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BackgroundAt-birth and point-of-care (POC) testing can expedite early infant diagnosis of HIV and improve infant outcomes. Guided by the Consolidated Framework for Implementation Research (CFIR), this study describes the implementation of an at-birth POC testing pilot from the perspective of implementing providers and identifies the factors that might support and hinder the scale up of these promising interventions.MethodsWe conducted 28 focus group discussions (FGDs) with 48 providers across 4 study sites throughout the course of a pilot study assessing the feasibility and impact of at-birth POC testing. FGDs were audio-recorded, transcribed, and analyzed for a priori themes related to CFIR constructs. This qualitative study was nested within a larger study to pilot and evaluate at-birth and POC HIV testing.ResultsOut of the 39 CFIR constructs, 30 were addressed in the FGDs. While all five domains were represented, major themes revolved around constructs related to intervention characteristics, inner setting, and outer setting. Regarding intervention characteristics, the advantages of at-birth POC (rapid turnaround time resulting in improved patient management and enhanced patient motivation) were significant enough to encourage provider uptake and enthusiasm. Challenges at the intervention level (machine breakdown, processing errors), inner settings (workload, limited leadership engagement, challenges with access to information), and outer setting (patient-level challenges, limited engagement with outer setting stakeholders) hindered implementation, frustrated providers, and resulted in missed opportunities for testing. Providers discussed how throughout the course of the study adaptations to implementation (improved channels of communication, modified implementation logistics) were made to overcome some of these challenges. To improve implementation, providers cited the need for enhanced training and for greater involvement among stakeholders outside of the implementing team (i.e., other clinicians, hospital administrators and implementing partners, county and national health officials). Despite provider enthusiasm for the intervention, providers felt that the lack of engagement from leadership within the hospital and in the outer setting would preclude sustained implementation outside of a research setting.ConclusionDespite demonstrated feasibility and enthusiasm among implementing providers, the lack of outer setting support makes sustained implementation of at-birth POC testing unlikely at this time. The findings highlight the multi-dimensional aspect of implementation and the need to consider facilitators and barriers within each of the five CFIR domains.Trial registrationClinicalTrials.gov,NCT03435887. Retrospectively registered on 19 February 2020

Background: In Kenya, standard early infant diagnosis (EID) with polymerase chain reaction (PCR) testing at 6-week postnatal achieves early treatment initiation (

Male involvement in prevention of mother to child transmission of HIV (PMTCT) care is associated with improved 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.

The presence and type of HIV drug resistance mutations among 5 infants diagnosed with HIV were assessed and compared with their mothers' viral mutations. Mother and infant blood samples were sequenced and screened for HIV drug resistance mutations using the Stanford HIV Sequence Database. Three of 5 (60%) mother-infant pairs harbored HIV drug resistance mutations.

BackgroundPrevention of mother-to-child HIV transmission (PMTCT) services in Kenya can be strengthened through the delivery of relevant and culturally appropriate SMS messages.MethodsThis 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.ResultsRespondents 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.ConclusionOverall, participants favored content that was brief, cheerful, and emotionally appealing.

BACKGROUND Evidence that text messages can support patient adherence to HIV care is growing. We conducted a pilot study of the HIV Infant Tracking System (HITSystem 2.0), an intervention that includes SMS to patients to support maternal medication adherence, appointment attendance, and hospital-based deliveries during the antenatal period. OBJECTIVE The objective of this study was to qualitatively assess women’s experiences receiving SMS to understand message utility and acceptability with the goal of refining and strengthening the intervention. METHODS As part of an intervention development pilot study, we conducted semi-structured interviews with 33 women living with HIV who received SMS through the HITSystem 2.0 throughout their pregnancy and postpartum period. Interview questions assessed women’s feedback of the SMS, the impact of the SMS on their PMTCT care, and suggestions for improvement. RESULTS Participants described how SMS reinforced existing strategies for medication adherence and served as cues to action for antenatal appointments and hospital-based deliveries. SMS also provided encouragement and enhanced their sense of engagement with their clinical care team. Given the neutral content of the messages, most women reported no concerns about message confidentiality. Recommendations to enhance utility included greater customizability (timing and frequency of messages) and a few women suggested more comprehensive counseling regarding the SMS content to anticipate at the time of enrollment. CONCLUSIONS SMS content was deemed useful and acceptable by pregnant and postpartum women living with HIV and engaged in PMTCT services. Participant recommendations to increase message customization options have been adopted to enhance the intervention. CLINICALTRIAL Trial registration: clinicaltrials.gov, NCT02726607. Registered 01 April 2016. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02726607

