Healthcare workers' views on decentralized primary health care management in Lesotho: a qualitative study.

BACKGROUND: Lesotho experienced high rates of maternal (566/100,000 live births) and under-five mortality (72.9/1000 live births). A 2013 national assessment found centralized healthcare management in Ministry of Health led to fragmented, ineffective district health team management. Launched in 2014 through collaboration between the Ministry of Health and Partners In Health, Lesotho's Primary Health Care Reform (LPHCR) aimed to improve service quality and quantity by decentralizing healthcare management to the district level. We conducted a qualitative study to explore health workers' perceptions regarding the effectiveness of LPHCR in enhancing the primary health care system. METHODS: We conducted 21 semi-structured key informant interviews (KII) with healthcare workers and Ministry of Health officials purposively sampled from various levels of Lesotho's health system, including the central Ministry of Health, district health management teams, health centers, and community health worker programs in four pilot districts of the LPHCR initiative. The World Health Organization's health systems building blocks framework was used to guide data collection and analysis. Interviews assessed health care workers' perspectives on the impact of the LPHCR initiative on the six-health system building blocks: service delivery, health information systems, access to essential medicines, health workforce, financing, and leadership/governance. Data were analyzed using directed content analysis. RESULTS: Participants described benefits of decentralization, including improved efficiency in service delivery, enhanced accountability and responsiveness, increased community participation, improved data availability, and better resource allocation. Participants highlighted how the reform resulted in more efficient procurement and distribution processes and increased recognition and status in part due to the empowerment of district health management teams. However, participants also identified limited decentralization of financial decision-making and encountered barriers to successful implementation, such as staff shortages, inadequate management of the village health worker program, and a lack of clear communication regarding autonomy in utilizing and mobilizing donor funds. CONCLUSION: Our study findings indicate that the implementation of decentralized primary health care management in Lesotho was associated a positive impact on health system building blocks related to primary health care. However, it is crucial to address the implementation challenges identified by healthcare workers to optimize the benefits of decentralized healthcare management.

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.

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 ).

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.

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.

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.

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.

Performance of family planning clinics in conducting recommended HIV counseling and testing in Mombasa County, Kenya: a cross-sectional study.

BACKGROUND: A high proportion of African women utilize family planning (FP) services. Accordingly, incorporating HIV testing into FP services may strategically target the first WHO 90-90-90 goal of 90% of people living with HIV knowing their status. METHODS: The objective of this analysis was to determine the proportion of new FP clients counseled and tested for HIV, as well as correlates of HIV testing, in a random sample of 58 FP clinics in Mombasa County, Kenya. Structured interviews of FP clinic managers collected data on characteristics of FP clinics and staff. Study staff performed a 3-month review of FP registers, summarizing new client HIV testing and counseling (HTC). Because overall rates of HTC were quite low, a binary variable was created comparing clinics performing any HIV counseling and/or testing to clinics performing none. Generalized linear models were used to calculate prevalence ratios (PR) and identify correlates of HTC. Factors associated with any HTC with a p-value < 0.10 in univariate analysis were included in a multivariate analysis. RESULTS: Of the 58 FP clinics, 26 (45%) performed any counseling for HIV testing, and 23 (40%) performed any HIV testing. Counseling for HIV testing was conducted for 815/4389 (19%) new clients, and HIV testing was performed for 420/4389 (10%). Clinics without trained HIV testing providers uniformly did not conduct HIV counseling and/or testing (0/12 [0%]), while 27/46 (59%) of clinics with ≥1 provider performed some HTC (p < 0.001). In the subset of 46 clinics with ≥1 trained HIV testing provider, correlates of performing HTC included being a public versus non-public clinic (PR 1.70 95%CI 1.01-2.88), and having an HIV comprehensive care center (CCC) onsite (PR 2.05, 95%CI 1.04-4.06). CONCLUSION: Trained HIV testing providers are crucial for FP clinics to perform any HTC. Approaches are needed to increase routine HTC in FP clinics including staffing changes and/or linkages with other testing services (in standalone VCT services or lab facilities) in order to improve the implementation of existing national guidelines. A future cluster randomized trial is planned to test an implementation strategy, the Systems Analysis and Improvement Approach (SAIA) to increase HTC in FP clinics.

Screening for Sexually Transmitted Infections in Adolescent Girls and Young Women in Mombasa, Kenya: Feasibility, Prevalence, and Correlates.

