Assessing COVID-related concerns and their impact on antenatal and delivery care among pregnant women living with HIV in Kenya: a brief report.

BACKGROUND: Some studies indicate that pregnant Kenyan women were concerned about Coronavirus disease 2019 (COVID-19) exposure during maternity care. We assessed concern regarding COVID-19 exposure and any impact on antenatal care (ANC) enrollment and/or hospital delivery among pregnant women living with human immunodeficiency virus (HIV) in Kenya. METHODS: Data were collected from 1,478 pregnant women living with HIV enrolled in prevention of mother to child transmission of HIV (PMTCT) care at 12 Kenyan hospitals from October 2020 to July 2022. Surveys were conducted when women first presented for PMTCT services at the study hospital and asked demographic questions as well as items related to concerns about COVID-19. A 5-point Likert scale (strongly disagree to strongly agree) assessed concerns about COVID-19 exposure and travel challenges. Gestational age at PMTCT enrollment, number of ANC appointments attended, and delivery location were compared among women who expressed COVID-19 concerns and those who did not. RESULTS: Few women reported delaying antenatal care (4.7%), attending fewer antenatal care appointments (5.0%), or having concerns about a hospital-based delivery (7.7%) because of COVID-19. More (25.8%) reported travel challenges because of COVID-19. There were no significant differences in gestational age at enrollment, number of ANC appointments, or rates of hospital-based delivery between women with concerns about COVID-19 and those without, CONCLUSION: Few pregnant women living with HIV expressed concerns about COVID-19 exposure in the context of routine ANC or delivery care. Women with and without concerns had similar care seeking behaviors. The recognized importance of routine ANC care and facility-based deliveries may have contributed to these positive pregnancy indicators, even among women who worried about COVID-19 exposure. TRIAL REGISTRATION: www. CLINICALTRIALS: gov identifier NCT04571684.

Assessing user preferences for design characteristics of oral dissolvable strips for pediatric HIV medication: a qualitative study.

BACKGROUND: Current infant antiretroviral therapy formulations pose barriers to daily adherence due to complex weight-based dosing, conspicuous preparation, and poor palatability. These adherence barriers jeopardize adherence, making patients vulnerable to virologic failure, development of drug resistance, and preventable mortality. Our team has previously established proof-of-principle for multi-drug oral dissolvable strips as alternative pediatric antiretroviral formulations with the potential to overcome these challenges and improve pediatric ART adherence and outcomes. The objective of this study was to assess caregiver and provider preferences for oral dissolvable strips and its packaging to inform its development. METHODS: Guided by concepts of user-centered design, we conducted key informant interviews with 30 HIV care providers and focus group discussions targeting caregivers of children < 10 years of age living with HIV at 3 Kenyan hospitals. Key informant interviews and focus group discussions were audio recorded, translated/transcribed verbatim, and hand coded for a-priori and emergent themes. RESULTS: A total of 30 providers and 72 caregivers (caring for 83 children, aged 5 months to 18 years) participated in the study. Caregivers and providers expressed a strong desire for an easier way to administer medication, especially among children too young to swallow tablets whole, and expressed enthusiasm around the idea of oral dissolvable strips. Key preferences included a pleasant taste; one strip per dose; small size with rapid dissolution; clear markings and instructions; and no special storage requirements. For packaging, stakeholders preferred individually wrapped strips within a dispenser. The individual packaging should be durable, waterproof, and easy to dispose of in communal spaces. They should also be easy to open, with clear indications where to open. The packaging holding the strips should be durable, re-usable, accommodating of various refill frequencies, and easy to use for children as young as 6. DISCUSSION: The concept of oral dissolvable strips was highly acceptable to caregivers of children living with HIV and HIV care providers. By engaging stakeholders in an iterative design process starting from the early phases of design and development, we will maximize the likelihood of developing a product that is acceptable to the caregiver and infant, therefore leading to sustainable adherence.

