Siobhan Crowley - Academia.edu (original) (raw)

Papers by Siobhan Crowley

Research paper thumbnail of RESEARCH ARTICLE CD4 Enumeration Technologies: A Systematic Review of Test Performance for Determining Eligibility for Antiretroviral Therapy

Background Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HI... more Background Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HIV patients, particularly in determining eligibility to initiate antiretroviral treatment (ART). A number of technologies exist for CD4 enumeration, with considerable variation in cost, com-plexity, and operational requirements. We conducted a systematic review of the perfor-mance of technologies for CD4 enumeration. Methods and Findings Studies were identified by searching electronic databases MEDLINE and EMBASE using a pre-defined search strategy. Data on test accuracy and precision included bias and limits of agreement with a reference standard, and misclassification probabilities around CD4 thresholds of 200 and 350 cells/μl over a clinically relevant range. The secondary outcome measure was test imprecision, expressed as % coefficient of variation. Thirty-two studies evaluating 15 CD4 technologies were included, of which less than half presented data on

Research paper thumbnail of Neglected tropical disease control in a world with COVID-19: an opportunity and a necessity for innovation

Transactions of The Royal Society of Tropical Medicine and Hygiene

Countries have seen substantial disruptions to usual health services related to coronavirus disea... more Countries have seen substantial disruptions to usual health services related to coronavirus disease 2019 and these are likely to have immediate and long-term indirect effects on many disease control programmes, including neglected tropical diseases (NTDs). The pandemic has highlighted the usefulness of mathematical modelling to understand the impacts of these disruptions and future control measures on progress towards 2030 NTD goals. The pandemic also provides an opportunity, and a practical necessity, to transform NTD programmes through innovation.

Research paper thumbnail of Supporting registration of child-focused clinical trials in Africa: the Child Strategy Project

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2011

Child-focused health care workers are compelled to prescribe medicines that lack adequate dosage ... more Child-focused health care workers are compelled to prescribe medicines that lack adequate dosage guidelines for children, as dosing is often derived from data extrapolated from adult studies. Given that the pharmacokinetics and pharmacodynamics of treatments are often unknown for children, and that effectiveness may vary according to age, developmental stage and body size, there is an urgent need to study diagnostic and therapeutic interventions in children to increase the evidence base. A 2005 report of African HIV trial activity identified 77 randomised controlled HIV/AIDS trials prior to 2004. Analysis revealed poor representation of children and adolescents. Currently there is no database dedicated to collating child-focused clinical research for the African continent. Our aim is to summarise evolving efforts for such a resource.

Research paper thumbnail of The role of water, sanitation and hygiene interventions in reducing soil-transmitted helminths: interpreting the evidence and identifying next steps

Parasites & Vectors

The transmission soil transmitted helminths (STH) occurs via ingestion of or contact with infecti... more The transmission soil transmitted helminths (STH) occurs via ingestion of or contact with infective stages present in soil contaminated with human faeces. It follows therefore that efforts to reduce faecal contamination of the environment should help to reduce risk of parasite exposure and improvements in water, sanitation and hygiene (WASH) are seen as essential for the long-term, sustainable control of STH. However, the link between WASH and STH is not always supported by the available evidence from randomised controlled trials, which report mixed effects of WASH intervention on infection risk. This review critically summarises the available trial evidence and offers an interpretation of the observed heterogeneity in findings. The review also discusses the implications of findings for control programmes and highlights three main issues which merit further consideration: intervention design, exposure assessment, and intervention fidelity assessment.

Research paper thumbnail of Impact of the National Prevention of Mother to Child Transmission of HIV (PMTCT) Program on Perinatal Mother-to-Child Transmission of HIV (MTCT) Measured at 6 weeks Postpartum, South Africa (SA): Results of the First Year of Implementation of the 2010 PMTCT Guidelines Recommended by the World Hea...

