Optimizing HIV case identification among children and understanding remaining gaps in pediatric HIV testing in Kinshasa, DRC.

BACKGROUND: It is critical to identify children living with HIV and initiate lifesaving antiretroviral treatment (ART) early. The Pediatric Accelerated Case Finding Effort focused on contact elicitation and HIV testing of ART clients' biological children. We describe HIV testing and seropositivity rates following the initiative and gaps along the index testing cascade to inform pediatric HIV case finding optimization. METHODS: This mixed-methods study involved collecting monthly data on index testing outcomes, including elicitation (identifying biological children < 15 years), HIV testing and linkage to treatment from March 2020 to July 2021 in 35 facilities in Kinshasa. Data were summarized and presented for the first month (as a baseline proxy) and the entire study period. Qualitative data were collected from 14 healthcare workers participating in in-depth interviews and 33 community health workers in four focus group discussions. Audio recordings were transcribed and translated from Lingala or French into English and coded using MAXQDA software. Data were thematically analyzed according pediatric case finding barriers and strategies. RESULTS: At baseline (March 2020), among 3337 eligible female index clients, 1634 (49.0%) underwent elicitation to identify children with unknown HIV status. By July 2021, all eligible clients (n = 11,734) had contacts identified. Of the contacts, 9871/11,848 (83.3%) were HIV-tested. Of contacts tested, 662 (6.7%) were diagnosed as HIV-positive, with 535 (80.8%) age 5-14 years; 99.5% initiated treatment. Providers attributed gaps in HIV testing primarily to testing refusals for children due to non-disclosure among parents and logistical or financial obstacles to transportation for tracing. COVID-19 movement restrictions and exposure fears also limited provider interactions for testing. Provider-implemented strategies included transport reimbursement, extensive counseling and alternative approaches to child testing for parents in sero-discordant relationships. CONCLUSIONS: Following intensified efforts around pediatric case finding, we found a high HIV positivity yield of 6.7% among previously undiagnosed children, with 81% of them aged ≥5 years. While elicitation improved over time, contact tracing for HIV testing remained the largest gap, missing opportunities to reach 17% of undiagnosed children. Ensuring adequate resources for tracing and HIV testing and supporting disclosure among couples, while emphasizing elicitation of ART clients' biological children can help to optimize pediatric case finding.

Clients' and providers' perspectives in informing a digital health intervention to improve linkage to care after Index HIV self-testing in Hai and Moshi Districts, Tanzania.

BACKGROUND: Digital health interventions have the potential to improve linkage to care after HIV self-testing (HIVST). This study aimed to understand clients' and providers' perceptions of benefits, and barriers of a digital health intervention designed to improve linkage to care after HIV self-testing in Tanzania. METHODS: This exploratory qualitative research study was conducted in Hai and Moshi, districts in Kilimanjaro region, Tanzania. Four health facilities were selected based on their involvement in an HIVST pilot program implemented by Elizabeth Glassier Pediatric AIDS Foundation (EGPAF) Tanzania through the USAID funded program. The study included female index clients and their partners, and healthcare providers at the healthcare facilities. We used a semi-structured interview guide with open-ended questions for data collection. Data collection was conducted from 16th January 2023 to 3rd February 2023. Thematic analysis of the qualitative data was conducted, guided by the Health Belief Model (HBM), and results were developed in collaboration with the community partners. RESULTS: A total of 42 participants were included in the study, comprising 9 male clients, 17 female index clients, and 16 health care workers (HCWs) (4 male and 12 female) who were involved in delivering HIVST services. The study's findings revealed mixed feelings about the use of a digital health intervention. Majority of participants perceived digital health as a valuable intervention for enhancing linkage to care, improved health outcomes, improved communication with healthcare workers, and increased privacy. Therefore, they supported scale-up of a digital health intervention. Participants also expressed that the potential benefits of a digital health intervention include the convenience of accessing healthcare services from the comfort of their homes or any location. However, a few participants expressed concerns about potential risks associated with sending health-related text messages. They feared that recipients might not be in a safe space, leading to stigma and avoidance of engagement. A few female participants expressed concerns about confidentiality breaches, particularly regarding shared phones with family or friends. Fear of being judged or misunderstood by others could deter them from reading or acting upon these messages. Most participants recommended tailored strategies that prioritize confidentiality and trust. Recognizing these psychological aspects is vital for customizing digital health interventions to effectively address participants' concerns. CONCLUSIONS: Digital health interventions may improve the linkage of HIV self-testers to care. Recommendations include personalized and culturally relevant communication and technical accessibility to make interventions effective and inclusive. This study provides valuable insights for designing patient-centered interventions for HIV care and treatment.

