Search

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial found no substantial difference in HIV acquisition risk between women randomised to injectable intramuscular depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant. We evaluated post-randomization sexual behavior using an objective marker of condomless vaginal sex in a subset of participants. We conducted a sub-study among 458 ECHO participants at three sites (Cape Town, Johannesburg, Kisumu) to evaluate the frequency of condomless vaginal sex, measured by prostate specific antigen (PSA) detection in vaginal swabs, collected at the month 6 and final visit and the concordance of self-reported condomless vaginal sex with PSA detection, by randomized arm. We compared PSA detection frequency and concordance of PSA and self-reported condomless vaginal sex, by randomized group using Cochran–Mantel–Haenszel tests and adjusted generalized logistic growth curve models. PSA was detected less frequently in the DMPA-IM (16%), compared to the Cu-IUD (21%) and LNG implant (24%) groups, although results were not statistically significant in the unadjusted model when accounting for pre-specified multiple-testing criteria. There were significant differences in PSA detection between the DMPA-IM and LNG-implant groups (odds ratio 0.61 (95% CI 0.40, 0.94) in the adjusted model. There was moderate discordance between self-reported condomless vaginal sex and detection of PSA that was similar across randomized groups. These data suggest that women randomized to Cu-IUD and LNG implant may have had condomless sex more frequently than women randomized to DMPA-IM. The discordance between detectable PSA and self-reported sexual behaviour has important implications for design of future HIV prevention studies.

BACKGROUND: Adherence to antiretroviral therapy (ART) among pregnant and postpartum women with HIV (PWLWH) is critical to promote maternal health and prevent HIV transmission. Tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) is an objective assessment of cumulative ART adherence that has not been fully assessed in PWLWH. SETTING: southwestern Kenya METHODS: PWLWH receiving tenofovir disoproxil fumarate-based ART from 24 health facilities provided DBS samples at three time points (pregnancy/early postpartum [PP], 6 months PP, and 9–12 months PP). Thresholds for daily adherence were defined as TFV-DP in DBS ≥650 fmol/punch in pregnancy and ≥950 postpartum. Descriptive analysis is presented. Cluster adjusted Chi squares and t-tests were used to test for association with clinical and demographic factors. RESULTS: A total of 419 DBS samples were collected from 150 PWLWH. Median TFV-DP in DBS was lowest, 552 fmol/punch (Interquartile range (IQR 395,759) in pregnancy and declined over time postpartum: 914 (IQR 644,1176) fmol/punch early PP, 838 (IQR 613,1063) fmol/punch 6 months PP, and 785 (IQR 510,1009) fmol/punch 9–12 months, p

Effective contraceptives are a global health imperative for reproductive-aged women. However, there remains a lack of rigorous data regarding the effects of contraceptive options on vaginal bacteria and inflammation. Among 218 women enrolled into a substudy of the ECHO Trial (NCT02550067), we evaluate the effect of injectable intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel implant (LNG), and a copper intrauterine device (Cu-IUD) on the vaginal environment after one and six consecutive months of use, using 16S rRNA gene sequencing and multiplex cytokine assays. Primary endpoints include incident BV occurrence, bacterial diversity, and bacterial and cytokine concentrations. Secondary endpoints are bacterial and cytokine concentrations associated with later HIV seroconversion. Participants randomized to Cu-IUD exhibit elevated bacterial diversity, increased cytokine concentrations, and decreased relative abundance of lactobacilli after one and six months of use, relative to enrollment and other contraceptive options. Total bacterial loads of women using Cu-IUD increase 5.5 fold after six months, predominantly driven by increases in the concentrations of several inflammatory anaerobes. Furthermore, growth of L. crispatus (MV-1A-US) is inhibited by Cu2+ ions below biologically relevant concentrations, in vitro. Our work illustrates deleterious effects on the vaginal environment induced by Cu-IUD initiation, which may adversely impact sexual and reproductive health.

Current guidelines recommend starting antiretroviral therapy (ART) as soon as possible after HIV diagnosis to reduce morbidity, mortality and onward HIV transmission. We examined factors influencing ART initiation by women who seroconverted during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. ECHO, conducted between 2015 and 2018, enrolled HIV-negative, sexually active women, aged 16-35 years, from four African countries. Follow-up was 12-18 months, with quarterly HIV testing. Women with incident HIV infection received extensive counselling by trial staff and referral to local facilities for HIV care. Of 304 women with ≥90 days follow-up time since HIV diagnosis, 186(61.2%) initiated ART within 90 days, 69(22.7%) initiated after 90 days, and 49(16.1%) had not initiated by the end of the study. There were no statistically significant differences in characteristics among women who initiated ART ≤90 days versus those who did not. Frequent reasons for delayed or non-initiation of ART included not feeling ready to start ART and being newly diagnosed. In a large clinical trial, ART initiation was modest within 90 days of HIV diagnosis and grew to 84% with longer observation. Despite extensive counselling on the importance of early ART initiation, personal barriers delayed some women from starting ART.

Background: Food insecurity (FI) is common globally and can have lifelong consequences. However, few studies have longitudinally examined how FI varies across gestation and the postpartum period (“the first 1000 days”); none have explored this in sub-Saharan Africa or in the context of HIV. Objective: To assess the prevalence and covariates of FI in the first 1000 days among Kenyan women. Methods: All pregnant women attending 7 clinics in western Kenya (n = 1247) were screened for HIV and FI (Individual Food Insecurity Access Scale) between September 2014 and June 2015. A subset of women (n = 371) was recruited into an observational cohort study and surveyed 11 times through 2 years postpartum (NCT02974972, NCT02979418). Data on FI, sociodemographics, and health were repeatedly collected. Severe FI was modeled using multilevel, mixed-effects logistic regressions (n = 346). Results: Of the 1247 pregnant women screened, 76.5% were severely food insecure in the prior month. Further, the prevalence of severe FI was higher among women living with HIV than those without (82.6% vs 74.6%, P < .05). In the cohort, the odds of being severely food insecure decreased monotonically after delivery. Each point higher on the Center for Epidemiologic Studies-Depression scale was associated with 1.08 times greater odds of being severely food insecure (95% CI: 1.05-1.10); each point higher on the Duke/UNC Functional Social Support Scale was associated with 0.97 lower odds of severe FI (95% CI: 0.94-0.99). Conclusions: Severe FI is prevalent during the first 1000 days in western Kenya. Services to mitigate the far-reaching consequences of this modifiable risk should be considered.

Background Antiretroviral therapy (ART) is essential for the elimination of mother-to-child transmission and improved health outcomes for women living with HIV (WLWH). However, adverse pregnancy outcomes (APOs) among pregnant women on ART are a growing concern. Methods We investigated the associations between timing of ART initiation and APOs among pregnant WLWH receiving behavioral interventions (community mentor mothers and text messaging) in the Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study in southwestern Kenya. Log binomial models were used for estimation of relative risks (RRs) (adjusted for the clustered nature of data) evaluating APOs with 3 exposure comparisons: (1) preconception ART initiation vs. postconception initiation; (2) among postconception ART initiating women, comparisons across gestational ages at cART initiation (first versus second and third trimester exposure), and (3) intervention allocation. Results Of the 1275 women included in this analysis, 388 (30%) had an APO: 306 preterm births, 38 low birth weight infants, 33 stillbirths, and 11 miscarriages. In multivariable analysis, viral load ≥1000 copies/mL, moderate and severe anemia at baseline increased risk of APOs. Among women initiating ART before and after conception, no difference was observed in the composite APO. Women who received community mentor mother visits alone (aRR 0.74: 95% CI: 0.71 to 0.76) or text messages alone (aRR 0.79: 95% CI: 0.70 to 0.89) had lower risks of experiencing any APOs. Conclusions Receiving supportive behavioral interventions may mitigate the risk of experiencing an APO among WLWH on ART. Further studies are needed to investigate the underlying mechanisms and optimize the benefits of these interventions.

