ABSTRACT
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 82â230 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 31â189 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.
Subject(s)
Cost-Effectiveness Analysis , HIV Infections , Child , Infant , Humans , Kenya , Africa, Eastern , Early Diagnosis , HIV Infections/diagnosis , HIV Infections/drug therapy , Cost-Benefit AnalysisABSTRACT
BACKGROUND: At-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. METHODS: We 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. RESULTS: Out 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. CONCLUSION: Despite 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 REGISTRATION: ClinicalTrials.gov, NCT03435887 . Retrospectively registered on 19 February 2020.
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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.
Subject(s)
HIV Infections , Text Messaging , Female , HIV Infections/prevention & control , Humans , Infectious Disease Transmission, Vertical/prevention & control , Kenya , Male , Postpartum Period , Reminder SystemsABSTRACT
BACKGROUND: In Kenya, standard early infant diagnosis (EID) with polymerase chain reaction (PCR) testing at 6-week postnatal achieves early treatment initiation (<12 weeks) in <20% of HIV+ infants. Kenya's new early infant diagnosis guidelines tentatively proposed adding PCR testing at birth, pending results from pilot studies. METHODS: We piloted birth testing at 4 Kenyan hospitals between November 2017 and November 2018. Eligible HIV-exposed infants were offered both point-of-care and PCR HIV testing at birth (window 0 to <4 weeks) and 6 weeks (window 4-12 weeks). We report the: proportion of infants tested at birth, 6-week, and both birth and 6-week testing; median infant age at results; seropositivity and antiretroviral therapy initiation. RESULTS: Final sample included 624 mother-infant pairs. Mean maternal age was 30.4 years, 73.2% enrolled during antenatal care and 89.9% had hospital deliveries. Among the 590 mother-infants pairs enrolled before 4 weeks postnatal, 452 (76.6%) completed birth testing before 4 weeks, with 360 (79.6%) testing within 2 weeks, and 178 (39.4%) before hospital discharge (0-2 days). Mothers were notified of birth PCR results at a median infant age of 5.4 weeks. Among all 624 enrolled infants, 575 (92.1%) were tested during the 6-week window; 417 (66.8%) received testing at both birth and 6-weeks; and 207 received incomplete testing (93.3% only 1 PCR and 6.7% no PCR). Four infants were diagnosed with HIV, and 3 infants were initiated on antiretroviral therapy early, before 12 weeks of age. CONCLUSIONS: Uptake of PCR testing at birth was high and a majority of infants received repeat testing at 6 weeks of age.
Subject(s)
HIV Infections/diagnosis , HIV Testing/methods , Infant, Newborn, Diseases/diagnosis , Adult , Early Diagnosis , Feasibility Studies , Female , HIV Infections/prevention & control , HIV Infections/transmission , Humans , Infant , Infant, Newborn , Infectious Disease Transmission, Vertical/prevention & control , Kenya/epidemiology , Pilot Projects , Point-of-Care Systems , Polymerase Chain Reaction , PregnancyABSTRACT
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).
Subject(s)
HIV Infections , Pregnancy Complications, Infectious , Child , Female , HIV Infections/prevention & control , Humans , Infant , Infectious Disease Transmission, Vertical/prevention & control , Kenya/epidemiology , Pilot Projects , Pregnancy , Pregnancy Complications, Infectious/prevention & controlABSTRACT
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.
Subject(s)
Antiretroviral Therapy, Highly Active/methods , HIV Infections/drug therapy , HIV/drug effects , HIV/genetics , Point-of-Care Testing/statistics & numerical data , Polymerase Chain Reaction/statistics & numerical data , Early Diagnosis , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Infections/virology , Humans , Infant , Infant, Newborn , Kenya , Male , Pilot Projects , Polymerase Chain Reaction/methodsABSTRACT
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.
Subject(s)
HIV Infections , Pregnancy Complications, Infectious , Child , Female , HIV Infections/prevention & control , Humans , Infectious Disease Transmission, Vertical/prevention & control , Kenya , Male , Motivation , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Sexual Partners , Social SupportABSTRACT
BACKGROUND: Testing 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. METHODS: Four 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). RESULTS: Of 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. DISCUSSION: At 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.