Effectiveness of an integrated multilevel early child development intervention on caregiver knowledge and behavior: a quasi-experimental evaluation of the Malezi program in Tanzania.

BACKGROUND: The quality of caregiving and the parent-child relationship is critical for early child development (ECD) and has been shown to be modifiable. This study evaluated an ECD project in Tanzania, assessing the effectiveness of radio messaging (RM) alone and a combined radio messaging/video job aids/ECD (RMV-ECD) intervention. METHODS: This two-arm pre-post evaluation study enrolled a cohort of caregivers of children 0-24 months in four districts of Tabora region, following them for 9 months. ECD radio messages were broadcast on popular stations at least 10 times/day reaching all study districts. In two districts, community health workers (CHW), trained in UNICEF's Care for Child Development package, used ECD videos in home- and facility-based sessions with caregivers. We used McNemar's testing (pre-post pairs) within intervention group to describe how the intervention was associated with change in five outcomes: ECD knowledge, early stimulation, father engagement, responsive care, and environment safety. Logistic regression was used to describe the relative benefits of the combined intervention package (RMV-ECD) compared to radio messaging (RM). RESULTS: In the RMV-ECD arm, all outcomes at endline except environment safety significantly improved after the intervention with the largest change seen in ECD knowledge (35.8% increase, p < .0001) and the smallest in father engagement (6.7%, p = .015). In the RM arm, ECD knowledge (5.7%, p = .031) and environment safety (18.1%, p = <.0001) improved. High measures of parenting stress were associated with lower likelihood of having good ECD knowledge (AOR 0.50, 95%CI: 0.35, 0.71), father engagement (AOR 0.72, 95%CI: 0.52, 0.99) and responsive care (AOR 0.31, 95%CI: 0.18, 0.54). CONCLUSIONS: An intervention that includes mass media, educational video content and CHWs who counsel caregivers in their homes and health facilities was associated with significant improvements in ECD parenting knowledge and behaviors but a relationship with responsive care could not be established. The less costly mass media-only intervention was associated with improved parenting knowledge and household environment safety. Parenting interventions targeting young children could be improved by incorporating more messaging and caregiver coaching in managing parental stress. TRIAL REGISTRATION: NCT05244161 (17/02/2022); retrospectively registered with the US National Institutes of Health ClinicalTrials.gov.

Adherence challenges and opportunities for optimizing care through enhanced adherence counseling for adolescents with suspected HIV treatment failure in Kenya.

BACKGROUND: Adolescents living with HIV (ALHIV) experience higher mortality and are more likely to have poor antiretroviral therapy (ART) adherence and unsuppressed viral load (VL) compared to adults. Enhanced adherence counseling (EAC) is a client-centered counseling strategy that aims to identify and address barriers to optimal ART use and can be tailored to the unique needs of adolescents. This study aimed to better understand adherence barriers among ALHIV with suspected treatment failure and their experience with EAC to inform future programming. METHODS: A qualitative study was conducted in Homa Bay and Turkana counties, Kenya in 2019 with adolescents and caregivers of children and adolescents living with HIV with suspected treatment failure after ≥6 months on ART and who had received ≥1 EAC sessions. Sixteen focus group discussions (FGDs) were conducted; five FGDs each were held with adolescents 12-14 years (n = 48) and 15-19 years (n = 36). Caregivers (n = 52) participated in six FGDs. Additionally, 17 healthcare workers providing pediatric/adolescent HIV services participated in in-depth interviews. Audio recordings were transcribed and translated from Kiswahili or Dholuo into English and coded using MAXQDA software. Data were thematically analyzed by participant group. RESULTS: Participants identified adolescents' fear of being stigmatized due to their HIV status and their relationship with and level of support provided by caregivers. This underpinned and often undermined adolescents' ART-taking behavior and progress towards more independent medication management. Adolescents were generally satisfied with EAC and perceived it to be important in improving adherence and reducing VL. However, problems were noted with facility-based, individual EAC counseling, including judgmental attitudes of providers and difficulties traveling to and keeping EAC clinic appointments. Participant-suggested improvements to EAC included peer support groups in addition to individual counseling, allowing for greater flexibility in the timing and location of sessions and greater caregiver involvement. CONCLUSIONS: The findings provide opportunities to better tailor EAC interventions to promote improved ALHIV adherence and caregiver-supported disease management. Multi-prong EAC interventions that include peer-led and community approaches and target adolescent and caregiver treatment literacy may improve EAC delivery, address issues contributing to poor adherence, and position adolescents to achieve viral suppression. TRIAL REGISTRATION: ClinicalTrials.gov : NCT04915469.