Food insecurity (FI), low social support, and low health-related quality of life (HRQoL) are associated with self-reported nonadherence to antiretroviral therapy (ART) among postpartum women, but these relationships have not been evaluated using objective adherence indicators. Hair samples were therefore analyzed among 83 postpartum Kenyan women living with HIV on efavirenz and nevirapine ART drug regimens in an observational cohort (NCT02974972). FI (0-27), social support (0-40), and HRQoL (8-40) in the prior month were also assessed. In multivariable models, each point increase in FI and decrease in HRQoL were associated with a 45.1% (95% CI:-64.3%,-15.6%) and 10.5% decrease (95% CI: 1.0%, 22.1%) in hair ART drug concentrations respectively, when social support was held constant. A significant interaction between social support and FI (β = 0.02, p = 0.017) indicated that greater social support was predicted to mitigate the negative impacts of FI on ART adherence. Addressing these modifiable barriers could improve ART adherence during this critical period.

Background COVID-19-related restrictions on in-person contact in healthcare, increasing psychiatric illness during the pandemic and pre-existing shortages of mental healthcare providers have led to the emergence of telepsychiatry as an attractive option for the delivery of care. Telepsychiatry has been promoted as economical and effective, but its acceptance in low- and middle-income countries is poorly understood. Aims To explore the acceptance, experiences and perspectives of patients and healthcare providers in the uptake of telepsychiatry services in a middle-income country. Method Focus group discussions were conducted on the WhatsApp platform with patients and care providers who have engaged in telepsychiatry. Data were analysed using a thematic approach. Results Three main themes emerged from the five focus groups: (a) technical access, (b) user experience and (c) perceived effectiveness compared with face-to-face (in-person) interactions. Care providers reported challenges establishing rapport with the patient, particularly for initial sessions, maintaining privacy during sessions and detecting non-verbal cues on video. Patients cited internet connectivity problems, difficulty finding private space to have their sessions and cost as major challenges. Patients also felt in-person sessions were better for initial visits. Both patients and providers reported difficulties making insurance payment claims for telepsychiatry services. Overall, participants were mostly positive about telepsychiatry, citing its convenience and overall perceived effectiveness compared with in-person sessions. Conclusions Telepsychiatry is an acceptable platform for delivery of out-patient psychiatric services in a middle-income country. Patients and providers appreciate the convenience it offers and would like it integrated as a routine mode of delivery of care.

Objective: To understand the preferences of women living with HIV (WLHIV) for methods of multipurpose technology (MPT) for the co-administration of contraception and antiretroviral therapy (ART) and non-oral ART to guide their development and implementation. Design: A cross-sectional telephone survey as part of a study of pregnancy incidence among contraception and ART users Setting: Our study was performed in western Kenya Population: We included 1132 WLHIV of reproductive potential with prior experience using injectable and long-acting contraception Methods: We performed descriptive statistics and multinomial logistic regression Main Outcome Measures: Main outcomes were interest in MPT, important characteristics and preferred methods for MPT and non-oral ART, and predictors of interest in specific methods Results: Two-thirds (67%) reported interest in MPT, most commonly due to ease of using a single medication for both HIV treatment and pregnancy prevention (26%). Main reasons for lack of interest in MPT were need to stop/not use contraception while continuing ART (21%) and risk of side effects (16%). Preferred methods for MPT and non-oral ART were injectables (50%, 54%) and implants (32%, 31%). Prior use of a contraceptive implant or injectable predicted interest in similar methods for MPT and non-oral ART, and this did not vary by age. Conclusions: Many WLHIV in western Kenya are interested in MPT for contraception and ART. Prior experience with contraceptive implants and injectables predicts interest in similar methods of MPT and non-oral ART. Funding: NIH NIAID (K23AI120855) and the NIH NIAID, NICHD, NIDA, NCI, & NIMH for the EA-IeDEA Consortium (U01AI069911)

Background Cervicovaginal CD4+ T cells are preferential targets for human immunodeficiency virus (HIV) infection and have consequently been used as a proxy measure for HIV susceptibility. The ECHO randomized trial offered a unique opportunity to consider the association between contraceptives and Th17-like cells within a trial designed to evaluate HIV risk. In a mucosal substudy of the ECHO trial, we compared the impact of initiating intramuscular depot medroxyprogesterone acetate (DMPA-IM), copper-IUD, and the levonorgestrel (LNG) implant on cervical T cells. Methods Cervical cytobrushes from 58 women enrolled in the ECHO trial were collected at baseline and 1 month after contraceptive initiation. We phenotyped cervical T cells using multiparameter flow cytometry, characterized the vaginal microbiome using 16s sequencing, and determined proteomic signatures associated with Th17-like cells using mass spectrometry. Results Unlike the LNG implant or copper-IUD, DMPA-IM was associated with higher frequencies of cervical Th17-like cells within 1 month of initiation (P = .012), including a highly susceptible, activated population co-expressing CD38, CCR5, and α4β7 (P = .003). After 1 month, women using DMPA-IM also had more Th17-like cells than women using the Cu-IUD (P = .0002) or LNG implant (P = .04). Importantly, in women using DMPA-IM, proteomic signatures signifying enhanced mucosal barrier function were associated with the increased abundance of Th17-like cells. We also found that a non–Lactobacillus-dominant microbiome at baseline was associated with more Th17-like cells post–DMPA-IM (P = .03), although this did not influence barrier function. Conclusions Our data suggest that DMPA-IM–driven accumulation of HIV-susceptible Th17-like cells might be counteracted by their role in maintaining mucosal barrier integrity. Clinical Trials Registration NCT02550067.

Globally, COVID-19 has had a negative impact on health systems and health outcomes, with evidence of differential gender impacts emerging. The COVID-19 timeline of events spanning from closures and restrictions to phased reopenings is well-documented in Kenya. This unique COVID-19 situation offered us the opportunity to study a natural experiment on pregnancy trends and outcomes in a cohort of Kenyan adolescent girls and young women (AGYW), enrolled in the KENya Single-dose HPV-vaccine Efficacy (KEN SHE) Study. The KEN SHE Study enrolled sexually active AGYW aged 15–20 years from central and western Kenya. Pregnancy testing was performed at enrollment and every 3 months. We determined pregnancy incidence trends pre- and post-COVID-19 lockdown, pregnancy outcomes (delivery, spontaneous, or induced abortion), and postabortion and postpartum contraceptive uptake. Kaplan–Meier survival estimates of incidence rates were used to estimate the cumulative probability of pregnancy during the study period. Cox regression was used to investigate factors associated with pregnancy incidence. Of the 2,223 AGYW included in the analysis, median age was 18.6 IQR (17.6–20.3), >90% had at least secondary school education, 95% were single at the time of enrollment, and 82% had a steady/primary sexual partner. Pregnancy incidence peaked at 2.27 (95% CI [1.84, 2.81])/100 women-years of observation at the end of the first quarter of 2020, a period coinciding with the government-imposed lockdown. AGYW had 60% increased risk of being pregnant during the lockdown when compared to prelockdown period (HR = 1.60, 95% CI [1.25, 2.05]). Among the 514 pregnancies reported, 127 (25%) ended in abortion, of which 66 (52%) were induced abortions. Our findings demonstrate the adverse sexual and reproductive health (SRH) consequences of the COVID-19 pandemic and the lockdown measures among AGYW. As services continue to be disrupted by the pandemic, there is an urgent need to strengthen and prioritize AGYW-centered SRH services, including contraception and safe abortion.