Research paper thumbnail of WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children

Research paper thumbnail of RESULTS of the 1ST SOUTH African NATIONAL Pmtct 6 WEEK Infant Survey

Background: The South African National Strategic plan (2007-2011) prioritises scaling up of PMTCT... more Background: The South African National Strategic plan (2007-2011) prioritises scaling up of PMTCT to reduce MTCT to less than 5% by 2011. The aim of this study is to conduct facility-based survey to monitor the effectiveness of the South African National PMTCT programme with a primary objective to measure rates of early MTCT at 6-weeks postpartum. Methods: A national cross-sectional facility-based survey, using a biomedical marker to determine MTCT, was conducted. The study population comprised infants aged 4-8 weeks visiting public health facilities for their 1st DTP dose between June-December 2010. Data were gathered by trained nurses using a questionnaire adapted from validated tools. Data entry was completed using a novel cell phone based technology. Infant DBSs were screened for the presence of HIV-antibody. HIV DNA PCR testing was undertaken on all ELISA positive samples to establish infant HIV infection status. Results: By 6 December 2010, data from 9610 (78.8%) of consenting...

Research paper thumbnail of Identifying Gaps Along the Prevention of Mother-to-Child Transmission of HIV (PMTCT) Cascade to Achieve the Mother-to-Child Transmission (MTCT) Elimination Goals: Results From the South African PMTCT Effectiveness Survey (SAPMTCTE), 2011

Background: This analysis was conducted to identify gaps along the PMTCT cascade and associated f... more Background: This analysis was conducted to identify gaps along the PMTCT cascade and associated factors needing attention to achieve the MTCT-elimination goals. Methods: We analyzed data from a national cross-sectional facility-based survey enrolling 10253 caregivers with infants aged 4-8 weeks attending the first immunization visit using a stratified multi-stage sampling design. Data were collected through caregiver interviews and/or from Road-to-Health cards. HIV testing was offered to all infants regardless of HIV-exposure status. Findings: Of 9933 participating mothers, 94% (9304) reported having antenatal HIV-testing performed during pregnancy; 99% of those received test results. HIV infection was reported in 27% (2653) of mothers, including those knowing their HIV status before pregnancy; 53% (n=3579) of HIV-negative mothers whose last HIV test occurred at <32wks gestation were not offered a repeat test. Of all (2653) HIV-infected mothers, 84% had a CD4 test and 43% receive...

Research paper thumbnail of Missed Opportunities for Early Infant HIV Diagnosis

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2014

Background: Services to diagnose early infant HIV infection should be offered at the 6-week immun... more Background: Services to diagnose early infant HIV infection should be offered at the 6-week immunization visit. Despite high 6-week immunization attendance, the coverage of early infant diagnosis (EID) is low in many sub-Saharan countries. We explored reasons for such missed opportunities at 6-week immunization visits. Methods: We used data from 2 cross-sectional surveys conducted in 2010 in South Africa. A national assessment was undertaken among randomly selected public facilities (n = 625) to ascertain procedures for EID. A subsample of these facilities (n = 565) was revisited to assess the HIV status of 4-to 8-week-old infants receiving 6-week immunization. We examined potential missed opportunities for EID. We used logistic regression to assess factors influencing maternal intention to report for EID at 6-week immunization visits. Results: EID services were available in .95% of facilities and 72% of immunization service points (ISPs). The majority (68%) of ISPs provide EID for infants with reported or documented (on infant's Road-to-Health Chart/booklet-iRtHC) HIV exposure. Only 9% of ISPs offered provider-initiated counseling and testing for infants of undocumented/unknown HIV exposure. Interviews with selfreported HIV-positive mothers at ISPs revealed that only 55% had their HIV status documented on their iRtHC and 35% intended to request EID during 6-week immunization. Maternal nonreporting for EID was associated with fear of discrimination, poor adherence to antiretrovirals, and inadequate knowledge about mother-to-child HIV transmission. Conclusions: Missed opportunities for EID were attributed to poor documentation of HIV status on iRtHC, inadequate maternal knowledge about mother-to-child HIV transmission, fear of discrimination, and the lack of provider-initiated counseling and testing service for undocumented, unknown, or undeclared HIV-exposed infants.

Research paper thumbnail of Programmatic Impact of the Evolution of WHO Pediatric Antiretroviral Treatment Guidelines for Resource-Limited Countries (Tukula Fenna Project, Uganda)

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2012

Background: World Health Organization (WHO) recommendations for the initiation of antiretroviral ... more Background: World Health Organization (WHO) recommendations for the initiation of antiretroviral therapy (ART) in children were revised in 2010, but the programmatic impact has had limited study. Methods: We used a cohort of 985 Ugandan children followed since 2003 by the Tukula Fenna project to model the differential impact of the 2006, 2008, and 2010 WHO pediatric ART inititation criteria on the proportion of children eligible for ART at enrollment and over time.

