Results of a cluster randomized trial testing the Systems Analysis and Improvement Approach to increase cervical cancer screening in family planning clinics in Mombasa County, Kenya.

BACKGROUND: Cervical cancer is the leading cause of cancer death in Kenyan women. Integrating cervical cancer screening into family planning (FP) clinics is a promising strategy to improve health for reproductive-aged women. The objective of this cluster randomized trial was to test the efficacy of an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), as a tool to increase cervical cancer screening in FP clinics in Mombasa County, Kenya. METHODS: Twenty FP clinics in Mombasa County were randomized 1:1 to SAIA versus usual procedures. SAIA has five steps: (1) cascade analysis tool to understand the cascade and identify inefficiencies, (2) sequential process flow mapping to identify bottlenecks, (3) develop and implement workflow modifications (micro-interventions) to address identified bottlenecks, (4) assess the micro-intervention in the cascade analysis tool, and (5) repeat the cycle. Prevalence ratios were calculated using Poisson regression with robust standard errors to compare the proportion of visits where women were screened for cervical cancer in SAIA clinics compared to control clinics. RESULTS: In the primary intent-to-treat analysis in the last quarter of the trial, 2.5% (37/1507) of visits with eligible FP clients at intervention facilities included cervical cancer screening compared to 3.7% (66/1793) in control clinics (prevalence ratio [PR] 0.67, 95% CI 0.45-1.00). When adjusted for having at least one provider trained to perform cervical cancer screening at baseline, there was no significant difference between screening in intervention clinics compared to control clinics (adjusted PR 1.14, 95% CI 0.74-1.75). CONCLUSIONS: The primary analysis did not show an effect on cervical cancer screening. However, the COVID-19 pandemic and a healthcare worker strike likely impacted SAIA's implementation with significant disruptions in FP care delivery during the trial. While SAIA's data-informed decision-making and clinic-derived solutions are likely important, future work should directly study the mechanisms through which SAIA operates and the influence of contextual factors on implementation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03514459. Registered on April 19, 2018.

Randomized controlled trial of a theory-informed mHealth intervention to support ART adherence and viral suppression among women with HIV in Mombasa, Kenya: preliminary efficacy and participant-level feasibility and acceptability.

BACKGROUND: Mobile Health ("mHealth") interventions have shown promise in improving HIV treatment outcomes for stigmatized populations. This paper presents the findings from a randomized controlled trial to assess the efficacy, participant-level feasibility and acceptability of a theory-informed mHealth intervention, Motivation Matters!, designed to improve viral suppression and ART adherence among HIV-seropositive women who engage in sex work in Mombasa, Kenya. METHODS: A total of 119 women were randomized between the intervention and standard of care control. The primary outcome examined viral suppression (≤ 30 copies/mL) six months following ART initiation. ART adherence was assessed monthly using a visual analogue scale. Participant-level feasibility was measured through response rates to study text messages. Acceptability was assessed through qualitative exit interviews. RESULTS: Six months following treatment initiation, 69% of intervention and 63% of control participants were virally suppressed (Risk Ratio [RR] = 1.09, 95% Confidence Interval [95% CI] (0.83, 1.44). Among women who were viremic at baseline and endorsed engagement in sex work, 74% of women in the intervention arm compared with 46% of women in the control arm achieved viral suppression at month six RR = 1.61, 95% CI (1.02, 2.55). Adherence was higher in intervention versus control participants every month. All participants responded to at least one message, and there was a 55% overall response rate to intervention text messages. Qualitative exit interviews suggested high acceptability and perceived impact of the intervention. CONCLUSION: The improvements in ART adherence and viral suppression, combined with encouraging data on feasibility and acceptability, provides preliminary evidence that Motivation Matters! could support ART adherence and viral suppression in women who engage in sex work. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT02627365, 10/12/2015; http://clinicaltrials.gov ).

Impact of the COVID-19 pandemic on obstetrical care at a tertiary care facility in Mombasa, Kenya: Time-series analyses and staff perspectives.

