Using social practice theory in measuring perceived stigma among female sex workers in Mombasa, Kenya.

BACKGROUND: Perceived stigma is a complex societal phenomenon that is harboured especially by female sex workers because of the interplay of a myriad of factors. As such, a precise measure of the contribution of different social practices and characteristics is necessary for both understanding and intervening in matters related to perceived stigma. We developed a Perceived Stigma Index that measures the factors that greatly contribute to the stigma among sex workers in Kenya, and thereby inform a framework for future interventions. METHODS: Social Practice Theory was adopted in the development of the Perceived Stigma Index in which three social domains were extracted from data collected in the WHISPER or SHOUT study conducted among female sex workers (FSW), aged 16-35 years in Mombasa, Kenya. The three domains included: Social demographics, Relationship Control and Sexual and Gender-based Violence, and Society awareness of sexual and reproductive history. The factor assessment entailed Exploratory Factor Analysis (EFA), Confirmatory Factor Analysis (CFA), and the internal consistency of the index was measured using Cronbach's alpha coefficient. RESULTS: We developed a perceived stigma index to measure perceived stigma among 882 FSWs with a median age of 26 years. A Cronbach's alpha coefficient of 0.86 (95% confidence interval (CI) 0.85-0.88) was obtained as a measure of the internal consistency of our index using the Social Practice Theory. In regression analysis, we identified three major factors that contribute to the perceived stigma and consists of : (i) income and family support (ß = 1.69; 95% CI); (ii) society's awareness of the sex workers' sexual and reproductive history (ß = 3.54; 95% CI); and (iii) different forms of relationship control e.g. physical abuse (ß = 1.48; 95%CI that propagate the perceived stigma among the FSWs. CONCLUSION: Social practice theory has solid properties that support and capture the multi-dimensional nature of perceived stigma. The findings support the fact that social practices contribute or provoke this fear of being discriminated against. Thus, in offering interventions to curb perceived stigma, focus should fall on the education of the society on the importance of acceptance and integration of the FSWs as part of the society and the eradication of sexual and gender based violence meted out on them. TRIAL REGISTRATION: The trial was registered in the Australian New Zealand Clinical Trials Registry, ACTRN12616000852459.

A clustered randomized control trial to assess feasibility, acceptability, and impact of implementing the birth companion intervention package in Ethiopia, Kenya, and Nigeria: study protocol.

BACKGROUND: A birth companion is a simple and low-cost intervention that can improve both maternal and newborn health outcomes. The evidence that birth companionship improves labor outcomes and experiences of care has been available for many years. Global and national policies exist in support of birth companions. Many countries including Ethiopia, Kenya, and Nigeria have not yet incorporated birth companions into routine practice in health facilities. This paper presents the protocol for a trial that aims to assess if a package of interventions that addresses known barriers can increase the coverage of birth companions. METHODS: This two parallel arm cluster randomized controlled trial will evaluate the impact of a targeted intervention package on scale-up of birth companionship at public sector health facilities in Ethiopia (five study sites encompassing 12 facilities), Kenya (two sites encompassing 12 facilities in Murang'a and 12 facilities in Machakos counties), and Nigeria (two sites encompassing 12 facilities in Kano and 12 facilities in Nasarawa states). Baseline and endline assessments at each site will include 744 women who have recently given birth in the quantitative component. We will interview a maximum of 16 birth companions, 48 health care providers, and eight unit managers quarterly for the qualitative component in each country. DISCUSSION: Ample evidence supports the contribution of birth companions to positive health outcomes for mothers and newborns. However, limited data are available on effective strategies to improve birth companion coverage and inform scale-up efforts. This trial tests a birth companion intervention package in diverse clinical settings and cultures to identify possible barriers and considerations to increasing uptake of birth companions. Findings from this study may provide valuable evidence for scaling up birth companionship in similar settings. TRIAL REGISTRATION: Trial is registered with ClinicalTrials.gov with identifier: NCT05565196, first posted 04/10/ 2022.

High-Risk Human Papillomavirus Messenger RNA Testing Using Urine, Cervicovaginal Self-Collected and Provider-Collected Cervical Samples Among Women in Mombasa, Kenya.

