545 couples proportionally representing all the different sizes of the fish-landing beaches in Kisumu County. We contacted a random sample of fishermen as our index participants and asked them to enroll in the study together with their spouses. The consenting couples were separated into different private rooms for concurrent interviews and thereafter reunited for couple rapid HIV counselling and testing. In addition to socio-economic and behavioural data, we collected information on overnight travels and divided couples in 4 groups as follows both partners not mobile, both partners mobile, only woman mobile, and only man mobile. Other than descriptive statistics, we used X(2) and U tests to compare groups of variables and multivariate logistic regression to measure association between mobility and HIV infection.We found significant differences in the number of trips women travelled in the preceding month (mean 4.6, SD 7.1) compared to men (mean 3.3, SD 4.9; p

Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma.A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines.This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving to eliminate vertical transmission of HIV and improve maternal health.ClinicalTrials.gov NCT00931216 http://clinicaltrials.gov/ct2/show/NCT00931216.

HIV prevalence among pregnant women in Kenya is high. Furthermore, there is a high risk of maternal mortality, as many women do not give birth with a skilled healthcare provider. Previous research suggests that fears of HIV testing and unwanted disclosure of HIV status may be important barriers to utilizing maternity services. We explored relationships between women's perceptions of HIV-related stigma and their attitudes and intentions regarding facility-based childbirth.1,777 pregnant women were interviewed at their first antenatal care visit. We included socio-demographic characteristics, stigma scales, HIV knowledge measures, and an 11-item scale measuring health facility birth attitudes (HFBA). HFBA includes items on cost, transport, comfort, interpersonal relations, and services during delivery at a health facility versus at home. A higher mean HFBA score indicates a more positive attitude towards facility-based childbirth. The mean HFBA score was dichotomized at the median and analyses were conducted with this dichotomized HFBA score using mixed effects logit models.Women who anticipated HIV-related stigma from their male partner had lower adjusted odds of having positive attitudes about giving birth at the health facility (adjusted OR = .63, 95% CI 0.50-0.78) and less positive attitudes about health facility birth were strongly related to women's intention to give birth outside a health facility (adjusted OR = 5.56, 95% CI 2.69-11.51).In this sample of pregnant women in rural Kenya, those who anticipated HIV-related stigma were less likely to have positive attitudes towards facility-based childbirth. Furthermore, negative attitudes about facility-based childbirth were associated with the intention to deliver outside a health facility. Thus, HIV-related stigma reduction efforts might result in more positive attitudes towards facility-based childbirth, and thereby lead to an increased level of skilled birth attendance, and reductions in maternal and infant mortality.

To conduct a preliminary evaluation of the utility and reliability of a diagnostic tool for HIV-associated dementia (HAD) for use by primary health care workers (HCW) which would be feasible to implement in resource-limited settings.In resource-limited settings, HAD is an indication for anti-retroviral therapy regardless of CD4 T-cell count. Anti-retroviral therapy, the treatment for HAD, is now increasingly available in resource-limited settings. Nonetheless, HAD remains under-diagnosed likely because of limited clinical expertise and availability of diagnostic tests. Thus, a simple diagnostic tool which is practical to implement in resource-limited settings is an urgent need.A convenience sample of 30 HIV-infected outpatients was enrolled in Western Kenya. We assessed the sensitivity and specificity of a diagnostic tool for HAD as administered by a primary HCW. This was compared to an expert clinical assessment which included examination by a physician, neuropsychological testing, and in selected cases, brain imaging. Agreement between HCW and an expert examiner on certain tool components was measured using Kappa statistic.The sample was 57% male, mean age was 38.6 years, mean CD4 T-cell count was 323 cells/µL, and 54% had less than a secondary school education. Six (20%) of the subjects were diagnosed with HAD by expert clinical assessment. The diagnostic tool was 63% sensitive and 67% specific for HAD. Agreement between HCW and expert examiners was poor for many individual items of the diagnostic tool (K = .03-.65). This diagnostic tool had moderate sensitivity and specificity for HAD. However, reliability was poor, suggesting that substantial training and formal evaluations of training adequacy will be critical to enable HCW to reliably administer a brief diagnostic tool for HAD.