Subject(s)
Early Diagnosis , HIV Infections/diagnosis , HIV-1/isolation & purification , Point-of-Care Testing , Feasibility Studies , Female , HIV Infections/pathology , HIV Infections/virology , HIV Testing/methods , HIV-1/pathogenicity , Humans , Infant , Infant, Newborn , Kenya/epidemiology , Male , Polymerase Chain Reaction/methods , PregnancyABSTRACT
BACKGROUND: Early infant diagnosis (EID) establishes the presence of HIV infection in HIV-exposed infants and children younger than 18 months of age. EID services are hospital-based, and thus fail to capture HIV-exposed infants who are not brought to the hospital for care. Point-of-care (POC) diagnostic systems deployed in the community could increase the proportion tested and linked to treatment, but little feasibility and acceptability data is available. METHODS: Semi-structured interviews (n = 74) were conducted by a Kenyan team with community members (Community Health Workers/Volunteers [CHW/CHV], Traditional Birth Attendants [TBAs], community leaders) and parents of HIV-exposed infants at four study sites in Kenya to elicit feedback on the acceptability and feasibility of community-based POC HIV testing. RESULTS: Participants described existing community health resources that could be leveraged to support integration of community-based POC HIV testing; however, the added demand placed on CHW/CHV could pose a challenge. Participants indicated that other potential barriers (concerns about confidentiality, disclosure, and HIV stigma) could be overcome with strong engagement from trusted community leaders and health providers, community sensitization, and strategic location and timing of testing. These steps were seen to improve acceptability and maximize the recognized benefits (rapid results, improved reach) of community-based testing. CONCLUSION: Community members felt that with strategic planning and engagement, community-based POC HIV testing could be a feasible and acceptable strategy to overcome the existing barriers of hospital-based EID.
Subject(s)
HIV Infections/diagnosis , HIV/isolation & purification , Health Plan Implementation , Infectious Disease Transmission, Vertical/prevention & control , Point-of-Care Systems/organization & administration , Point-of-Care Testing/statistics & numerical data , Social Support , Early Diagnosis , Female , HIV Infections/epidemiology , Humans , Infant , Kenya/epidemiology , Male , Parents , Postnatal CareABSTRACT
BACKGROUND: Kenya's guidelines for prevention of mother-to-child transmission of HIV (PMTCT) recommend routine viral load (VL) monitoring for pregnant and breastfeeding women. METHOD: We assessed PMTCT VL monitoring and clinical action occurring between last menstrual period (LMP) and 6 months postpartum at 4 Kenyan government hospitals. Pregnant women enrolled in the HIV Infant Tracking System from May 2016-March 2018 were included. We computed proportions who received VL testing within recommended timeframes and who received clinical action after unsuppressed VL result. RESULTS: Of 424 participants, any VL testing was documented for 305 (72%) women and repeat VL testing was documented for 79 (19%). Only 115 women (27%) received a guideline-adherent baseline VL test and 27 (6%) received a guideline-adherent baseline and repeat VL test sequence. Return of baseline and repeat VL test results to the facility was high (average 96%), but patient notification of VL results was low (36% baseline and 49% repeat). Clinical action for unsuppressed VL results was even lower: 11 of 38 (29%) unsuppressed baseline results and 2 of 14 (14%) unsuppressed repeat results triggered clinical action. DISCUSSION: Guideline-adherent VL testing and clinical intervention during PMTCT must be prioritized to improve maternal care and reduce the risk of HIV transmission to infants.
Subject(s)
HIV/physiology , Hospitals/statistics & numerical data , Infectious Disease Transmission, Vertical/prevention & control , Mothers , Viral Load , Adult , Anti-HIV Agents/pharmacology , Female , HIV/drug effects , Humans , Infant , PregnancyABSTRACT
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.
Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/prevention & control , Infectious Disease Transmission, Vertical/statistics & numerical data , Adult , Early Diagnosis , Female , HIV Infections/epidemiology , HIV Infections/transmission , Hospitals , Humans , Infant , Infant, Newborn , Infectious Disease Transmission, Vertical/prevention & control , Kenya , Male , Retrospective Studies , Young AdultABSTRACT
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.
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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.