Research paper thumbnail of What Strategies to Boost Production of Affordable Fixed-Dose Anti-Retroviral Drug Combinations for Children in the Developing World?

Current HIV Research, 2007

Background: No more than 8% of HIV positive children needing treatment in low-and middle-income c... more Background: No more than 8% of HIV positive children needing treatment in low-and middle-income countries have access to antiretroviral drugs (ARVs). Children presently account for about 4% of all treated patients, while for equitable access they should make up at least 13%. Aims: This study explores key issues, implications and interaction dynamics to boost production of easy-to-use and affordable fixed-dose combination (FDC) ARVs for children in the developing world. Potentials for equitable solutions are examined including priority steps and actions, appropriate treatment options and reliable forecasting methods for paediatric ARVs, as well as combination incentives to generic companies against market unattractiveness and enforced intellectual property (IP) rights. Moreover, implementation strategies to enhance the development and production of affordable ARV paediatric formulations and appropriate supply systems to ensure availability are investigated.

Research paper thumbnail of Monitoring scale-up of antiretroviral therapy programmes

Bulletin of the World Health Organization, 2006

This paper reviews the data sources and methods used to estimate the number of people on, and cov... more This paper reviews the data sources and methods used to estimate the number of people on, and coverage of, antiretroviral therapy (ART) programmes in low-and middle-income countries and to monitor the progress towards the "3 by 5" target set by WHO and UNAIDS. We include a review of the data sources used to estimate the coverage of ART programmes as well as the efforts made to avoid double counting and over-reporting. The methods used to estimate the number of people in need of ART are described and expanded with estimates of treatment needs for children, both for ART and for cotrimoxazole prophylaxis. An estimated 6.5 million people were in need of treatment in low-and middle-income countries by the end of 2004, including 660 000 children under age 15 years. The mid-2005 estimate of 970 000 people receiving ART in low-and middle-income countries (with an uncertainty range 840 000-1 100 000) corresponds to a coverage of 15% of people in need of treatment.

Research paper thumbnail of Costing Human Rights and Community Support Interventions as a Part of Universal Access to HIV Treatment and Care in a Southern African Setting

Current HIV Research, 2011

Expanding access to antiretroviral therapy (ART) has both individual health benefits and potentia... more Expanding access to antiretroviral therapy (ART) has both individual health benefits and potential to decrease HIV incidence. Ensuring access to HIV services is a significant human rights issue and successful programmes require adequate human rights protections and community support. However, the cost of specific human rights and community support interventions for equitable, sustainable and non-discriminatory access to ART are not well described. Human rights and community support interventions were identified using the literature and through consultations with experts. Specific costs were then determined for these health sector interventions. Population and epidemic data were provided through the Statistics South Africa 2009 national midyear estimates. Costs of scale up of HIV prevention and treatment were taken from recently published estimates. Interventions addressed access to services, minimising stigma and discrimination against people living with HIV, confidentiality, informed consent and counselling quality. Integrated HIV programme interventions included training for counsellors, 'Know Your Rights' information desks, outreach campaigns for most at risk populations, and adherence support. Complementary measures included post-service interviews, human rights abuse monitoring, transportation costs, legal assistance, and funding for human rights and community support organisations. Other essential non-health sector interventions were identified but not included in the costing framework. The annual costs for the human rights and community support interventions are United States (US) 63.8million(US63.8 million (US 63.8million(US1.22 per capita), representing 1.5% of total health sector HIV programme costs. Respect for human rights and community engagement can be understood both as an obligation of expanded ART programmes and as a critically important factor in their success. Basic rights-based and community support interventions constitute only a small percentage of overall programmes costs. ART programs should consider measuring the cost and impact of human rights and community support interventions as key aspects of successful programme expansion.