INTRODUCTION: As adolescents and young women become sexually active, they are at risk of adverse reproductive health outcomes including sexually transmitted infections (STIs). We assessed feasibility and acceptability of STI screening among 15- to 24-year-old women in Mombasa, Kenya. METHODS: After sensitization activities, participants were recruited from 3 high schools and 1 university. Study staff conducted informational sessions. Students interested in participating were given consent forms to take home, and invited to visit our clinic for STI screening. During clinic visits, participants completed a self-administered questionnaire and provided a urine specimen for STI testing using a nucleic acid amplification test. RESULTS: Between August 2014 and March 2015, 463 high school and 165 university students collected consent forms. Of these, 293 (63%) from high schools versus 158 (95%) from university attended clinic for STI screening (P < 0.001). Of the 150 (33%) who reported any history of insertive vaginal sex, 78 (52.0%) reported condom use at the last sex act, 31 (20.7%) reported using modern nonbarrier contraceptive methods, and 37 (24.7%) reported not using any contraception at the last sex act. Twenty-six (5.8%) participants were diagnosed with STIs (7 [1.6%] Neisseria gonorrhoeae, 16 [3.6%] Chlamydia trachomatis, 3 [0.7%] Trichomonas vaginalis). In multivariable analyses, reporting receptive vaginal sex without a condom was associated with having a laboratory confirmed STI (odds ratio, 6.21; 95% confidence interval, 1.72-22.28). CONCLUSIONS: These findings support the need for reproductive health interventions to reduce the risk of STIs in a population of adolescent girls and young women in East Africa.

Parents' and teachers' views on sexual health education and screening for sexually transmitted infections among in-school adolescent girls in Kenya: a qualitative study.

BACKGROUND: To successfully develop and implement school-based sexual health interventions for adolescent girls, such as screening for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, it is important to understand parents' and teachers' attitudes towards sexual health education and acceptability of sexually transmitted infection (STI) screening interventions. METHODS: In this qualitative study, we approached parents and teachers from three high schools to participate in in-depth interviews (IDIs) and focus-group discussions (FGDs). Parents and teachers were asked about their general knowledge of STIs and sexual health education. In addition, they were asked whether they would support utilizing outreach to schools to facilitate provision of sexual health education and screening for STIs in adolescent girls. Data were audio-recorded, transcribed, and translated into English. An initial coding matrix was developed and refined throughout the coding process. Transcripts were coded by two researchers and analyzed using the content analysis approach. RESULTS: We conducted 10 IDIs (5 parents and 5 teachers) and 4 FGDs (2 with parents, 2 with teachers, total of 26 participants). Most parents reported few or no discussions regarding STIs with their adolescent girls. Parents were more comfortable discussing consequences of sexual activity including loss of virginity and the potential for pregnancy. Parents tended to place responsibility for sexual health education with teachers. The teachers, in turn, provided basic sexual and reproductive health education including puberty, abstinence, and overview of STIs. Both parents and teachers found the idea of screening for STIs in adolescent girls to be acceptable, and were comfortable with research staff contacting girls through informational meetings at schools. Parents felt that adolescents' STI screening results should be shared with their parents. CONCLUSION: In this African setting, parents and teachers provide limited sexual health education, with a focus on negative consequences including loss of virginity, pregnancy, and risk for STIs. Nonetheless, both parents and teachers were supportive of STI screening for adolescent girls, beginning with school-based informational meetings for the girls. Research and programs that aim to provide STI screening in this setting must offer treatment and address the issue of whether results will be disclosed to parents.

Risky Business: condom failures as experienced by female sex workers in Mombasa, Kenya.

Limited research exists about condom failure as experienced by female sex workers. We conducted a qualitative study to examine how female sex workers in Mombasa, Kenya contextualise and explain the occurrence of condom failure. In-depth, semi-structured interviews were conducted with thirty female sex workers to ascertain their condom failure experiences. We qualitatively analysed interview transcripts to determine how the women mitigate risk and cope with condom failure. Condom failure was not uncommon, but women mitigated the risk by learning about correct use, and by supplying and applying condoms themselves. Many female sex workers felt that men intentionally rupture condoms. Few women were aware of or felt empowered to prevent HIV, STIs, and pregnancy after condom failure. Interventions to equip female sex workers with strategies for minimising the risk of HIV, STIs, and pregnancy in the aftermath of a condom failure should be investigated.

Alcohol Use and Associations With Biological Markers and Self-Reported Indicators of Unprotected Sex in Human Immunodeficiency Virus-Positive Female Sex Workers in Mombasa, Kenya.

