Severity of COVID-19 among Residents in Aged Care Facilities in Victoria, Australia: A Retrospective Cohort Study Comparing the Delta and Omicron Epidemic Periods.

OBJECTIVES: During the COVID-19 pandemic, no country with widespread community transmission has avoided outbreaks or deaths in residential aged care facilities (RACFs). As RACF residents are at high risk of morbidity and mortality from COVID-19, understanding disease severity risk factors is imperative. DESIGN: This retrospective cohort study aimed to compare COVID-19 disease severity (hospitalization and deaths) and associated risk factors among RACF residents in Victoria, Australia, across Delta and Omicron epidemic periods. SETTINGS AND PARTICIPANTS: Resident case hospitalization risk (HR) and case fatality risk (CFR) were assessed using Victorian RACFs COVID-19 outbreaks data across 2 epidemic periods; Delta, 994 resident cases linked to 86 outbreaks; and Omicron, 1882 resident cases linked to 209 outbreaks. METHODS: Adjusting for outbreak-level clustering, age, sex, up-to-date vaccination status, and time since last vaccination, the odds of hospitalization and death were compared using mixed effects logistic regression. RESULTS: The HR and CFR was lower during the Omicron period compared with the Delta period [HR 8.2% vs 24.6%, odds ratio (OR) 0.17, 95% CI 0.11-0.26, and CFR: 11.4% vs 18.7%, OR 0.40, 95% CI 0.28-0.56]. During both periods, males had higher odds of hospitalization and odds of death; being up to date with vaccination reduced odds of hospitalization by 40% (excluding nonemergency patient transfers) and odds of death by 43%; and for each month since last vaccination, odds of hospitalization increased by 9% and odds of death by 16%. CONCLUSIONS AND IMPLICATIONS: This study provides empirical evidence of lower COVID-19 severity among RACF residents in the Omicron period and highlights the importance of up-to-date and timely vaccination to reduce disease severity in this cohort.

Assessment of the lifetime prevalence and incidence of induced abortion and correlates among female sex workers in Mombasa, Kenya: a secondary cohort analysis.

INTRODUCTION: Prevalence of lifetime-induced abortion in female sex workers (FSWs) in Kenya was previously estimated between 43% and 86%. Our analysis aimed at assessing lifetime prevalence and correlates, and incidence and predictors of induced abortions among FSWs in Kenya. METHODS: This is a secondary prospective cohort analysis using data collected as part of the WHISPER or SHOUT cluster-randomised trial in Mombasa, assessing effectiveness of an SMS-intervention to reduce incidence of unintended pregnancy. Eligible participants were current FSWs, 16-34 years and not pregnant or planning pregnancy. Baseline data on self-reported lifetime abortion, correlates and predictors were collected between September 2016 and May 2017. Abortion incidence was measured at 6-month and 12-month follow-up. A multivariable logistic regression model was used to assess correlates of lifetime abortion and discrete-time survival analysis was used to assess predictors of abortions during follow-up. RESULTS: Among 866 eligible participants, lifetime abortion prevalence was 11.9%, while lifetime unintended pregnancy prevalence was 51.2%. Correlates of lifetime abortions were currently not using a highly effective contraceptive (adjusted OR (AOR)=1.76 (95% CI=1.11 to 2.79), p=0.017) and having ever-experienced intimate partner violence (IPV) (AOR=2.61 (95% CI=1.35 to 5.06), p=0.005). Incidence of unintended pregnancy and induced abortion were 15.5 and 3.9 per 100 women-years, respectively. No statistically significant associations were found between hazard of abortion and age, sex work duration, partner status, contraceptive use and IPV experience. CONCLUSION: Although experience of unintended pregnancy remains high, lifetime prevalence of abortion may have decreased among FSW in Kenya. Addressing IPV could further decrease induced abortions in this population. TRIAL REGISTRATION NUMBER: ACTRN12616000852459.

Effect of a mobile phone intervention for female sex workers on unintended pregnancy in Kenya (WHISPER or SHOUT): a cluster-randomised controlled trial.

