Predict trial hiv

Abstract The pox-protein regimen tested in the RV trial is the only vaccine strategy demonstrated to prevent HIV-1 infection.

Publication types Research Support, N. Table 3 HIV clinical disease progression and rate of hospital admissions. Figure 3. Supplementary Material appendix Click here to view.

SJK wrote the statistical analysis plan, which was reviewed by all authors. SJK did the final analysis. All authors contributed to the interpretation of the findings.

All authors commented extensively, critically revised the report, and approved the final version. See appendix for a full list of collaborators and research sites. References 1. Early infant HIV-1 diagnosis programs in resource-limited settings: opportunities for improved outcomes and more cost-effective interventions.

BMC Med. Effectiveness of pediatric antiretroviral therapy in resource-limited settings: a systematic review and meta-analysis. Clin Infect Dis. Morbidity and mortality in European children vertically infected by HIV Survival, disease manifestations, and early predictors of disease progression among children with perinatal human immunodeficiency virus infection in Thailand.

Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. Recommendations for a public health approach. Geneva: World Health Organization; Antiretroviral therapy for HIV infection in infants and children: towards universal access.

Reduction in mortality with availability of antiretroviral therapy for children with perinatal HIV-1 infection. Revised classification system for human immunodeficiency virus infection in children less than 13 years of age. Antiretroviral therapy of HIV infection in infants and children in resource-limited settings: towards universal access.

Table for grading the severity of adult and pediatric adverse events. Initiation of antiretroviral treatment with dual nucleoside reverse transcriptase inhibitors in human immunodeficiency virus-infected infants with less advanced disease in a resource-limited setting: a multi-center study in Thailand — J Med Assoc Thai. J Acquir Immune Defic Syndr. Long-term survival of HIV-infected children receiving antiretroviral therapy in Thailand: a 5-year observational cohort study.

Short-term risk of disease progression in HIVinfected children receiving no antiretroviral therapy or zidovudine monotherapy: a meta-analysis. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti.

Taylor KM. Relationship between visual motor integration skill and academic performance in kindergarten through third grade. Optom Vis Sci. Are the results of the Beery-Buktenica Developmental Test of Visual-Motor Integration and its subtests related to achievement test scores?

Correlations of scores on the developmental test of visual-motor integration and copying test in a South African multi-ethnic preschool sample. Percept Mot Skills. Poor cognitive functioning of school-aged children in Thailand with perinatally acquired HIV infection taking antiretroviral therapy. Early antiretroviral therapy improves neurodevelopmental outcomes in infants. Pattern and predictors of immunologic recovery in human immunodeficiency virus-infected children receiving non-nucleoside reverse transcriptase inhibitor-based highly active antiretroviral therapy.

QI uptake maybe enhanced in settings where monitoring data for improvement has been a routine practice. The effects of QI interventions are enhanced in contexts that are supportive of change and well organized for delivering integrated HIV-TB services. The Context Assessment for Community Health tool should be considered for rapid assessment of whether a setting is receptive and ready for change.

Fostering a culture of using data for improvement can be facilitated by ensuring data is accurate and accessible to clinic teams. Among high burden countries for tuberculosis TB , South Africa ranks second highest for TB incidence rates, estimated at cases per population [ 1 ]. South Africa has a significant contribution to make in achieving these targets and addressing the HIV-TB burden is a key public health priority [ 3 ].

Recent studies have highlighted gaps in integrated HIV-TB service delivery such as patients missed for screening and diagnosis of HIV and TB [ 5 , 6 , 7 ]; missed viral load monitoring [ 8 ]; and sub-optimal coverage of TB prevention treatment for eligible HIV patients [ 1 ]. Missed opportunities to offer HIV-TB services to patients already accessing healthcare point to health systems weaknesses at the frontline of healthcare. QI collaboratives offer a potentially effective strategy to facilitate scale-up of best practices in HIV-TB service delivery [ 9 ].