Addressing Early Retention in Antenatal Care Among HIV-Positive Women Through a Simple Intervention in Kinshasa, DRC: The Elombe "Champion" Standard Operating Procedure.

This cluster-randomized study aimed to assess the Elombe ("Champion") standard operating procedure (SOP), implemented by providers and Mentor Mothers, on HIV-positive pregnant women's retention between first and second antenatal visits. Sixteen facilities in Kinshasa were randomly assigned to intervention (SOP) or comparison (no SOP). Effect of the SOP was estimated using relative risk. Women in comparison facilities were more likely to miss second visits (RR 2.5, 95% CI 1.05-5.98) than women in intervention facilities (30.0%, n = 27 vs. 12.0%, n = 9, p < 0.002). Findings demonstrate that a simple intervention can reduce critical early loss to care in PMTCT programs providing universal, lifelong treatment.

Mother-to-Child Transmission of HIV and HIV-Free Survival in Swaziland: A Community-Based Household Survey.

In Swaziland, no data are available on the rates of HIV infection and HIV-free survival among children at the end of the breastfeeding period. We performed a national crosssectional community survey of children born 18-24 months prior to the study, in randomly selected constituencies in all 4 administrative regions of Swaziland, from April to June 2015. Mother-to-child transmission (MTCT) of HIV and HIV-free survival rates were calculated for all HIV-exposed children. The overall HIV-free survival rate at 18-24 months was 95.9% (95% CI 94.1-97.2). The estimated proportion of HIV infected children among known HIV-exposed children was 3.6% (95% CI 2.4-5.2). Older maternal age, delivering at a health facility, and receiving antenatal antiretroviral drugs were independently associated with reduced risk for child infection or death. The Swaziland program for prevention of MTCT achieved high HIV-free survival (95.9%) and low MTCT (3.6%) rates at 18-24 months of age when Option A (infant prophylaxis) of the WHO 2010 guidelines was implemented.

"The co-authors of pregnancy": leveraging men's sense of responsibility and other factors for male involvement in antenatal services in Kinshasa, DRC.

BACKGROUND: Despite efforts to improve male involvement (MI), few male partners typically attend antenatal care (ANC). MI in ANC and interventions to prevent mother-to-child HIV transmission have been demonstrated to be beneficial for the HIV-positive mother and her child. This study aimed to explore factors influencing partner attendance and highlight interventions with potential to improve MI within a Congolese context. METHODS: This was an exploratory, qualitative study conducted in two urban and two semi-urban catchment areas of Kinshasa, DRC in June-September 2016. Two women-only and two men-only focus group discussions (FGDs) were held; participants were recruited from ANC clinics and surrounding communities. Key informants purposively selected from health facility leadership and central government were also interviewed. Guide topics included MI barriers and facilitators, experiences with couples' ANC attendance and perceptions of MI interventions and how to improve them. Data from FGDs and interviews were analyzed to determine three interventions that best addressed the identified MI facilitators and barriers. These interventions were explored further through dialogues held with representatives from community organizations. RESULTS: This study included 17 female and 18 male FGD participants, 3 key informants and 21 community dialogue participants. Receipt of clinic staff advice was the most commonly-reported factor facilitating male attendance. No time off work was the most commonly-reported barrier. Only men identified responsibility, referring to themselves as "authors of the pregnancy," and wanting to be tested for HIV as facilitators. The most promising interventions perceived by FGD and interview participants were male partner invitation letters, couple- and male-friendly improvements to ANC, and expert peer-to-peer outreach. Community dialogue participants provided further detail on these approaches, such as invitation letter content and counseling messages targeting men attending ANC. CONCLUSIONS: Common themes regarding male involvement in ANC that emerged from this study included men's need to understand how the pregnancy is progressing and how best to care for their female partners and unborn children, and ANC settings that were misaligned to the needs of men and couples. Interventions at the individual, facility and community levels were discussed that could result in improvements to male attendance at pregnancy-related services.

Consistency of Multi-Month Antiretroviral Therapy Dispensing and Association with Viral Load Coverage among Pediatric Clients Living with HIV in Mozambique.