We identified mortality predictors among HIV-exposed uninfected infants and infants living with HIV in Kenyan early infant diagnosis services between 2012 and 2017. Younger maternal age and absence of antenatal antiretroviral therapy among HIV-exposed uninfected infants (n = 2366) and travel time to hospital and delayed infant testing among infants living with HIV (n = 130) predicted mortality, highlighting the importance of supporting engagement in maternal/pediatric HIV services.

Early infant diagnosis (EID) involves age-specific tracking and testing of HIV-exposed infants during the first 18 months of life and rapid initiation of life-saving treatment for those infected. In Kenya, pre-2013 data estimate EID lost to follow-up (LTFU) at 39–65%, yet no study has documented LTFU rates and predictors throughout the EID cascade since Option B+ fundamentally changed services by placing all HIV-positive expectant mothers on lifelong treatment. Using an explanatory mixed-method design, we assessed LTFU rates and predictors among 870 mother–infant dyads enrolled in EID in six urban/peri-urban Kenyan government hospitals. Mothers completed baseline surveys, and dyads were tracked through EID. We selected 12 baseline variables and modeled odds of LTFU at 9 and 18 months using mixed logistic regression. Qualitative interviews were conducted with 61 mothers to assess barriers and facilitators to completing EID. Thematically coded transcripts were used to interpret quantitative predictors of LTFU. By the 18-month test, 145 dyads (22%) were LTFU, with three-quarters of LTFU occurring between 9- and 18-month tests. Odds of LTFU at 18 months decreased by 10% for each additional year of maternal age and by 66% with HIV status disclosure. Qualitative data revealed how disclosure facilitated essential social support for EID completion and how older mothers attributed maturity and life experience to successful engagement in care. Findings suggest LTFU rates in Kenya have declined, but gaps remain in ensuring universal coverage. Efforts to improve retention should focus on increasing support for younger mothers and those who have not disclosed their HIV status.

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.