BACKGROUND: Female sex workers in low-income and middle-income countries face high risks of unintended pregnancy. We developed a 12-month, multifaceted short messaging service intervention (WHISPER) for female sex workers in Kenya who had the potential to become pregnant, to improve their contraceptive knowledge and behaviours. The aim of this study was to assess the effectiveness of the intervention to reduce the incidence of unintended pregnancy among sex workers in Kenya compared with an equal-attention control group receiving nutrition-focused messages (SHOUT). METHODS: Our two-arm, cluster-randomised controlled trial was done in sex-work venues in two subcounties of Mombasa, Kenya (Kisauni and Changamwe). Participants, aged 16-34 years, not pregnant or planning pregnancy, able to read text messages in English, residing in the study area, and who had a personal mobile phone with one of two phone networks, were recruited from 93 randomly selected sex-work venues (clusters). Random cluster allocation (1:1) to the intervention or control group was concealed from participants and researchers until the intervention started. Both groups received text messages in English delivered two to three times per week for 12 months (137 messages in total), as well as additional on-demand messages. Message content in the intervention group focused on promotion of contraception, particularly long-acting reversible contraception and dual method contraceptive use; message content in the control group focused on promotion of nutritional knowledge and practices, including food safety, preparation, and purchasing. The primary endpoint, analysed in all participants who were randomly assigned and attended at least one follow-up visit, compared unintended pregnancy incidence between groups using discrete-time survival analysis at 6 and 12 months. This trial is registered with Australian New Zealand Clinical Trials Registry, ACTRN12616000852459, and is closed to new participants. FINDINGS: Between Sept 14, 2016, and May 16, 2017, 1728 individuals were approached to take part in the study. Of these, 1155 were eligible for full screening, 1035 were screened, and 882 were eligible, enrolled, and randomly assigned (451 participants from 47 venues in the intervention group; 431 participants from 46 venues in the control group). 401 participants from the intervention group and 385 participants from the control group were included in the primary analysis. Incidence of unintended pregnancy was 15·5 per 100 person-years in the intervention group and 14·7 per 100 person-years in the control group (hazard ratio 0·98, 95% CI 0·69-1·39). INTERPRETATION: The intervention had no measurable effect on unintended pregnancy incidence. Mobile health interventions, even when acceptable and rigorously designed, are unlikely to have a sufficient effect on behaviour among female sex workers to change pregnancy incidence when used in isolation. FUNDING: National Health and Medical Research Council of Australia.

HIV infections among female sex workers in Mombasa, Kenya: current prevalence and trends over 25 years.

Over 20 years, interventions have targeted HIV among female sex workers (FSWs) in Kenya given their central role in new infections. To determine the effects of these interventions, we assessed the prevalence and correlates of HIV among a random sample of FSWs and modelled prevalence estimates from studies since 1993. FSWs aged 16-34 years were enrolled through multi-stage sampling. Regression models identified correlates of HIV infection. Generalised linear mixed modelling estimated temporal changes in prevalence between 1993 and 2016. 882 FSWs were enrolled. Prevalence rose from 3.6% among 16-20-year-olds to 31.6% among 31-34-year-old FSWs. Those aged 31 to 34 years had greater odds of HIV compared to those 16 to 20 years (AOR 14.2, 95% CI, 5.5-36.8). Infection was less prevalent among FSWs with tertiary education compared to those with primary or no education (AOR 0.23, 95% CI, 0.07-0.78). There was an overall 30% reduction in prevalence from 1993 to 2016 with an average annual decline of 3%. About one in ten FSWs in Mombasa are currently infected with HIV. Considering FSWs' central role in sustaining population-level infections, these initiatives require continued support, focusing on reducing transmission from older FSWs and those with less education.

A Mobile Phone-Based Sexual and Reproductive Health Intervention for Female Sex Workers in Kenya: Development and Qualitative Study.