The COVID-19 pandemic caused disruption in healthcare delivery due to reductions in both health facility capacity and care-seeking behavior. For women experiencing obstetric complications, access to comprehensive emergency obstetric care is critical for maternal and child health. In Kenya, pandemic-related restrictions began in March 2020 and were compounded by a healthcare worker strike in December 2020. We examined medical record data at Coast General Teaching and Referral Hospital, a large public hospital, and conducted staff interviews to understand how healthcare disruptions impacted care delivery and perinatal outcomes. Routinely collected data from all mother-baby dyads admitted to the Labor and Delivery Ward from January 2019 through March 2021 were included in interrupted time-series analyses. Outcomes included number of admissions and proportion of deliveries that resulted in caesarean sections and adverse birth outcomes. Interviews were conducted with nurses and medical officers to understand how the pandemic impacted clinical care. Pre-pandemic, the ward averaged 810 admissions/month, compared to 492 admissions/month post-pandemic (average monthly decrease: 24.9 admissions; 95% CI: -48.0, -1.8). The proportion of stillbirths increased 0.3% per month during the pandemic compared to the pre-pandemic period (95% CI: 0.1, 0.4). No significant differences were seen in the proportion of other adverse obstetrical outcomes. Interview results suggested that pandemic-related disruptions included reduced access to surgical theaters and protective equipment, and absence of COVID-19 guidelines. While these disruptions were perceived as impacting care for high-risk pregnancies, providers believed that overall quality of care did not diminish during the pandemic. However, they expressed concern about a likely increase in at-home births. In conclusion, while the pandemic had minimal adverse impact on hospital-based obstetrical outcomes, it reduced the number of patients able to access care. Emergency preparedness guidelines and public health messaging promoting timely obstetrical care are needed to ensure continuation of services during future healthcare disruptions.

The Systems Analysis and Improvement Approach: specifying core components of an implementation strategy to optimize care cascades in public health.

BACKGROUND: Healthcare systems in low-resource settings need simple, low-cost interventions to improve services and address gaps in care. Though routine data provide opportunities to guide these efforts, frontline providers are rarely engaged in analyzing them for facility-level decision making. The Systems Analysis and Improvement Approach (SAIA) is an evidence-based, multi-component implementation strategy that engages providers in use of facility-level data to promote systems-level thinking and quality improvement (QI) efforts within multi-step care cascades. SAIA was originally developed to address HIV care in resource-limited settings but has since been adapted to a variety of clinical care systems including cervical cancer screening, mental health treatment, and hypertension management, among others; and across a variety of settings in sub-Saharan Africa and the USA. We aimed to extend the growing body of SAIA research by defining the core elements of SAIA using established specification approaches and thus improve reproducibility, guide future adaptations, and lay the groundwork to define its mechanisms of action. METHODS: Specification of the SAIA strategy was undertaken over 12 months by an expert panel of SAIA-researchers, implementing agents and stakeholders using a three-round, modified nominal group technique approach to match core SAIA components to the Expert Recommendations for Implementing Change (ERIC) list of distinct implementation strategies. Core implementation strategies were then specified according to Proctor's recommendations for specifying and reporting, followed by synthesis of data on related implementation outcomes linked to the SAIA strategy across projects. RESULTS: Based on this review and clarification of the operational definitions of the components of the SAIA, the four components of SAIA were mapped to 13 ERIC strategies. SAIA strategy meetings encompassed external facilitation, organization of provider implementation meetings, and provision of ongoing consultation. Cascade analysis mapped to three ERIC strategies: facilitating relay of clinical data to providers, use of audit and feedback of routine data with healthcare teams, and modeling and simulation of change. Process mapping matched to local needs assessment, local consensus discussions and assessment of readiness and identification of barriers and facilitators. Finally, continuous quality improvement encompassed tailoring strategies, developing a formal implementation blueprint, cyclical tests of change, and purposefully re-examining the implementation process. CONCLUSIONS: Specifying the components of SAIA provides improved conceptual clarity to enhance reproducibility for other researchers and practitioners interested in applying the SAIA across novel settings.

Fertility Desire and Associations with Condomless Sex, Antiretroviral Adherence, and Transmission Potential in a Cohort of Kenyan Women Living with HIV in Sero-discordant Relationships: A Mixed Methods Study.