The HIV Infant Tracking System (HITSystem) is a web-based intervention linking providers of early infant diagnosis, laboratory technicians, and mothers and infants to improve outcomes for HIV-exposed infants. We aimed to evaluate the efficacy of the HITSystem on key outcomes of early infant diagnosis.We did a cluster-randomised trial at six hospitals in Kenya, which were matched on geographic region, resource level, and volume of patients (high, medium, and low). We randomly allocated hospitals within a matched pair to either the HITSystem (intervention; n=3) or standard of care (control; n=3). A random number generator was used to assign clusters. Investigators were unaware of the randomisation process. Eligible participants were mothers aged 18 years or older with an infant younger than 24 weeks presenting for their first early infant diagnosis appointment. The primary outcome was complete early infant diagnosis retention, which was defined as receipt of all indicated age-specific interventions until 18 months post partum (for HIV-negative infants) or antiretroviral therapy initiation (for HIV-positive infants). Analysis was per protocol in all randomised pairs judged eligible, excluding infant deaths and those who moved or were transferred to another health facility. Modified intention-to-treat sensitivity analyses judged all infant deaths and transfers as incomplete early infant diagnosis retention. Separate multivariable logistic regression analyses were done with intervention group, hospital volume, and significant covariates as fixed effects. This trial is registered with ClinicalTrials.gov, number NCT02072603; the trial has been completed.Between Feb 16, 2014, and Dec 31, 2015, 895 mother-infant pairs were enrolled. Of these, 87 were judged ineligible for analysis, 26 infants died, and 92 pairs moved or were transferred to another health facility. Thus, data from 690 mother-infant pairs were analysed, of whom 392 were allocated to the HITSystem and 298 to standard of care. Mother-infant pairs were followed up to Sept 30, 2017. Infants diagnosed as HIV-positive were followed up for a median of 2·1 months (IQR 1·6-4·8) and HIV-negative infants were followed up for a median of 17·0 months (IQR 16·6-17·6). Infants enrolled in the HITSystem were significantly more likely to receive complete early infant diagnosis services compared with those assigned standard of care (334 of 392 [85%] vs 180 of 298 [60%]; adjusted odds ratio [OR] 3·7, 95% CI 2·5-5·5; p0·0001). No intervention effect was recorded at high-volume hospitals, but strong effects were seen at medium-volume and low-volume hospitals. Modified intention-to-treat analyses for complete early infant diagnosis were also significant (334 of 474 [70%] vs 180 of 334 [54%]; adjusted OR 2·0, 95% CI 1·4-2·7; p0·0001). No adverse events related to study participation were reported.The HITSystem intervention is effective and feasible to implement in low-resource settings. The HITSystem algorithms have been modified to include HIV testing at birth, and an adapted HITSystem 2.0 version is supporting HIV-positive pregnant women to prevent perinatal transmission and optimise maternal and infant outcomes.National Institute of Child Health and Human Development.

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

We sought to understand the sequence of testing and treatment among nine infants offered both conventional and point-of-care testing and diagnosed as HIV-positive by 6 months of age in Kenya. One infant received per protocol testing and treatment. Patient-level (late presentation and disengagement), provider-level (reluctance and error/oversight) and system-level (stock outs, errors) challenges delayed diagnosis and treatment. Early point-of-care testing can streamline testing; however, challenges mitigate benefits.

BackgroundTesting infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya.MethodsFour government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities).ResultsOf 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing.DiscussionAt birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff. However, maternal disengagement and missed opportunities for testing must be addressed to realize the full benefits of at birth POC testing.

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.

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.

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

Rationale Early Infant Diagnosis (EID) is critical to timely identification of HIV and rapid treatment initiation for infants found to be infected. Completing the EID cascade involves a series of age-specific tests between birth and 18 months and can be challenging for mother- infant pairs in low-resource settings. Even prior to recent increases in Kenya's testing recommendations, approximately 22% of mother-infant pairs enrolled in EID were lost to follow-up. As EID cascades become increasingly complex, identifying strategies to maximize retention becomes even more essential. Despite ongoing health system improvements, we still lack a framework for understanding the individual-level, psychosocial processes underlying EID completion—insight that could be essential for shaping strategies to support patients and close gaps in retention. Objective Our objective was to explain individual-level processes that lead to EID completion among mothers who successfully completed the EID cascade. Methods Using qualitative methods informed by grounded theory, we conducted 65 interviews with Kenyan mothers who completed EID. Results We identified three themes related to completion: (1) Negative motivation, from the consequences of infant infection, fear of postnatal transmission, and burden of maternal failure; (2) Positive motivation, from achieving a final goal, responding to provider support, and maximizing infant health; and (3) Overcoming challenges, through resolve/resiliency, planning/privatizing and rejecting stigma/leveraging support. Conclusion Overall, the EID cascade served as a framing process for women to secure an identity as a good mother. Successful EID completion was the product of a strong motivational foundation channeled into strategies to surmount persistent challenges. Participant accounts of overcoming challenges highlight their resiliency as well as the outstanding need to address financial, logistical, and social barriers to care. Future EID programs may capitalize on these findings by affirming patients' quest for identity control, leveraging positive motivators, and expanding peer support structures to help mothers feel connected throughout the cascade.