BACKGROUND: Female sex workers (FSWs) have high rates of both unintended pregnancy and HIV, but few health promotion interventions address their contraceptive needs or other sexual and reproductive health and rights (SRHR) concerns. A broader approach integrates contraceptive promotion with HIV and sexually transmitted infection (STI) prevention and management, alcohol awareness, gender-based violence and rights, and health care utilization. The Women's Health Intervention using SMS for Preventing Pregnancy (WHISPER) mobile phone intervention uses a participatory development approach and behavior change theory to address these high-priority concerns of FSWs in Mombasa, Kenya. OBJECTIVE: This paper aimed to (1) describe the process of development of the WHISPER intervention, its theoretical framework, key content domains and strategies and (2) explore workshop participants' responses to the proposed intervention, particularly with regard to message content, behavior change constructs, and feasibility and acceptability. METHODS: The research team worked closely with FSWs in two phases of intervention development. First, we drafted content for three different types of messages based on a review of the literature and behavior change theories. Second, we piloted the intervention by conducting six workshops with 42 FSWs to test and refine message content and 12 interviews to assess the technical performance of the intervention. Workshop data were thematically analyzed using a mixed deductive and inductive approach. RESULTS: The intervention framework specified six SRHR domains that were viewed as highly relevant by FSWs. Reactions to intervention content revealed that social cognitive strategies to improve knowledge, outcome expectations, skills, and self-efficacy resonated well with workshop participants. Participants found the content empowering, and most said they would share the messages with others. The refined intervention was a 12-month SMS program consisting of informational and motivational messages, role model stories portraying behavior change among FSWs, and on-demand contraceptive information. CONCLUSIONS: Our results highlight the need for health promotion interventions that incorporate broader components of SRHR, not only HIV prevention. Using a theory-based, participatory approach, we developed a digital health intervention that reflects the complex reality of FSWs' lives and provides a feasible, acceptable approach for addressing SRHR concerns and needs. FSWs may benefit from health promotion interventions that provide relevant, actionable, and engaging content to support behavior change.

HIV pre-exposure prophylaxis for female sex workers: ensuring women's family planning needs are not left behind.

INTRODUCTION: Female sex workers (FSWs) experience overlapping burdens of HIV, sexually transmitted infections and unintended pregnancy. Pre-exposure prophylaxis (PrEP) is highly efficacious for HIV prevention. It represents a promising strategy to reduce HIV acquisition risks among FSWs specifically given complex social and structural factors that challenge consistent condom use. However, the potential impact on unintended pregnancy has garnered little attention. We discuss the potential concerns and opportunities for PrEP to positively or negatively impact the sexual and reproductive health and rights (SRHR) of FSWs. DISCUSSION: FSWs have high unmet need for effective contraception and unintended pregnancy is common in low- and middle-income countries. Unintended pregnancy can have enduring health and social effects for FSWs, including consequences of unsafe abortion and financial impacts affecting subsequent risk-taking. It is possible that PrEP could negatively impact condom and other contraceptive use among FSWs due to condom substitution, normalization, external pressures or PrEP provision by single-focus services. There are limited empirical data available to assess the impact of PrEP on pregnancy rates in real-life settings. However, pregnancy rates are relatively high in PrEP trials and modelling suggests a potential two-fold increase in condomless sex among FSWs on PrEP, which, given low use of non-barrier contraceptive methods, would increase rates of unintended pregnancy. Opportunities for integrating family planning with PrEP and HIV services may circumvent these concerns and support improved SRHR. Synergies between PrEP and family planning could promote uptake and maintenance for both interventions. Integrating family planning into FSW-focused community-based HIV services is likely to be the most effective model for improving access to non-barrier contraception among FSWs. However, barriers to integration, such as provider skills and training and funding mechanisms, need to be addressed. CONCLUSIONS: As PrEP is scaled up among FSWs, there is growing impetus to consider integrating family planning services with PrEP delivery in order to better meet the diverse SRHR needs of FSWs and to prevent unintended consequences. Programme monitoring combined with research can close data gaps and mobilize adequate resources to deliver comprehensive SRHR services respectful of all women's rights.

Use of long-acting reversible contraception in a cluster-random sample of female sex workers in Kenya.

OBJECTIVE: To assess correlates of long-acting reversible contraceptive (LARC) use, and explore patterns of LARC use among female sex workers (FSWs) in Kenya. METHODS: Baseline cross-sectional data were collected between September 2016 and May 2017 in a cluster-randomized controlled trial in Mombasa. Eligibility criteria included current sex work, age 16-34 years, not pregnant, and not planning pregnancy. Peer educators recruited FSWs from randomly selected sex-work venues. Multiple logistic regression identified correlates of LARC use. Prevalence estimates were weighted to adjust for variation in FSW numbers recruited across venues. RESULTS: Among 879 participants, the prevalence of contraceptive use was 22.6% for implants and 1.6% for intra-uterine devices (IUDs). LARC use was independently associated with previous pregnancy (adjusted odds ratio for one pregnancy, 11.4; 95% confidence interval, 4.25-30.8), positive attitude to and better knowledge of family planning, younger age, and lower education. High rates of adverse effects were reported for all methods. CONCLUSION: The findings suggest that implant use has increased among FSWs in Kenya. Unintended pregnancy risks remain high and IUD use is negligible. Although LARC rates are encouraging, further intervention is required to improve both uptake (particularly of IUDs) and greater access to family planning services.