A Pilot Study to Evaluate the Impact of the HIV Infant Tracking System (HITSystem 2.0) on Priority Prevention of Mother-to-Child Transmission (PMTCT) Outcomes.

We assessed the preliminary impact of the adapted HIV Infant Tracking System (HITSystem v2.0) intervention on prevention of mother-to-child transmission (PMTCT) outcomes using a matched cluster randomized design in two Kenyan government hospitals. Between November 2017 and June 2019, n = 157 pregnant women with HIV were enrolled and followed from their first PMTCT appointment until 12-weeks postpartum. Data from 135 women were analyzed (HITSystem 2.0: n = 53, standard of care (SOC): n = 82), excluding eight deaths, eight pregnancy losses, and six transfers/moves. The primary outcome, complete PMTCT retention, is an aggregate measure of attendance at all scheduled antenatal appointments, hospital-based delivery, and infant HIV-testing before 7-weeks postnatal. HITSystem 2.0 participants were more likely to receive complete PMTCT services compared to SOC (56.6% vs. 17.1% p < 0.001). In multivariate modeling, HITSystem 2.0 was the strongest predictor of complete PMTCT retention (aOR 5.7, [1.2-90.8], p = 0.032). SOC participants had 1.91 increased hazard rate of PMTCT disengagement; (aHR 6.8, [2.2-21.1]; p < 0.001).

Women's preferences, expectations, and experiences with male partner support throughout prevention of mother to child transmission of HIV services: a mixed-methods study.

Male involvement in prevention of mother to child transmission of HIV (PMTCT) care improves maternal and child outcomes. We conducted a mixed-methods study at two Kenyan government hospitals. We quantitatively assessed women's expectations and preferences for male partner involvement in PMTCT and male partner attendance at PMTCT appointments. Qualitative interviews with women during the postpartum period assessed types of support women received from their male partners. At enrollment, most participants wanted (75%) and expected (69%) male partners to attend appointments; yet, only 9% had a male partner attend any appointments. Most women agreed that their partner would: support them financially (81%), help follow doctor's guidance (61%), support a hospital-based delivery (85%), and want to receive text messages (68%). Expectations and preferences varied by women's characteristics, most notably experiences with mistreatment, disclosure status, and knowledge of male partner's HIV status. In qualitative interviews, instrumental (financial) support was the most frequently discussed type of support. Male partners also provided informational support by reminding women of medication or appointments. Women reported a variety of ways in which their male partners supported them through PMTCT; however, there was a gap between women's expectation for male partner attendance and the level of male attendance achieved.

"Friendly reminder: hi! It is that time again ☺": understanding PMTCT care text message design preferences amongst pre- and post-partum women and their male partners.

BACKGROUND: Prevention of mother-to-child HIV transmission (PMTCT) services in Kenya can be strengthened through the delivery of relevant and culturally appropriate SMS messages. METHODS: This study reports on the results of focus groups conducted with pre and postnatal women living with HIV (5 groups, n = 40) and their male partners (3 groups, n = 33) to elicit feedback and develop messages to support HIV+ women's adherence to ART medication, ANC appointments and a facility-based birth. The principles of message design informed message development. RESULTS: Respondents wanted ART adherence messages that were low in verbal immediacy (ambiguous), came from an anonymous source, and were customized in timing and frequency. Unlike other studies, low message immediacy was prioritized over customization of message content. For retention, participants preferred messages with high verbal immediacy-direct appointment reminders and references to the baby-sent infrequently from a clinical source. CONCLUSION: Overall, participants favored content that was brief, cheerful, and emotionally appealing.

Using a Social Support Framework to Understand How HIV Positive Kenyan Men Engage in PMTCT/EID Care: Qualitative Insights From Male Partners.