Background: Despite progress to expand access to HIV testing and treatment during pregnancy in Kenya, gaps still remain in prevention of mother-to-child transmission of HIV (PMTCT) services. This study addresses the need for effective and scalable interventions to support women throughout the continuum of care for PMTCT services in low-resource settings. Our research team has successfully implemented the HIV Infant Tracking System (HITSystem), a Web-based, system-level intervention to improve early infant diagnosis (EID) outcomes. Objective: This study will expand the scope of the HITSystem to address PMTCT services to bridge the gap between maternal and pediatric HIV services and improve outcomes. This paper describes the intervention development protocol to adapt and pilot an HITSystem version 2.0 to assess acceptability, feasibility, and preliminary PMTCT outcomes in Kenya. Methods: This is a 3-year intervention development study to adapt the current HITSystem intervention to support a range of PMTCT outcomes including appointment attendance, antiretroviral therapy (ART) adherence, hospital deliveries, and integration of maternal and pediatric HIV services in low-resource settings. The study will be conducted in 3 phases. Phase 1 will elicit feedback from intervention users (patients and providers) to guide development and refinement of the new PMTCT components and inform optimal implementation. In Phase 2, we will design and develop the HITSystem 2.0 features to support key PMTCT outcomes guided by clinical content experts and findings from Phase 1. Phase 3 will assess complete PMTCT retention (before, during, and after delivery) using a matched randomized pilot study design in 2 hospitals over 18 months. A total of N=108 HIV-positive pregnant women (n=54 per site) will be enrolled and followed from their first PMTCT appointment until infant HIV DNA Polymerase Chain Reaction testing at the target age of 6 weeks (

Background Infant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants’ first 2–3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines to include HIV DNA PCR testing at birth (pilot only), 6 weeks, 6 months, and 12 months postnatal and a final 18-month antibody test. The World Health Organization (WHO) approved point-of-care (POC) diagnostic platforms for infant HIV testing in resource-limited countries that could simplify logistics and expedite infant diagnosis. Sustainable scale-up and optimal utility in Kenya and other high-prevalence countries depend on robust implementation studies in diverse clinical settings. Methods We will pilot the implementation of birth testing by HIV DNA PCR, as well as two POC testing systems (Xpert HIV-1 Qual [Xpert] and Alere q HIV-1/2 Detect [Alere q]), on specimens collected from Kenyan infants at birth (0 to 2 weeks) and 6 weeks (4 to

UNSTRUCTURED Background: Despite progress to expand access to HIV testing and treatment during pregnancy in Kenya, gaps still remain in prevention of mother-to-child transmission of HIV (PMTCT) services. This study addresses the need for effective and scalable interventions to support women throughout the continuum of care for PMTCT services in low resource settings. Our research team has successfully implemented the HIV Infant Tracking System (HITSystem), a web-based, system-level intervention to improve early infant diagnosis (EID) outcomes. This study will expand the scope of the HITSystem to address PMTCT services to bridge the gap between maternal and pediatric HIV services and improve outcomes. This paper describes the intervention development protocol to adapt and pilot a HITSystem version 2.0 to assess acceptability, feasibility, and preliminary PMTCT outcomes in Kenya. Methods/design: This is a three-year intervention development study to adapt the current HITSystem intervention to support a range of PMTCT outcomes including: retention in care, ART adherence, hospital deliveries, and integration of maternal and pediatric HIV services in low-resource settings. The study will be conducted in three phases. Phase 1 will elicit feedback from intervention users (patients and providers) to guide development and refinement of the new PMTCT components and inform optimal implementation. In Phase 2, we will design and develop the HITSystem 2.0 features to support key PMTCT outcomes guided by clinical content experts and findings from Phase 1. Phase 3 will assess complete PMTCT retention (before, during, and after delivery) using a matched randomized pilot study design in two hospitals over 18-months. A total of n=108 HIV+ pregnant women (n=54 per site) will be enrolled and followed from their first PMTCT appointment until infant HIV DNA PCR testing at the target age of 6 weeks (< 7 weeks) postnatal. Discussion: This protocol will extend, adapt, and pilot a HITSystem 2.0 version to improve attendance of PMTCT appointments, increase ART adherence and hospital-based deliveries, and prompt early infant diagnosis by 6 weeks postnatal. The HITSystem 2.0 aims improve the integration of maternal and pediatric HIV services. Trial registration: ClinicalTrials.gov: NCT02726607. Registered on April 1, 2016.