With the increase in uptake of multi-month antiretroviral therapy dispensing (MMD) for children, little is known about consistency of MMD receipt over time and its association with virological outcomes. This analysis aims to assess the uptake of 3-month MMD among children, consistent receipt of MMD after uptake, and clinical outcomes following transition to MMD in 16 health facilities in Gaza and Inhambane Provinces. This is a secondary analysis involving children <15 years living with HIV with clinical visits during the period from September 2019 to August 2020. Of 4383 children, 82% ever received MMD (at least one pickup of a 3-month MMD supply) during the study period but only 40% received it consistently (defined as MMD at every visit during the study period). Consistent MMD was most common among older children and children without indications of clinical instability. Overall viral load (VL) coverage was 40% (733/1851). Consistent MMD was significantly associated with lower odds of having a VL (0.78, 95% CI: 0.64-0.95). In conclusion, while receipt of a multi-month supply was common particularly during the early days of the COVID-19 pandemic, only a minority of children received consistent MMD; however, there is a need to ensure children with fewer visits still receive timely VL monitoring.

The rollout of paediatric dolutegravir and virological outcomes among children living with HIV in Mozambique.

Background: In 2022, Mozambique introduced Dolutegravir 10mg (pDTG), as part of paediatric antiretroviral therapy for children weighing < 20 kg. Understanding real-world challenges during national rollout can strengthen health systems in resource-limited settings. Objectives: We described the transition rate to, and new initiation of, pDTG, viral load suppression (VLS) post-pDTG, and factors associated with VLS among children living with HIV. Method: We conducted a retrospective cohort study involving children aged < 9 years and abstracted data from clinical sources. We used logistic regression to assess VLS and pDTG initiation predictors. Results: Of 1353 children, 1146 initiated pDTG; 196 (14.5%) had no recorded weight. Post-pDTG switch, 98.9% (950/961) of children maintained the same nucleoside reverse transcriptase inhibitor backbone. After initiating Abacavir/Lamivudine+pDTG, 834 (72.8%) children remained on the regimen, 156 (13.6%) switched off (majority to Dolutegravir 50mg), 22 (1.9%) had ≥ 2 anchor drug switches; 134 (11.7%) had no documented follow-up regimen. Factors associated with pDTG initiation or switch were younger age (adjusted odds ratio [AOR] = 0.71 [0.63-0.80]) and a recorded weight (AOR = 55.58 [33.88-91.18]). VLS among the 294 children with a viral load (VL) test after ≥ 5 months post-pDTG was 75.5% (n = 222/294). Pre-pDTG VLS rate among treatment-experienced children was 56.5% (n = 130/230). Factors associated with VLS were older age (AOR = 1.18 [1.03-1.34]) and previous VLS (AOR = 2.27 [1.27-4.06]). Conclusion: Most eligible children initiated pDTG per guidelines, improving post-pDTG VLS. Challenges included unexplained switches off pDTG after initiation, low VL coverage and inadequate documentation in clinic records.

Virological and care outcomes of community ART distribution: Experience with the PODI+ model in Kinshasa, Democratic Republic of the Congo.

INTRODUCTION: Differentiated service delivery models for HIV treatment can minimize unnecessary burdens on health systems and promote efficient delivery of antiretroviral therapy (ART). Under the PODI+ (poste de distribution communautaire) model, ART multi-month dispensation (MMD) was provided by lay workers (peers) in communities. We compared outcomes among clinically stable adults living with HIV receiving MMD via PODI+ or health facility (HF). METHODS: Clients receiving MMD at nine HFs and two PODI+ sites in Kinshasa were followed prospectively for one year (2018-2020). Medication possession ratio (MPR) was measured as proportion of total days with medication during the study through record abstraction at 3-month intervals. Viral load was assessed at enrollment and 12 months. We compared MPR and viral load suppression by arm and examined associations and potential confounders using unadjusted and adjusted odds ratios (AOR). Likert-style client satisfaction was collected during 12-month interviews and described by arm. RESULTS: Odds of maintaining viral load suppression at 12 months for PODI+ participants were two times that for HF participants. In adjusted models, PODI+ participants had 1.89 times the odds of being suppressed at 12 months compared to HF participants (95% CI: 1.10, 3.27). No significant differences in MPR were found between groups (OR: 0.86, 0.38-1.99). Older participants had significantly higher odds of MPR (AOR: 1.02, 95% CI: 1.01, 1.03) and viral suppression (AOR: 1.03, 95% CI: 1.00, 1.07). Satisfaction with services was ≥87% overall, but PODI+ participants rated time spent at site, provider attributes and other care aspects more favorably. CONCLUSIONS: Participants receiving MMD via peer-run community distribution points had similar MPR, but better virological outcomes and greater satisfaction with care than clinically similar participants receiving MMD through facilities. PODI+ could be a useful model for expansion to serve larger clinic populations from overburdened health facilities, particularly as policy shifts towards more inclusive MMD eligibility requirements.

