Growth Trajectories Over the First Year of Life Among Early-Treated Infants with Human Immunodeficiency Virus and Infants Who are Human Immunodeficiency Virus-Exposed Uninfected.

OBJECTIVE: To investigate the role of early antiretroviral therapy (ART) on growth trajectories of infants with human immunodeficiency virus (IHIV) in the first year of life. STUDY DESIGN: As part of a clinical trial of early ART in Johannesburg, South Africa (2015-2018), 116 IHIV diagnosed within 48 hours of birth were started on ART as soon as possible, and 80 uninfected infants born to mothers living with HIV (IHEU) were enrolled. Both groups were followed prospectively from birth through 48 weeks and growth parameters collected. The groups were compared and risk factors for poor growth investigated, in the full cohort and among IHIV separately. RESULTS: IHIV had lower mean weight-for-age Z-scores (WAZ) than IHEU at 4 and 8 weeks (-1.17 [SE:0.14] vs -0.72 [0.14], P = .035 and -1.23 [0.15] vs -0.67 [0.14], P = .012). Although there was some closing of the gap over time, means remained lower in IHIV through 48 weeks. In length-for-age Z-scores (LAZ), differences widened over time and IHIV had lower Z-scores by 48 weeks (-1.41 [0.15] vs -0.80 [0.18], P = .011). Deficits in WAZ and LAZ in IHIV vs IHEU were most marked among girls. IHIV with pre-ART viral load ≥1000 copies/ml had significantly lower weight-for-length and mid-upper arm circumference Z-scores across all time points through 48 weeks. CONCLUSIONS: IHIV on early ART had deficits in WAZ over the first 8 weeks of life and lower LAZ at 48 weeks than IHEU. Among IHIV, higher pre-ART viral load was associated with worse anthropometric indicators through 48 weeks.

HIV retesting for pregnant and breastfeeding women across maternal child health services in Nampula, Mozambique

Background: Repeat HIV testing during pregnancy and breastfeeding identifies women with incident infections, those living with HIV who have been lost to care, and infants at risk for HIV infection. We report data from repeat testing for women in maternal and child health (MCH) services at 10 health facilities in Mozambique. Methods: Routinely collected data from health facility registers are reported from April-November 2019. From antenatal care (ANC), we report numbers and proportions of women eligible for retesting; returned for care when retesting eligible; retested; and HIV-positive (HIV+) at retesting. From child welfare clinics (CWC), we report mothers retested; tested HIV-positive; HIV+ mothers linked to ART services; HIV-exposed infants (HEI) tested for HIV with polymerase chain reaction (PCR) tests; HEI testing PCR positive; PCR-positive infants linked to care. Results: In ANC, 28,233 pregnant women tested HIV-negative at first ANC visit, 40.7% had a follow-up visit when retesting eligible, among whom 84.8% were retested and 0.3%(N = 26) tested HIV+. In CWC, 26,503 women were tested; 0.8%(N = 212) tested HIV+ and 74.1%(N = 157) of HIV+ women were linked to care. Among 157 HEI identified in CWC, 68.4%(N = 145) received PCR testing and 19.3%(N = 28) tested positive. Conclusion: In ANC, less than half of pregnant women eligible for retesting returned for follow-up visits, and test positivity was low among women retested in ANC and CWC. In CWC, linkage to infant testing was poor and almost 20% of HEI were PCR-positive. Implementing retesting for pregnant and breastfeeding women is challenging due to high numbers of women and low testing yield

Point-of-care viral load testing among adolescents and young adults living with HIV in Haiti: a randomized control trial.

