A socio-ecological exploration to identify factors influencing the COVID-19 vaccine decision-making process among pregnant and lactating women: Findings from Kenya.

The vaccine decision-making process of pregnant and lactating women is complex. Regarding COVID-19, pregnant women are at increased risk for severe disease and poor health outcomes. While pregnant and lactating women were excluded from COVID-19 vaccine trials, available evidence suggests that COVID-19 vaccines are safe and protective during pregnancy. In this study, we used a socio-ecological approach to explore factors influencing the decision-making process for COVID-19 vaccines in pregnant and lactating women in Kenya, for the purpose of informing demand generation strategies. As pregnant and lactating women are influenced by many factors, we conducted 84 in-depth interviews with a variety of stakeholders, including 31 pregnant or lactating women, 20 healthcare workers such as nurses, midwives, doctors, and frontline workers, 25 male family members of pregnant or lactating women, and 8 gatekeepers such as community leaders and faith-based leaders. These individuals were recruited from six communities in Kenya: three urban, and three rural. We applied a grounded theory approach to identify emerging themes and organized emerging themes using the SAGE Vaccine Hesitancy model, which includes three categories of determinants of vaccine acceptance, including contextual influences, individual and group influences, and vaccine and vaccination specific issues. Myths, interpersonal norms, and religion emerged as themes related to contextual influences. Safety, risk perception, and the role of the healthcare worker emerged as themes related to individual and group influences. For vaccine and vaccination specific issues, emerging themes included availability, accessibility, and eligibility. While maternal immunization can substantially reduce the effect of infectious diseases in mothers and infants, vaccine acceptance is critical. However, vaccines do not save lives; vaccination does. We hope the results of this study can be used to tailor communication efforts to increase vaccine demand among pregnant and lactating women.

Lack of clear national policy guidance on COVID-19 vaccines influences behaviors in pregnant and lactating women in Kenya.

SARS-CoV-2 infection in pregnancy is associated with a greater risk of maternal and newborn morbidity and maternal death. In Kenya, pregnant and lactating women (PLW) were ineligible to receive COVID-19 vaccines until August 2021. How shifts in policy influence vaccine behaviors, such as health worker recommendations and vaccine uptake, is not well documented. We conducted qualitative interviews with PLW, health workers, and policymakers in Kenya to understand how different stakeholders' perceptions of national policy regarding COVID-19 vaccination in pregnancy shaped vaccine behaviors and decision-making. Policymakers and health workers described pervasive uncertainty and lack of communication about the national policy, cited vaccine safety as their primary concern for administering COVID-19 vaccines to PLW, and expressed that PLW were inadequately prioritized in the COVID-19 vaccine program. PLW perceived the restrictive policy as indicative of a safety risk, resulting in vaccine hesitancy and potentially exacerbated inequities in vaccine access. These findings support the need for the development and dissemination of effective vaccine communication guidelines and the prioritization of PLW in COVID-19 vaccination policies and campaigns. To ensure PLW do not face the same inequities in future epidemics, data on infectious disease burdens and vaccine uptake should be collected systematically among pregnant women, and PLW should be included in future vaccine trials.

Client satisfaction determinants in four Kenyan slums.

PURPOSE: In Kenya, gaps exist in health service provision to slum residents, especially service availability and access to quality care. There is also little information on the health status of people living in slums other than in Nairobi. The purpose of this paper is to generate evidence for use in designing interventions to improve health services in four mid-sized slums in Embu, Nyeri and Thika, Kenya. DESIGN/METHODOLOGY/APPROACH: A cross-sectional survey of clients receiving services in health facilities was conducted in the targeted slums. Data were collected through face-to-face interviews. Factor scores were generated using the Rasch model; simple and multivariate logistic regression analyses were done using the R statistical software. FINDINGS: Overall, 81 per cent of the 203 participants reported being satisfied with health services. Most clients (89 per cent) reported that health facility staff greeted them warmly; 82 per cent said their consultation was private. The facility type, waiting time and client experience with service providers determined their satisfaction (p<0.05). PRACTICAL IMPLICATIONS: Healthcare managers can improve client satisfaction levels by understanding the client flow in their facilities and addressing causes of client dissatisfaction, such as long waiting times, while at the same time promoting facilitating factors. ORIGINALITY/VALUE: The authors use latent variable modelling to compute client satisfaction scores, which were dichotomised into two categories and fitted into a logistic regression model to identify factors that influence client satisfaction. Health facility clients in the four slums are satisfied with services and have confidence the providers will serve them in a friendly and professional manner that promotes respect and quality care. The paper recommend healthcare managers in similar settings carry out client flow analysis and institute remedial measures to address long waiting times. Qualitative studies are recommended to determine the reasons behind the high satisfaction levels reported in this study.

Implementation of clinic-based modified-directly observed therapy (m-DOT) for ART; experiences in Mombasa, Kenya.