For women living with HIV (WLH) in serodiscordant partnerships, decisions about childbearing can challenge condom use and antiretroviral adherence. In a prospective cohort of 148 WLH in serodiscordant partnerships, 58 (39%) wanted more children in the future but were not currently trying to conceive (fertility desire), and 32 (22%) were currently trying to become pregnant (fertility intent). Detection of prostate specific antigen (PSA) in vaginal secretions, a marker for recent condomless sex, was lowest in women with fertility desire and highest in women with fertility intent. Detectable viral load followed a similar pattern. Risk of HIV transmission, when condomless sex and PSA detection occurred concurrently, was three to fourfold higher at visits with fertility intent compared to visits with fertility desire. Qualitative interviews underscored the importance women place on childbearing and suggested that they had limited information about the role of antiretroviral therapy in reducing sexual HIV transmission.

The cost of implementing the Systems Analysis and Improvement Approach for a cluster randomized trial integrating HIV testing into family planning services in Mombasa County, Kenya.

BACKGROUND: Although HIV testing in family planning (FP) clinics is a promising approach for engaging women in HIV treatment and prevention services, HIV testing rates are low in FP clinics in Kenya. In 2018, a cluster randomized trial was implemented in Mombasa, Kenya applying the Systems Analysis and Improvement Approach (SAIA) to integrate HIV testing into FP services (1K24HD088229-01). We estimated the incremental costs and explored cost drivers of the FP HIV SAIA implementation in Mombasa, Kenya. METHODS: We conducted a costing evaluation from the payer perspective for the FP HIV SAIA randomized control trial. We identified relevant activities for the intervention including start-up, training, research and FP HIV SAIA. We estimated activity time burden using a time-and motion study. We derived unit costs through staff interviews and programmatic budgets. We present cost estimates for two different scenarios: as-implemented including research and projected costs for a Ministry of Health-supported intervention. All costs are reported in 2018 USD. RESULTS: For an annual program output of 36,086 HIV tests administered to new FP clients, we estimated the total annual program cost to be $91,994 with an average cost per new FP client served of $2.55. Personnel and HIV rapid testing kits comprised 55% and 21% of programmatic costs, respectively. Assuming no changes to program outputs and with efficiency gains under the MOH scenario, the estimated cost per new FP client served decreased to $1.30 with a programmatic cost reduction of 49%. CONCLUSION: FP HIV SAIA is a low-cost and flexible implementation strategy for facilitating integrated delivery of HIV testing alongside FP services. Although cost implications of the FP HIV SAIA intervention must continue to be evaluated over time, these findings provide context-specific cost data useful for budget planning and decision-making regarding intervention delivery and expansion. TRIAL REGISTRATION: The trial was registered on December 15, 2016, with clinicaltrials.gov (NCT02994355).

A cross-sectional study of the prevalence, barriers, and facilitators of cervical cancer screening in family planning clinics in Mombasa County, Kenya.

BACKGROUND: Cervical cancer is the most common cancer in sub-Saharan Africa. With appropriate screening and treatment, cervical cancer can be prevented. In Kenya, cervical cancer screening is recommended for all women of reproductive age who visit a health facility. In particular, the Kenyan Ministry of Health has tasked family planning clinics and HIV clinics with implementing cervical cancer screening as part of the overall cervical cancer screening strategy. A cross-sectional survey was conducted to understand cervical cancer screening practices and explore clinic-level barriers and facilitators to screening in family planning clinics (FP) in Mombasa County, Kenya. METHODS: Structured interviews were conducted with randomly sampled FP clinic managers to collect information about clinic size, location, type, management support, infrastructure, screening practices, and availability of screening commodities. Data were abstracted from FP registers for a 15-month period from October 1, 2017 until December 31, 2018 to understand cervical cancer screening prevalence. Generalized linear models were used to calculate prevalence ratios (PR) and identify clinic-level correlates of reporting any cervical cancer screening. RESULTS: A total of 70 clinics were sampled, 54% (38) were urban and 27% (19) were public facilities. The median number of staff in a clinic was 4 (interquartile range [IQR] 2-6) with a median of 1 provider trained to perform screening (IQR 0-3). Fifty-four percent (38/70) of clinic managers reported that their clinics performed cervical cancer screening. Of these, only 87% (33) and 71% (27) had dependable access to speculums and acetic acid, respectively. Being a public FP clinic was associated with higher prevalence of reported screening (14/38 [37%] vs 6/32 [16%]; prevalence rate ratio [PR] 1.57, 95%CI 1.05-2.33). Clinics that reported cervical cancer screening were much more likely to have at least one provider trained to perform cervical cancer screening (84%, 32/38) compared to clinics that did not report screening (28%, 9/32; PR 3.77, 95%CI 1.82-7.83). CONCLUSION: Integration of cervical cancer screening into FP clinics offers great potential to reach large numbers of reproductive-aged women. Increasing training of healthcare providers and ensuring adequate commodity supplies in FP clinics offer concrete solutions to increase screening in a largely unscreened population.