Incidence of unintended pregnancy among female sex workers in low-income and middle-income countries: a systematic review and meta-analysis.

OBJECTIVES: To determine the incidence of unintended pregnancy among female sex workers (FSWs) in low-income and middle-income countries (LMICs). DESIGN: We searched MEDLINE, PsychInfo, Embase and Popline for papers published in English between January 2000 and January 2016, and Web of Science and Proquest for conference abstracts. Meta-analysis was performed on the primary outcomes using random effects models, with subgroup analysis used to explore heterogeneity. PARTICIPANTS: Eligible studies targeted FSWs aged 15-49 years living or working in an LMIC. OUTCOME MEASURES: Studies were eligible if they provided data on one of two primary outcomes: incidence of unintended pregnancy and incidence of pregnancy where intention is undefined. Secondary outcomes were also extracted when they were reported in included studies: incidence of induced abortion; incidence of birth; and correlates/predictors of pregnancy or unintended pregnancy. RESULTS: Twenty-five eligible studies were identified from 3866 articles. Methodological quality was low overall. Unintended pregnancy incidence showed high heterogeneity (I²>95%), ranging from 7.2 to 59.6 per 100 person-years across 10 studies. Study design and duration were found to account for heterogeneity. On subgroup analysis, the three cohort studies in which no intervention was introduced had a pooled incidence of 27.1 per 100 person-years (95% CI 24.4 to 29.8; I2=0%). Incidence of pregnancy (intention undefined) was also highly heterogeneous, ranging from 2.0 to 23.4 per 100 person-years (15 studies). CONCLUSIONS: Of the many studies examining FSWs' sexual and reproductive health in LMICs, very few measured pregnancy and fewer assessed pregnancy intention. Incidence varied widely, likely due to differences in study design, duration and baseline population risk, but was high in most studies, representing a considerable concern for this key population. Evidence-based approaches that place greater importance on unintended pregnancy prevention need to be incorporated into existing sexual and reproductive health programmes for FSWs. PROSPERO REGISTRATION NUMBER: CRD42016029185.

WHISPER or SHOUT study: protocol of a cluster-randomised controlled trial assessing mHealth sexual reproductive health and nutrition interventions among female sex workers in Mombasa, Kenya.

INTRODUCTION: New interventions are required to reduce unintended pregnancies among female sex workers (FSWs) in low- and middle-income countries and to improve their nutritional health. Given sex workers' high mobile phone usage, repeated exposure to short messaging service (SMS) messages could address individual and interpersonal barriers to contraceptive uptake and better nutrition. METHODS: In this two-arm cluster randomised trial, each arm constitutes an equal-attention control group for the other. SMS messages were developed systematically, participatory and theory-driven and cover either sexual and reproductive health (WHISPER) or nutrition (SHOUT). Messages are sent to participants 2-3 times/week for 12 months and include fact-based and motivational content as well as role model stories. Participants can send reply texts to obtain additional information. Sex work venues (clusters) in Mombasa, Kenya, were randomly sampled with a probability proportionate to venue size. Up to 10 women were recruited from each venue to enrol 860 women. FSWs aged 16-35 years, who owned a mobile phone and were not pregnant at enrolment were eligible. Structured questionnaires, pregnancy tests, HIV and syphilis rapid tests and full blood counts were performed at enrolment, with subsequent visits at 6 and 12 months. ANALYSIS: The primary outcomes of WHISPER and SHOUT are unintended pregnancy incidence and prevalence of anaemia at 12 months, respectively. Each will be compared between study groups using discrete-time survival analysis. POTENTIAL LIMITATIONS: Contamination may occur if participants discuss their intervention with those in the other trial arm. This is mitigated by cluster recruitment and only sampling a small proportion of sex work venues from the sampling frame. CONCLUSIONS: The design allows for the simultaneous testing of two independent mHealth interventions for which messaging frequency and study procedures are identical. This trial may guide future mHealth initiatives and provide methodological insights into use of reciprocal control groups. TRIAL REGISTRATION NUMBER: ACTRN12616000852459; Pre-results.