ABSTRACT: We compared human papillomavirus messenger RNA testing using urine, self-, and provider-collected samples for the detection of high-grade cervical cytology and assessed acceptability of urine self-collection among females who engage in sex work in Kenya. Participants found urine sampling comfortable, but high-risk human papillomavirus messenger RNA detection in urine samples was less likely to detect high-grade lesions than self- and provider-collected cervical samples.

Increased condom use among key populations using oral PrEP in Kenya: results from large scale programmatic surveillance.

BACKGROUND: Female sex workers (FSW) and men having sex with men (MSM) in Kenya have high rates of HIV infection. Following a 2015 WHO recommendation, Kenya initiated national scale-up of pre-exposure prophylaxis (PrEP) for all persons at high-risk. Concerns have been raised about PrEP users' potential changes in sexual behaviors such adopting condomless sex and multiple partners as a result of perceived reduction in HIV risk, a phenomenon known as risk compensation. Increased condomless sex may lead to unintended pregnancies and sexually transmitted infections and has been described in research contexts but not in the programmatic setting. This study looks at changes in condom use among FSW and MSM on PrEP through a national a scale-up program. METHODS: Routine program data collected between February 2017 and December 2019 were used to assess changes in condom use during the first three months of PrEP in 80 health facilities supported by a scale-up project, Jilinde. The primary outcome was self-reported condom use. Analyses were conducted separately for FSW and for MSM. Log-Binomial Regression with Generalized Estimating Equations was used to compare the incidence proportion ("risk") of consistent condom use at the month 1, and month 3 visits relative to the initiation visit. RESULTS: At initiation, 69% of FSW and 65% of MSM reported consistent condom use. At month 3, this rose to 87% for FSW and 91% for MSM. MSM were 24% more likely to report consistent condom use at month 1 (Relative Risk [RR], 1.24, 95% Confidence Interval [CI], 1.18-1.30) and 40% more likely at month 3 (RR, 1.40, 95% CI, 1.33-1.47) compared to at initiation. FSW were 15% more likely to report consistent condom use at the month one visit (RR, 1.15, 95% CI, 1.13-1.17) and 27% more likely to report condom use on the month 3 visit (RR 1.27, 95% CI, 1.24-1.29). CONCLUSION: Condom use increased substantially among both FSW and MSM. This may be because oral PrEP was provided as part of a combination prevention strategy that included counseling and condoms but could also be due to the low retention rates among those who initiated.

High-risk Human Papillomavirus Messenger RNA Testing in Wet and Dry Self-collected Specimens for High-grade Cervical Lesion Detection in Mombasa, Kenya.

BACKGROUND: Self-collection for high-risk human papillomavirus (hr-HPV) messenger RNA (mRNA) testing may improve cervical cancer screening. High-risk HPV mRNA with self-collected specimens stored dry could enhance feasibility and acceptance of specimen collection and storage; however, its performance is unknown. We compared the performance of hr-HPV mRNA testing with dry- as compared with wet-stored self-collected specimens for detecting high-grade squamous intraepithelial lesion or more severe (≥HSIL). METHODS: A total of 400 female sex workers in Kenya participated (2013-2018), of which 50% were HIV positive based on enrollment procedures. Participants provided 2 self-collected specimens: one stored dry (sc-DRY) using a Viba brush (Rovers) and one stored wet (sc-WET) with Aptima media (Hologic) using an Evalyn brush (Rovers). Physician-collected specimens were collected for HPV mRNA testing (Aptima) and conventional cytology. We estimated test characteristics for each hr-HPV screening method using conventional cytology as the reference standard (≥HSIL detection). We also examined participant preference for sc-DRY and sc-WET collection. RESULTS: High-risk HPV mRNA positivity was higher in sc-WET (36.8%) than sc-DRY samples (31.8%). Prevalence of ≥HSIL was 6.9% (10.3% HIV positive, 4.0% HIV negative). Sensitivity of hr-HPV mRNA for detecting ≥HSIL was similar in sc-WET (85%; 95% confidence interval [CI], 66%-96%), sc-DRY specimens (78%; 95% CI, 58%-91%), and physician-collected specimens (93%; 95% CI, 76%-99%). Overall, the specificity of hr-HPV mRNA for ≥HSIL detection was similar when comparing sc-WET with physician collection. However, specificity was lower for sc-WET (66% [61%-71%]) than sc-DRY (71% [66%-76%]). Women preferred sc-DRY specimen collection (46.1%) compared with sc-WET (31.1%). However, more women preferred physician collection (63.9%) compared with self-collection (36.1%). CONCLUSIONS: Self-collected stored-dry specimens seemed to perform similarly to sc-WET for the detection of ≥HSIL.