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.

BackgroundLiterature suggests that electronic health (eHealth) interventions can improve the efficiency and accuracy of health service delivery and improve health outcomes and are generally well received by patients; however, there are limited data on provider experiences using eHealth interventions in resource-limited settings. The HIV Infant Tracking System (HITSystem) is an eHealth intervention designed to improve early infant diagnosis (EID) outcomes among HIV-exposed infants. ObjectiveWe aimed to compare provider experiences with standard EID and HITSystem implementation at 6 Kenyan hospitals and 3 laboratories. The objective of this study was to better understand provider experiences implementing and using the HITSystem in order to assess facilitators and barriers that may impact adoption and sustainability of this eHealth intervention. MethodsAs part of a randomized controlled trial to evaluate the HITSystem, we conducted semistructured interviews with 17 EID providers at participating intervention and control hospitals and laboratories. ResultsProviders emphasized the perceived usefulness of the HITSystem, including improved efficiency in sample tracking and patient follow-up, strengthened communication networks among key stakeholders, and improved capacity to meet patient needs compared to standard EID. These advantages were realized from an intervention that providers saw as easy to use and largely compatible with workflow. However, supply stock outs and patient psychosocial factors (including fear of HIV status disclosure and poverty) provided ongoing challenges to EID service provision. Furthermore, slow or sporadic internet access and heavy workload prevented real-time HITSystem data entry for some clinicians. ConclusionsProvider experiences with the HITSystem indicate that the usefulness of the HITSystem, along with the ease with which it is able to be incorporated into hospital workflows, contributes to its sustained adoption and use in Kenyan hospitals. To maximize implementation success, care should be taken in intervention design and implementation to ensure that end users see clear advantages to using the technology and to account for variations in workflows, patient populations, and resource levels by allowing flexibility to suit user needs. Trial RegistrationClinicalTrials.gov NCT02072603; https://clinicaltrials.gov/ct2/show/NCT02072603 (Archived by WebCite at http://www.webcitation.org/71NgMCrAm)

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.

BACKGROUND Literature suggests that electronic health (eHealth) interventions can improve the efficiency and accuracy of health service delivery and improve health outcomes and are generally well received by patients; however, there are limited data on provider experiences using eHealth interventions in resource-limited settings. The HIV Infant Tracking System (HITSystem) is an eHealth intervention designed to improve early infant diagnosis (EID) outcomes among HIV-exposed infants. OBJECTIVE We aimed to compare provider experiences with standard EID and HITSystem implementation at 6 Kenyan hospitals and 3 laboratories. The objective of this study was to better understand provider experiences implementing and using the HITSystem in order to assess facilitators and barriers that may impact adoption and sustainability of this eHealth intervention. METHODS As part of a randomized controlled trial to evaluate the HITSystem, we conducted semistructured interviews with 17 EID providers at participating intervention and control hospitals and laboratories. RESULTS Providers emphasized the perceived usefulness of the HITSystem, including improved efficiency in sample tracking and patient follow-up, strengthened communication networks among key stakeholders, and improved capacity to meet patient needs compared to standard EID. These advantages were realized from an intervention that providers saw as easy to use and largely compatible with workflow. However, supply stock outs and patient psychosocial factors (including fear of HIV status disclosure and poverty) provided ongoing challenges to EID service provision. Furthermore, slow or sporadic internet access and heavy workload prevented real-time HITSystem data entry for some clinicians. CONCLUSIONS Provider experiences with the HITSystem indicate that the usefulness of the HITSystem, along with the ease with which it is able to be incorporated into hospital workflows, contributes to its sustained adoption and use in Kenyan hospitals. To maximize implementation success, care should be taken in intervention design and implementation to ensure that end users see clear advantages to using the technology and to account for variations in workflows, patient populations, and resource levels by allowing flexibility to suit user needs. CLINICALTRIAL ClinicalTrials.gov NCT02072603; https://clinicaltrials.gov/ct2/show/NCT02072603 (Archived by WebCite at http://www.webcitation.org/71NgMCrAm)

