270 research outputs found
Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol
In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resource settings, centralized systems often lead to result turnaround times of several months, long delays in diagnosis, and adverse outcomes for HIV-infected children. Our clinical trial tests the effectiveness of a new point-of-care (POC) diagnostic technology to identify HIV-infected infants and start providing them life-saving ART as soon as possible
Modern Contraceptive and Dual Method Use among HIV-Infected Women in Lusaka, Zambia
HIV-infected women
in sub-Saharan Africa are at substantial risk of
unintended pregnancy and sexually transmitted
infections (STIs). Linkages between HIV and
reproductive health services are advocated. We
describe implementation of a reproductive health
counseling intervention in 16 HIV clinics in
Lusaka, Zambia. Between November 2009 and
November 2010, 18,407 women on antiretroviral
treatment (ART) were counseled. The median age
was 34.6 years (interquartile range (IQR):
29.9–39.7), and 60.1% of women were
married. The median CD4+ cell count
was 394 cells/uL (IQR: 256–558). Of
the women counseled, 10,904 (59.2%) reported
current modern contraceptive use. Among
contraceptive users, only 17.7% reported
dual method use. After counseling, 737 of 7,503
women not previously using modern contraception
desired family planning referrals, and 61.6%
of these women successfully accessed services
within 90 days. Unmet contraceptive need remains
high among HIV-infected women. Additional
efforts are needed to promote reproductive
health, particularly dual method
use
Antiretroviral drug regimens to prevent mother-to-child transmission of HIV : a review of scientific, program, and policy advances for sub-Saharan Africa.
CAPRISA 2013.Considerable advances have been made in the effort to prevent mother-to-child HIV transmission
(PMTCT) in sub-Saharan Africa. Clinical trials have demonstrated the efficacy of antiretroviral
regimens to interrupt HIV transmission through the antenatal, intrapartum, and postnatal periods.
Scientific discoveries have been rapidly translated into health policy, bolstered by substantial
investment in health infrastructure capable of delivering increasingly complex services. A new
scientific agenda is also emerging, one that is focused on the challenges of effective and
sustainable program implementation. Finally, global campaigns to “virtually eliminate” pediatric
HIV and dramatically reduce HIV-related maternal mortality have mobilized new resources and
renewed political will. Each of these developments marks a major step in regional PMTCT efforts;
their convergence signals a time of rapid progress in the field, characterized by an increased
interdependency between clinical research, program implementation, and policy. In this review,
we take stock of recent advances across each of these areas, highlighting the challenges – and
opportunities – of improving health services for HIV-infected mothers and their children across
the region
Lost but Not Forgotten—The Economics of Improving Patient Retention in AIDS Treatment Programs
Gregory Bisson and Jeffrey Stringer discuss the implications of a new study showing how loss to follow-up affects the effectiveness of a public sector HIV program in Côte d'Ivoire
Design of the HIV Prevention Trials Network (HPTN) Protocol 054: A cluster randomized crossover trial to evaluate combined access to Nevirapine in developing countries
HPTN054 is a cluster randomized trial designed to compare two approaches to providing single dose nevirapine to HIV-seropositive mothers and their infants to prevent mother-to-child transmission of HIV in resource limited settings. A number of challenging issues arose during the design of this trial. Most importantly, the need to achieve high participation rates among pregnant, HIV-seropositive women in selected prenatal care clinics led us to develop a method of collecting anonymous and unlinked information on a key surrogate endpoint instead of pursuing linked and identified information on a clinical endpoint. In addition, since group counseling is the standard model for prenatal care in sub-Saharan Africa, the prenatal care clinic serves as the unit of randomization. However, constraints on the number of suitable clinics and other logistical difficulties necessitated a unique type of hybrid parallel/stepped wedge cluster randomized design in which some clinics cross over between the two treatment modalities and some do not. We describe the design for the HPTN054 trial with an emphasis on the logistic and statistical features that allowed us to address these issues. We also provide some general statistical results that are useful for computing power in parallel, crossover, stepped wedge or mixed designs of cluster randomized trials
A Controlled Trial of Three Methods for Neonatal Circumcision in Lusaka, Zambia
Neonatal male circumcision (NMC) is not routinely practiced in Zambia, but it promising long-term HIV prevention strategy. We studied the feasibility and safety of three different NMC method
A Preliminary Assessment of Rotavirus Vaccine Effectiveness in Zambia
BACKGROUND: Diarrhea is the third leading cause of child death in Zambia. Up to one-third of diarrhea cases resulting in hospitalization and/or death are caused by vaccine-preventable rotavirus. In January 2012, Zambia initiated a pilot introduction of the Rotarix live, oral rotavirus vaccine in all public health facilities in Lusaka Province.
METHODS: Between July 2012 and October 2013, we conducted a case-control study at 6 public sector sites to estimate rotavirus vaccine effectiveness (VE) in age-eligible children presenting with diarrhea. We computed the odds of having received at least 1 dose of Rotarix among children whose stool was positive for rotavirus antigen (cases) and children whose stool was negative (controls). We adjusted the resulting odds ratio (OR) for patient age, calendar month of presentation, and clinical site, and expressed VE as (1 - adjusted OR) × 100.
RESULTS: A total of 91 rotavirus-positive cases and 298 rotavirus-negative controls who had under-5 card-confirmed vaccination status and were ≥6 months of age were included in the case-control analysis. Among rotavirus-positive children who were age-eligible to be vaccinated, 20% were hospitalized. Against rotavirus diarrhea of all severity, the adjusted 2-dose VE was 26% (95% confidence interval [CI], -30% to 58%) among children ≥6 months of age. VE against hospitalized children ≥6 months of age was 56% (95% CI, -34% to 86%).
CONCLUSIONS: We observed a higher point estimate for VE against increased severity of illness compared with milder disease, but were not powered to detect a low level of VE against milder disease
Multiple Overimputation to Address Missing Data and Measurement Error: Application to HIV Treatment During Pregnancy and Pregnancy Outcomes
Investigations of the association of combination antiretroviral therapy (ART) with pregnancy outcomes often rely on routinely collected clinical data, which are prone to missing data and measurement error. Measurement error in gestational age may bias the relationship between combination ART and gestational age-based outcomes
Advancing Cervical Cancer Prevention Initiatives in Resource-Constrained Settings: Insights from the Cervical Cancer Prevention Program in Zambia
Groesbeck Parham and colleagues describe their Cervical Cancer Prevention Program
in Zambia, which has provided services to over 58,000 women over the past five
years, and share lessons learned from the program's implementation and
integration with existing HIV/AIDS programs
A Cluster Randomized Trial of Routine HIV-1 Viral Load Monitoring in Zambia: Study Design, Implementation, and Baseline Cohort Characteristics
The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree).Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months.From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites.A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings.Clinicaltrials.gov NCT00929604
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