The gender-based violence and recovery centre at Coast Provincial General Hospital, Mombasa, Kenya: An integrated care model for survivors of sexual violence.

Marleen Temmerman and colleagues describe a model of care for people who have experienced sexual violence, set in Kenya.

Association between vaginal washing and detection of Lactobacillus by culture and quantitative PCR in HIV-seronegative Kenyan women: a cross-sectional analysis.

OBJECTIVES: Vaginal washing has been associated with reductions in cultivable Lactobacillus and an increased risk of both bacterial vaginosis (BV) and HIV infection. The effect of vaginal washing on the quantity of individual Lactobacillus species is not well characterised. This analysis tested the hypothesis that vaginal washing would be associated with a lower likelihood of Lactobacillus spp. detected by both culture and quantitative PCR (qPCR). METHODS: We conducted a cross-sectional study of 272 HIV-seronegative women enrolled in an open-cohort study in Mombasa, Kenya. Vaginal washing and sexual risk behaviours were assessed using face-to-face interviews. Vaginal Lactobacillus spp. were detected using cultivation and PCR methods, with L. crispatus, L. jensenii and L. iners concentrations measured using qPCR assays targeting the 16S rRNA gene. Poisson regression with robust SEs was used to assess associations between vaginal washing and Lactobacillus detection by culture and qPCR. RESULTS: Eighty percent (n=217) of participants reported vaginal washing in the prior week. One-fifth (n=58) of participants had BV by Nugent score. In unadjusted analysis, vaginal washing was associated with a 45% decreased likelihood of Lactobacillus spp. detection by culture (prevalence ratio (PR): 0.55, 95% CI 0.37 to 0.82). Adjusting for age and condomless sex in the prior week did not change the magnitude of the association (adjusted PR (aPR): 0.56, 95% CI (0.37 to 0.85). Vaginal washing was associated with approximately a 40% reduction in L. crispatus detection (aPR: 0.57, 95% CI 0.36 to 0.92), but was not significantly associated with L. jensenii (aPR: 0.68, 95% CI 0.42 to 1.09) or L. iners detection (aPR: 1.03, 95% CI 0.92 to 1.15). CONCLUSIONS: Vaginal washing in the prior week was associated with a significantly reduced likelihood of detecting cultivable Lactobacillus and L. crispatus by qPCR. Given associations between Lactobacillus detection and improved reproductive health outcomes, these results provide motivation for additional study of vaginal washing cessation interventions to improve vaginal health.

Correction to: Preference of specimen collection methods for human papillomavirus detection for cervical cancer screening: a cross-sectional study of high-risk women in Mombasa, Kenya.

Following publication of the original article [1], we have been notified that another author should be added to the team of authors. The Name and affiliation details are below.

Preference of specimen collection methods for human papillomavirus detection for cervical cancer screening: a cross-sectional study of high-risk women in Mombasa, Kenya.

OBJECTIVES: Self-collection of genital specimens for high-risk types of human papillomavirus (hrHPV) detection may increase cervical cancer screening uptake. We hypothesized that women would prefer self-collection to clinician-collection of genital specimens. To test this hypothesis, and women's preference between two different self-collection approaches, a total of 199 women were enrolled in a cross-sectional study in Mombasa, Kenya. MATERIALS AND METHODS: Participants provided self-collected specimens using the Evalyn cytobrush (Rovers) stored in a dry tube and the Viba cytobrush (Rovers) stored in wet Aptima media (Hologic). A clinician also collected cervical specimens for hrHPV testing and for cytology, and performed visual inspection using acetic acid. A post-examination questionnaire assessed preferences for the different methods of specimen collection. To test the difference in proportions for each collection method, we performed an exact binomial probability test, under the null hypothesis that women would prefer each specimen-collection method equally. RESULTS: Most women preferred clinician-collection over self-collection (68% versus 32%, p < 0.01). For self-collection, dry-self collection with the Evalyn brush was preferred over the wet-selection with the Viba brush (53% versus 27%, p < 0.01). There was no association between preference for self-collection and preference for a particular self-collection cytobrush. CONCLUSION: Further research to understand and address obstacles to self-collection of genital specimens may be needed to improve the uptake of self-collection for cervical cancer screening, especially in settings with poor access to trained healthcare providers.