Assessing the sustainability of the Systems Analysis and Improvement Approach to increase HIV testing in family planning clinics in Mombasa, Kenya: results of a cluster randomized trial.

BACKGROUND: In Kenya, HIV incidence is highest among reproductive-age women. A key HIV mitigation strategy is the integration of HIV testing and counseling (HTC) into family planning services, but successful integration remains problematic. We conducted a cluster-randomized trial using the Systems Analysis and Improvement Approach (SAIA) to identify and address bottlenecks in HTC integration in family planning clinics in Mombasa County, Kenya. This trial (1) assessed the efficacy of this approach and (2) examined if SAIA could be sustainably incorporated into the Department of Health Services (DOHS) programmatic activities. In Stage 1, SAIA was effective at increasing HTC uptake. Here, we present Stage 2, which assessed if SAIA delivery would be sustained when implemented by the Mombasa County DOHS and if high HTC performance would continue to be observed. METHODS: Twenty-four family planning clinics in Mombasa County were randomized to either the SAIA implementation strategy or standard care. In Stage 1, the study staff conducted all study activities. In Stage 2, we transitioned SAIA implementation to DOHS staff and compared HTC in the intervention versus control clinics 1-year post-transition. Study staff provided training and minimal support to DOHS implementers and collected quarterly HTC outcome data. Interviews were conducted with family planning clinic staff to assess barriers and facilitators to sustaining HTC delivery. RESULTS: Only 39% (56/144) of planned SAIA visits were completed, largely due to the COVID-19 pandemic and a prolonged healthcare worker strike. In the final study quarter, 81.6% (160/196) of new clients at intervention facilities received HIV counseling, compared to 22.4% (55/245) in control facilities (prevalence rate ratio [PRR]=3.64, 95% confidence interval [CI]=2.68-4.94). HIV testing was conducted with 60.5% (118/195) of new family planning clients in intervention clinics, compared to 18.8% (45/240) in control clinics (PRR=3.23, 95% CI=2.29-4.55). Interviews with family planning clinic staff suggested institutionalization contributed to sustained HTC delivery, facilitated by low implementation strategy complexity and continued oversight. CONCLUSIONS: Intervention clinics demonstrated sustained improvement in HTC after SAIA was transitioned to DOHS leadership despite wide-scale healthcare disruptions and incomplete delivery of the implementation strategy. These findings suggest that system interventions may be sustained when integrated into DOHS programmatic activities. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02994355) registered on 16 December 2016.

Qualitative evaluation of the Systems Analysis and Improvement Approach as a strategy to increase HIV testing in family planning clinics using the Consolidated Framework for Implementation Research and the Implementation Outcomes Framework.