Research paper thumbnail of Supporting registration of child-focused clinical trials in Africa: the Child Strategy Project

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2011

Research paper thumbnail of Supporting registration of child-focused clinical trials in Africa: the Child Strategy Project

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2011

Research paper thumbnail of CD4 enumeration technologies: a systematic review of test performance for determining eligibility for antiretroviral therapy

PloS one, 2015

Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HIV patients,... more Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HIV patients, particularly in determining eligibility to initiate antiretroviral treatment (ART). A number of technologies exist for CD4 enumeration, with considerable variation in cost, complexity, and operational requirements. We conducted a systematic review of the performance of technologies for CD4 enumeration. Studies were identified by searching electronic databases MEDLINE and EMBASE using a pre-defined search strategy. Data on test accuracy and precision included bias and limits of agreement with a reference standard, and misclassification probabilities around CD4 thresholds of 200 and 350 cells/μl over a clinically relevant range. The secondary outcome measure was test imprecision, expressed as % coefficient of variation. Thirty-two studies evaluating 15 CD4 technologies were included, of which less than half presented data on bias and misclassification compared to the same reference techno...

Research paper thumbnail of Changes in antiretroviral therapy guidelines: implications for public health policy and public purses

Sexually transmitted infections, 2010

The World Health Organization (WHO) published a revision of the antiretroviral therapy (ART) guid... more The World Health Organization (WHO) published a revision of the antiretroviral therapy (ART) guidelines and now recommends ART for all those with a CD4 cell count ≤350/mm(3), for people with HIV and active tuberculosis (TB) or chronic active hepatitis B irrespective of CD4 cell count and all HIV-positive pregnant women. A study was undertaken to estimate the impact of the new guidelines using four countries as examples. The current WHO/UNAIDS country projections were accessed based on the 2007 estimates for Zambia, Kenya, Cameroon and Vietnam. New projections were created using Spectrum. CD4 progression rates to need for ART were modified and compared with the baseline projections. The pattern of increased need for treatment is similar across the four projections. Initiating treatment at a CD4 count <250/mm(3) will increase the need for treatment by a median of 22% immediately, initiating ART at a CD4 count <350/mm(3) increases the need for treatment by a median of 60%, and th...

Research paper thumbnail of Role of the Laboratory in Ensuring Global Access to ARV Treatment for HIV-Infected Children: Consensus Statement on the Performance of Laboratory Assays for Early Infant Diagnosis

The Open AIDS Journal, 2008

A two day meeting hosted by the World Health Organization (WHO) and the U.S. Centers for Disease ... more A two day meeting hosted by the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) was held in May 2006 in Entebbe, Uganda to review the laboratory performance of virologic molecular methods, particularly the Roche Amplicor DNA PCR version 1.5 assay, in the diagnosis of HIV-1 infection in infants. The meeting was attended by approximately 60 participants from 17 countries. Data on the performance and limitations of the HIV-1 DNA PCR assay from 9 African countries with high-burdens of HIV/AIDS were shared with respect to different settings and HIV-subtypes. A consensus statement on the use of the assay for early infant diagnosis was developed and areas of needed operational research were identified. In addition, consensus was reached on the usefulness of dried blood spot (DBS) specimens in childhood as a means for ensuring greater accessibility to serologic and virologic HIV testing for the paediatric population.

Research paper thumbnail of First population-level effectiveness evaluation of a national programme to prevent HIV transmission from mother to child, South Africa

Journal of epidemiology and community health, Jan 4, 2014

There is a paucity of data on the national population-level effectiveness of preventing mother-to... more There is a paucity of data on the national population-level effectiveness of preventing mother-to-child transmission (PMTCT) programmes in high-HIV-prevalence, resource-limited settings. We assessed national PMTCT impact in South Africa (SA), 2010. A facility-based survey was conducted using a stratified multistage, cluster sampling design. A nationally representative sample of 10 178 infants aged 4-8 weeks was recruited from 565 clinics. Data collection included caregiver interviews, record reviews and infant dried blood spots to identify HIV-exposed infants (HEI) and HIV-infected infants. During analysis, self-reported antiretroviral (ARV) use was categorised: 1a: triple ARV treatment; 1b: azidothymidine >10 weeks; 2a: azidothymidine ≤10 weeks; 2b: incomplete ARV prophylaxis; 3a: no antenatal ARV and 3b: missing ARV information. Findings were adjusted for non-response, survey design and weighted for live-birth distributions. Nationally, 32% of live infants were HEI; early mothe...