Prevalence and correlates of depressive disorders in commercially sexual exploited children: A cross-sectional study in Mombasa, Kenya.

BACKGROUND: Commercial sexual exploitation of children (CSEC) is a global concern and is among the common forms of sexual violence against children. In Kenya, about 32 % of girls and 16 % of boys experience sexual violence before the age of 18 years. While much has been written about the impact of child sexual exploitation, there's little on the prevalence of depressive disorders among CSE children. OBJECTIVES: This study was conducted to assess the prevalence and correlates of depressive disorders among CSE children in Mombasa, Kenya. PARTICIPANTS AND SETTING: The study was conducted among CSE children (10-17 years) in Mombasa County. METHODS: A cross-sectional study conducted between May 2021 and June 2022. A total of 409 CSE children were enrolled, using a case management approach. Data was collected using the child identification tool and the Patient Health Questionnaire (PHQ-9), at the first counselling session to determine the prevalence of depression levels. RESULTS: Of the 409 children, 367 (90 %) were girls while 42 (10 %) were boys. The mean age was 15 years (10-17) (SD = 1.4, t = 0.765). In 286 (70 %) 'Depression unlikely' was recorded, while 123 (30 %) 'Depression likelihood.' Prevalence of mild to severe depression was significantly higher in girls than boys (p = 0.002). Other determinants of depression were having a primary level of education (p = 0.03) and being an orphan. (p = 0.03). CONCLUSION: It is important to prioritize mental health interventions such as screening and early diagnosis of mental health among CSE children in order to prevent and manage both short and long term effects.

A critical review of adolescent sexual and reproductive health and rights in Kenya.

Despite recent efforts from governments and international organizations to promote adolescent sexual and reproductive health (SRH) rights, some of the current policies fall short of achieving the desired outcomes because of a failure to understand adolescent emerging needs and capacity, the diversity of adolescent populations, and the recognition that deliberate and intense actions are required to make this a reality.

Sub optimal HIV status ascertainment at antenatal clinics and the impact on HIV prevalence estimates: A cross sectional study.

BACKGROUND: While many countries including Kenya transitioned from sentinel surveillance to the use of routine antenatal care (ANC) data to estimate the burden of HIV, countries in Sub Saharan Africa reported several challenges of this transition, including low uptake of HIV testing and sub national / site-level differences in HIV prevalence estimates. In Kenya voluntary HIV testing is offered to all 1st ANC clients. However, some women may decline testing. We aim to predict the HIV positivity (as a proxy of prevalence) at ANC assuming 100% uptake of HIV testing and compare this to the observed positivity. METHODS: Using a cross sectional study design, we examine routine data on HIV testing among all women attending ANC in Kwale County, Kenya, for the period January 2015 to December 2019.We used a generalized estimating equation with binomial distribution to model the observed HIV prevalence as explained by HIV status ascertainment. We then used marginal standardization to predict the HIV prevalence at 100% HIV status ascertainment and make recommendations to improve the utility of ANC routine data for HIV surveillance. RESULTS: HIV testing at ANC was at 91.3%, slightly above the global target of 90%. If there was 100% HIV status ascertainment at ANC, the HIV prevalence would be 2.7% (95% CI 2.3-3.2). This was 0.3% lower than the observed prevalence. Across the yearly predictions, there was no difference between the observed and predicted values except for 2018 where the HIV prevalence was underestimated with an absolute bias of -0.2 percent. This implies missed opportunities for identifying new HIV infections in the year 2018. CONCLUSIONS: Imperfect HIV status ascertainment at ANC overestimates HIV prevalence among women attending ANC in Kwale County. However, the use of ANC routine data may underestimate the true population prevalence. There is need to address both community level and health facility level barriers to the uptake of ANC services.

HIV prevention programme with young women who sell sex in Mombasa, Kenya: learnings for scale-up.