Introduction Community‐based mentor mothers (cMMs) are women living with HIV who provide peer support to pregnant/postpartum women living with HIV (PWLWH) to enhance antiretroviral therapy (ART) adherence, retention in care and prevent perinatal transmission of HIV. The goal of this study was to explore the experiences, perceptions, mechanisms and health impact of cMMs on PWLWH in Kenya from the perspective of cMMs. Methods We conducted a prospective mixed‐methods study in southwestern Kenya in 2015–2018. In the qualitative phase, we completed in‐depth interviews with cMMs to explore their perceptions and experiences in supporting PWLWH. Transcripts were broad‐coded according to identified themes, then fine‐coded using an inductive approach. In the quantitative phase, we analysed medical record data from PWLWH who were randomized in the cMM intervention to examine the impact of cMM visits on optimal prevention of mother‐to‐child transmission (PMTCT). We used cluster‐adjusted generalized estimating equation models to examine relationships with a composite outcome (facility delivery, infant HIV testing, ART adherence and undetectable viral load at 6 weeks postpartum). Finally, qualitative and quantitative results were integrated. Results Convergence of findings from cMM interviews (n = 24) and PWLWH medical data (n = 589) revealed: (1) The cMM intervention was utilized and perceived as acceptable. PWLWH received, on average, 6.2 of 8 intended home visits through 6 weeks postpartum. (2) The cMMs reported serving as role models and confidantes, supporting PWLWH's acceptance of their HIV status, providing assurances about PMTCT and assisting with male partner disclosure and communication. cMMs also described benefits for themselves, including empowerment and increased income. (3) The cMM visits supported PWLWH's completion of PMTCT steps. Having ≥4 cMM home visits up to 6 weeks postpartum, as compared to

Background Food insecurity is an important underlying driver of HIV risk and vulnerability among adolescents in sub-Saharan Africa. In this region, adolescents account for 80% of all new HIV infections. The primary purpose of this analysis is to understand perceived mechanisms for how a multisectoral agricultural intervention influenced sexual risk taking among HIV-affected adolescents in southwestern Kenya. Methods We conducted semi-structured, individual interviews with 34 adolescent-caregiver dyads who were participants in Adolescent Shamba Maisha (NCT03741634), a sub-study of adolescent girls and caregivers with a household member participating in the Shamba Maisha trial (NCT01548599), a multi-sectoral agricultural and microfinance intervention. Interviews were audiotaped, transcribed, translated, and analyzed using framework and interpretive description analysis methods. Results Adolescents receiving the Shamba Maisha intervention described no longer needing to engage in transactional sex or have multiple concurrent sexual partners as a way to meet their basic needs, including food. Key mechanisms for these effects include greater sexual agency among adolescent girls, and increased confidence and self-efficacy in overcoming existing reciprocity norms and sexual relationship power inequity; as well as staying in school. The intervention also increased caregiver confidence in talking about adolescent sexual reproductive health issues. In contrast, driven primarily by the need for food and basic needs, girls in the control arms described engaging in transactional sex, having multiple sexual partners, being unable to focus in school, getting pregnant or becoming HIV infected. Conclusion These findings emphasize the need to address food insecurity as a part of structural interventions targeting adolescent HIV risk in low-resource countries. We recommend that future interventions build upon the Shamba Maisha model by combining sustainable agricultural production, with household level interventions that deliberately target gender norms that contribute to unequal power dynamics.

Background The ECHO trial randomized women to intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel implant (LNG-implant), or copper intrauterine device (Cu-IUD). In a substudy of the ECHO trial, we tested the hypothesis that contraceptives influence genital inflammation by comparing cervicovaginal cytokine changes following contraception initiation. In addition, we compared cytokine profiles in women who acquired HIV (cases) versus those remaining HIV negative (controls). Methods Women (n = 251) from South Africa and Kenya were included. Twenty-seven cervicovaginal cytokines were measured by Luminex at baseline, and 1 and 6 months after contraceptive iTanko et alnitiation. In addition, cytokines were measured preseroconversion in HIV cases (n = 25) and controls (n = 100). Results At 6 months after contraceptive initiation, women using Cu-IUD had increased concentrations of 25/27 cytokines compared to their respective baseline concentrations. In contrast, women initiating DMPA-IM and LNG-implant did not experience changes in cervicovaginal cytokines. Preseroconversion concentrations of IL-1β, IL-6, and TNF-α, previously associated with HIV risk, correlated with increased HIV risk in a logistic regression analysis, although not significantly after correcting for multiple comparisons. Adjusting for contraceptive arm did not alter these results. Conclusions Although Cu-IUD use broadly increased cervicovaginal cytokine concentrations at 6 months postinsertion, these inflammatory changes were found not to be a significant driver of HIV risk. Clinical Trials Registration NCT02550067.

Background HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule. Methods We are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15–20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to (1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; (2) assess the memory B cell immune response at months 36 and 37; and (3) estimate cost-effectiveness using the trial results and health economic models. Discussion This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery. Trial registration ClinicalTrials.gov NCT03675256. Registered on September 18, 2018

INTRODUCTION : Lower levels of adherence to antiretroviral therapy (ART) among older adolescents as compared to adults are influenced by individual, psychosocial, and treatment-related factors. Successful transition of older adolescents into HIV adult care from paediatric & adolescent focused care requires an understanding of barriers to ART adherence. This study aimed at determining individual factors affecting ART adherence among older HIV positive adolescents transitioning to adult care. METHODS: Between December 2018 and January 2019, we conducted a cross-sectional study among 82 perinatally infected adolescents aged 16–19 years in an HIV care and treatment clinic in Nairobi, Kenya. We used completed structured questionnaires and abstracted data from clinical charts. We performed multivariate logistic regression to identify factors independently associated >95% self-reported ART adherence (7-day recall). RESULTS: The study participants had a median age of 17 (IQR 16,18) on ART for a median duration of 11 years (IQR 7,13). Sixty-four per cent (52) of the adolescents reported optimal adherence was of >95%, and 15% reported missing doses for three or more months. Self -reported adherence had a high correlation with viral loads of 95% [OR 8.1, 95% CI (2.31– 28.18)]. Once a day, dosing was also independently associated with adherence [OR 1.58, 95 %CI [0.62–4.08]. CONCLUSIONS: The reduction of ART pill burden and the inclusion of assessment of ART self –efficacy may contribute to transition preparedness among adolescents.