Research paper thumbnail of O progresso global da PTV e tratamento do HIV pediátrico em países de baixa e média renda em 2004-2005

Resumo: Um crescente número de países busca ampliar as intervenções para prevenção da transmissão... more Resumo: Um crescente número de países busca ampliar as intervenções para prevenção da transmissão vertical do HIV de mãe para filho (PTV) nos serviços de saúde materna e infantil. Similarmente, muitos desses países estão trabalhando para melhorar o acesso ao tratamento do HIV pediátrico. Este artigo analisa dados de programas nacionais de 2004-2005 de países de baixa e média renda, acompanhando os progressos desses programas. A realização do objetivo do UNGASS de reduzir as infecções do HIV em 50% até 2010 necessita que 80% de todas as grávidas fazendo pré-natal recebam cuidados de PTV. Em 2005, apenas sete dos 71 países estavam alinhados com esse objetivo. Todavia, a cobertura de PTV aumentou de 7% em 2004 (58 países) para 11% em 2005 (71 países). Em 2005, 8% de todas as crianças nascidas de mães HIV-positivo receberam profilaxia anti-retroviral para PTV, comparados a 5% em 2004, apesar de somente 4% terem recebido o cotrimoxazole. Em 2005, 11% das crianças HIV-positivo que necessitavam tratamento anti-retroviral o receberam. Em 31 países que apresentaram dados, 28% das mulheres que receberam anti-retrovirais para PTV também relataram receber tratamento anti-retroviral para sua própria saúde. Atingir o objetivo do UNGASS é possível, mas serão necessários investimentos substanciais e compromissos para fortalecer os serviços de saúde materna e infantil, a força de trabalho em saúde e os sistemas de saúde, para passar de projetos pilotos a uma abordagem descentralizada e integrada. Palavras-chave: PTV, tratamento do HIV pediátrico, testagem e aconselhamento em HIV, tratamento anti-retroviral, cotrimoxazole, saúde materno-infantil, ampliação dos serviços.

Research paper thumbnail of RESEARCH ARTICLE CD4 Enumeration Technologies: A Systematic Review of Test Performance for Determining Eligibility for Antiretroviral Therapy

Background Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HI... more Background Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HIV patients, particularly in determining eligibility to initiate antiretroviral treatment (ART). A number of technologies exist for CD4 enumeration, with considerable variation in cost, com-plexity, and operational requirements. We conducted a systematic review of the perfor-mance of technologies for CD4 enumeration. Methods and Findings Studies were identified by searching electronic databases MEDLINE and EMBASE using a pre-defined search strategy. Data on test accuracy and precision included bias and limits of agreement with a reference standard, and misclassification probabilities around CD4 thresholds of 200 and 350 cells/μl over a clinically relevant range. The secondary outcome measure was test imprecision, expressed as % coefficient of variation. Thirty-two studies evaluating 15 CD4 technologies were included, of which less than half presented data on

Research paper thumbnail of Neglected tropical disease control in a world with COVID-19: an opportunity and a necessity for innovation

Transactions of The Royal Society of Tropical Medicine and Hygiene

Countries have seen substantial disruptions to usual health services related to coronavirus disea... more Countries have seen substantial disruptions to usual health services related to coronavirus disease 2019 and these are likely to have immediate and long-term indirect effects on many disease control programmes, including neglected tropical diseases (NTDs). The pandemic has highlighted the usefulness of mathematical modelling to understand the impacts of these disruptions and future control measures on progress towards 2030 NTD goals. The pandemic also provides an opportunity, and a practical necessity, to transform NTD programmes through innovation.

Research paper thumbnail of Supporting registration of child-focused clinical trials in Africa: the Child Strategy Project

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2011

Child-focused health care workers are compelled to prescribe medicines that lack adequate dosage ... more Child-focused health care workers are compelled to prescribe medicines that lack adequate dosage guidelines for children, as dosing is often derived from data extrapolated from adult studies. Given that the pharmacokinetics and pharmacodynamics of treatments are often unknown for children, and that effectiveness may vary according to age, developmental stage and body size, there is an urgent need to study diagnostic and therapeutic interventions in children to increase the evidence base. A 2005 report of African HIV trial activity identified 77 randomised controlled HIV/AIDS trials prior to 2004. Analysis revealed poor representation of children and adolescents. Currently there is no database dedicated to collating child-focused clinical research for the African continent. Our aim is to summarise evolving efforts for such a resource.