BackgroundAt-birth and point-of-care (POC) HIV testing are emerging strategies to streamline infant HIV diagnosis and expedite ART initiation for HIV-positive infants. The purpose of this qualitative study was to evaluate factors influencing the provision and acceptance of at-birth POC testing among both HIV care providers and parents of HIV-exposed infants in Kenya.MethodsWe conducted semi-structured interviews with 26 HIV care providers and 35 parents of HIV-exposed infants (including 23 mothers, 6 fathers, and 3 mother-father pairs) at four study hospitals prior to POC implementation. An overview of best available evidence related to POC was presented to participants prior to each interview. Interviews probed about standard EID services, perceived benefits and risk of at-birth and POC testing, and suggested logistics of providing at-birth and POC. Interviews were audio recorded, translated (if necessary), and transcribed verbatim. Using the Transdisciplinary Model of Evidence Based Practice to guide analysis, transcripts were coded based on a priori themes related to environmental context, patient characteristics, and resources.ResultsMost providers (24/26) and parents (30/35) held favorable attitudes towards at-birth POC testing. The potential for earlier results to improve infant care and reduce parental anxiety drove preferences for at-birth POC testing. Parents with unfavorable views towards at-birth POC testing preferred standard testing at 6 weeks so that mothers could heal after birth and have time to bond with their newborn before-possibly-learning that their child was HIV-positive. Providers identified lack of resources (shortage of staff, expertise, and space) as a barrier.DiscussionWhile overall acceptability of at-birth POC testing among HIV care providers and parents of HIV-exposed infants may facilitate uptake, barriers remain. Applying a task-shifting approach to implementation and ensuring providers receive training on at-birth POC testing may mitigate provider-related challenges. Comprehensive counseling throughout the antenatal and postpartum periods may mitigate patient-related challenges.

Objective A biomarker with increased specificity for cervical dysplasia compared with human papillomavirus (HPV) testing would be an attractive option for cervical cancer screening among HIV-infected women in resource-limited settings. p16INK4a has been explored as a biomarker for screening in general populations. Design A 2-year cross-sectional study. Setting 2 large HIV primary care clinics in western Kenya. Participants 1054 HIV-infected women in western Kenya undergoing cervical cancer screening as part of routine HIV care from October 2010 to November 2012. Interventions Participants underwent p16INK4a specimen collection and colposcopy. Lesions with unsatisfactory colposcopy or suspicious for cervical intraepithelial neoplasia 2+ (CIN2+; including CIN2/3 or invasive cervical cancer) were biopsied. Following biopsy, disease status was determined by histopathological diagnosis. Primary and secondary outcome measures We measured the sensitivity, specificity and predictive values of p16INK4a ELISA for CIN2+ detection among HIV-infected women and compared them to the test characteristics of current screening methods used in general as well as HIV-infected populations. Results Average p16INK4a concentration in cervical samples was 37.4 U/mL. After colposcopically directed biopsy, 127 (12%) women were determined to have CIN2+. Receiver operating characteristic analysis showed an area under the curve of 0.664 for p16INK4a to detect biopsy-proven CIN2+. At a p16INK4a cut-off level of 9 U/mL, sensitivity, specificity, positive and negative predictive values were 89.0%, 22.9%, 13.6% and 93.8%, respectively. The overall p16INK4a positivity at a cut-off level of 9 U/mL was 828 (78.6%) women. There were 325 (30.8%) cases of correct p16INK4a prediction to detect or rule out CIN2+, and 729 (69.2%) cases of incorrect p16INK4a prediction. Conclusions p16INK4a ELISA did not perform well as a screening test for CIN2+ detection among HIV-infected women due to low specificity. Our study contributes to the ongoing search for a more specific alternative to HPV testing for CIN2+ detection.

