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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

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.

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.

Introduction Retention in HIV care and adherence to antiretroviral therapy (ART) during pregnancy and postpartum for women living with HIV (WLWH) are necessary to optimize health outcomes for women and infants. The objective of this study was to evaluate the impact of two evidenced‐based behavioural interventions on postpartum adherence and retention in WLWH in Kenya. Methods The Mother‐Infant Visit Adherence and Treatment Engagement (MOTIVATE) study was a cluster‐randomized trial enrolling pregnant WLWH from December 2015 to August 2017. Twenty‐four health facilities in southwestern Kenya were randomized to: (1) standard care (control), (2) text‐messaging, (3) community‐based mentor mothers (cMM) or (4) text‐messaging and cMM. Primary outcomes included retention in care and ART adherence at 12 months postpartum. Analyses utilized generalized estimating equations and competing risks regression. Per‐protocol analyses examined differences in postpartum retention for women with high versus low levels of exposure to the interventions. Results We enrolled 1331 pregnant WLWH (mean age 28 years). At 12 months postpartum, 1140 (85.6%) women were retained in care, 96 women (7.2%) were lost‐to‐follow‐up (LTFU) and 95 (7.1%) were discontinued from the study. In intention‐to‐treat analyses, the relative risk of being retained at 12‐months postpartum was not significantly higher in the intervention arms versus the control arm. In time‐to‐event analysis, the cMM and text arm had significantly lower rates of LTFU (hazard ratio 0.44, p = 0.019). In per‐protocol analysis, the relative risk of 12‐month postpartum retention was 24–29% higher for women receiving at least 80% of the expected intervention compared to the control arm; text message only risk ratio (RR) 1.24 (95% confidence interval [CI] 1.16–1.32, p

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.

Author(s): Patel, Rena C; Amorim, Gustavo; Jakait, Beatrice; Shepherd, Bryan E; Mocello, A Rain; Musick, Beverly; Bernard, Caitlin; Onono, Maricianah; Bukusi, Elizabeth A; Wools-Kaloustian, Kara; Cohen, Craig R; Yiannoutsos, Constantin T; Implant/Efavirenz Study Group and the East Africa IeDEA Regional Consortium | Abstract: BackgroundPreventing unintended pregnancies is paramount for women living with HIV (WLHIV). Previous studies have suggested that efavirenz-containing antiretroviral therapy (ART) reduces contraceptive effectiveness of implants, but there are uncertainties regarding the quality of the electronic medical record (EMR) data used in these prior studies.MethodsWe conducted a retrospective, cohort study of EMR data from 2011 to 2015 among WLHIV of reproductive age accessing HIV care in public facilities in western Kenya. We validated a large subsample of records with manual chart review and telephone interviews. We estimated adjusted incidence rate ratios (aIRRs) with Poisson regression accounting for the validation sampling using inverse probability weighting and generalized raking.ResultsA total of 85,324 women contributed a total of 170,845 women-years (w-y) of observation time; a subset of 5080 women had their charts reviewed, and 1285 underwent interviews. Among implant users, the aIRR of pregnancy for efavirenz- vs. nevirapine-containing ART was 1.9 (95% CI 1.6, 2.4) using EMR data only and 3.2 (95% CI 1.8, 5.7) when additionally using both chart review and interview validated data. Among efavirenz users, the aIRR of pregnancy for depomedroxyprogesterone acetate (DMPA) vs. implant use was 1.8 (95% CI 1.5, 2.1) in EMR only and 2.4 (95% CI 1.0, 6.1) using validated data.ConclusionPregnancy rates are higher when contraceptive implants are concomitantly used with efavirenz-containing ART, though rates were similar to leading alternative contraceptive methods such as DMPA. Our data provides policymakers, program staff, and WLHIV greater confidence in guiding their decision-making around contraceptive and ART options. Our novel, 3-phase validation sampling provides an innovative tool for using routine EMR data to improve the robustness of data quality.

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.

Between 1990 and 2015, Kenya had a 0.9% annual reduction in maternal mortality, one of the lowest reductions globally. This slow decline was linked to the relatively low utilization of delivery services. We designed a mobile phone–enhanced 24-hour transport navigation system coupled with personalized and interactive gestation-based text messages (MAccess) to address maternal child health service utilization. The primary purpose of this analysis is to explore the ways in which pregnant and postnatal women made decisions regarding care-seeking for pregnancy and childbirth services, the processes of getting care from home to the hospital as well their perceptions on how the MAccess intervention affected their pregnancy and childbirth care-seeking and utilization experience. We conducted semistructured, individual interviews with 18 postpartum women. Participants were purposively sampled. Interviews were audiotaped, transcribed, and analyzed using thematic analysis. For participants in this study, all three delays interacted in a complex manner to affect women’s utilization of pregnancy and childbirth services. Even though women were aware of the benefits of skilled birth attendance, other health system factors such as opening hours, or health workers’ attitudes still deterred women from delivering in health facilities. The MAccess innovation was highly acceptable to women throughout pregnancy and childbirth and helped them navigate the complex and layered individual, infrastructural, and health system factors that put them at risk of adverse maternal and newborn outcomes. These findings emphasize that an integrated approach, which addresses all delays simultaneously, is important for reducing perinatal morbidity and mortality.