BACKGROUND: Significant gaps remain in HIV testing and counseling (HTC) in family planning (FP) clinics. To address these gaps, our group tested an implementation strategy called the Systems Analysis and Improvement Approach (SAIA), an evidenced-based multi-component implementation strategy focused on improving entire care cascades. In a cluster randomized trial of 24 FP clinics in Mombasa County, Kenya, SAIA led to a significant increase in HTC in intervention clinics compared to control clinics. The objective of this manuscript was to evaluate SAIA using the Consolidated Framework for Implementation Research (CFIR) and assess the Implementation Outcomes Framework outcomes of acceptability, appropriateness, and feasibility. METHODS: This qualitative assessment was nested within the cluster-randomized trial. Data collection included questionnaires to assess modifiable and non-modifiable health system factors related to HTC and in-depth interviews to query clinic norms, priorities, communication strategies, and readiness for change. The primary outcomes of interest were feasibility, appropriateness, and acceptability of SAIA. Data on inner setting and structural characteristics of FP clinics were collected to inform how context may impact outcomes. All interviews were recorded and analyzed using a rapid assessment approach. RESULTS: Of the 12 intervention clinics, 6 (50%) were public facilities. Availability of resources varied by clinic. Most clinics had a positive implementation climate, engaged leadership, and access to resources and information. While not all clinics identified HTC as a clinic priority, most reported a strong culture of embracing change and recognition of the importance of HIV testing within FP clinics. Interviews highlighted very high acceptability, appropriateness, and feasibility of SAIA. The implementation strategy was not complicated and fit well into existing clinic processes. In particular, staff appreciated that SAIA allowed clinic staff to generate contextually relevant solutions that they implemented. CONCLUSIONS: SAIA was implemented in FP clinics of varying sizes, capacity, and management support and was found to be acceptable, appropriate, and feasible. The agency that clinic staff felt in proposing and implementing their own solutions was likely part of SAIA's success. We anticipate this will continue to be a mechanism of SAIA's success when it is scaled up to more clinics in future trials. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02994355) registered 16 December 2016.

Adaptation of a social vulnerability index for measuring social frailty among East African women.

BACKGROUND: The number of older women living with HIV in Africa is growing, and their health outcomes may be adversely impacted by social frailty, which reflects deficits in social resources that accumulate over the lifespan. Our objective was to adapt a Social Vulnerability Index (SVI) originally developed in Canada for use in a study of older women living with or without HIV infection in Mombasa, Kenya. METHODS: We adapted the SVI using a five-step process: formative qualitative work, translation into Kiswahili, a Delphi procedure, exploration of potential SVI items in qualitative work, and a rating and ranking exercise. Four focus group discussions (FGD) were conducted (three with women living with HIV and one with HIV-negative women), and two expert panels were constituted for this process. RESULTS: Themes that emerged in the qualitative work were physical impairment with aging, decreased family support, a turn to religion and social groups, lack of a financial safety net, mixed support from healthcare providers, and stigma as an added burden for women living with HIV. Based on the formative FGD, the expert panel expanded the original 19-item SVI to include 34 items. The exploratory FGD and rating and ranking exercise led to a final 16-item Kenyan version of the SVI (SVI-Kenya) with six domains: physical safety, support from family, group participation, instrumental support, emotional support, and financial security. CONCLUSIONS: The SVI-Kenya is a holistic index to measure social frailty among older women in Kenya, incorporating questions in multiple domains. Further research is needed to validate this adapted instrument.

Results of a cluster randomized trial testing the systems analysis and improvement approach to increase HIV testing in family planning clinics.

OBJECTIVE: The aim of this study was to test an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), to increase rates of HIV testing and counseling (HTC) in family planning clinics in Mombasa, Kenya. DESIGN: A cluster randomized trial. METHODS: Twenty-four family planning clinics were randomized 1 : 1 to implementing SAIA versus usual procedures. Study staff implemented monthly SAIA cycles with family planning clinic staff for 12 months. SAIA has five steps. Step 1 uses a "cascade analysis' tool to quantify the number of individuals who complete each step of a process. Step 2 involves sequential process flow mapping to identify modifiable bottlenecks in the system. Step 3 develops and implements workflow modifications to address bottlenecks. Step 4 assesses impact of the modification by recalculating the cascade analysis. Step 5 repeats the cycle. The primary outcome was the proportion of new family planning clients tested for HIV during the last quarter of the trial. RESULTS: During the last 3 months of the trial, 85% (740/868) of new family planning clients were counseled for HIV in intervention clinics compared with 67% (1036/1542) in control clinics (prevalence rate ratio [PRR] 1.27, 95% confidence interval [CI] 1.15-1.30). Forty-two percent (364/859) of family planning clients were tested for HIV at intervention clinics compared with 32% (485/1521) at control clinics (PRR 1.33, 95% CI 1.16-1.52). CONCLUSION: SAIA led to a significant increase in HIV testing in family planning clinics in Mombasa. Integrating routine HTC into family planning clinics is a promising strategy to achieve the UNAIDS goal of 95% of people living with HIV being aware of their status.