We explored the association between HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence in postpartum women receiving lifelong antiretroviral therapy (ART) (N = 200). We administered a cross-sectional survey to 200 women with HIV at 12 months postpartum who were enrolled in the MOTIVATE trial. The MOTIVATE study is a cluster-randomized trial evaluating the impact of community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya. Simple and multivariable logistic regression analysis was performed in STATA. Women who experienced stigma or IPV were more likely to miss clinic visits (internalized stigma aOR 1.30 95%CI 1.03-1.64; anticipated stigma aOR 1.20 95%CI 1.04-1.42; IPV aOR 15.71 95%CI 1.47-167.80), report difficulty taking ART drugs (internalized stigma aOR 1.32 95%CI 1.10-1.58; anticipated stigma aOR 1.14 95%CI 1.01-1.30) and not taking medication as prescribed (IPV aOR 2.00 95%CI 1.05-3.74). Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76). There is need to develop tailored psychosocial interventions within PMTCT programs that appropriately address mental health, stigma, and violence.

OBJECTIVE: Our objective was to evaluate if increasing body mass index (BMI) or weight influences the association between efavirenz-based antiretroviral therapy (ART) and implant effectiveness. STUDY DESIGN: We conducted a secondary cohort analysis of HIV-positive women aged 15 to 45 years enrolled in HIV care in western Kenya using an implant from January 2011 to December 2015. Implant use, ART regimen, and weight were documented at each clinic visit and height at enrollment. We categorized BMI as underweight, normal weight, overweight, or obese, and weight as

Disclosure of HIV status to sexual partners in the context of prevention of mother-to-child transmission (PMTCT) may contribute to improved PMTCT outcomes. We administered a questionnaire to 200 women with HIV enrolled in a PMTCT study during pregnancy at 12 months after birth in Western Kenya between May-September 2017. Descriptive analysis of disclosure patterns and multivariate analysis of factors associated with male partner reactions is presented. Among 180 (90%) women who reported having a male partner, 95.5% reported disclosing their HIV status to that partner. The majority of women (82.8%) reported disclosure occurred within one year of their diagnosis, with 62.7% occurring within one week. The most common forms of disclosure were: self-disclosure (55.4%), during couple’s HIV testing and counselling (CHTC) (31.5%), or at an antenatal care visit (7.7%). Most women (87.5%) reported that male partner reactions to their HIV status disclosure were positive. Those with negative reactions reported their partners were confused, annoyed, or threatened to leave, however there were no reports of intimate partner violence (IPV) or break ups. Disclosure via CHTC was associated with a positive male partner reaction compared to self-disclosure (adjusted OR (aOR) 20.2, 95% Confidence Interval (CI) 1.8 – 221.4). Those in concordant HIV status partnerships were more likely to have a positive reaction (aOR. 6.7, 95% CI 1.7 – 26.6). Women experiencing frequent verbal IPV were less likely to report a positive response (aOR 0.21, 95%CI 0.1 – 0.8). Most postpartum women with HIV in this cohort had disclosed to their male partners early after diagnosis and experienced a positive reaction. However, a minority had still not disclosed by 12 months after the birth and some experienced negative reactions to disclosure. The form of status disclosure and impact of intimate partner violence should be given greater attention within the context of PMTCT.

Summary Background Observational and laboratory studies suggest that some hormonal contraceptive methods, particularly intramuscular depot medroxyprogesterone acetate (DMPA-IM), might increase women's susceptibility to HIV acquisition. We aimed to compare DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant among African women seeking effective contraception and living in areas of high HIV incidence. Methods We did a randomised, multicentre, open-label trial across 12 research sites in eSwatini, Kenya, South Africa, and Zambia. We included HIV-seronegative women aged 16–35 years who were seeking effective contraception, had no medical contraindications to the trial contraceptive methods, agreed to use the assigned method for 18 months, and reported not using injectable, intrauterine, or implantable contraception for the previous 6 months. Participants were randomly assigned (1:1:1) to receive an injection of 150 mg/mL DMPA-IM every 3 months, a copper IUD, or a LNG implant with random block sizes between 15 and 30, stratified by site. Participants were assigned using an online randomisation system, which was accessed for each randomisation by study staff at each site. The primary endpoint was incident HIV infection in the modified intention-to-treat population, including all randomised participants who were HIV negative at enrolment and who contributed at least one HIV test. The primary safety endpoint was any serious adverse event or any adverse event resulting in method discontinuation, until the trial exit visit at 18 months and was assessed in all enrolled and randomly assigned women. This study is registered with ClinicalTrials.gov, number NCT02550067. Findings Between Dec 14, 2015, and Sept 12, 2017, 7830 women were enrolled and 7829 were randomly assigned to the DMPA-IM group (n=2609), the copper IUD group (n=2607), or the LNG implant group (n=2613). 7715 (99%) participants were included in the modified intention-to-treat population (2556 in the DMPA-IM group, 2571 in the copper IUD group, and 2588 in the LNG implant group), and women used their assigned method for 9567 (92%) of 10 409 woman-years of follow-up time. 397 HIV infections occurred (incidence 3·81 per 100 woman-years [95% CI 3·45–4·21]): 143 (36%; 4·19 per 100 woman-years [3·54–4·94]) in the DMPA-IM group, 138 (35%: 3·94 per 100 woman-years [3·31–4·66]) in the copper IUD group, and 116 (29%; 3·31 per 100 woman-years [2·74–3·98]) in the LNG implant group. In the modified intention-to-treat analysis, the hazard ratios for HIV acquisition were 1·04 (96% CI 0·82–1·33, p=0·72) for DMPA-IM compared with copper IUD, 1·23 (0·95–1·59, p=0·097) for DMPA-IM compared with LNG implant, and 1·18 (0·91–1·53, p=0·19) for copper IUD compared with LNG implant. 12 women died during the study: six in the DMPA-IM group, five in the copper IUD group, and one in the LNG implant group. Serious adverse events occurred in 49 (2%) of 2609 participants in the DMPA-IM group, 92 (4%) of 2607 participants in the copper IUD group, and 78 (3%) of 2613 participants in the LNG implant group. Adverse events resulting in discontinuation of the randomly assigned method occurred in 109 (4%) women in the DMPA-IM group, 218 (8%) women in the copper IUD group, and 226 (9%) women in the LNG implant group (p Interpretation We did not find a substantial difference in HIV risk among the methods evaluated, and all methods were safe and highly effective. HIV incidence was high in this population of women seeking pregnancy prevention, emphasising the need for integration of HIV prevention within contraceptive services for African women. These results support continued and increased access to these three contraceptive methods. Funding Bill & Melinda Gates Foundation, US Agency for International Development and the President's Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council, and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development.