BACKGROUND: Studies of alcohol use and sexual behavior in African populations have primarily been cross-sectional, used nonvalidated measures of alcohol use, or relied on self-reported sexual risk endpoints. Few have focused on human immunodeficiency virus (HIV)-positive women. METHODS: Longitudinal data were collected from a cohort of HIV-positive Kenyan female sex workers. At enrollment and annual visits, participants were asked about past-year alcohol use using the Alcohol Use Disorders Identification Test (AUDIT). The primary endpoint was detection of prostate-specific antigen (PSA) in vaginal secretions at quarterly examinations. Associations between hazardous/harmful alcohol use (AUDIT score ≥7), PSA detection, and secondary measures of sexual risk were evaluated using generalized estimating equations with a log binomial regression model. RESULTS: A total of 405 women contributed 2750 vaginal samples over 606 person-years of follow-up. Hazardous/harmful alcohol use was reported at 16.6% of AUDIT assessments and was associated with higher risk of PSA detection (relative risk 1.50; 95% confidence interval, 1.11-2.01) relative to no alcohol use. This association was attenuated and no longer statistically significant, after adjusting for age, work venue, intimate partner violence, depression, and partnership status (adjusted relative risk, 1.13; 95% confidence interval, 0.82-1.56). In exploratory analyses, alcohol use was associated with self-report of unprotected sex and with sexually transmitted infection acquisition. CONCLUSIONS: Although hazardous/harmful alcohol use was not associated with detection of PSA in adjusted analysis, associations with secondary outcomes suggest that alcohol use is at least a marker of sexual risk behavior.

A Prospective Study of Intimate Partner Violence as a Risk Factor for Detectable Plasma Viral Load in HIV-Positive Women Engaged in Transactional Sex in Mombasa, Kenya.

We conducted a prospective cohort study to evaluate intimate partner violence (IPV) as a risk factor for detectable plasma viral load in HIV-positive female sex workers (FSWs) on antiretroviral therapy (ART) in Kenya. IPV in the past year was defined as ≥1 act of physical, sexual, or emotional violence by the index partner (i.e. boyfriend/husband). The primary outcome was detectable viral load (≥180 copies/ml). In-depth interviews and focus groups were included to contextualize results. Analyses included 195 women (570 visits). Unexpectedly, IPV was associated with significantly lower risk of detectable viral load (adjusted relative risk 0.21, 95 % CI 0.05-0.84, p-value = 0.02). Qualitative findings revealed that women valued emotional and financial support from index partners, despite IPV. IPV was not a major barrier to ART adherence. The observed association between IPV and lower risk of detectable viral load in FSWs may be due to unmeasured personal and relationship factors, warranting further research.

Association between alcohol use and sexually transmitted infection incidence among kenyan women engaged in transactional sex.

Few prospective studies have evaluated the association between alcohol use and STI acquisition among African women. We examined the association between baseline drinking frequency and STIs in a cohort of Kenyan women reporting transactional sex. The association between alcohol use and STI differed significantly by HIV status. Among 139 HIV-positive women, STI acquisition was significantly associated with consuming 1-7 drinks/week and marginally associated with ≥8 drinks/week in unadjusted analyses. However, no association between alcohol use and STIs was observed among 335 HIV-negative women. Addressing alcohol use within comprehensive HIV care may also reduce the burden of STIs among high-risk women.

A pilot study of the feasibility of a vaginal washing cessation intervention among Kenyan female sex workers.

BACKGROUND: Intravaginal practices including vaginal washing have been associated with HIV-1 acquisition. This association may be mediated by mucosal disruption, changes in vaginal flora or genital tract inflammatory responses. Reducing vaginal washing could lower women's risk of HIV-1 acquisition. METHODS: 23 HIV-1 seronegative women who reported current vaginal washing were recruited from a prospective cohort study of high-risk women in Mombasa, Kenya. A theoretical framework including information-motivation-behavioural skills and harm reduction was implemented to encourage participants to reduce or eliminate vaginal washing. At baseline and after 1 month, we evaluated vaginal epithelial lesions by colposcopy, vaginal microbiota by Nugent's criteria and vaginal cytokine milieu using ELISA on cervicovaginal lavage specimens. RESULTS: The most commonly reported vaginal washing substance was soap with water (N=14, 60.9%). The median frequency of vaginal washing was 7 (IQR 7-14) times per week. After 1 month, all participants reported cessation of vaginal washing (p=0.01). The probability of detecting cervicovaginal epithelial lesions was lower (OR 0.48; 95% CI 0.20 to 1.16; p=0.10) and the likelihood of detecting Lactobacillus by culture was higher (OR 3.71, 95% CI 0.73 to 18.76, p=0.11) compared with baseline, although these results were not statistically significant. There was no change in the prevalence of bacterial vaginosis. Most cytokine levels were reduced, but these changes were not statistically significant. CONCLUSIONS: A theory-based intervention appeared to have a positive effect in reducing vaginal washing over 1 month. Larger studies with longer follow-up are important to further characterise the effects of vaginal washing cessation on biological markers.

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.

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.

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.

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.