BackgroundBacterial vaginosis (BV), a disruption of the normal vaginal flora, has been associated with a 60% increased risk of HIV-1 acquisition in women and higher concentration of HIV-1 RNA in the genital tract of HIV-1-infected women. However, whether BV, which is present in up to half of African HIV-1-infected women, is associated with an increase in HIV-1 transmission to male partners has not been assessed in previous studies.Methods and findingsWe assessed the association between BV on female-to-male HIV-1 transmission risk in a prospective study of 2,236 HIV-1-seropositive women and their HIV-1 uninfected male partners from seven African countries from a randomized placebo-controlled trial that enrolled heterosexual African adults who were seropositive for both HIV-1 and herpes simplex virus (HSV)-2, and their HIV-1-seronegative partners. Participants were followed for up to 24 months; every three months, vaginal swabs were obtained from female partners for Gram stain and male partners were tested for HIV-1. BV and normal vaginal flora were defined as a Nugent score of 7-10 and 0-3, respectively. To reduce misclassification, HIV-1 sequence analysis of viruses from seroconverters and their partners was performed to determine linkage of HIV-1 transmissions. Overall, 50 incident HIV-1 infections occurred in men in which the HIV-1-infected female partner had an evaluable vaginal Gram stain. HIV-1 incidence in men whose HIV-1-infected female partners had BV was 2.91 versus 0.76 per 100 person-years in men whose female partners had normal vaginal flora (hazard ratio 3.62, 95% CI 1.74-7.52). After controlling for sociodemographic factors, sexual behavior, male circumcision, sexually transmitted infections, pregnancy, and plasma HIV-1 RNA levels in female partners, BV was associated with a greater than 3-fold increased risk of female-to-male HIV-1 transmission (adjusted hazard ratio 3.17, 95% CI 1.37-7.33).ConclusionsThis study identified an association between BV and increased risk of HIV-1 transmission to male partners. Several limitations may affect the generalizability of our results including: all participants underwent couples HIV counseling and testing and enrolled in an HIV-1 prevention trial, and index participants had a baseline CD4 count ≥ 250 cells/mm³ and were HSV-2 seropositive. Given the high prevalence of BV and the association of BV with increased risk of both female HIV-1 acquisition and transmission found in our study, if this association proves to be causal, BV could be responsible for a substantial proportion of new HIV-1 infections in Africa. Normalization of vaginal flora in HIV-1-infected women could mitigate female-to-male HIV-1 transmission.Trial registrationClinicalTrials.com NCT00194519.

Following male circumcision for HIV prevention, a high proportion of men fail to return for their scheduled seven-day post-operative visit. We evaluated the effect of short message service (SMS) text messages on attendance at this important visit.We enrolled 1200 participants >18 years old in a two-arm, parallel, randomized controlled trial at 12 sites in Nyanza province, Kenya. Participants received daily SMS text messages for seven days (n = 600) or usual care (n = 600). The primary outcome was attendance at the scheduled seven-day post-operative visit. The primary analysis was by intention-to-treat.Of participants receiving SMS, 387/592 (65.4%) returned, compared to 356/596 (59.7%) in the control group (relative risk [RR] = 1.09, 95% confidence interval [CI] 1.00-1.20; p = 0.04). Men who paid more than US$1.25 to travel to clinic were at higher risk for failure to return compared to those who spent ≤ US$1.25 (adjusted relative risk [aRR] 1.35, 95% CI 1.15-1.58; p

Childbirth with a skilled attendant is crucial for preventing maternal mortality and is an important opportunity for prevention of mother-to-child transmission of HIV. The Maternity in Migori and AIDS Stigma Study (MAMAS Study) is a prospective mixed-methods investigation conducted in a high HIV prevalence area in rural Kenya, in which we examined the role of women's perceptions of HIV-related stigma during pregnancy in their subsequent utilization of maternity services.From 2007-2009, 1,777 pregnant women with unknown HIV status completed an interviewer-administered questionnaire assessing their perceptions of HIV-related stigma before being offered HIV testing during their first antenatal care visit. After the visit, a sub-sample of women was selected for follow-up (all women who tested HIV-positive or were not tested for HIV, and a random sample of HIV-negative women, n = 598); 411 (69%) were located and completed another questionnaire postpartum. Additional qualitative in-depth interviews with community health workers, childbearing women, and family members (n = 48) aided our interpretation of the quantitative findings and highlighted ways in which HIV-related stigma may influence birth decisions. Qualitative data revealed that health facility birth is commonly viewed as most appropriate for women with pregnancy complications, such as HIV. Thus, women delivering at health facilities face the risk of being labeled as HIV-positive in the community. Our quantitative data revealed that women with higher perceptions of HIV-related stigma (specifically those who held negative attitudes about persons living with HIV) at baseline were subsequently less likely to deliver in a health facility with a skilled attendant, even after adjusting for other known predictors of health facility delivery (adjusted odds ratio = 0.44, 95% CI 0.22-0.88).Our findings point to the urgent need for interventions to reduce HIV-related stigma, not only for improving quality of life among persons living with HIV, but also for better health outcomes among all childbearing women and their families.