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

Food insecurity (FI) is an understudied risk factor for depression among perinatal women in sub-Saharan Africa. We therefore explored the longitudinal relationship between FI and depressive symptoms among a cohort of perinatal women of mixed HIV status (n = 371) in Kenya (NCT02974972, NCT02979418). Using longitudinal linear and logistic regressions with random effects, we assessed bivariate and adjusted associations between maternal FI and depressive symptoms. HIV status was also assessed as a potential effect modifier. At baseline, 58% of pregnant women had probable depression (CES-D score 16) and 84% were severely food insecure. In adjusted analyses, severely food-insecure women had 5.90 greater odds (95% CI 2.32, 15.02, p 0.001) of having probable depression and scored 4.58 points higher on the CES-D scale (SE: 1.04, p 0.001) relative to food-secure women. HIV status did not modify the association between FI and depressive symptoms. Interventions to reduce FI may reduce perinatal depression, benefiting mothers and their infants.La inseguridad alimentaria es un factor de riesgo del estrés en el periodo de posparto entre mujeres en África Sub-sahariana que es poco estudiado. Por lo tanto exploramos la relación entre la seguridad alimentaria y los síntomas de depresión con un estudio longitudinal entre un cohorte de mujeres en diferentes etapas perinatal y con diferentes estatus de VIH (n=371) en Kenia (NCT02974972, NCT02979418). Se evaluaron asociaciones bi-variadas y asociaciones ajustadas entre la inseguridad alimentaria y las síntomas de depresión usando regresión lineal y logística con efectos aleatorios. El estatus de VIH también se evaluó como modificador de efecto. Al inicio del estudio el 58% de mujeres embarazadas tenían depresión probable (CES-D score16) y el 84% tenían un nivel de inseguridad alimentaria severa. Mujeres con un nivel de inseguridad alimentaria severa tenían mayores posibilidades del 5.90 (95% IC: 2.32, 15.02, p0.001) de depresión probable y una puntuación mas alta del 4.58 en el CES-D (EE: 1.04, p0.001) en comparación a las mujeres con un nivel de inseguridad alimentaria seguro. El estatus de VIH no modifico la asociación entre la inseguridad alimentaria y los síntomas de depresión. Intervenciones destinadas para mitigar la inseguridad alimentaria podrían reducir la depresión en el periodo perinatal, proporcionando beneficios a las mamas y sus bebes.

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.

OBJECTIVES: Food insecurity (FI) is recognized as an important predictor of a range of health outcomes, including HIV acquisition and progression. Less is understood about the drivers of FI during the first 1000 days. Therefore we assessed the prevalence and covariates of FI among women of mixed HIV status in southwestern Kenya from pregnancy to 21 months postpartum. METHODS: The prevalence of FI was measured amongst all pregnant women attending 7 antenatal clinics in the Nyanza region, Kenya (n = 954) between 2015 and 2017 using the Individually Focused Food Insecurity Access Scale (IFIAS, range: 0–27). Subsequently, equal proportions of HIV-infected and -uninfected pregnant women (n = 363) were enrolled into an observational study and surveyed at 9 timepoints. RESULTS: In the population-based sample, 81% were severely food insecure. In the study cohort, the mean (SD) IFIAS score was 15.4 (6.1); 88% were considered severely food insecure. In longitudinal logistic regression models of FI (severe vs. not severe) from pregnancy to 21 m postpartum, greater depression scores, lower social support, greater stress, rural residence, and having dependents under 15-years were associated with greater IFIAS scores. Surprisingly, HIV infection, gestation age, education, and maternal age did not predict IFIAS scores. CONCLUSIONS: These findings suggest programs in severely food insecure communities should also address psychosocial well-being of women to improve health outcomes. FUNDING SOURCES: National Institute of Mental Health (K01 MH098902 and R21MH108444).

Depression is a leading cause of disability worldwide and a major contributor to the overall global burden of disease, especially for women of childbearing age. Social science scholarship has demonstrated significant relationships between mental health, food insecurity (FI), water insecurity (WI), and HIV. Little is known, however, about the temporal relationships between food and water insecurity or the mechanisms through which these multiple stressors may operate or interact to impact depression. We therefore used syndemic theory to explore the complex relationships between FI, WI, and HIV on depressive symptomatology among Kenyan women of mixed HIV status (n=183, NCT02979418). We sought to 1) understand the temporal relationships between time-variant risk factors for depression, i.e. FI and WI, and 2) assess how these factors potentially interacted with HIV to impact depressive symptomatology. We first assessed the bidirectional relationship between WI and FI using a cross-lagged three-wave, two-variable panel model. Next, we modeled depressive symptomatology at 21 months as a linear function of the potentially syndemic interaction between FI, WI, and HIV status, adjusting for household wealth. WI had a predominant predictive effect on FI (Bayesian posterior predictive p-value=0.13); there was no reverse causality for the influence of FI on WI. The interaction effect of FI, WI, and HIV was significantly associated with greater depressive symptomatology (β=0.06) at 21 months postpartum. These data suggest that water insecurity may be an important determinant of food insecurity. Further, the co-occurrence of FI, WI, and HIV increases the likelihood of maternal depressive symptomatology, i.e. there is a syndemic relationship. These findings suggest that the role of household WI in other adverse health outcomes beyond mental well-being should be examined, and that interventions to improve mental health will be more effective if they also consider concurrent resource insecurities, regardless of HIV status.

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