The effectiveness of modified-directly observed therapy (m-DOT), an adherence support intervention adapted from TB DOTS programmes, has been documented. Describing the implementation process and acceptability of this intervention is important for scaling up, replication in other settings and future research. In a randomised trial in Mombasa, Kenya, patients were assigned to m-DOT or standard of care for 24 weeks. m-DOT entailed twice weekly visits to a health centre for medication collection, ongoing adherence counselling and nurse-observed pill ingestion. Community health workers (CHWs) traced non-attendees, observing pill taking at participant's home. Using process indicators and a semi-structured questionnaire, implementation of m-DOT was evaluated among 94 participants who completed 24 weeks m-DOT (81%; 94/116). Two-thirds of m-DOT recipients were female (64%; 74/116) and a mean 37 years (SD = 7.8). Selection of the m-DOT observation site was determined by proximity to home for 73% (69/94), with the remainder choosing sites near their workplace, or due to perceived high-quality services. A median 42 of 48 scheduled m-DOT visits (IQR = 28-45) were attended. Most found m-DOT is very useful (87%; 82/94) and had positive attitudes to the services. A high proportion received CHWs home visits (96%; 90/94) and looked forward to these. Use of CHWs and several satellite observation sites facilitated provision of services closer to patient's homes. A substantial number, however, thought 24 weeks of m-DOT was too long (43%; 42/94). Our experience suggests that m-DOT services could be implemented widely and are acceptable if delivered with adequate attention to coordination, provision of a broad set of interventions, shifting tasks to less-specialised workers and integration within the health system. m-DOT programmes should utilise existing resources while simultaneously expanding capacity within communities and the public sector. These findings could be used to inform replication of such services and to improve the design of m-DOT in future studies.

Perceived stigma among patients receiving antiretroviral treatment: a prospective randomised trial comparing an m-DOT strategy with standard-of-care in Kenya.

HIV and AIDS remain highly stigmatised. Modified directly observed therapy (m-DOT) supports antiretroviral treatment (ART) adherence but little is known about its association with perceived stigma in resource-constrained settings. In 2003, 234 HIV-infected adults enrolled in a two-arm randomised trial comparing a health centre-based m-DOT strategy with standard self-administration of ART. Data on perceived stigma were collected using Berger's HIV stigma scale prior to starting ART and after 12 months. This was a secondary analysis to examine whether perceived stigma was related to treatment delivery. Perceived stigma scores declined after 12 months of treatment from a mean of 44.9 (sd=7.6) to a mean of 41.4 (sd=7.7), (t=6.14, P<0.001). No differences were found between the mean scores of participants in both study arms. Also, no difference in scores was detected using GLM, controlling for socio-demographic characteristics and baseline scores. Findings indicate that a well managed clinic-based m-DOT does not increase perceived HIV-related stigma.

Safer sexual behaviors after 12 months of antiretroviral treatment in Mombasa, Kenya: a prospective cohort.

Roll-out of antiretroviral treatment (ART) raises concerns about the potential for unprotected sex if sexual activity increases with well-being, resulting in continued HIV spread. Beliefs about reduced risk for HIV transmission with ART may also influence behavior. From September 2003 to November 2004, 234 adults enrolled in a trial assessing the efficacy of modified directly observed therapy in improving adherence to ART. Unsafe sexual behavior (unprotected sex with an HIV-negative or unknown status partner) before starting ART and 12 months thereafter was compared. Participants were a mean 37.2 years (standard deviation [SD] = 7.9 years) and 64% (149/234) were female. Nearly half (107/225) were sexually active in the 12 months prior to ART, the majority (96/107) reporting one sexual partner. Unsafe sex was reported by half of those sexually active in the 12 months before ART (54/107), while after 12 months ART, this reduced to 28% (30/107). Unsafe sex was associated with nondisclosure of HIV status to partner; recent HIV diagnosis; not being married or cohabiting; stigma; depression and body mass index <18.5 kg/m(2). ART beliefs, adherence, and viral suppression were not associated with unsafe sex. After adjusting for gender and stigma, unsafe sex was 0.59 times less likely after 12 months ART than before initiation (95% confidence interval [CI] = 0.37-0.94; p = 0.026). In conclusion, although risky sexual behaviors had decreased, a considerable portion do not practice safe sex. Beliefs about ART's effect on transmission, viral load, and adherence appear not to influence sexual behavior but require long-term surveillance. Positive prevention interventions for those receiving ART must reinforce safer sex practices and partner disclosure.

Short- and long-term efficacy of modified directly observed antiretroviral treatment in Mombasa, Kenya: a randomized trial.

OBJECTIVES: To determine short- and long-term efficacy of modified directly observed therapy (m-DOT) on antiretroviral adherence. DESIGN: Randomized controlled trial. SETTING AND ANALYTIC APPROACH: From September 2003 to November 2004, 234 HIV-infected adults were assigned m-DOT (24 weeks of twice weekly health center visits for nurse-observed pill ingestion, adherence support, and medication collection) or standard care. Follow-up continued until week 72. Self-reported and pill-count adherence and, secondarily, viral suppression and body mass index measures are reported. Generalized estimating equations adjusted for intraclient clustering and covariates were used. RESULTS: During weeks 1-24, 9.1% (9/99) of m-DOT participants reported missing doses compared with 19.1% (20/105) of controls (P = 0.04) and 96.5% (517/571) of m-DOT pill-count measures were >or=95% compared with 86.1% (445/517) in controls [adjusted odds ratio = 4.4; 95% confidence interval (CI) = 2.6 to 7.5; P < 0.001. Adherence with m-DOT was 4.8 times greater (95% CI = 2.7 to 8.6; P < 0.001) with adjustment for depression and HIV-related hospitalization. In weeks 25-48, adherence with m-DOT (488/589) was similar to controls (507/630). Viral suppression at 48 weeks was 2.0 times (95% CI = 0.8 to 5.2; P = 0.13) as likely in m-DOT participants as controls. M-DOT patients had larger body mass index increases at 24 weeks (2.2 vs 1.4 kg/m3; P = 0.014). Viral suppression was more likely at week 48 (21/25 vs 13/22; P = 0.057) and week 72 (27/30 vs 15/23; P = 0.027) among depressed participants receiving m-DOT. CONCLUSIONS: M-DOT increased adherence, most notably among depressed participants.