Late antiretroviral refills and condomless sex in a cohort of HIV-seropositive pregnant and postpartum Kenyan women.

INTRODUCTION: The postpartum period can be challenging for women living with HIV. Understanding how the postpartum period impacts ART adherence and condomless sex could inform the development of comprehensive sexual and reproductive health and HIV services tailored to the needs of women living with HIV during this critical interval. METHODS: In a longitudinal cohort study of HIV-seropositive Kenyan women, late ART refills and self-reported condomless sex were compared between the woman's pregnancy and the postpartum period. Analyses were conducted using generalized estimating equations and adjusted for alcohol use, depressive symptoms, intimate partner violence (IPV), and having a recent regular partner. Effect modification was explored for selected variables. RESULTS AND DISCUSSION: 151 women contributed visits. Late ART refills occurred at 7% (32/439) of pregnancy visits compared to 18% (178/1016) during the postpartum period (adjusted relative risk [aRR] 2.44, 95% confidence interval [CI] 1.62-3.67). This association differed by women's education level. Women with ≥8 years of education had late ART refills more during the postpartum period than pregnancy (aRR 3.00, 95%CI 1.95-4.62). In contrast, in women with <8 years of education, late ART refills occurred similarly during pregnancy and the postpartum period (aRR 0.88, 95%CI 0.18-4.35). Women reported condomless sex at 10% (60/600) of pregnancy visits compared to 7% (72/1081) of postpartum visits (aRR 0.76, 95%CI 0.45-1.27). This association differed by whether women had experienced recent IPV. Women without recent IPV had a significant decline in condomless sex from pregnancy to postpartum (aRR 0.53, 95%CI 0.30-0.95) while women with recent IPV had no significant change in condomless sex from pregnancy to postpartum (aRR 1.76, 95%CI 0.87-3.55). CONCLUSION: Improved support for ART adherence during the postpartum period and addressing IPV to limit condomless sex could improve HIV treatment and prevention outcomes for HIV-seropositive women as well as their infants and sexual partners.

A Prospective Study of Depressive Symptoms, Condomless Sex, and HIV Viral Load in HIV-Positive Female Sex Workers in Kenya.

The relationships between depressive symptoms, viral suppression, and condomless sex were examined in a prospective cohort study of 369 HIV-positive Kenyan female sex workers. Participants were screened for depressive symptoms at baseline and every six months until completion of the study (up to 66 months). HIV viral load (VL) was measured every six months and prostate specific antigen (PSA) testing in vaginal secretions was performed quarterly. Mild or greater depressive symptoms were found in 100 (27.1%) women and were associated with increased risk of detectable VL (aRR 1.41, 95%CI 0.97-2.07, p-value = 0.07), but were not associated with detectable PSA. The co-occurrence of PSA detection and detectable VL at the same visit suggests the potential for HIV transmission but was uncommon (2.4% of visits). The prevalence of depressive symptoms and the association with detectable VL suggests the need for screening and treatment of depression for comprehensive HIV care in this population.

"Lighten This Burden of Ours": Acceptability and Preferences Regarding Injectable Antiretroviral Treatment Among Adults and Youth Living With HIV in Coastal Kenya.

BACKGROUND: Long-acting injectable (LAI) antiretroviral therapy (ART) may offer persons living with HIV (PLWH) an attractive alternative to pill-based treatment options, yet acceptability data remain scant, especially in sub-Saharan Africa. METHODS: We conducted 6 focus group discussions with PLWH, including key stake holder groups, and analyzed data with content analysis. RESULTS: Initial reactions to the idea of LAI-ART were often positive. The primary advantages voiced were potential to facilitate improved adherence and alleviate the burden of daily pill-taking while avoiding inadvertent disclosure and HIV stigma. Potential side effects were a particular concern of the women. Most participants preferred clinic-based administration over self-injections at home due to concerns about safety, privacy, and potential need for refrigeration. CONCLUSIONS: LAI-ART may be acceptable in Kenya, provided injections are infrequent and delivered in a clinic setting. However, HIV stigma, fear of potential side effects, and limited clinical capacity would need to be addressed.