Greater male partner involvement in Prevention of Mother to Child Transmission (PMTCT) and Early Infant Diagnosis (EID) is associated with improved outcomes. Perceived low social support for the mother can negatively impact the uptake of PMTCT/EID services. Most research relies on women's reports of the types and quality of male partner support received versus what is desired. This qualitative study examines Kenyan male partners' reported social support provision pre- and post-partum from their own perspective. The study was embedded within intervention development studies in Kenya designed to develop and pilot a PMTCT module of a web based system to improve EID. Focus groups were conducted with male partners of pregnant women with HIV and elicited feedback on male partner involvement in maternal and child care and factors affecting participation. Interviews were analyzed within a theoretical social support framework. Participants described providing tangible support (financial resources), informational support (appointment reminders) and emotional support (stress alleviation in the face of HIV-related adversity). African conceptualizations of masculinity and gender norms influenced the types of support provided. Challenges included economic hardship; insufficient social support from providers, peers and bosses; and HIV stigma. Collaboration among providers, mothers and partners; a community-based social support system; and recasting notions of traditional masculinity were identified as ways to foster male partner support.

Predictors of Early ART Initiation Among HIV + Infants in Kenya: A Retrospective Review of HITSystem Data from 2013 to 2017.

OBJECTIVE: Early initiation of antiretroviral therapy (ART, before 12 weeks of age) among infants living with HIV reduces infant mortality and slows disease progression. However, inefficiencies in early infant diagnosis processes prevents timely ART initiation among infants living with HIV in Kenya. This study assesses predictors of early ART initiation among infants living with HIV in Kenya. DESIGN: We retrospectively reviewed data from 96 infants living with HIV born between January 2013 and June 2017 at 6 Kenyan government hospitals. METHODS: The primary outcome was infant receipt of ART by 12 weeks of age. We assessed bivariable and multivariable predictors of ART initiation by 12 weeks of age. RESULTS: Among 96 infants living with HIV, 82 (85.4%) infants initiated ART at a median infant age of 17.1 weeks. Of the 82 infants who started ART, only 17 (20.7%) initiated ART by 12 weeks of age. In multivariable logistic regression analyses, testing per national guidelines (< 7 weeks of age) (aOR 40.14 [3.96-406.97], p = 0.002), shorter turnaround time for result notification (≤ 4 weeks) (aOR 11.30 [2.02-63.34], p = 0.006), and ART initiation within 3 days of mother notification (aOR 7.32 [1.41-38.03], p = 0.006) were significantly associated with ART initiation by 12 weeks of age. CONCLUSION: Current implementation of early infant diagnosis services in Kenyan only achieves targets for early ART initiation in one-fifth of infants with HIV. Strengthening services to support earlier infant testing and streamlined processes for early infant diagnosis may increase the proportion of infants who receive timely ART.

eHealth Interventions for Early Infant Diagnosis: Mothers' Satisfaction with the HIV Infant Tracking System in Kenya.

The HIV Infant Tracking System (HITSystem) is an eHealth intervention to improve early infant diagnosis (EID) through alerts to providers and text messages to mothers. This study explored mothers' experiences receiving standard and HITSystem-enhanced EID services to assess perceived intervention benefits, acceptability, and opportunities for improvement. This qualitative study was embedded within a cluster-randomized control trial to evaluate the HITSystem at six Kenyan government hospitals (3 intervention, 3 control). We conducted semi-structured interviews with 137 mothers attending EID follow-up visits. Compared to control sites, participants at HITSystem sites described enhanced EID quality; HITSystem-generated texts informed them of result availability and retesting needs, provided cues-to-action for clinic attendance, and engendered opportunities for patient support. They described improved EID efficiency through shorter waiting periods for results and fewer hospital visits. Participants reported high satisfaction with EID and acceptability of text messages; however, modifications to ensure text delivery, increase repeat testing reminders, include low literacy content options, and provide encouraging messages were suggested. These user experience data suggest improvements in EID at HITSystem sites when compared with control sites.

"Closing the Gap": Provider Recommendations for Implementing Birth Point of Care HIV Testing.