INTRODUCTION: In 2018, the National AIDS and sexually transmitted infection (STI) Control Programme developed a national guidelines to facilitate the inclusion of young women who sell sex (YWSS) in the HIV prevention response in Kenya. Following that, a 1-year pilot intervention, where a package of structural, behavioural and biomedical services was provided to 1376 cisgender YWSS to address their HIV-related risk and vulnerability, was implemented. METHODS: Through a mixed-methods, pre/post study design, we assessed the effectiveness of the pilot, and elucidated implementation lessons learnt. The three data sources used included: (1) monthly routine programme monitoring data collected between October 2019 and September 2020 to assess the reach and coverage; (2) two polling booth surveys, conducted before and after implementation, to determine the effectiveness; and (3) focus group discussions and key informant interviews conducted before and after intervention to assess the feasibility of the intervention. Descriptive analysis was performed to produce proportions and comparative statistics. RESULTS: During the intervention, 1376 YWSS were registered in the programme, 28% were below 19 years of age and 88% of the registered YWSS were active in the last month of intervention. In the survey, respondents reported increases in HIV-related knowledge (61.7% vs. 90%, p <0.001), ever usage of pre-exposure prophylaxis (8.5% vs. 32.2%, p < 0.001); current usage of pre-exposure prophylaxis (5.3% vs. 21.1%, p<0.002); ever testing for HIV (87.2% vs. 95.6%, p <0.04) and any clinic visit (35.1 vs. 61.1, p <0.001). However, increase in harassment by family (11.7% vs. 23.3%, p<0.04) and discrimination at educational institutions (5.3% vs. 14.4%, p<0.04) was also reported. In qualitative assessment, respondents reported early signs of success, and identified missed opportunities and made recommendations for scale-up. CONCLUSIONS: Our intervention successfully rolled out HIV prevention services for YWSS in Mombasa, Kenya, and demonstrated that programming for YWSS is feasible and can effectively be done through YWSS peer-led combination prevention approaches. However, while reported uptake of treatment and prevention services increased, there was also an increase in reported harassment and discrimination requiring further attention. Lessons learnt from the pilot intervention can inform replication and scale-up of such interventions in Kenya.

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.

Are Kenyans Likely to Use COVID-19 Self-Testing Kits? Results From a Cross-Sectional Survey.

Objectives: To understand the public's perceptions around rapid SARS-CoV-2 antigen self-testing in Kenya, including the drivers of acceptability, willingness to pay, and adherence to hygiene and prevention recommendations following a positive self-test. Methods: A household-based, cross-sectional survey, using a 35-item questionnaire, was conducted in Mombasa and Taita-Taveta counties, Kenya, during August 2021. Individuals aged ≥18 years were enrolled using a stratified sampling approach. Results: There were 419 participants (mean age 35.7 years). A minority (10.5%) had ever tested for SARS-CoV-2. If SARS-CoV-2 self-testing were available, 39.9% and 41.5% would be likely and very likely, respectively, to use it. If unavailable free-of-charge, 63.01% would pay for it. Multivariate analyses suggested that people in rural areas (Coefficient 0.30, 95%CI: 0.11-0.48, p = 0.002), aged 36-55 (Coefficient 0.21, 95%CI: 0.03-0.40, p = 0.023), and employed full time (Coefficient 0.32, 95%CI: 0.06-0.58, p = 0.016) would have more odds to adhere to recommended hygiene and prevention actions. Conclusion: SARS-CoV-2 self-testing was considered acceptable. Availability of self-testing could expand access to COVID-19 testing in Kenya, particularly among rural communities who have limited access to testing, and among mildly symptomatic individuals.

An implementation model for scaling up oral pre-exposure prophylaxis in Kenya: Jilinde project.

Oral pre-exposure prophylaxis (PrEP) is an efficacious way to lower the risk of HIV acquisition among high-risk individuals. Despite the World Health Organization's 2015 recommendation that all persons at substantial risk of HIV infection be provided with access to oral PrEP, the rollout has been slow in many low- and middle-income countries. Initiatives for national rollout are few, and subtle skepticism persists in several countries about the feasibility of national PrEP implementation. We describe the conceptual design of the Jilinde project, which is implementing oral PrEP as a routine service at a public health scale in Kenya. We describe the overlapping domains of supply, demand, and government and community ownership, which combine to produce a learning laboratory environment to explore the scale-up of PrEP. We describe how Jilinde approaches PrEP uptake and continuation by applying supply and demand principles and ensures that government and community ownership informs policy, coordination, and sustainability. We describe the "learning laboratory" approach that informs strategic and continuous learning, which allows for adjustments to the project. Jilinde's conceptual model illustrates how the coalescence of these concepts can promote scale-up of PrEP in real-world conditions and offers critical lessons on an implementation model for scaling up oral PrEP in low- and middle-income countries.