Background: HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limits widespread implementation of the current two or three dose HPV vaccine schedule. Methods: We are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15-20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to: 1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; 2) assess the memory B cell immune response at months 36 and 37; and 3) estimate cost-effectiveness using the trial results and health economic models. Discussion: This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery. Trial registration: NCT03675256

OBJECTIVE: To examine the relationship between male partner involvement (MPI) in prevention of mother-to-child transmission (PMTCT) activities and successful completion of the PMTCT continuum of care, which remains sub-optimal in settings with high prevalence of HIV. METHODS: A cross-sectional survey was administered in June–August 2017 to a sample of 200 postpartum Kenyan women with HIV enrolled in a parent trial. Composite PMTCT and MPI variables were created. Descriptive, simple and multivariable regression, and mediation analyses were performed. RESULTS: Of the women, 54% reported successful completion of PMTCT. Depression and internalized HIV stigma were independently associated with lower likelihood of successful completion of PMTCT (adjusted risk ratio [aRR] 0.97; 95% confidence interval [CI] 0.94–0.99; aRR 0.92; 95% CI 0.88–0.98, respectively). Each MPI activity was associated with 10% greater likelihood of successful completion of PMTCT (P

ObjectivesReproductive aged women are at risk of pregnancy and sexually transmitted infections (STI). Understanding drivers of STI acquisition, including any association with widely used contraceptives, could help us to reduce STI prevalence and comorbidities. We compared the risk of STI among women randomised to three contraceptive methods.MethodsWe conducted a secondary analysis to assess the risk of chlamydia and gonorrhoea in a clinical trial evaluating HIV risk among 7829 women aged 16–35 randomised to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUD) or a levonorgestrel (LNG) implant. We estimated chlamydia and gonorrhoea prevalences by contraceptive group and prevalence ratios (PR) using log-binomial regression.ResultsAt baseline, chlamydia and gonorrhoea prevalences were 18% and 5%, respectively. Final visit chlamydia prevalence did not differ significantly between DMPA-IM and copper IUD groups or between copper IUD and LNG implant groups. The DMPA-IM group had significantly lower risk of chlamydia compared with the LNG implant group (PR 0.83, 95% CI 0.72 to 0.95). Final visit gonorrhoea prevalence differed significantly only between the DMPA-IM and the copper IUD groups (PR 0.67, 95% CI 0.52 to 0.87).ConclusionsThe findings suggest that chlamydia and gonorrhoea risk may vary with contraceptive method use. Further investigation is warranted to better understand the mechanisms of chlamydia and gonorrhoea susceptibility in the context of contraceptive use.

Stress and food insecurity (FI) are associated with poor perinatal and HIV outcomes. We hypothesized that FI would increase postpartum stress among women in Kenya, and that the impact would be greater in women with HIV. Among 371 pregnant women, we identified latent FI trajectories across the perinatal period, and estimated their association with postpartum stress. Stress metrics included the Perceived Stress Scale (PSS) and hair cortisol concentrations (HCC). We identified two FI trajectories: persistent moderate FI and persistent mild FI. Moderate FI (vs. mild) was associated with higher PSS; this association was stronger among HIV-negative women. We observed a trend towards higher HCC associated with moderate FI, which did not differ by HIV status. HCC and PSS were not correlated. In summary, moderate FI (vs. mild) was associated with increased stress. The lack of PSS-HCC correlation could reflect different physiological pathways. Interventions to mitigate FI could alleviate postpartum stress.

Limited data exist on the effects of contraceptives on HIV disease progression. We studied the association between intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD), and the levonorgestrel (LNG) implant on markers of HIV disease progression at the time of HIV detection and 3 months postdetection and time from detection to CD4 count

Objectives: The timely receipt of the recommended vaccination regimen, i.e. vaccination maintenance, is an underexplored, but important, indicator of public health. However, there is currently no standardized method for quantifying cumulative vaccination maintenance, and no simple way to explore predictors of adherence to vaccination schedules. We therefore sought to 1) develop a Vaccination Maintenance Score (VMS) and 2) apply this score to determine the predictors of vaccination behavior among infants in western Kenya (n=245).Methods: Women in western Kenya were enrolled during pregnancy and surveyed repeatedly through one year postpartum. Data were collected on a range of sociodemographic and health indicators and vaccinations. For each infant, we analyzed receipt of 11 vaccines recommended by the Kenyan Ministry of Health. We operationalized VMS as the total number of vaccines received on schedule. Vaccines that were not received or received off-schedule were scored 0. VMS was modeled using multivariable tobit regression models.Results: We found that 85.7% of infants were fully immunized, but only 42.4% had optimal VMS, i.e. scored 11. The median(IQR) VMS was 10(3). In multivariable regression, each one-point increase in maternal quality of life score (range: 0-32) was associated with a 0.22-point increase in VMS; each additional child in the household was associated with a 0.34-point increase in VMS; and initiating breastfeeding at birth was associated a 2.01-point increase in VMS.Conclusions: Coverage of the recommended vaccinations (85.7%) was nearly twice as high as the cumulative timely receipt (42.4%). The VMS satisfies a need for a location-specific but easily adaptable metric of vaccination adherence behavior. It can be used to complement traditional methods of vaccination coverage and timeliness to better understand underlying behaviors that influence vaccination events, and thereby inform interventions to improve vaccination rates and decrease the burden of vaccine-preventable disease.

BackgroundCervical 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.MethodsUsing 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.FindingsIn 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.InterpretationHPV 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.FundingNational Institutes of Health, Bill and Melinda Gates Foundation.

Aim To evaluate an integrated community case management programme for sick children aged 2 to 59 months in western Kenya using the Research, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Methods This was a prospective observational research project conducted between December 2013 and February 2016. Outcome variables were measured before, during and at end of implementation using a series of surveys as well as by looking at routine service statistics. Results A total of 2604 community health workers were trained in 245 community units. The average post-training knowledge level (73.5%) and retention rates (89.7) of trained community health workers was high. At the end of study, there was an increase in the proportion of children who received appropriate treatment for diarrhoea (49.2%), pneumonia (19.5%), malaria (16.4%) and vitamin A (51.5%) from baseline. Community health workers were able to assess, classify and treat sick children with a similar quality as that provided by facility-based healthcare workers (>85% concordance). Conclusion Based on the RE-AIM metrics, our results demonstrate promising practical approaches and outcomes of a large-scale implementation of integrated community case management in western Kenya. The findings have important implications for future design and expansion of the programme in Kenya.

Aim To determine the accuracy and effectiveness of community health workers (CHWs) when compared to trained nurses for management of pneumonia in Kenyan children. Methods In Homabay County in western Kenya, children 2-59 months of age with lower chest indrawing pneumonia were identified, classified and treated by CHWs with oral amoxicillin (90 mg/kg per day) for five days at home. Trained nurses visited the child within 24 hours to verify diagnosis; and on day 4 and 14 to assess treatment outcomes. Results CHWs identified 1906 children with lower chest indrawing pneumonia. There was an 88.7% concordance in classification and treatment for lower chest indrawing pneumonia by CHWs compared to nurses. Children with moderate malnutrition (OR 1.68; 95% CI: 1.22-2.30), comorbidities such as diarrhoea or malaria (OR 1.55; 95% CI: 1.32-1.81) or an additional day of delay in care seeking (OR 1.06; 95% CI: 1.02-1.10) were more likely to have an incorrect classification of lower chest indrawing by the CHW. Comorbidity (OR 1.66; 95% CI: 1.12-2.48) and fast breathing (OR 4.66; 95% CI: 1.26-17.27) were significantly associated with treatment failure on day 14. Conclusion CHWs can correctly manage lower chest indrawing pneumonia even in high-mortality settings, such as western Kenya, in sub-Saharan Africa.

There is rapidly evolving literature on water insecurity in the general adult population, but the role of water insecurity during the vulnerable periods of pregnancy and postpartum, or in the context of HIV, has been largely overlooked. Therefore, we conducted an exploratory study, using Go Along interviews, photo-elicitation interviews, and pile sorts with 40 pregnant and postpartum Kenyan women living in an area of high HIV prevalence. We sought to (1) describe their lived experiences of water acquisition, prioritisation, and use and (2) explore the consequences of water insecurity. The results suggest that water insecurity is particularly acute in this period, and impacts women in far-reaching and unexpected ways. We propose a broader conceptualisation of water insecurity to include consideration of the consequences of water insecurity for maternal and infant psychosocial and physical health, nutrition, and economic well-being.