Uptake, Acceptability, and Results of SARS-CoV-2 Antigen Rapid Diagnostic Testing in Community Settings in Cameroon.

Mass gathering event restrictions were part of mitigation measures during the COVID-19 pandemic that were lifted as prevalence decreased and after vaccination rollout. We explored SARS-CoV-2 antigen rapid diagnostic test acceptability and positivity in community settings in Cameroon. In August-October 2022, community workers sensitized and referred individuals for COVID-19 testing to nearby testing points in Douala and Yaoundé. Participants consented to SARS-CoV-2 antigen rapid diagnostic testing, a survey, or both components. We describe the positivity rate, COVID-19-related history, and Likert-scale testing perceptions. Factors associated with testing acceptance were analyzed using logistic regression. Overall, 20.5% (2,449/11,945) of sensitized individuals visited testing points, and 1,864 (76.1%) were enrolled; 50.6% accepted the survey and testing (46.0% accepted survey only). Seven (0.7%) of 1,006 individuals tested positive. Most (71.8%; 1,292/1,800) considered community testing more accessible than hospital-based testing. Individuals accepting versus refusing testing differed in perceived COVID-19 risk (67%, 49%; P <0.001), belief in accurate test results (79%, 47%; P <0.001), and ability to test easily (96%, 55%; P <0.001). Males (adjusted odds ratio [aOR]: 1.26 [1.04-1.53]) and those over 50 years (aOR: 1.9 [1.4-2.7]), with symptoms (aOR: 1.80 [1.30-2.50]), and at least partial vaccination (aOR: 0.76 [0.58-0.99]) were significantly associated with test acceptance. Refusal reasons included lack of perceived need for testing (33.8%) and testing discomfort (26.3%). Although community-based testing was generally perceived as important, actual testing uptake was low. In future pandemics, community testing should be optimized by addressing misinformation, offering alternative testing modalities for greater comfort, creating demand, and tailoring approaches to maximize testing uptake.

Lessons from a decade of adult vaccine rollout in low- and middle-income countries: a scoping review.

INTRODUCTION: The historical focus of vaccines on child health coupled with the advent of novel vaccines targeting adult populations necessitates exploring strategies for adult vaccine implementation. AREAS COVERED: This scoping review extracts insights from the past decade's experiences introducing adult vaccines in low- and middle-income countries. Among 25 papers reviewed, 19 focused on oral cholera vaccine, 2 on Meningococcal A vaccines, 2 on tetanus toxoid vaccine, 1 on typhoid vaccine, and 1 on Ebola vaccine. Aligned with WHO's Global Framework for New TB Vaccines for Adults and Adolescents, our findings center on vaccine availability, accessibility, and acceptance. EXPERT OPINION: Availability findings underscore the importance of understanding disease burden for prioritization, multi-sectoral collaboration during planning, and strategic resource allocation and coordination. Accessibility results highlight the benefits of leveraging existing health infrastructure and adequately training healthcare workers, and contextually tailoring vaccine delivery approaches to reach challenging sub-groups like working male adults. Central to fostering acceptance, resonant sensitization, and communication campaigns engaging the communities and utilizing trusted local leaders countered rumors and increased awareness and uptake. As we approach the introduction of a new adult TB vaccine, insights from this review equips decision-makers with key evidence-based recommendations to support successful and equitable vaccinations targeting adults.

Optimizing antiretroviral therapy for children living with HIV: Experience from an observational cohort in Lesotho.

INTRODUCTION: We describe transition of HIV-positive children from efavirenz- or nevirapine-based antiretroviral therapy (ART) to optimal dolutegravir (DTG) or lopinavir/ritonavir (LPV/r) (solid formulation)-based ART in Lesotho. METHODS: We followed a cohort of children less than 15 years of age who were initiated on ART on or after January 1, 2018 from 21 selected health facilities in Lesotho. From March 2020 to May 2022, we collected data retrospectively through chart abstraction and prospectively through caregiver interviews to cover a period of 24 months following treatment initiation. We used a structured questionnaire to collect data on demographics, ART regimen, drug formulations and switches, viral suppression, retention, and drug administration challenges. Data were summarized as frequencies and percentages, using SAS ver.9.4. RESULTS: Of 310 children enrolled in the study, 169 (54.5%) were female, and median age at ART initiation was 5.9 years (IQR 1.1-11.1). During follow-up, 19 (6.1%) children died, 41 (13.2%) were lost to follow-up and 74 (23.9%) transferred to non-study sites. At baseline, 144 (46.4%) children were receiving efavirenz-based ART regimen, 133 (42.9%) LPV/r, 27 (8.7%) DTG, 5 (1.6%) nevirapine; 1 child had incomplete records. By study end, 143 (46.1%) children were receiving LPV/r-based ART regimen, 109 (35.2%) DTG, and 58 (18.7%) were on efavirenz or nevirapine-based regimen. Of 116 children with viral load results after six months or more on a consistent regimen, viral suppression was seen in 35/53 (66.0%) children on LPV/r, 36/38 (94.7%) children on DTG and 19/24 (79.2%) children on efavirenz. CONCLUSION: Following optimal ART introduction in Lesotho, most children in the cohort were transitioned and many attained or maintained viral suppression after transition; however, we recommend more robust viral load monitoring and patient tracking to reduce losses and improve outcomes after ART transition.