HIV viral load (VL) monitoring can reinforce antiretroviral therapy (ART) adherence. Standard VL testing requires high laboratory capacity and coordination between clinic and laboratory which can delay results. A randomized trial comparing point-of-care (POC) VL testing to standard VL testing among 150 adolescents and young adults, ages 10-24 years, living with HIV in Haiti determined if POC VL testing could return faster results and improve ART adherence and viral suppression. Participants received a POC VL test with same-day result (POC arm) or a standard VL test with result given 1 month later (SOC arm). POC arm participants were more likely to receive a test result within 6 weeks than SOC arm participants (94.7% vs. 80.1%; p1000 copies/ml and low self-reported ART adherence was stronger in the POC arm (OR: 6.57; 95%CI: 2.12-25.21) than the SOC arm (OR: 2.62; 95%CI: 0.97-7.44) suggesting more accurate self-report in the POC arm. POC VL testing was effectively implemented in this low-resource setting with faster results and is a pragmatic intervention that may enable clinicians to identify those with high VL to provide enhanced counseling or regimen changes sooner.Trial registration: ClinicalTrials.gov identifier: NCT03288246.

Characteristics of adolescents aged 15-19 years living with vertically and horizontally acquired HIV in Nampula, Mozambique

Background: Adolescents living with HIV (ALHIV) 15-19 years of age are a growing proportion of all people living with HIV globally and the population includes adolescents with vertically acquired HIV (AVH) and behaviorally acquired HIV (ABH). Methods: We conducted a survey to measure sociodemographic characteristics, educational status, health history, and antiretroviral therapy (ART) adherence among a convenience sample of ALHIV at three government health facilities in 2019 in Nampula, Mozambique. ALHIV 15-19 years on ART, including females attending antenatal care, were eligible. Routine HIV care data were extracted from medical charts. Classification of ALHIV by mode of transmission was based on medical charts and survey data. ALHIV who initiated ART <15 years or reported no sex were considered AVH; all others ABH. Frequencies were compared by sex, and within sex, by mode of transmission (AVH vs. ABH) using Chi-square, Fishers exact tests and Wilcoxon rank-sum tests. Results: Among 208 ALHIV, 143 (69%) were female and median age was 18 years [interquartile range (IQR) 16-19]. Just over half of ALHIV (53%) were in or had completed secondary or higher levels of education; the most common reason for not being in school reported by 36% of females was pregnancy or having a child. Of all ALHIV, 122 (59%) had VL data, 62% of whom were <1000 copies/mL. Almost half (46%) of ALHIV reported missing ARVs ≥ 1 day in the past month (62% of males vs. 39% of females; p = 0.003). Just over half (58%) of ALHIV in relationships had disclosed their HIV status: 13% of males vs. 69% of females (p<0.001). Among sexually active males, 61% reported using a condom at last sex compared to 26% of females (p<0.001). Among female ALHIV, 50 (35%) were AVH and 93 (65%) were ABH, 67% of whom were not in school compared to 16% of ABH, (p<0.001). Discussion: Data from our study underscore the high level of deprivation among ALHIV enrolled in HIV care in Mozambique, as well as important disparities by sex and mode of transmission. These data can inform the development of effective interventions for this complex and important population.

Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect.

INTRODUCTION: Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression. METHODS AND ANALYSIS: This non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10-24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence. ETHICS AND DISSEMINATION: This study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV. TRIAL REGISTRATION NUMBER: NCT03288246.

Behavioral Functioning and Quality of Life in South African Children Living with HIV on Antiretroviral Therapy.

This study examined behavioral functioning and quality of life in South African children living with perinatally acquired HIV. Compared with controls, children living with perinatally acquired HIV had a higher mean total difficulties score assessed by the Strengths and Difficulties Questionnaire and lower mean quality of life scores assessed by the Pediatric Quality of Life Inventory.

The FANMI ("my FAMILY" in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial.