Background/objectivesBody composition changes markedly during reproduction. In sub-Saharan Africa, impacts of HIV infection on body composition across pregnancy and lactation in the context of Option B+ antiretroviral therapy are unknown. Therefore, we sought to evaluate the role of HIV infection on body composition during pregnancy and lactation among Kenyan women.Subjects/methodsA cohort of pregnant women (n = 333; 50.5% HIV+, receiving ART) were enrolled at seven clinics in western Kenya. Two prenatal (mean ± SD: 23.6 ± 4.4 and 33.4 ± 2.0 weeks gestation) and three postpartum (6, 14, and 36 weeks) measurements included: individual-level food insecurity, height, weight, fat mass (FM), and fat-free mass (FFM) by bioimpedance analysis (BIA), mid-upper arm circumference (MUAC), and triceps skinfold (TSF), allowing for AMA (arm muscle area) and AFA (arm fat area) derivation. Multivariable longitudinal regression models were used to relate HIV to body composition changes.ResultsIn longitudinal models, HIV-infected women had lower weight (ß = -3.0 kg, p = 0.003), fat mass (ß = -1.5 kg, p = 0.02), fat-free mass (ß = -1.5 kg, p = 0.01), TSF (ß = -2.6 mm, p

Background:Livestock can promote resilience in low-income communities through a number of pathways. Livestock development programs seek to amplify these benefits but often fail to consider the costs to intended beneficiaries or the effect of prevailing gender norms.Objective:To explore perceptions of livestock ownership among female smallholder livestock keepers in Nyanza Region, Kenya, and unpack how the distribution of livestock benefits and investments varies by gender within households.Methods:We used multiple ethnographic techniques, including Photovoice, a photo-elicitation interview method, focus group discussions, and pile sorts, with female smallholder livestock owners (n = 18) participating in an ongoing cohort study. Transcripts were coded using a combination of a priori constructs and grounded theory.Results:We found that livestock benefited households by providing financial security, food security, social benefits, and human time and labor savings. However, these benefits largely promoted long-term household resilience rather than immediate gains. Livestock ownership also had major costs to household time and labor, which were overwhelmingly borne by women and children. Despite this investment, women had limited livestock ownership rights, decision-making power, control over income, or access to meat.Conclusions:Our findings suggest that livestock ownership requires significant investments of household time and labor, which disproportionately burden women. Prevailing gender inequalities may therefore constrain the net benefit of livestock ownership for many women and their households in some contexts. Livestock development programs must assess both program benefits and costs at multiple levels to ensure that women’s participation in livestock production leads to improved individual and household outcomes.

Author(s): Onono, Maricianah A; Rutherford, George W; Bukusi, Elizabeth A; White, Justin S; Goosby, Eric; Brindis, Claire D | Abstract: 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.

Additional file 1: Figure S1. PM_EBF_Supp_Figure1.pdf; study flow; Progress of participants through the Pith Moromo study. Three hundred seventy-one women enrolled into the parent study; 8.1% were lost to follow-up.

Water insecurity (WI) is a serious and worsening problem worldwide, but its role in health outcomes among people living with HIV or pregnant women is unknown. We assessed experiences of WI in a cohort of 323 pregnant Kenyan women of mixed HIV status. The majority (77.7%) had at least one experience of WI in the previous month; it was associated with negative economic, nutrition, disease, and psychosocial outcomes. A standardized cross-culturally valid household WI scale would facilitate assessment of the prevalence and consequences of WI, and increased attention to WI could reveal an overlooked, but modifiable, cause of adverse HIV outcomes.

Author(s): Onono, Maricianah Atieno; Brindis, Claire D; White, Justin S; Goosby, Eric; Okoro, Dan Odhiambo; Bukusi, Elizabeth Anne; Rutherford, George W | Abstract: BackgroundDespite the high burden of adverse adolescent sexual and reproductive health (SRH) outcomes, it has remained a low political priority in Kenya. We examined factors that have shaped the lack of current political prioritization of adolescent SRH service provision.MethodsWe used the Shiffman and Smith policy framework consisting of four categories-actor power, ideas, political contexts, and issue characteristics-to analyse factors that have shaped political prioritization of adolescent SRH. We undertook semi-structured interviews with 14 members of adolescent SRH networks between February and April 2019 at the national level and conducted thematic analysis of the interviews.FindingsSeveral factors hinder the attainment of political priority for adolescent SRH in Kenya. On actor power, the adolescent SRH community was diverse and united in adoption of international norms and policies, but lacked policy entrepreneurs to provide strong leadership, and policy windows were often missed. Regarding ideas, community members lacked consensus on a cohesive public positioning of the problem. On issue characteristics, the perception of adolescents as lacking political power made politicians reluctant to act on the existing data on the severity of adolescent SRH. There was also a lack of consensus on the nature of interventions to be implemented. Pertaining to political contexts, sectoral funding by donors and government treasury brought about tension within the different government ministries resulting in siloed approaches, lack of coordination and overall inefficiency. However, the SRH community has several strengths that augur well for future political support. These include the diverse multi-sectoral background of its members, commitment to improving adolescent SRH, and the potential to link with other health priorities such as maternal health and HIV/AIDS.ConclusionIn order to increase political attention to adolescent SRH in Kenya, there is an urgent need for policy actors to: 1) create a more cohesive community of advocates across sectors, 2) develop a clearer public positioning of adolescent SRH, 3) agree on a set of precise approaches that will resonate with the political system, and 4) identify and nurture policy entrepreneurs to facilitate the coupling of adolescent SRH with potential solutions when windows of opportunity arise.

A rapid results initiative (RRI) aimed at increasing male involvement in prevention of mother-to-child transmission (PMTCT) and service uptake among pregnant women at 116 antenatal clinics in Western Kenya was compared at baseline, during the RRI, and 3-months post-RRI. Male involvement increased from 7.4 to 54.2% during RRI (risk difference [RD] 0.47, CI 0.45-0.48) then 43.4% post-RRI (RD 0.36, CI 0.35-0.37). Among HIV-infected women, facility delivery increased from 40.0 to 49.9% (RD 0.10, 95% CI 0.06-0.13) and 65.0% post-RRI (RD 0.25, 95% CI 0.22-0.28). HIV-infected pregnant women linkage to HIV care increased from 58.6 to 85.9% (RD 0.27, CI 0.24-0.30) and 97.3% post-RRI (RD 0.39, CI 0.36-0.41). Time to ART initiation reduced from 29days (interquartile range [IQR] 6-56) to 14days (IQR 0-28) to 7days (IQR 0-20). A male-centered RRI can significantly increase men's engagement in antenatal care leading to improved partner utilization of PMTCT and antenatal services.