Delays in traditional HIV DNA PCR testing for early infant diagnosis (EID) at 6 weeks of age result in late antiretroviral treatment (ART). Birth point of care (POC) testing is an emerging strategy with the potential to streamline EID services. We elicited providers' recommendations for introducing birth POC testing to guide strategies in Kenya and similar settings. We conducted formative interviews with 26 EID providers from four Kenyan hospitals prior to POC implementation. Providers discussed the need for comprehensive training, covering both EID and POC-specific topics for all key personnel. Providers highlighted equipment considerations, such as protocols for maintenance and safe storage. Providers emphasized the need for maternal counseling to ensure patient acceptance and most agreed that specimen collection for birth POC testing should occur in the maternity department and supported a multidisciplinary approach. Though most providers supported ART initiation based on a positive birth POC result, a few expressed concerns with result validity. To maximize implementation success, provider training, equipment security, maternal counseling, and logistics of testing must be planned and communicated to providers.

Retention and viral suppression of newly diagnosed and known HIV positive pregnant women on Option B+ in Western Kenya.

Kenya introduced universal antiretroviral treatment (ART) for pregnant and breastfeeding women living with HIV (Option B+) in 2014. A retrospective study was conducted to review consecutive records for HIV positive pregnant women presenting for antenatal care (ANC) at five clinics in western Kenya. Known positive women (KP :HIV diagnosis prior to current pregnancy) were compared to newly positive (NP) women regarding virologic suppression and retention in care. Among 165 women included, 71 (43%) NP and 94 (57%) KP, NP were younger (24.5 years (SD 4.6) vs. 28.1 years (SD 5.6) compared to KP (p < .001). Almost all NP (97%) were initiated on Option B+ while over half of KP (59%) started ART for clinical/immunological criteria (p < .0001). KPs were more likely than NPs to have a VL performed following Kenyan guidelines (64% vs. 31%; p < .001). Among those tested, virologic suppression was high in both groups (92% KP vs. 100% NP; p = .31). More KPs (82%) vs. NPs (66%) remained active in care at 15-18 months of follow-up (p = .02). Women newly diagnosed with HIV during pregnancy show poorer uptake of VL testing and worse retention in care than those diagnosed prior to pregnancy.

Evaluating a community-based cervical cancer screening strategy in Western Kenya: a descriptive study.

BACKGROUND: The incidence of cervical cancer in Kenya is among the highest in the world. Few Kenyan women are able to access screening, thus fueling the high cervical cancer burden. Self-collected human papilloma Virus (HPV) tests, administered during community-health campaigns in rural areas may be a way to expand access to screening. METHODS: In December 2015, we carried out a four-day community health campaign (CHC) to educate participants about cervical cancer prevention and offer self-administered HPV screening. Community enumeration, outreach and mobilization preceded the CHC. Samples were sent to Migori County Hospital for HPV DNA testing using careHPV Test Kits. Women were notified of results through their choice of short message service (SMS), phone call, home visit or clinic visit. HPV positive women were referred for cryotherapy following a screen-and-treat strategy. RESULTS: Door-to-door enumeration identified approximately 870 eligible women in Ngodhe Community in Migori County. Among the 267 women attending the campaign, 255 women enrolled and collected samples: 243 tests were successfully resulted and 12 were indeterminate. Of the 243 resulted tests, 47 (19%) were positive for HPV, with young age being the only significant predictor of positivity. In multivariate analysis, each additional year of age conferred about a 4% decrease in the odds of testing positive (95% CI 0.1 to 7%, p = 0.046). Just over three-quarters of all women (195/255), were notified of their results. Those who were unable to be reached were more likely to prefer receiving results from clinic (54/60, 90%) and were less likely to have mobile phones (24/60, 73%). Although 76% of HPV positive women were notified of their results, just half (51%) of those testing positive presented for treatment. HPV positive women who successfully accessed the treatment facility did not differ from their non-presenting counterparts by demographics, health history, desired route of notification or access to a mobile phone. CONCLUSION: Nearly a third of eligible women in Ngodhe Community attended the CHC and were screened for cervical cancer. Nearly all women who attended the CHC underwent cervical cancer screening by self-collected HPV tests. Three-quarters of all participants received results, but just half of HPV positive participants presented for treatment in a timely fashion, suggesting that linkage to treatment remains a major challenge. TRIAL REGISTRATION: NCT02124252 , Registered 25 April 2014.