Virologic Outcomes and ARV Switch Profiles 2 Years After National Rollout of Dolutegravir to Children Less Than 15 Years in Southern Mozambique.

BACKGROUND: Dolutegravir (DTG) was scaled up globally to optimize treatment for children living with HIV. We evaluated the rollout and virological outcomes after DTG introduction in Mozambique. METHODS: Data from children 0-14 years with visits from September 2019 to August 2021 were extracted from records in 16 facilities in 12 districts. Among children ever on DTG, we report treatment switches, defined as changes in anchor drug, regardless of changes to nucleoside reverse transcriptase inhibitor (NRTI) backbones. Among those on DTG for ≥6 months, we described viral load suppression rates by children newly initiating and switching to DTG and by the NRTI backbone at the time of the DTG switch. RESULTS: Overall, 3,347 children were ever on DTG-based treatment (median age 9.5 years; 52.8% female). Most children (3,202, 95.7%) switched to DTG from another antiretroviral regimen. During the 2-year follow-up, 9.9% never switched from DTG; 52.7% had 1 regimen change, of which 97.6% were switched to DTG. However, 37.2% of children experienced ≥2 anchor drug changes. Overall median time on DTG was 18.6 months; nearly all children ≥5 years (98.6%) were on DTG at the last visit. Viral suppression was 79.7% (63/79) for children newly initiating DTG and 85.8% (1,775/2,068) for those switching to DTG. Suppression rates were 84.8% and 85.7% among children who switched and maintained NRTI backbones, respectively. CONCLUSIONS: Viral suppression rates of ≥80% with minor variations by backbone were achieved during the 2-year DTG rollout. However, there were multiple anchor drug switches for over one-third of children, which may be attributable in part to drug stockouts. Long-term pediatric HIV management will only be successful with immediate and sustainable access to optimized child-friendly drugs and formulations.

Strengthening the Evidence: Similar Rates of Neural Tube Defects Among Deliveries Regardless of Maternal HIV Status and Dolutegravir Exposure in Hospital Birth Surveillance in Eswatini.

Birth defect surveillance in Eswatini in 2020-2021 identified 0.80% defects (197/24 599 live and stillborn infants). Neural tube defect (NTD) prevalence was 0.08%, 0.08%, and 0.15% for 4902 women on dolutegravir preconception, 17 285 HIV-negative women, and 1320 women on efavirenz preconception, respectively, more definitively refuting the dolutegravir preconception NTD safety signal.

Improvement of community health worker counseling skills through early childhood development (ECD) videos, supervision and mentorship: A mixed methods pre-post evaluation from Tanzania.

BACKGROUND: Community health workers (CHWs) play significant roles in improving health practices in under- resourced communities. This study evaluated an early childhood development (ECD) project in Tanzania assessing the effect of mobile video use, supervision and mentorship to improve quality of CHW counseling skills. METHODS: CHWs participating in the Malezi Project in Tabora Region were enrolled in a mixed methods pre-post evaluation. CHWs previously trained in UNICEF's Care for Child Development package were further trained in counselling caregivers on nurturing care and father engagement using videos. Health providers were trained to provide ECD-focused supervision/mentorship of CHWs in facilities and during home visits. At baseline and endline, CHWs completed interviews and trained study staff observed and scored CHW counseling sessions using a structured checklist which were reduced into six dimensions through principal component analysis: introduce, educate, ask, plan/problem solve, interact/encourage, and responsive care. Twenty-five in-depth interviews were completed with caregivers and four focus group discussions with CHWs were conducted. RESULTS: Almost all (n = 107; 95%) 119 enrolled CHWs completed the expected eight observations (n = 471 baseline; n = 453 endline). At endline, more CHWs reported having one-on-one meetings with their supervisors (51% increasing to 75%; p < .0002) and that supervisors accompanied them to households for mentoring (60% increasing to 89%; p < .0001). We observed a shift in CHW counselling skills in clinic and home sessions. Scores in the categories of introduce, plan/problem solve, and interact/encourage significantly improved between baseline and endline; scores for ask and educate remained unchanged or decreased at both timepoints. Two-thirds of caregivers interviewed reported that father's involvement with their child increased due to CHW visits. Male participation increased in home observation sessions from 5.6% at baseline to 17.6% at endline (p < .0001). CONCLUSION: Use of videos, supervision, and mentorship were associated with CHW performance improvements in providing nurturing care counselling and in father engagement, especially in home settings.