Subject(s)
HIV Infections/mortality , Infant Mortality , Anti-Retroviral Agents/therapeutic use , Antiretroviral Therapy, Highly Active , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , HIV Infections/transmission , Humans , Infant , Infant, Newborn , Infectious Disease Transmission, Vertical , Kenya/epidemiology , Male , Odds Ratio , Pregnancy , Public Health Surveillance , Retrospective StudiesABSTRACT
BACKGROUND: At-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. METHODS: We 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. RESULTS: Most 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. DISCUSSION: While 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.
Subject(s)
HIV Infections/diagnosis , Health Personnel/psychology , Parents/psychology , Adult , Attitude , Decision Making , Female , Humans , Infant Care , Infant, Newborn , Interviews as Topic , Kenya , Male , Parturition , Point-of-Care Systems , Pregnancy , Qualitative ResearchABSTRACT
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.
Subject(s)
HIV Infections/prevention & control , HIV Infections/transmission , Infectious Disease Transmission, Vertical/statistics & numerical data , Lost to Follow-Up , Mothers/statistics & numerical data , Pregnancy Complications, Infectious/drug therapy , Adult , Anti-Retroviral Agents/therapeutic use , Early Diagnosis , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , Health Services Accessibility , Hospitals, Urban , Humans , Infant , Infant, Newborn , Interviews as Topic , Kenya/epidemiology , Male , Mothers/psychology , Postnatal Care , Pregnancy , Qualitative Research , Social Support , Surveys and Questionnaires , Truth DisclosureABSTRACT
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.
Subject(s)
HIV Infections/diagnosis , Mothers/psychology , Patient Acceptance of Health Care , Personal Satisfaction , Text Messaging , Adult , Cell Phone , Early Diagnosis , Female , Humans , Infant , Infant, Newborn , Interviews as Topic , Kenya , Male , Qualitative Research , TelemedicineABSTRACT
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 (<7 weeks) postnatal. RESULTS: Funding for this study was received in August 2015, enrollment in Phase 1 began in March 2016, and completion of data collection is expected by May 2019. CONCLUSIONS: This protocol will extend, adapt, and pilot an HITSystem 2.0 version to improve attendance of PMTCT appointments, increase ART adherence and hospital-based deliveries, and prompt EID by 6 weeks postnatal. The HITSystem 2.0 aims to improve the integration of maternal and pediatric HIV services. TRIAL REGISTRATION: ClinicalTrials.gov NCT02726607; https://clinicaltrials.gov/ct2/show/NCT02726607 (Archived by WebCite at http://www.webcitation.org/78VraLrOb). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13268.
ABSTRACT
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 < 24 weeks) postnatal. The formative phase will inform optimal implementation of birth testing and two POC testing technologies. Qualitative interviews with stakeholders (providers, parents of HIV-exposed infants, and community members) will assess attitudes, barriers, and recommendations to optimize implementation at their respective sites. A non-blinded pilot study at four Kenyan hospitals (n = 2 Xpert, n = 2 Alere q platforms) will evaluate infant HIV POC testing compared with standard of care HIV DNA PCR testing in both the birth and 6-week windows. Objectives of the pilot are to assess uptake, efficiency, quality, implementation variables, user experiences of birth testing with both POC testing systems or with HIV DNA PCR, and costs. DISCUSSION: This study will generate data on the clinical impact and feasibility of adding HIV testing at birth utilizing POC and traditional PCR HIV testing strategies in resource-limited settings. Data from this pilot will inform the optimal implementation of Kenya's birth testing guidelines and of POC testing systems for the improvement of EID outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03435887. Registered 26 February 2018.
ABSTRACT
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.
Subject(s)
Anti-Retroviral Agents/administration & dosage , Early Diagnosis , HIV Infections/diagnosis , Health Personnel , Mass Screening/methods , Point-of-Care Systems/organization & administration , Point-of-Care Testing , Adult , Female , HIV Infections/drug therapy , HIV Infections/prevention & control , Humans , Infant, Newborn , Kenya , Male , Middle Aged , Serologic TestsABSTRACT
BACKGROUND: 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. METHODS: 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. FINDINGS: 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; p<0·0001). 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; p<0·0001). No adverse events related to study participation were reported. INTERPRETATION: 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. FUNDING: National Institute of Child Health and Human Development.