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.

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.

INTRODUCTION HIV-infected women may have higher rates of recurrent cervical precancer after treatment. Knowledge about rates and predictors of recurrence could impact guidelines and program planning, especially in low-resource settings. METHODS In this prospective cohort study in Western Kenya, we followed HIV-infected women at 6 and 12 months after treatment for cervical intraepithelial neoplasia 2 or greater (CIN2+) after treatment with loop electrosurgical excision procedure (LEEP). All women underwent follow-up colposcopy with biopsy as indicated for the diagnosis of CIN2+. We calculated the incidence and predictors of primary disease recurrence after treatment. RESULTS Among the 284 women who underwent LEEP and had at least 1 follow-up visit, there were 37 (13%) cases of CIN2+ detected by 12-month follow-up. Four (10.8%) of the recurrences were invasive cancer, all stage IA1. The 6- and 12-month rates of recurrence were 13.7 and 12.8 cases per 100 person-years of follow-up, respectively. Antiretroviral therapy use did not significantly impact the rate of recurrence (hazard ratio: 1.24, 95% confidence interval: 0.59 to 2.79). The only significant predictor of recurrence in the multivariate analysis was CD4(+) nadir

Visual inspection with Acetic Acid (VIA) and Visual Inspection with Lugol’s Iodine (VILI) are increasingly recommended in various cervical cancer screening protocols in low-resource settings. Although VIA is more widely used, VILI has been advocated as an easier and more specific screening test. VILI has not been well-validated as a stand-alone screening test, compared to VIA or validated for use in HIV-infected women. We carried out a randomized clinical trial to compare the diagnostic accuracy of VIA and VILI among HIV-infected women. Women attending the Family AIDS Care and Education Services (FACES) clinic in western Kenya were enrolled and randomized to undergo either VIA or VILI with colposcopy. Lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Between October 2011 and June 2012, 654 were randomized to undergo VIA or VILI. The test positivity rates were 26.2% for VIA and 30.6% for VILI (p = 0.22). The rate of detection of CIN2+ was 7.7% in the VIA arm and 11.5% in the VILI arm (p = 0.10). There was no significant difference in the diagnostic performance of VIA and VILI for the detection of CIN2+. Sensitivity and specificity were 84.0% and 78.6%, respectively, for VIA and 84.2% and 76.4% for VILI. The positive and negative predictive values were 24.7% and 98.3% for VIA, and 31.7% and 97.4% for VILI. Among women with CD4+ count < 350, VILI had a significantly decreased specificity (66.2%) compared to VIA in the same group (83.9%, p = 0.02) and compared to VILI performed among women with CD4+ count ≥ 350 (79.7%, p = 0.02). VIA and VILI had similar diagnostic accuracy and rates of CIN2+ detection among HIV-infected women. Trial Registration ClinicalTrials.gov NCT02237326