While there are many adaptions of QI collaboratives, the essential components include i different facility teams work together to improve performance on a common health topic, led by a faculty of experts; ii sharing of experiences, change ideas, and best practices between clinic teams; and iii mentorship of clinic teams to develop and rapidly test change ideas for a given improvement aim [ 10 ].

This approach is premised on the principle that group learning accelerates the generation of change ideas and optimally utilizes experts to facilitate learning and inform best practices [ 10 , 11 ].

First becoming popular in high-income countries before spreading to low- and middle-income countries, QI collaboratives are widely adopted and utilized for improvement in a multitude of health topics since their introduction over 30 years ago [ 10 , 11 ]. As the strategy proliferated, concerns regarding lack of clear evidence of effectiveness, cost-effectiveness, replicability, and sustainability have been raised [ 10 , 11 , 12 , 13 , 14 , 15 ].

Similarly, a review of 29 QI collaboratives, specifically from low- and middle-income countries, found variations in improvement; however, larger improvements were more likely when a training component was added to the QI collaborative strategy as opposed to QI collaborative alone [ 14 ]. The variation between settings suggests that what works in one setting may not work in other settings [ 10 ].

The few studies that investigated contextual factors influencing the QI outcomes, attribute variations to baseline performance low performing indicators have a larger room for improvement [ 13 ], simplicity of interventions [ 20 ], and clinic team characteristics such as leadership, access to resources, and clinical skills [ 21 , 22 ].

In recent literature, supportiveness of organizational contexts for change is emerging as a key factor for implementing new interventions or changes [ 23 , 24 ]. Given the use of experts, time away from clinics to attend collaborative meetings, and in-person mentorship activities, QI collaboratives represent a substantial investment in time and resources and have been cited as costly [ 12 ].

Understanding which and how contextual factors impact QI collaboratives is important to enhance success and sustainability of this strategy [ 11 , 17 ]. This is a sub-study of the SUTHI trial, to determine which organizational contextual factors influenced the QI intervention to improve HIV-TB services so that these factors can be strengthened in future scale-up efforts.

A secondary objective was to determine if there were any major differences in organizational contextual factors OCF in the QI arm compared to the standard of care arm comparator group which may explain the differences in HIV-TB process outcomes observed in the two study arms.

Sixteen nurse supervisors clusters and the 40 primary healthcare PHC clinics under their oversight, were randomly assigned to either a QI intervention hereafter known as the QI arm or to standard of care SOC support and supervision hereafter known as the SOC arm. Eight nurse supervisors and their 20 clinics were assigned to the QI arm and eight nurse supervisors and their 20 clinics were assigned to the SOC arm.

All study clinics were followed up for 18 months. Parallel to the implementation of the parent study, OCFs were assessed at set study time points using surveys administered to consenting clinic staff, and study exit focus group discussions FGDs conducted with clinic staff from both study arms.

Nurse supervisors and clinics in the QI arm formed the QI collaborative. The collaborative met for three 2-day learning sessions timed at 6-month intervals. Learning sessions included coursework on the principles and practice of QI methods and interactive group-based work. Figure 1 illustrates the topics covered at each learning session. Six-month intervals allowed clinic teams time to develop and test changes ideas, and acquire best practices to present to each other. Between learning sessions, a QI nurse mentor, made in-person visits to clinics and provided QI mentorship, reinforced knowledge from learning sessions, and reviewed clinic data.

The Model for Improvement was the methodological framework to identify, develop and test change ideas [ 26 ]. Rapid, plan-do-study-act cycles facilitated the development and testing of change ideas at the clinic level.

QI mentorship visits were fortnightly for the first 12 months and reduced to once a month for the last six months of the study period. The framework proposes that successful implementation of evidence is a function of three inter-related key elements: i the strength of the evidence being implemented, ii the supportiveness of the context in which implementation is occurring, and iii the facilitation mechanism used to introduce change [ 19 ].

The PARIHS framework identified key elements of a supportive organizational context, namely: physical infrastructure, human resources, leadership support, monitoring and evaluation of performance, and receptiveness of contexts to implement changes [ 19 ]. These key elements were adopted and assessed in this sub-study.