Alcohol use and viral suppression in HIV-positive Kenyan female sex workers on antiretroviral therapy.

BACKGROUND: Excessive alcohol intake has been associated with poor adherence to antiretroviral therapy (ART). The impact of alcohol on viral suppression is particularly important among groups at high risk of HIV transmission, such as female sex workers (FSWs). Few studies have directly evaluated the association between alcohol use and HIV viral load. We hypothesized that hazardous or harmful alcohol use is associated with detectable plasma viral load among HIV-positive FSWs. METHODS: A prospective cohort study was conducted among HIV-positive FSWs in Mombasa, Kenya. Hazardous or harmful alcohol use was assessed yearly and defined as an Alcohol Use Disorders Identification Test (AUDIT) score ≥7. Detectable viral load was assessed every six months and defined as ≥180 c/mL. Adherence measures were collected monthly and included late ART refill (>48 hours) and self-reported adherence, using both a validated self-rating scale of ability to take medication and visual analog scale (VAS) of ART use in the last month. Generalized estimating equations were used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI). RESULTS: This analysis included 366 participants followed monthly between October 2012 and March 2018. At baseline, AUDIT scores indicated hazardous alcohol use (AUDIT 7-15) in 14.3%, harmful alcohol use (AUDIT 16-19) in 1.4%, and alcohol dependency (AUDIT ≥20) in 1.4% of participants. After adjusting for potential confounders, a combined exposure including hazardous, harmful, and dependent alcohol use was not associated with detectable viral load (aRR 1.10, 95%CI 0.63-1.92) or late ART refill (aRR 1.13, 95%CI 0.82-1.56), but was associated with lower self-rated ability to take medication (aRR 2.38, 95%CI 1.42-3.99) and a lower rate of self-reported perfect ART adherence by VAS (aRR 2.62, 95%CI 1.84-3.71). CONCLUSIONS: In this FSW cohort, while participants reporting hazardous, harmful, or dependent alcohol use were not more likely to have a detectable viral load, they were more likely to report lower ART adherence. These results suggest that interventions targeting alcohol use among this population of FSWs may not have a large impact on viral suppression.

Religious, socio-cultural norms and gender stereotypes influence uptake and utilization of maternal health services among the Digo community in Kwale, Kenya: a qualitative study.

BACKGROUND: Maternal health outcomes in resource-limited settings are typically influenced by supply-side factors affecting the provision of quality health services. The extent to which demand-side factors contribute to this influence is unclear. We aimed to explore how individual and community-wide factors influenced uptake and utilization of maternal health services among the Digo community residing in Kwale County of coastal Kenya. METHODS: Between March and December 2015, we conducted 5 focus group discussions (FGDs) and 15 in-depth interviews (IDIs) with members of the Digo community predominant in Kwale county, Kenya. Respondents were sampled purposively and included female (pregnant and postpartum) as well as male adult community members. A thematic content analytic approach was used. RESULTS: There were a total of 47 FGD respondents, including 15 (32%) females with a median (interquartile, IQR) age of 38 (27-55) years and 6 (3-8) children. Majority (40%) reported attaining secondary-level education. All IDI respondents were female with a median (IQR) age of 27 (24-35) years and 4 (2-5) children. Majority (80%) had attained primary-level education. We found that religious and socio-cultural norms as well as gender stereotypes were important influences on the uptake and utilization of maternal health services, including facility-based delivery and contraception. Key amongst this was the unspoken deference to the counsel of a prominent matriarchal figure in the decision-making process. CONCLUSIONS: Among the Digo community of coastal Kenya, a unique social-cultural context comprising of a religious and gendered value belief system influences women's reproductive health and rights. These findings highlight the important role of demand-side factors in influencing maternal health outcomes. In addition to addressing supply-side factors, programs in such settings should aim to address factors that leverage inherent social capital to drive demand for maternal health services ensuring that they are not only effective, but also responsive to the local context.

Brief Report: Incidence and Correlates of Pregnancy in HIV-Positive Kenyan Sex Workers.

