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.

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.

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.

Young primigravidae in Barbados - abstract

A study was made of the pattern of excretion of human chorionic gonadotrophin in young primigravdae (under 18 years of age) in Barbados to see if there were any essential differences from the pattern described for European women of an older age group. Human chrorionic gonadotrophin (HCG) was measured in 24-hour urine specimens as well as in early morning specimens of urine in some cases at varying times up to the 22nd week of gestation. Immuno assays of H.C.G. were carried out by the haemagglutination-inhibition test-PREPUERIN-prepared by Burrowes Wellcome. For European women, the level of H.C.G. reaches a maximum at around the 9th week of pregnancy when the output may be as high as 100,000 i.u. in 24 hours. Therafter it falls rapidly to a level of about 8,000 i.u. in 24 hours by the 12th week. In the Barbadian primigravidae the peak level was 85,000 i.u./24 hours and the rate of decline was much slower than that observed for European women. Certain clinical observations were made on over 1200 young primigravidae delivered at the Queen Elizabeth Hospital during the three years, 1968 to 1970, most of whom attended a research antenatal clinic and came under detailed study in the Labour Ward. It has been found that the incidence of clinical cedema in the antenatal period was around 5 percent as compared with 20 percent in European antenatal clinics and the average total weight gain throughout pregnancy was around 15 lbs. as compared with 25 lbs. in European women. In the present series it can be shown that when an occipito-posterior position of the head occurred, the incidence of spontaneous long internal rotation was very much less (25 percent) than has been reported for European women (60-70 percent). The Barbadian primigravidae were more prone to develop an "anxiety state" in labour calling for more effective sedation and analgesia than is required by older women. There was a relatively low incidence of Pre-eclamptic toxaemia but late manifestations of toxaemia occurred after delivery much more frequently than is observed in obstetric practice in England (AU)