ABSTRACT
BACKGROUND: In 1999, we reported safety and efficacy data for short-course nevirapine from a Ugandan perinatal HIV-1 prevention trial when 496 babies were followed up to age 14-16 weeks. Safety and efficacy data are now presented for all babies followed up to 18 months of age. METHODS: From November, 1997, to April, 1999, HIV-1 infected pregnant women in Kampala, Uganda, were randomly assigned nevirapine (200 mg at labour onset and 2mg/kg for babies within 72 h of birth; regimen A) or zidovudine (600 mg orally at labour onset and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily for babies for 7 days, regimenB). Infant HIV-1 testing was done at birth, age 6-8 and 14-16 weeks, and age 12 months by HIV-1 RNA PCR, and by HIV-1 antibody at 18 months. HIV-1 transmission and HIV-1-free survival were assessed using Kaplan-Meier analysis. We recorded adverse experiences through 6-8 weeks postpartum for mothers, and 18 months for babies. Efficacy analyses were by intention to treat. FINDINGS: We enrolled 645 mothers to the study: 313 were assigned regimen A, 313 regimen B, and 19 placebo. Eight mothers were lost to follow-up before delivery. 99% of babies were breastfed (median duration 9 months). Estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were 10.3% and 8.1% at birth (p=0.35); 20.0% and 11.8% by age 6-8 weeks (p=0.0063); 22.1% and 13.5% by age 14-16 weeks (p=0.0064); and 25.8% and 15.7% by age 18 months (p=0.0023). Nevirapine was associated with a 41% (95% CI 16-59) reduction in relative risk of transmission through to age 18 months. Both regimens were well-tolerated with few serious side-effects. INTERPRETATION: Intrapartum/neonatal nevirapine significantly lowered HIV-1 transmission risk in a breastfeeding population in Uganda compared with a short intrapartum/neonatal zidovudine regimen. The absolute 8.2% reduction in transmission at 6-8 weeks was sustained at age 18 months (10.1% [95% CI 3.5-16.6]). This simple, inexpensive, well-tolerated regimen has the potential to significantly decrease HIV-1 perinatal transmission in less-developed countries.
Subject(s)
Anti-HIV Agents/therapeutic use , Disease Transmission, Infectious/prevention & control , HIV Infections/drug therapy , HIV Infections/prevention & control , HIV-1 , Infectious Disease Transmission, Vertical/prevention & control , Nevirapine/therapeutic use , Pregnancy Complications, Infectious/drug therapy , Zidovudine/therapeutic use , Adult , Drug Administration Schedule , Female , Follow-Up Studies , HIV Infections/transmission , Humans , Infant , Infant, Newborn , Labor Onset/drug effects , Pregnancy , UgandaABSTRACT
BACKGROUND: Few population-based studies exist on the HIV care continuum in sub-Saharan Africa. We aimed to describe engagement in care in all adults with an existing diagnosis of HIV and to assess the time to and predictors of linkage and engagement in adults newly diagnosed via home-based counselling and testing (HBCT) in a high-prevalence setting in western Kenya. METHODS: Data were derived from AMPATH (Academic Model Providing Access to Healthcare), which has provided HIV care in western Kenya since 2001 and the HBCT programme, which has been operating since 2007. After a widespread HBCT programme in Bunyala subcounty from December, 2009, to February, 2011, we reviewed electronic medical records to identify uptake of care in individuals (aged 13 years or older) with previously known (self-reported) infection and new (identified at HBCT) HIV diagnoses as of June 1, 2014. We defined engagement in HIV care as an initial encounter with an HIV care provider. We used Cox regression analysis to examine the predictors of engagement in care for newly diagnosed individuals. FINDINGS: Of the 3482 adults with HIV identified at HBCT, 2122 (61%) had previously been diagnosed with HIV, of whom 1778 (84%) had had at least one clinical encounter within AMPATH. 993 (73%) of the 1360 individuals with new diagnoses at HBCT were registered in the electronic medical records, although only 209 (15%) had seen a clinician over a median of 3·4 years since diagnosis. The median time to engagement in the newly diagnosed individuals was 60 days (IQR 10411). INTERPRETATION: Creative and innovative strategies are needed to support people to engage with care when they are newly diagnosed with HIV through population-based case-finding initiatives. FUNDING: US President's Emergency Plan for AIDS Relief (PEPFAR), Abbott Laboratories, the Purpleville Foundation, the Global Business Coalition, the US National Institute of Mental Health, and the Bill & Melinda Gates Foundation.
Subject(s)
Continuity of Patient Care , Adult , Continuity of Patient Care/standards , Continuity of Patient Care/statistics & numerical data , Counseling , Electronic Health Records , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , Humans , Kenya/epidemiology , Male , Middle Aged , Standard of CareABSTRACT
OBJECTIVE: To describe the nutritional status of orphaned and separated children and adolescents (OSCA) living in households in the community (HH), on the street, and those in institutional environments in western Kenya. METHODS: The study enrolled OSCA from 300 randomly selected households (HH), 19 Charitable Children's Institutions (CCIs), and 100 street-involved children. Measures of malnutrition were standardized with Z-scores using World Health Organization criteria; Z-scores ≤-2 standard deviations (sd) were moderate-severe malnutrition. Data were analyzed using multivariable logistic regression adjusting for child age, sex, HIV status, whether the child had been hospitalized in the previous year, time living with current guardian, and intra-household clustering for adequacy of diet and moderate-severe malnutrition. RESULTS: Included are data from 2862 participants (1337 in CCI's, 1425 in HH's, and 100 street youth). The population was 46% female with median age at enrolment of 11.1 years. Only 4.4% of households and institutions reported household food security; 93% of children in HH reported an adequate diet vs. 95% in CCI's and 99% among street youth. After adjustment, OSCA in HH were less likely to have an adequate diet compared to those in CCI's (AOR 0.4, 95% CI 0.2-1.0). After adjustment, there were no differences between the categories of children on weight-for-age, weight-for-height, or BMI-for-age. Children living in HH (AOR 2.6, 95% CI: 2.0-3.4) and street youth (AOR: 5.9, 95% CI: 3.6-9.5) were more likely than children in CCI's to be low height-for-age. CONCLUSION: OSCA in HH are less likely to have an adequate diet compared to children in CCI's. They and street children are more likely to be moderately-severely low height-for-age compared to children in CCI's, suggesting chronic malnutrition among them.