HIV risk screening and HIV testing among orphans and vulnerable children in community settings in Tanzania: Acceptability and fidelity to lay-cadre administration of the screening tool.

INTRODUCTION: HIV risk screening tool validation studies have not typically included process evaluations to understand tool implementation. The study aim was to assess the fidelity to which an HIV risk screening tool was administered by lay workers and acceptability of delivering home-based screening coupled with HIV testing to beneficiaries in an orphans and vulnerable children (OVC) program. METHODS: This cross-sectional study was conducted March-April 2019 in two regions of Tanzania. Community case workers (CCW) were observed conducting screenings with OVC 2-19 years and participated in focus group discussions. Research staff used structured observation checklists to capture if screening questions were asked or reworded by CCW. In-depth interviews were conducted with older adolescents and caregivers in their homes following screening and testing. A composite score was developed for the checklist. Qualitative data were thematically analyzed to address screening and testing perceptions and experiences. RESULTS: CCW (n = 32) participated in 166 observations. Commonly skipped items were malnutrition (34% of all observed screenings) and sexual activity and pregnancy (20% and 45% of screenings for adolescents only). Items frequently re-worded included child abuse (22%) and malnutrition (15%). CCW had an average composite observation score of 42/50. CCW in focus groups (n = 34) found the screening process acceptable. However, they described rewording some questions viewed as harsh or socially inappropriate to ask. Overall, adolescent beneficiaries (n = 17) and caregivers (n = 25) were satisfied with home-based screening and testing and reported no negative consequences. Learning one's HIV negative status was seen as an opportunity to discuss or recommit to healthy behaviors. While respondents identified multiple benefits of home testing, they noted the potential for privacy breaches in household settings. CONCLUSIONS: We found sub-optimal fidelity to the administration of the screening tool by CCW in home environments to children and adolescents enrolled in an OVC program. Improvements to questions and their delivery and ongoing mentorship could strengthen tool performance and HIV case finding using a targeted testing approach. Overall, home-based HIV risk screening and testing were acceptable to beneficiaries and CCW, could improve testing uptake, and serve as a platform to promote healthy behaviors for those with limited health system interactions.

Balancing HIV testing efficiency with HIV case-identification among children and adolescents (2-19 years) using an HIV risk screening approach in Tanzania.

To optimize HIV testing resources, programs are moving away from universal testing strategies toward a risk-based screening approach to testing children/adolescents, but there is little consensus around what defines an optimal risk screening tool. This study aimed to validate a 12-item risk screening tool among children and adolescents and provide suggested fewer-item tool options for screening both facility out-patient and community populations by age strata (<10 and ≥10 years). Children/adolescents (2-19 years) with unknown HIV status were recruited from a community-based vulnerable children program and health facilities in 5 regions of Tanzania in 2019. Lay workers administered the screening questions to caregivers/adolescents; nurses enrolled those eligible for the study and tested all participants for HIV. For each screening item, we estimated sensitivity, specificity, positive predictive value and negative predictive value and associated 95% confidence intervals (CI). We generated a score based on the count of items with a positive risk response and fit a receiver operating characteristic curve to determine a cut-off score. Sensitivity, specificity, positive predictive value (PPV; yield) and number needed to test to detect an HIV-positive child (NNT) were estimated for various tool options by age group. We enrolled 21,008 children and adolescents. The proportion of undiagnosed HIV-positive children was low (n = 76; 0.36%; CI:0.29,0.45%). A screening algorithm based on reporting at least one or more items on the 10 to 12-item tool had sensitivity 89.2% (CI:79.1,95.6), specificity 37.5% (CI:36.8,38.2), positive predictive value 0.5% (CI:0.4,0.6) and NNT = 211. An algorithm based on at least two or more items resulted in lower sensitivity (64.6%), improved specificity (69.1%), PPV (0.7%) and NNT = 145. A shorter tool derived from the 10 to 12-item screening tool with a score of "1" or more on the following items: relative died, ever hospitalized, cough, family member with HIV, and sexually active if 10-19 years performed optimally with 85.3% (CI:74.6,92.7) sensitivity, 44.2% (CI:43.5,44.9) specificity, 0.5% (CI:0.4,0.7) PPV and NNT = 193. We propose that different short-tool options (3-5 items) can achieve an optimal balance between reduced HIV testing costs (lower NNT) with acceptable sensitivity. In low prevalence settings, changes in yield may be negligible and NNT may remain high even for an effective tool.