Progress Toward Eliminating Mother to Child Transmission of HIV in Kenya: Review of Treatment Guidelines Uptake and Pediatric Transmission Between 2013 and 2016-A Follow Up.

Background Prevention of mother to child transmission of HIV (PMTCT) services are critical to achieve national and global targets of 90% antiretroviral therapy (ART) coverage in PMTCT, and mother to child transmission rates less than 5%. In 2012, Kenya adopted WHO's recommended ART regimen for PMTCT "Option B+". Aims This study assesses progress made in adopting these new guidelines and associated outcomes. Methods We analysed programmatic data of 2604 mother-infant pairs enrolled in the HIV Infant Tracking System (HITSystem) at four government hospitals in Kenya between January, 2013 and December, 2016. We then compared PMTCT trends between 2010 and 2012 and 2013-2016 for the same four government hospitals. Results A total of 2,371 (91.1%) received some ART regimen, however; only 911 (56.2%) mothers received ART regimens compliant with WHO Option B+. From 2013 to 2016, the percent of mothers on WHO Option B + doubled from 42 to 84% (p < 0.001), the mean week of ART initiation decreased from 19.0 to 9.7 weeks (p < 0.001), the percent of pregnant women who were already on ART at the time of PMTCT enrolment increased from 5.8 to 31.7% (p < 0.001), and the paediatric transmission rate decreased from 5.9 to 2.5% (p = 0.002). Conclusion Comparing data at these four Kenyan hospitals indicates significant progress has been made from 2010 to 2016. To continue these positive gains, concerted focus will be needed to target and improve the integration of new guidelines into clinical practice at the facility level, adherence to treatment and retention in care.

Cervical cancer prevention and treatment research in Africa: a systematic review from a public health perspective.

BACKGROUND: Women living in Africa experience the highest burden of cervical cancer. Research and investment to improve vaccination, screening, and treatment efforts are critically needed. We systematically reviewed and characterized recent research within a broader public health framework to organize and assess the range of cervical cancer research in Africa. METHODS: We searched online databases and the Internet for published articles and cervical cancer reports in African countries. Inclusion criteria included publication between 2004 and 2014, cervical cancer-related content pertinent to one of the four public health categories (primary, secondary, tertiary prevention or quality of life), and conducted in or specifically relevant to countries or regions within the African continent. The study design, geographic region/country, focus of research, and key findings were documented for each eligible article and summarized to illustrate the weight and research coverage in each area. Publications with more than one focus (e.g. secondary and tertiary prevention) were categorized by the primary emphasis of the paper. Research specific to HIV-infected women or focused on feasibility issues was delineated within each of the four public health categories. RESULTS: A total of 380 research articles/reports were included. The majority (54.6 %) of cervical cancer research in Africa focused on secondary prevention (i.e., screening). The number of publication focusing on primary prevention (23.4 %), particularly HPV vaccination, increased significantly in the past decade. Research regarding the treatment of precancerous lesions and invasive cervical cancer is emerging (17.6 %), but infrastructure and feasibility challenges in many countries have impeded efforts to provide and evaluate treatment. Studies assessing aspects of quality of life among women living with cervical cancer are severely limited (4.1 %). Across all categories, 11.3 % of publications focused on cervical cancer among HIV-infected women, while 17.1 % focused on aspects of feasibility for cervical cancer control efforts. CONCLUSIONS: Cervical cancer research in African countries has increased steadily over the past decade, but more is needed. Tertiary prevention (i.e. treatment of disease with effective medicine) and quality of life of cervical cancer survivors are two severely under-researched areas. Similarly, there are several countries in Africa with little to no research ever conducted on cervical cancer.