BACKGROUND: Adolescent girls and young women living with HIV in resource-limited settings have the poorest health outcomes of any age group, due in part to poor retention in care. Differentiated models of HIV care that target the specific challenges of young people living with HIV are urgently needed. METHODS: The FANMI study is an unblinded randomized controlled trial designed to evaluate the efficacy of an adolescent-specific model of HIV care in Port-au-Prince, Haiti. The FANMI intervention places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location. In contrast, participants in the standard care arm receive routine HIV care and individual counseling each month in GHESKIO's Adolescent Clinic. A total of 160 participants ages 16-23 years old are being randomized on a 1:1 basis. The primary outcome is retention in HIV care defined as being alive and in care at 12 months after enrollment. Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs. DISCUSSION: The FANMI study evaluates a novel community-based cohort model of HIV care aimed at improving retention in care and reducing risk behaviors for HIV transmission among adolescent girls and young women living with HIV. Specifically, the FANMI model of care addresses social isolation by placing participants in cohorts of 5-10 peers to provide intensified peer support and makes HIV health management a group norm; reduces stigma and improves convenience by providing care in a community setting; and integrates clinical care and social support by the same providers to streamline care and promote long-term patient-provider relationships. If shown to be effective, the FANMI intervention may serve as a model of HIV care for improving retention among hard-to-reach adolescents and young adults in Haiti and could be adapted for other high-risk groups globally. TRIAL REGISTRATION: Identifier: NCT03286504, Registered September 18, 2017.

Fifteen years of HIV and syphilis outcomes among a prevention of mother-to-child transmission program in Haiti: from monotherapy to Option B.

OBJECTIVE: To evaluate mother and infant outcomes in the largest prevention of mother-to-child-transmission (PMTCT) programme in Haiti in order to identify gaps towards elimination of HIV and syphilis. METHODS: Based on retrospective data from HIV+ pregnant women and their infants enrolled in PMTCT care from 1999 to 2014, we assessed maternal enrolment in PMTCT, receipt of antiretrovirals before delivery, maternal retention through delivery as well as infant enrolment in PMTCT, HIV testing and HIV infection. Four PMTCT programme periods were compared: period 1 (1999-2004, mono ARV), period 2 (2005-2009, dual ARV), period 3 (2010-2012, Option B) and period 4 (Oct 2012-2014, Option B+). Kaplan-Meier methods were used to assess retention in PMTCT care. RESULTS: Among 4665 pregnancies, median age was 27 years and median CD4+ was 494 cells/µl (IQR 328-691). A total of 75% of women received antiretrovirals before delivery, and 73% were retained in care through delivery. Twenty-two percent of women were lost before delivery, <1% died and 6% had stillbirths or abortions. Ninety-four percent of infants who were born alive enrolled in PMTCT, of whom 92% had complete HIV testing. One hundred and sixty-one infants were HIV+, giving a 5.4% HIV transmission rate (9.8%, 4.6%, 5.8% and 3.6% in periods 1-4). Retention among women through 12 months after PMTCT enrolment did not significantly differ across periods. However, among women who received antiretrovirals at the time of enrolment, retention 12 months later was lower in the Option B+ period (83%) than in periods 2 and 3 (94% and 93%) (P < 0.001). Syphilis infection among women decreased from 16% in period 1 to 8% in period 4, whereas syphilis testing of infants increased from 17% to 91%. CONCLUSION: Despite dramatic reductions in MTCT in Haiti, interventions are needed to improve retention to achieve MTCT elimination of HIV and syphilis.

Community-Based HIV and Health Testing for High-Risk Adolescents and Youth.

Adolescents account for 40% of new HIV infections, and HIV testing strategies to increase uptake of testing are needed. A community-based adolescent and youth HIV and health testing campaign was conducted in seven slum neighborhoods of Port-au-Prince, Haiti, from December 2014 to September 2015. Community health workers provided community sensitization and recruited 10- to 24-year-olds to test for HIV, syphilis, gonorrhea/chlamydia, and to screen for tuberculosis (TB) and pregnancy. HIV-infected individuals were escorted to the GHESKIO HIV clinic for same-day enrollment in care. Among 3425 individuals eligible for testing, 3348 (98%) accepted an HIV test. HIV prevalence was 2.65% (n = 89). Median age was 19 [interquartile range (IQR) 17-20]; 73% were female. HIV prevalence was 0.6-7.4% across slum neighborhoods. All HIV-infected individuals enrolled in care the same day as testing; median CD4 was 529 cells/µL [IQR 363-761]. Syphilis prevalence was 2.60% (65/2536) and gonorrhea/chlamydia prevalence was 6.25% (96/1536). Among 168 (5%) individuals who reported TB symptoms, 7.7% (13/168) had microbiologically confirmed disease. One hundred twenty-nine females (5% of all females) were pregnant. This community-based testing campaign identified an adolescent and youth population with an HIV prevalence six times higher than the estimated national adolescent HIV prevalence (0.4%) in Haiti, including perinatally infected adolescents. This type of community-based campaign for HIV testing within a package of services can serve as a model for other resource-poor settings to identify high-risk adolescents and youth, and curb the global HIV epidemic among adolescents.