In addition, we reviewed other studies that measured clinic-level factors and identified flexibility in clinic hours, and clinic-level organization and planning for integrated HIV-TB service delivery, as elements of organizational context that were relevant to this sub-study [ 27 , 28 ]. In Table 1 , we define each the OCFs assessed in this study.

We searched for piloted, validated, and published measures to quantitatively assess the selected OCFs. We adopted tools appropriate for low-and middle-income countries and where no tool was available or appropriate, we designed a tool in-house. Figure 1 illustrates the study time points at which each survey was administered and Table 1 shows who were involved in completing the surveys. Amendments included using words and terms that were familiar to clinic staff in our setting and we added on items pertaining to integration of HIV and TB systems.

The CPT contained several sub-scales; however, we only assessed the following: physical infrastructure, key staff availability, flexibility of clinic hours, monitoring data for improvement, and leadership support from the District Health Offices. This survey was completed jointly by a trained study staff member and the clinic facility manager and in some instances direct observation by study staff were used to confirm responses.

Table 1 shows the scoring method used to assess each OCF. The CPT was administered at baseline only Fig. Due to limited study resources and time, the CPT was not validated.

Additional file 1 contains the full CPT. Developed by Bergstrom et al. The survey has eight sub-scales, namely: resources, community engagement, monitoring services for action, knowledge sources, commitment to work, work culture, leadership, and informal payment Additional file 2. Importantly, some sub-scales in the COACH survey overlap with the CPT Leadership, Resources, and Monitoring data for improvement ; however, the defining characteristic is that the COACH measures perceptions of clinic staff and the CPT was a relatively more objective measure where direct observation and verification of data were used.

The degree to which HIV and TB services are integrated at a clinic level is a function of joint planning and coordination of different clinic teams and systems. Uyei et al. The tool was administered at baseline and months 6, 12, and The parent study collected data on HIV-TB process indicators in both study arms from clinic registers and patient electronic database downloads.

Monthly summary data on the number of patients that received a service numerator and number of patients who were eligible for a service denominator were collected and proportions calculated to monitor improvement for each HIV-TB process indicator. Clinic staff from both arms were recruited to participate in a study exit interview.

A purposive sample of clinic staff were recruited based on category of staff, availability and years spent in the clinic at least 1 year. FGDs were conducted, using a semi-structured interview guide that was developed in-house Additional file 4. FGDs were conducted primarily in isiZulu and voice recorded. All participating clinic staff provided signed consent. Voice recordings were transcribed verbatim and then translated to English for analyses.

Two study staff read the transcripts separately and extracted themes, including any barriers or facilitators to implementing QI or HIV-TB service integration.

Themes were compared and common themes adopted. Direct quotes that supported a theme were highlighted. Eleven FGDs involving 43 clinic staff were conducted. In the QI arm, there were 16 female and four male participants and the mean number of years served in the clinic was 5. In the SOC arm there were 18 female and three male participants and the mean number of years served in the clinic was 6.

Participation in the surveys and FGDs were offered to professional nurses, enrolled nurses, lay counsellors, and data capturers. Written consent and at least 1 year of full-time employment were the minimum criteria. At baseline, we approached clinic staff in both the QI and SOC arms and gauged their interest for participation in the surveys once every 6 months.

This study will last weeks. The HAART regimen will consist of two nucleoside reverse transcriptase inhibitors, zidovudine and lamivudine. In addition, participants will also receive either one non-nucleoside reverse transcriptase inhibitor, nevirapine or efavirenz, or one protease inhibitor, ritonavir-boosted lopinavir or nelfinavir. Abacavir will replace zidovudine or lamivudine if participants experience toxicity to the regimen.

Study visits will occur every 4 weeks for the first 12 weeks and then every 12 weeks until the end of the study. Blood collection, physical exams, and medical and medication history reviews will occur at all visits.

Adherence, quality of life, and lipodystrophy assessments will occur every 12 weeks for participants on HAART. Participants will be encouraged to enroll in a related substudy to examine the neurodevelopment of HIV infected children. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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