Introduction : HIV and cervical cancer are intersecting epidemics that disproportionately affect one of the most vulnerable populations in the world: women in low- and middle-income countries (LMICs). Historically, the disparity in cervical cancer risk for women in LMICs has been due to the lack of organized screening and prevention programmes. In recent years, this risk has been augmented by the severity of the HIV epidemic in LMICs. HIV-positive women are at increased risk for developing cervical precancer and cancer, and while the introduction of antiretroviral therapy has dramatically improved life expectancies among HIV-positive women it has not been shown to improve cancer-related outcomes. Therefore, an increasing number of HIV-positive women are living in LMICs with limited or no access to cervical cancer screening programmes. In this commentary, we describe the gaps in cervical cancer prevention, the state of evidence for integrating cervical cancer prevention into HIV programmes and future directions for programme implementation and research. Discussion : Despite the biologic, behavioural and demographic overlap between HIV and cervical cancer, cervical cancer prevention has for the most part been left out of sexual and reproductive health (SRH) services for HIV-positive women. Lower cost primary and secondary prevention strategies for cervical cancer are becoming more widely available in LMICs, with increasing evidence for their efficacy and cost-effectiveness. Going forward, cervical cancer prevention must be considered a part of the essential package of SRH services for HIV-positive women. Effective cervical cancer prevention programmes will require a coordinated response from international policymakers and funders, national governments and community leaders. Leveraging the improvements in healthcare infrastructure created by the response to the global HIV epidemic through integration of services may be an effective way to make an impact to prevent cervical cancer among HIV-positive women, but more work remains to determine optimal approaches. Conclusions : Cervical cancer prevention is an essential part of comprehensive HIV care. In order to ensure maximal impact and cost-effectiveness, implementation strategies for screening programmes must be adapted and rigorously evaluated through a framework that includes equal participation with policymakers, programme planners and key stakeholders in the target communities. Keywords: cervical cancer prevention; HIV; integration; low- and middle-income countries. (Published: 1 December 2015) Citation: Huchko MJ et al. Journal of the International AIDS Society 2015, 18(Suppl 5) :20282 http://www.jiasociety.org/index.php/jias/article/view/20282 | http://dx.doi.org/10.7448/IAS.18.6.20282

Abstract 42 Background: Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), and cytology-based programs are not feasible for use in these settings. This has prompted a search for alternative cervical-cancer screening or surveillance methods that can be adopted in LMICs to address the high disease burden. In this study, we seek to evaluate the performance and reliability of cervical p16INK4a biomarker as measured by an ELISA assay among a group of HIV-positive women in a low-resource setting who had normal screening results by gold standard at baseline and at 12-month follow-up. Methods: This prospective study took place at the Family AIDS Care and Education Services (FACES) clinic in Kisumu, Kenya. Participants underwent cervical cancer screening using VIA, colposcopy and collection of cervical HPV p16INK4a samples. Women with negative colposcopies were rescreened at 12-months, and cervical p16INK4a samples were collected. Among women with negative colposcopies at both baseline and follow-up, we investigated the reproducibility of p16INK4a biomarker levels within the same woman between the two visits. Biomarker levels were determined using an ELISA-based biochemical assay. We compared median p16INK4a levels between baseline and follow-up using the paired t-test. We also examined correlation using correlation coefficients and a Bland-Atman plot of differences versus average. A multivariate regression model was fit to identify demographic and clinical variables associated with absolute change in p16INK4a levels. Results: Among the ninety-three women who had normal cervical exams, mean p16INK4a levels increased significantly between baseline and follow-up period, at 20.2 U/ml vs 30.1 U/ml (pConclusion: Our results suggest that there is variability in levels of p16INK4a biomarker as measured by ELISA in HIV-positive women in low-resource settings with normal screening as determined by colposcopy over a 12-month follow-up period. Biomarker levels varied significantly more among older women and those who were HPV positive at baseline, despite normal cervical exams. These data suggest that elevations in p16INK4a biomarker levels may not be a reliable marker of dysplasia in this group of women. Further research in this population as well as replication of these results will be important. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: Chemtai Mungo No relationship to disclose Carol Conell No relationship to disclose May Maloba No relationship to disclose Elizabeth Bukusi No relationship to disclose Craig Cohen Consulting or Advisory Role: Symbiomix Inc. Megan Huchko No relationship to disclose