An Insight Into Cervical Cancer Screening and Treatment Capacity in Sub Saharan Africa.

OBJECTIVE: Approximately 85% of cervical cancer cases and deaths occur in resource-constrained countries where best practices for prevention, particularly for women with HIV infection, still need to be developed. The aim of this study was to assess cervical cancer prevention capacity in select HIV clinics located in resource-constrained countries. MATERIALS AND METHODS: A cross-sectional survey of sub-Saharan African sites of 4 National Institutes of Health-funded HIV/AIDS networks was conducted. Sites were surveyed on the availability of cervical cancer screening and treatment among women with HIV infection and without HIV infection. Descriptive statistics and χ or Fisher exact test were used as appropriate. RESULTS: Fifty-one (65%) of 78 sites responded. Access to cervical cancer screening was reported by 49 sites (96%). Of these sites, 39 (80%) performed screening on-site. Central African sites were less likely to have screening on-site (p = .02) versus other areas. Visual inspection with acetic acid and Pap testing were the most commonly available on-site screening methods at 31 (79%) and 26 (67%) sites, respectively. High-risk HPV testing was available at 29% of sites with visual inspection with acetic acid and 50% of sites with Pap testing. Cryotherapy and radical hysterectomy were the most commonly available on-site treatment methods for premalignant and malignant lesions at 29 (74%) and 18 (46%) sites, respectively. CONCLUSIONS: Despite limited resources, most sites surveyed had the capacity to perform cervical cancer screening and treatment. The existing infrastructure of HIV clinical and research sites may provide the ideal framework for scale-up of cervical cancer prevention in resource-constrained countries with a high burden of cervical dysplasia.

Accuracy of visual inspection with acetic acid to detect cervical cancer precursors among HIV-infected women in Kenya.

Visual inspection with acetic acid (VIA) is becoming a more widely recommended and implemented screening tool for cervical cancer prevention programs in low-resource settings. Many of these settings have a high prevalence of HIV-infected women. We carried out a cross-sectional validation study to define the sensitivity, specificity and predictive values of VIA among HIV-infected women. Women enrolled in HIV care at the Family AIDS Care and Education Services clinic in Kisumu, Kenya, were recruited for participation. All participants underwent VIA followed by colposcopy performed by a second blinded clinician. At colposcopy, lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Disease status was determined by final histopathologic diagnosis in women who underwent biopsies. A satisfactory colposcopy with no lesions was considered a negative result. From October 2010 to June 2012, 1,432 women underwent VIA and colposcopy. A total of 514 (35.7%) women had a positive VIA, and 179 (12.2%) had CIN2+ confirmed by colposcopically directed biopsy. Sensitivity, specificity, positive and negative predictive values of VIA for CIN2+ were 86.6, 71.6, 30.3 and 97.4%, respectively. Specificity, but not sensitivity, increased with older age. Among older women, sensitivity was affected by CD4+ count and use of antiretroviral therapy. Although they are impacted by age and immune status, test characteristics for VIA among HIV-infected women are similar to what has been reported for general populations. Recommendations to use VIA as a screening tool should not vary by HIV status.

Risk factors for cervical precancer detection among previously unscreened HIV-infected women in Western Kenya.