With high rates of unintended pregnancy in sub-Saharan Africa, integration of family planning (FP) into HIV care is being explored as a strategy to reduce unmet need for contraception. Perspectives and experiences of healthcare providers are critical in order to create sustainable models of integrated care. This qualitative study offers insight into how HIV care providers view and experience the benefits and challenges of providing integrated FP/HIV services in Nyanza Province, Kenya. Sixteen individual interviews were conducted among healthcare workers at six public sector HIV care facilities one year after the implementation of integrated FP and HIV services. Data were transcribed and analyzed qualitatively using grounded theory methods and Atlas.ti. Providers reported a number of benefits of integrated services that they believed increased the uptake and continuation of contraceptive methods. They felt that integrated services enabled them to reach a larger number of female and male patients and in a more efficient way for patients compared to non-integrated services. Availability of FP services in the same place as HIV care also eliminated the need for most referrals, which many providers saw as a barrier for patients seeking FP. Providers reported many challenges to providing integrated services, including the lack of space, time, and sufficient staff, inadequate training, and commodity shortages. Despite these challenges, the vast majority of providers was supportive of FP/HIV integration and found integrated services to be beneficial to HIV-infected patients. Providers' concerns relating to staffing, infrastructure, and training need to be addressed in order to create sustainable, cost-effective FP/HIV integrated service models.

Background Many HIV-infected pregnant women identified during antenatal care (ANC) do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. Methods We performed a cluster randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, prevention of mother-to-child transmission, and HIV care delivered in the ANC clinic; n = 6 intervention facilities) or standard ANC services (including prevention of mother-to-child transmission and referral to a separate clinic for HIV care; n = 6 control facilities). Results There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was 12-month follow-up data for 256 of 611 (41.8%) women and postpartum data for only 325 of 1172 (28%) women. By 9 months of age, 382 of 568 (67.3%) infants at intervention sites and 338 of 594 (57.0%) at control sites had tested for HIV [odds ratio (OR) 1.45, 95% confidence interval (CI): 0.71 to 2.82]; 7.3% of infants tested HIV positive at intervention sites compared with 8.0% of infants at control sites (OR 0.89, 95% CI: 0.56 to 1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1%, OR 0.83, 95% CI: 0.41 to 1.68). Conclusions Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes.

Research has indicated that gender dynamics-and in particular men's disapproval of family planning-have had an influence on the low levels of contraceptive use in sub-Saharan Africa. Limited evidence exists, however, on effective strategies to increase male approval. We conducted 12 focus group discussions with married men aged 20-66 (N = 106) in Kenya to explore FP perceptions. Men's disapproval of FP was associated with anxieties regarding male identity and gender roles. Men often distrusted FP information provided by their wives because they suspected infidelity or feared being viewed as "herded." Men also feared that providers might pressure them into vasectomies or into disclosing extramarital sexual activity or HIV diagnoses to their wives. Suggested strategies include programs targeting couples jointly and FP education for men provided by male outreach workers. To encourage men's acceptance, community-based programs directly targeting men are needed to reduce stigma and misconceptions and to increase awareness of the benefits of FP.

Background Successful completion and retention throughout the multi-step cascade of prevention of mother-to-child HIV transmission (PMTCT) remains difficult to achieve. The Mother and Infant Visit Adherence and Treatment Engagement study aims to evaluate the effect of mobile text messaging, community-based mentor mothers (cMMs), or both on increasing antiretroviral therapy (ART) adherence, retention in HIV care, maternal viral load suppression, and mother-to-child HIV transmission for mother-infant pairs receiving lifelong ART. Methods/design This study is a cluster randomized, 2 × 2 factorial, controlled trial. The trial will be undertaken in the western Kenyan counties of Migori, Kisumu, and Homa Bay. Study sites will be randomized into one of four groups: six sites will implement both text messaging and cMM, six sites will implement cMM only, six sites will implement text messaging only, and six sites will implement the existing standard of care. The primary analysis will be based on the intention-to-treat principle and will compare maternal ART adherence and maternal retention in care. Discussion This study will determine the impact of long-term (up to 12 months postpartum) text messaging and cMMs on retention in and adherence to ART among pregnant and breastfeeding women living with HIV in Kenya. It will address key gaps in our understanding of what interventions may successfully promote long-term retention in the PMTCT cascade of care. Trial registration ClinicalTrials.gov, NCT02491177. Registered on 11 March 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-2464-3) contains supplementary material, which is available to authorized users.

Background Option B+ is a comprehensive antiretroviral treatment (ART) designed for HIV-infected pregnant/ postpartum women. However, barriers to implementing Option B+ and establishing long-term ART adherence while facilitating retention in prevention of mother to child transmission of HIV (PMTCT) services remain. Community-based mentor mothers (cMMs) who can provide home-based support for PMTCT services may address some of the barriers to successful adoption and retention in Option B+. Thus, we evaluated the acceptability of using cMMs as home-based support for PMTCT services. Methods Gender-matched in-depth interviews were conducted between September–November 2014 for HIV-infected pregnant/postpartum women and their male partners living in southwestern Kenya (n = 40); additionally, we conducted four focus groups involving 30 health workers (n = 70) within four health facilities. Audio-recordings were transcribed, translated, and then coded using a thematic analytical approach in which data were deductively and inductively coded with support from prior literature, identified themes within the interview guides, and emerging themes from the transcripts utilizing Dedoose software. Results Overall, the study results suggest high acceptability of cMMs among individual participants and health workers. Stigma reduction, improvement of utilization of health care services, as well as ART adherence were most frequently discussed potential benefits of cMMs. Participants pictured a cMM as someone acting as a role model and confidant, and who was over 30 years old. Many respondents raised concerns about breaches of confidentiality and inadvertent disclosure. Respondent suggestions to overcome these issues included the cMM working in different communities than where she lives and attending home-visits with no identifying clothing as an HIV-related health worker. Conclusions The home-based cMM approach may be a beneficial and acceptable strategy for promoting ART adherence and retention within PMTCT services for pregnant/postpartum women living with HIV. Considering the risks of inadvertent disclosure of HIV-infected status and related negative consequences for pregnant/postpartum women living with HIV, similar cMM program designs may benefit from recognizing and addressing these risks. Trial registration The MOTIVATE! study was registered on July 7, 2015 at the ClinicalTrials.gov (NCT02491177). Electronic supplementary material The online version of this article (10.1186/s12884-019-2419-z) contains supplementary material, which is available to authorized users.

Objective The objective was to address bias in contraception efficacy studies through a randomized study trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUDs) and a levonorgestrel (LNG) implant. Study design We analyzed data from the Evidence for Contraceptive Options and HIV Outcomes Trial, which assessed HIV incidence among 7829 women from 12 sites in eSwatini, Kenya, South Africa and Zambia seeking effective contraception and who consented to be randomized to DMPA-IM, copper IUD or LNG implant. We used Cox proportional hazards regression adjusted for condom use to compare pregnancy incidence during both perfect and typical (i.e., allowing temporary interruptions) use. Results A total of 7710 women contributed to this analysis. Seventy pregnancies occurred during perfect and 85 during typical use. There was no statistically significant difference in perfect use pregnancy incidence among the methods: 0.61 per 100 woman-years for DMPA-IM [95% confidence interval (CI) 0.36–0.96], 1.06 for copper IUD (95% CI 0.72–1.50) and 0.63 for LNG implants (95% CI 0.39–0.96). Typical use pregnancy rates were also largely similar: 0.87 per 100 woman-years for DMPA-IM (95% CI 0.58–1.25), 1.11 for copper IUD (95% CI 0.77–1.54) and 0.63 for LNG implants (95% CI 0.39–0.96). Conclusions In this randomized trial of highly effective contraceptive methods among African women, both perfect and typical use resulted in low pregnancy rates. Our findings provide strong justification for improving access to a broader range of longer-acting contraceptive options including LNG implants and copper IUD for African women. Implications statement Data from this study support recommendations to providers, policy makers and patients that all of these methods provide safe and highly effective contraception for African women.