Developing and Validating an Effective Pediatric and Adolescent HIV Testing Eligibility Screening Tool for High-Volume Entry Points in Uganda.

INTRODUCTION: Because of low pediatric HIV prevalence, more tests are needed to find 1 HIV-positive child compared with adults. In Uganda, the number needed to test (NNT) to find 1 new HIV-positive child was 64 in outpatient departments (OPDs) and 31 through index testing. We aimed to develop and validate a pediatric (1.5-14 years) screening tool to optimize testing approaches. METHODS: Phase 1 evaluated the performance of 10 screening questions in 14 OPDs using a variable selection algorithm to evaluate combinations of screening questions. Using logistic regression, we identified the number of screening questions with the best predictive accuracy using the receiver operation characteristic curve. Phase 2 validated the proposed tool in 15 OPDs and 7 orphan and vulnerable children programs. We estimated sensitivity, specificity, and NNT accounting for intercluster correlations. RESULTS: A total of 3482 children were enrolled. The optimal model included reported HIV-positive maternal status or 2/5 symptoms (sickly in the last 3 months, recurring skin problems, weight loss, not growing well, and history of tuberculosis). The proposed tool had sensitivity of 83.6% [95% confidence interval (CI): 68.1 to 92.4] and specificity of 62.5% (95% CI: 55.0 to 69.4). The tool was validated in a sample of 11,342 children; sensitivity was 87.8% (95% CI: 80.9 to 92.5) and specificity 62.6% (95% CI: 54.8 to 69.7) across OPDs and community sites. In OPDs, sensitivity was 88.1% (95% CI: 80.8 to 92.8) and specificity 69.0% (95% CI: 61.9 to 75.3). The NNT was 43 (95% CI: 28 to 67) across settings and 28 (95% CI: 20 to 38) for OPD. CONCLUSIONS: This HIV screening tool has high sensitivity and reasonable specificity, increasing testing efficiency and yield for children and adolescents.

Active pediatric HIV case finding in Kenya and Uganda: A look at missed opportunities along the prevention of mother-to-child transmission of HIV (PMTCT) cascade.

BACKGROUND: Children living with HIV remain undiagnosed due to missed opportunities along the prevention of mother-to-child HIV transmission cascade. This study addresses programmatic gaps in the cascade by describing pregnancy and HIV-related services received by mothers of children newly identified as HIV-positive through active case finding. METHODS: This was a prospective observational cohort (2017-2018) of HIV-positive children <15 years of age newly diagnosed at study facilities and/or surrounding communities in Kenya and Uganda. At enrollment, caregivers were interviewed about maternal and child health and HIV history. Child medical and laboratory information was abstracted at two months post-diagnosis. Descriptive summary statistics were calculated; associations between selected factors and child age at HIV diagnosis were evaluated using generalized estimating equations. RESULTS: 174 HIV-positive children (median age 2.4 years) were enrolled. Among maternal caregivers, 110/132 (83.3%) attended antenatal care and 60 (45.5%) reported testing HIV-negative in antenatal care. Of 41 and 56 women known to be HIV-positive during pregnancy and breastfeeding respectively, 17 (41.5%) and 15 (26.8%) did not receive antiretroviral drugs. Despite known maternal HIV-positive status during pregnancy, 39% of these children were not diagnosed until after two years of age; children were diagnosed at younger ages in Uganda (p = 0.0074) and if mother was the caregiver (p<0.0001). The most common HIV testing points identifying children were outpatient (44.3%) and maternal/child health departments (29.9%). Nearly all children initiated antiretroviral therapy within two weeks of diagnosis. CONCLUSIONS: Multiple missed opportunities for HIV prevention and delays in HIV testing of HIV-exposed children were identified in newly diagnosed children. Findings support critical prevention messaging and retesting of HIV-negative women during pregnancy and breastfeeding, strengthening HIV treatment initiation and follow-up systems and interventions to ensure HIV-positive women receive lifelong antiretroviral therapy throughout the cascade, and broader implementation of community case finding so children not engaged in care receive testing services.