HIV and cervical cancer are intersecting epidemics in many low-resource settings, yet there are few accurate estimates of the scope of this public health challenge. To understand disease prevalence and risk factors for cervical intraepithelial neoplasia 2 or greater (CIN2+), we conducted a cross-sectional study of women undergoing cervical cancer screening as part of routine HIV care in Kisumu, Kenya. Women were offered screening with visual inspection with acetic acid, followed by confirmation with colposcopy and biopsy as needed. Univariable and multivariable analyses were carried out to determine clinical and demographic predictors of prevalent CIN2+. Among 3,241 women screened, 287 (9%) had an initial diagnosis of biopsy-confirmed CIN2+. On multivariable analysis, combined oral contraceptives remained significantly associated with detection of CIN2+ among women on HAART (AOR 1.84, CI 1.20-2.82), and not on HAART (AOR 1.72, 95% CI 1.08-2.73), while use of a progesterone implant was associated with increased detection of CIN2+ (AOR 9.43, 95% CI 2.85-31.20) only among women not on HAART. CD4+ nadir over 500 cells/mm(3) was associated with reduced detection of CIN2+ (AOR 0.61, CI 0.38, 0.97) in the overall group, but current CD4+ was only associated with reduced detection of CIN2+ among women not on HAART (AOR 0.42, CI 0.22, 0.80). In conclusion, a history of less severe immunosuppression appeared to reduce the risk of CIN2+ detection, but current CD4+ count was significant only in non-HAART users. The association of CIN2+ with hormonal contraception should be explored more in prospective studies designed to better control for confounding factors.

A comparison of two visual inspection methods for cervical cancer screening among HIV-infected women in Kenya.

OBJECTIVE: To determine the optimal strategy for cervical cancer screening in women with human immunodeficiency virus (HIV) infection by comparing two strategies: visual inspection of the cervix with acetic acid (VIA) and VIA followed immediately by visual inspection with Lugol's iodine (VIA/VILI) in women with a positive VIA result. METHODS: Data from a cervical cancer screening programme embedded in two HIV clinic sites in western Kenya were evaluated. Women at a central site underwent VIA, while women at a peripheral site underwent VIA/VILI. All women positive for cervical intraepithelial neoplasia grade 2 or worse (CIN 2+) on VIA and/or VILI had a confirmatory colposcopy, with a biopsy if necessary. Overall test positivity, positive predictive value (PPV) and the CIN 2+ detection rate were calculated for the two screening methods, with biopsy being the gold standard. FINDINGS: Between October 2007 and October 2010, 2338 women were screened with VIA and 1124 with VIA/VILI. In the VIA group, 26.4% of the women tested positive for CIN 2+; in the VIA/VILI group, 21.7% tested positive (P < 0.01). Histologically confirmed CIN 2+ was detected in 8.9% and 7.8% (P = 0.27) of women in the VIA and VIA/VILI groups, respectively. The PPV of VIA for biopsy-confirmed CIN 2+ in a single round of screening was 35.2%, compared with 38.2% for VIA/VILI (P = 0.41). CONCLUSION: The absence of any differences between VIA and VIA/VILI in detection rates or PPV for CIN 2+ suggests that VIA, an easy testing procedure, can be used alone as a cervical cancer screening strategy in low-income settings.

Challenges with pediatric antiretroviral therapy administration: Qualitative perspectives from caregivers and HIV providers in Kenya.

BACKGROUND: Current formulations of pediatric antiretroviral therapy (ART) for children with HIV present significant barriers to adherence, leading to drug resistance, ART ineffectiveness, and preventable child morbidity and mortality. Understanding these challenges and how they contribute to suboptimal adherence is an important step in improving outcomes. This qualitative study describes how regimen-related challenges create barriers to adherence and impact families. METHODS: We conducted key informant interviews (KIIs) with 30 healthcare providers and 9 focus group discussions (FGDs) with a total of 72 caregivers, across three public hospitals in Siaya and Mombasa Kenya. The KIIs and FGDs were audio recorded, translated, and transcribed verbatim. The transcripts were hand coded based on emergent and a-priori themes. RESULTS: Caregivers discussed major regimen-related challenges to adherence included poor palatability of current formulations, complex preparation, and administration (including measuring, crushing, dissolving, mixing), complex drug storage, and frequent refill appointments and how these regimen-related challenges contributed to individual and intrapersonal barriers to adherence. Caregivers discussed how poor taste led to child anxiety, refusal of medications, and the need for caregivers to use bribes or threats during administration. Complex preparation led to concerns and challenges about maintaining privacy and confidentiality, especially during times of travel. Providers corroborated this patient experience and described how these challenges with administration led to poor infant outcomes, including high viral load and preventable morbidity. Providers discussed how the frequency of refills could range from every 2 weeks to every 3 months, depending on the patient. Caregivers discussed how these refill frequencies interrupted work and school schedules, risked unwanted disclosure to peers, required use of financial resources for travel, and ultimately were a challenge to adherence. CONCLUSION: These findings highlight the need for improved formulations for pediatric ART to ease the daily burden on caregivers and children to increase adherence, improve child health, and overall quality of life of families.