Initiation of antiretroviral therapy before 6 months of age is associated with faster growth recovery in South African children perinatally infected with human immunodeficiency virus.

OBJECTIVE: To describe the effects of age at antiretroviral therapy (ART) initiation on growth outcomes among children infected with HIV followed for 48 months after treatment initiation. STUDY DESIGN: This secondary analysis describes anthropometric changes in children infected with HIV in Johannesburg, South Africa who initiated ritonavir-boosted lopinavir-based ART before 24 months of age and were randomized to continue ritonavir-boosted lopinavir or to receive nevirapine after achieving and maintaining virologic suppression. Weight, height, and head circumference were measured at visits over 48 months post-ART initiation. Growth patterns including weight-for-age z-scores (WAZs), height-for-age z-scores, body mass index-for-age z-scores, and head circumference for age z-score were compared between children initiating ART<6 months, 6-12 months, and 12-24 months of age. RESULTS: A total of 195 children (mean±SD age 10.7±5.9 months), including 54 (27.7%)<6 months, 69 (35.4%) 6-12 months, and 72 (36.9%) 12-24 months of age at ART initiation, were evaluated. In the first 12 months on treatment, children<6 months of age at ART initiation experienced more rapid improvement in WAZ (1.98 vs 1.44, P=.084) and head circumference for age z-score (1.24 vs 0.45, P=.004) than children who initiated ART between 12-24 months of age. By 48 months on ART, growth outcomes were similar, regardless of age at ART initiation. WAZ approached population norms by 12 months on ART. Although improving, height-for-age z-scores remained on average 1.0 z-score below population norms at 48 months of therapy. CONCLUSIONS: Initiation of ART before 6 months of age results in more rapid growth recovery in children infected with HIV. These data provide further evidence for the importance of prompt diagnosis and early initiation of ART for infants infected with HIV.

Incidence and prevalence of HIV encephalopathy in children with HIV infection receiving highly active anti-retroviral therapy (HAART).

OBJECTIVE: To describe neurologic outcomes in children infected with HIV in the era of highly active anti-retroviral therapy (HAART), including rates of progressive HIV encephalopathy (PHE) and clinical sequelae among PHE survivors. STUDY DESIGN: Neurobehavior and school placement was assessed prospectively in the year 2000 in 126 children infected with HIV. PHE, developmental delay, and attention deficit disorder (ADHD) were the main outcome variables analyzed. Predictors of PHE were assessed in controlled analysis among age-matched controls. RESULTS: The rate of active PHE in 2000 was 1.6% (n = 2), and the prevalence of arrested PHE was 10% (n = 13). Residual motor and cognitive sequelae and need for special education was found in the majority of survivors. PHE relapse occurred in 3 (23%) children with previously arrested PHE. Viral load (VL) was the only significant factor associated with PHE. HIV or PHE was not associated with ADHD. Isolated developmental delay was not associated with HIV. CONCLUSIONS: PHE is an infrequent and reversible complication of HIV infection that responds to HAART and that may relapse if control of the virus is lost. Children with arrested PHE show higher rates of residual neurologic, cognitive, and scholastic impairments compared with children who never had PHE. Children with arrested PHE are the group of children with HIV infection most at risk for PHE, in the form of a relapse.