INTRODUCTION: The incidence of pregnancy in female sex workers (FSWs) living with HIV is not well characterized. METHODS: Current and former FSWs living with HIV and enrolled in a prospective cohort study in Mombasa, Kenya, were followed monthly to ascertain sexual behavior and underwent quarterly pregnancy testing. Pregnancies were considered planned, mistimed, or unwanted according to fertility desires and pregnancy intentions. Cox proportional hazards models were used to estimate hazard ratios (HRs) of the association between characteristics and incident pregnancy. RESULTS: Two hundred seventy-nine FSWs were eligible (October 2012-April 2017). Most women had a nonpaying, regular partner (83.2%, 232/279), were not using modern nonbarrier contraception (69.5%, 194/279), and did not desire additional children (70.6%, 197/279). Of 34 first incident pregnancies [5.8/100 person-years (p-y); 95% confidence interval (CI): 4.1 to 8.0], 91.2% (n = 31) were unintended. The incidences of planned (5.7/100 p-y, n = 3), mistimed (10.4/100 p-y, n = 9), and unwanted pregnancies (4.9/100 p-y, n = 22) were similar (P = 0.15). In univariable analysis, oral contraceptive pill use (versus no contraception), having a nonpaying, regular partner, transactional sex, vaginal washing, condomless sex, and higher sex frequency were associated with an increased pregnancy risk. Older age was associated with a lower pregnancy risk. In multivariable analysis, having a nonpaying, regular partner (adjusted HR 4.0, 95% CI: 1.2 to 14.1) and age ≥40 years (aHR 0.2, 95% CI: 0.0 to 0.9) remained significantly associated with a higher and lower pregnancy risk, respectively. CONCLUSION: In this cohort of HIV-positive FSWs, most pregnancies were unintended. Identifying FSWs' fertility desires and pregnancy intentions could facilitate efforts to increase contraceptive use and implement safer conception strategies.

Iterative Development of an mHealth Intervention to Support Antiretroviral Therapy Initiation and Adherence Among Female Sex Workers in Mombasa, Kenya.

Nurses have an integral role to play in achieving the 95-95-95 goals to stem the HIV epidemic. We used the Information-Motivation-Behavioral Skills (IMB) theoretical model to develop a nurse-delivered, mHealth intervention to support antiretroviral therapy adherence among female sex workers living with HIV in Mombasa, Kenya. Twenty-three purposively sampled female sex workers living with HIV participated in 5 focus group discussions to iteratively develop the message content as well as the format and structure of the nurse-delivered, text-based intervention. Focus group discussion interview guides were developed in accordance with the IMB model. Transcripts were analyzed according to IMB themes, and findings were used to develop the intervention. Information-oriented texts addressed concerns and misconceptions; motivation-oriented texts reinforced women's desires to feel healthy enough to engage in activities; and behavioral skills-oriented texts included strategies to remember medication doses. The nurse-delivered, theory-based, culturally tailored intervention to support medication adherence was evaluated.

Cascade Analysis: An Adaptable Implementation Strategy Across HIV and Non-HIV Delivery Platforms.

BACKGROUND: Cascades have been used to characterize sequential steps within a complex health system and are used in diverse disease areas and across prevention, testing, and treatment. Routine data have great potential to inform prioritization within a system, but are often inaccessible to frontline health care workers (HCWs) who may have the greatest opportunity to innovate health system improvement. METHODS: The cascade analysis tool (CAT) is an Excel-based, simple simulation model with an optimization function. It identifies the step within a cascade that could most improve the system. The original CAT was developed for HIV treatment and the prevention of mother-to-child transmission of HIV. RESULTS: CAT has been adapted 7 times: to a mobile application for prevention of mother-to-child transmission; for hypertension screening and management and for mental health outpatient services in Mozambique; for pediatric and adolescent HIV testing and treatment, HIV testing in family planning, and cervical cancer screening and treatment in Kenya; and for naloxone distribution and opioid overdose reversal in the United States. The main domains of adaptation have been technical-estimating denominators and structuring steps to be binary sequential steps-as well as logistical-identifying acceptable approaches for data abstraction and aggregation, and not overburdening HCW. DISCUSSION: CAT allows for prompt feedback to HCWs, increases HCW autonomy, and allows managers to allocate resources and time in an equitable manner. CAT is an effective, feasible, and acceptable implementation strategy to prioritize areas most requiring improvement within complex health systems, although adaptations are being currently evaluated.