Incorporating the HIV Infant Tracking System into standard-of-care early infant diagnosis of HIV services in Kenya: a cost-effectiveness analysis of the HITSystem randomised trial.

BACKGROUND: The HITSystem efficacy trial showed significant improvements in early infant diagnosis retention, return and notification of infant test results, and earlier antiretroviral therapy (ART) initiation compared with standard-of-care early infant diagnosis services in Kenya. This study aimed to analyse data from the HITSystem trial to assess the cost-effectiveness of the intervention in Kenya. METHODS: In this analysis, we extrapolated results from the HITSystem cluster randomised controlled trial to model early infant diagnosis outcomes and cost-effectiveness if the HITSystem was scaled up nationally in Kenya, compared with standard-of-care outcomes. We used a micro-costing method to collect cost data, which were analysed from a health-system perspective, reflecting the investment required to add HITSystem to existing early infant diagnosis services and infrastructure. The base model used to calculate cost-effectiveness was deterministic and calculated the progression of infants through early infant diagnosis. Differences in progression across study arms were used to establish efficacy outcomes. The number of life-years gained per infant successfully initiating ART were based on the Cost Effectiveness of Preventing AIDS Complications model in east Africa. HITSystem cost data were integrated into the model, and the incremental cost-effectiveness ratio was calculated in terms of cost per life-year gained. Sensitivity analyses were done using the deterministic model with triangular stochastic probability functions for key model parameters added. The number of life-years gained was discounted at 3% and costs were adjusted to 2021 values. FINDINGS: The cost per life-year gained from the HITSystem was US$82·72. Total cost for national HITSystem coverage in Kenya was estimated to be around $2·6 million; covering 82 230 infants exposed to HIV at a cost of $31·38 per infant and a yield of 1133 infants receiving timely ART, which would result in 31 189 life-years gained. With sensitivity analyses, the cost per life-year gained varied from $40·13 to $215·05. 90% of model values across iterations ranged between $55·58 (lower 5% threshold) and $132·38 (upper 95% threshold). INTERPRETATION: The HITSystem would be very cost-effective in Kenya and can optimise the return on the existing investment in the national early infant diagnosis programme. FUNDING: The US National Institute of Child Health and Human Development.

Toward Strengthening the Capacity of the Health System: A Cross-Sectional Study of Factors Predicting Quality of Life in 545 Nigerian Children Exposed to Sexual Abuse.

In Nigeria, the predictors of quality of life among children exposed to sexual abuse are unknown. Addressing this gap may strengthen the capacity of the health system to care for this population. Thus, this cross-sectional study selected 545 (mean age = 14.4 ± 1.4 years) Nigerian children exposed to sexual abuse. Results show that self-compassion, resilience, and meaning in life jointly predicted quality of life and explained 39% variance. The independent prediction of each predictor variable shows that self-compassion, resilience, and meaning in life have significant independent predictions, with self-compassion showing the greatest independent prediction, followed by resilience and meaning in life. Sex, age, and how long ago respondents were exposed to sexual abuse jointly predicted quality of life and explained 6% variance. However, how long ago respondents were exposed to sexual abuse shows a significant independent prediction. Results offer clinical implications that may strengthen the capacity of the health system to care for this population.