Venue-Based HIV Testing at Sex Work Hotspots to Reach Adolescent Girls and Young Women Living With HIV: A Cross-sectional Study in Mombasa, Kenya.

BACKGROUND: We estimated the potential number of newly diagnosed HIV infections among adolescent girls and young women (AGYW) using a venue-based approach to HIV testing at sex work hotspots. METHODS: We used hotspot enumeration and cross-sectional biobehavioral survey data from the 2015 Transition Study of AGYW aged 14-24 years who frequented hotspots in Mombasa, Kenya. We described the HIV cascade among young females who sell sex (YFSS) (N = 408) versus those young females who do not sell sex (YFNS) (N = 891) and triangulated the potential (100% test acceptance and accuracy) and feasible (accounting for test acceptance and sensitivity) number of AGYW that could be newly diagnosed through hotspot-based HIV rapid testing in Mombasa. We identified the profile of AGYW with an HIV in the past year using generalized linear mixed regression models. RESULTS: N = 37/365 (10.1%) YFSS and N = 30/828 (3.6%) YFNS were living with HIV, of whom 27.0% (N = 10/37) and 30.0% (N = 9/30) were diagnosed and aware (P = 0.79). Rapid test acceptance was 89.3%, and sensitivity was 80.4%. There were an estimated 15,635 (range: 12,172-19,097) AGYW at hotspots. The potential and feasible number of new diagnosis was 627 (310-1081), and 450 (223-776), respectively. Thus, hotspot-based testing could feasibly reduce the undiagnosed fraction from 71.6% to 20.2%. The profile of AGYW who recently tested was similar among YFSS and YFNS. YFSS were 2-fold more likely to report a recent HIV test after adjusting for other determinants [odds ratio (95% confidence interval): 2.2 (1.5 to 3.1)]. CONCLUSION: Reaching AGYW through hotspot-based HIV testing could fill gaps left by traditional, clinic-based HIV testing services.

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.

Using a HIV prevention cascade for identifying missed opportunities in PrEP delivery in Kenya: results from a programmatic surveillance study.

INTRODUCTION: HIV prevention cascades have been systematically evaluated in high-income countries, but steps in the pre-exposure prophylaxis (PrEP) service delivery cascade have not been systematically quantified in sub-Saharan Africa. We analysed missed opportunities in the PrEP cascade in a large-scale project serving female sex workers (FSW), men who have sex with men (MSM) and adolescent girls and young women (AGYW) in Kenya. METHODS: Programmatic surveillance was conducted using routine programme data from 89 project-supported sites from February 2017 to December 2019, and complemented by qualitative data. Healthcare providers used nationally approved tools to document service statistics. The analyses examined proportions of people moving onto the next step in the PrEP continuum, and identified missed opportunities. Missed opportunities were defined as implementation gaps exemplified by the proportion of individuals who could have potentially accessed each step of the PrEP cascade and did not. We also assessed trends in the cascade indicators at monthly intervals. Qualitative data were collected through 28 focus group discussions with 241 FSW, MSM, AGYW and healthcare providers, and analysed thematically to identify reasons underpinning the missed opportunities. RESULTS: During the study period, 299,798 individuals tested HIV negative (211,927 FSW, 47,533 MSM and 40,338 AGYW). Missed opportunities in screening for PrEP eligibility was 58% for FSW, 45% for MSM and 78% for AGYW. Of those screened, 28% FSW, 25% MSM and 65% AGYW were ineligible. Missed opportunities for PrEP initiation were lower among AGYW (8%) compared to FSW (72%) and MSM (75%). Continuation rates were low across all populations at Month-1 (ranging from 29% to 32%) and Month-3 (6% to 8%). Improvements in average annual Month-1 (from 26% to 41%) and Month-3 (from 4% to 15%) continuation rates were observed between 2017 and 2019. While initiation rates were better among younger FSW, MSM and AGYW (<30 years), the reverse was true for continuation. CONCLUSIONS: The application of a PrEP cascade framework facilitated this large-scale oral PrEP programme to conduct granular programmatic analysis, detecting "leaks" in the cascade. These informed programme adjustments to mitigate identified gaps resulting in improvement of selected programmatic outcomes. PrEP programmes are encouraged to introduce the cascade analysis framework into new and existing programming to optimize HIV prevention outcomes.

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.