Integration of family planning (FP) services into HIV care and increasing male partner involvement in FP are being explored as strategies to reduce unmet need for contraception. Providers' views can give valuable insight into current FP care. We evaluated the perspectives of HIV care providers working at HIV clinics in Nyanza Province, Kenya, on male partner involvement in FP. This qualitative study was part of a cluster-randomized controlled trial evaluating the impact of integrating FP into HIV services on contraceptive prevalence among HIV-positive patients in Nyanza Province, Kenya. Thirty individual interviews were conducted among health-care workers at 11 HIV care facilities in Nyanza Province, Kenya. Interviews were conducted from integrated and control sites one year after implementation of FP/HIV integration. Data were transcribed and analyzed using grounded theory methods and ATLAS-ti. Providers supported male partner inclusion when choosing FP and emphasized that decisions should be made collaboratively. Providers believed that men have traditionally played a prohibitive role in FP but identified several benefits to partner involvement in FP decision-making including: reducing relationship conflicts, improving FP knowledge and contraceptive continuation, and increasing partner cohesion. Providers suggested that integrated FP/HIV services facilitate male partner involvement in FP decision-making since HIV-positive men are already established patients in HIV clinics. Some providers stated that women had a right to choose and start FP alone if their partners did not agree with using FP. Integrated FP services may be a useful strategy to help increase male participation to reduce the unmet FP need in sub-Saharan Africa. It is important to determine effective ways to engage male partners in FP, without impinging upon women's autonomy and reproductive rights.

ObjectiveTo determine if a health talk on family planning (FP) by community clinic health assistants (CCHAs) will improve knowledge, attitudes and behavioral intentions about contraception in HIV-infected individuals.MethodsA 15-min FP health talk was given by CCHAs in six rural HIV clinics to a sample of 49 HIV-infected men and women. Effects of the health talk were assessed through a questionnaire administered before the health talk and after completion of the participant's clinic visit.ResultsFollowing the health talk, there was a significant increase in knowledge about contraceptives (p

Background Globally, pneumonia accounted for 16% of deaths among children under 5 years of age and was one of the major causes of death overall in 2018. Kenya is ranked among the top 15 countries with regard to pneumonia prevalence and contributed approximately 74% of the world's annual pneumonia cases in 2018. Unfortunately, less than 50% of children with pneumonia receive appropriate antibiotics for treatment. Homa-Bay County implemented pneumonia community case management utilizing community health workers, as recommended by the World Health Organization (WHO), in 2014. However, since implementation of the program, the relative patient-level cost of home-based and facility-based treatment of pneumonia, as well as the main drivers of these costs in Suba Subcounty, remain uncertain. Therefore, the main objective of this study was to compare the patient-level costs of home based treatment of pneumonia by a community health worker with those of health facility-based treatment. Methods and findings Using a cross-sectional study design, a structured questionnaire was used to collect quantitative data from 208 caregivers on the direct costs (consultation, medicine, transportation) and indirect costs (opportunity cost) of pneumonia treatment. The average household cost for the community managed patients was KSH 122.65 ($1.29) compared with KSh 447.46 ($4.71), a 4-fold difference, for those treated at the health facility. The largest cost drivers for home treatment and health facility treatment were opportunity costs (KSH 88.25 ($ 0.93)) and medicine costs (KSH 126.16 ($ 1.33)), respectively. Conclusion This study demonstrates that the costs incurred for home-based pneumonia management are considerably lower compared to those incurred for facility-based management. Opportunity costs (caregiver time and forgone wages) and the cost of medication were the key cost-drivers in the management of pneumonia at the health facility and at home, respectively. These findings emphasize the need to strengthen and scale community case management to overcome barriers and delays in accessing the correct treatment for pneumonia for sick children under 5 years of age.

OBJECTIVES: Antiretroviral (ARV) adherence is a strong predictor of improved health outcomes and treatment effectiveness among persons living with HIV. Food insecurity and low social support are have been demonstrated to predict reported nonadherence among pregnant women, but the relationship has not been evaluated using an objective indicator of adherence. Therefore, we explored the impacts of social support and food insecurity on ARV adherence using ARV drug concentrations in hair among postpartum Kenyan women living with HIV. METHODS: Hair samples were collected from 83 HIV + women, a subset from an observational pregnancy cohort study (NCT02974972), on Efavirenz (n = 58) and Nevirapine (n = 25)-based ARVs at nine months postpartum. Hair ARV concentrations were log transformed to approximate a normal distribution. Food insecurity [Individual Food Insecurity Access Scale (IFIAS, 0–27)], social support (Perceived Social Support Scale, 0–40), and quality of life (Short Form 8 Health Survey, 0–40] were recalled for the prior month. These covariables, along with sociodemographic characteristics, were included in a multivariable linear regression model (P

Objective: To evaluate costs cost-efficiency and cost-effectiveness of integration of family planning into HIV services. Intervention: Integration of family planning services into HIV care and treatment clinics. Design: A cluster-randomized trial. Setting: Twelve health facilities in Nyanza Kenya were randomized to integrate family planning into HIV care and treatment; six health facilities were randomized to (nonintegrated) standard-of-care with separately delivered family planning and HIV services. Main outcome measures: We assessed costs cost-efficiency (cost per additional use of more effective family planning) and cost-effectiveness (cost per pregnancy averted) associated with the first year of integration of family planning into HIV care. More effective family planning methods included oral and injectable contraceptives subdermal implants intrauterine device and female and male sterilization. Patients and participants: We collected cost data through interviews with study staff and review of financial records to determine costs of service integration. Results: Integration of services was associated with an average marginal cost of $841 per site and $48 per female patient. Average overall and marginal costs of integration were associated with personnel costs [initial ($1003 vs. $872) and refresher ($498 vs. $330) training mentoring ($1175 vs. $902) and supervision ($1694 vs. $1636)] with fewer resources required for other fixed ($18 vs. $0) and recurring expenses ($471 vs. $287). Integration was associated with a marginal cost of $65 for each additional use of more effective family planning and $1368 for each pregnancy averted. Conclusion: Integration of family planning and HIV services is feasible inexpensive to implement and cost-efficient in the Kenyan setting and thus supports current Kenyan integration policy.

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.

This study explored barriers to and facilitators of using family planning services among HIV-positive men in Nyanza Province, Kenya. From May to June 2010, in-depth interviews were conducted with 30 men receiving care at 15 HIV clinics. The key barriers to the use of family planning included concerns about side effects of contraceptives, lack of knowledge about contraceptive methods, myths and misconceptions including fear of infertility, structural barriers such as staffing shortages at HIV clinics, and a lack of male focus in family planning methods and service delivery. The integration of family planning into HIV clinics including family planning counseling and education was cited as an important strategy to improve family planning receptivity among men. Integrating family planning into HIV services is a promising strategy to facilitate male involvement in family planning. Integration needs to be rigorously evaluated in order to measure its impact on unmet need for contraception among HIV-positive women and their partners and assure that it is implemented in a manner that engages both men and women.