Research paper thumbnail of The role of water, sanitation and hygiene interventions in reducing soil-transmitted helminths: interpreting the evidence and identifying next steps

Parasites & Vectors

The transmission soil transmitted helminths (STH) occurs via ingestion of or contact with infecti... more The transmission soil transmitted helminths (STH) occurs via ingestion of or contact with infective stages present in soil contaminated with human faeces. It follows therefore that efforts to reduce faecal contamination of the environment should help to reduce risk of parasite exposure and improvements in water, sanitation and hygiene (WASH) are seen as essential for the long-term, sustainable control of STH. However, the link between WASH and STH is not always supported by the available evidence from randomised controlled trials, which report mixed effects of WASH intervention on infection risk. This review critically summarises the available trial evidence and offers an interpretation of the observed heterogeneity in findings. The review also discusses the implications of findings for control programmes and highlights three main issues which merit further consideration: intervention design, exposure assessment, and intervention fidelity assessment.

Research paper thumbnail of Impact of the National Prevention of Mother to Child Transmission of HIV (PMTCT) Program on Perinatal Mother-to-Child Transmission of HIV (MTCT) Measured at 6 weeks Postpartum, South Africa (SA): Results of the First Year of Implementation of the 2010 PMTCT Guidelines Recommended by the World Hea...

Research paper thumbnail of WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children

Research paper thumbnail of RESULTS of the 1ST SOUTH African NATIONAL Pmtct 6 WEEK Infant Survey

Background: The South African National Strategic plan (2007-2011) prioritises scaling up of PMTCT... more Background: The South African National Strategic plan (2007-2011) prioritises scaling up of PMTCT to reduce MTCT to less than 5% by 2011. The aim of this study is to conduct facility-based survey to monitor the effectiveness of the South African National PMTCT programme with a primary objective to measure rates of early MTCT at 6-weeks postpartum. Methods: A national cross-sectional facility-based survey, using a biomedical marker to determine MTCT, was conducted. The study population comprised infants aged 4-8 weeks visiting public health facilities for their 1st DTP dose between June-December 2010. Data were gathered by trained nurses using a questionnaire adapted from validated tools. Data entry was completed using a novel cell phone based technology. Infant DBSs were screened for the presence of HIV-antibody. HIV DNA PCR testing was undertaken on all ELISA positive samples to establish infant HIV infection status. Results: By 6 December 2010, data from 9610 (78.8%) of consenting...

Research paper thumbnail of Identifying Gaps Along the Prevention of Mother-to-Child Transmission of HIV (PMTCT) Cascade to Achieve the Mother-to-Child Transmission (MTCT) Elimination Goals: Results From the South African PMTCT Effectiveness Survey (SAPMTCTE), 2011

Background: This analysis was conducted to identify gaps along the PMTCT cascade and associated f... more Background: This analysis was conducted to identify gaps along the PMTCT cascade and associated factors needing attention to achieve the MTCT-elimination goals. Methods: We analyzed data from a national cross-sectional facility-based survey enrolling 10253 caregivers with infants aged 4-8 weeks attending the first immunization visit using a stratified multi-stage sampling design. Data were collected through caregiver interviews and/or from Road-to-Health cards. HIV testing was offered to all infants regardless of HIV-exposure status. Findings: Of 9933 participating mothers, 94% (9304) reported having antenatal HIV-testing performed during pregnancy; 99% of those received test results. HIV infection was reported in 27% (2653) of mothers, including those knowing their HIV status before pregnancy; 53% (n=3579) of HIV-negative mothers whose last HIV test occurred at <32wks gestation were not offered a repeat test. Of all (2653) HIV-infected mothers, 84% had a CD4 test and 43% receive...

Research paper thumbnail of Missed Opportunities for Early Infant HIV Diagnosis

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2014

Background: Services to diagnose early infant HIV infection should be offered at the 6-week immun... more Background: Services to diagnose early infant HIV infection should be offered at the 6-week immunization visit. Despite high 6-week immunization attendance, the coverage of early infant diagnosis (EID) is low in many sub-Saharan countries. We explored reasons for such missed opportunities at 6-week immunization visits. Methods: We used data from 2 cross-sectional surveys conducted in 2010 in South Africa. A national assessment was undertaken among randomly selected public facilities (n = 625) to ascertain procedures for EID. A subsample of these facilities (n = 565) was revisited to assess the HIV status of 4-to 8-week-old infants receiving 6-week immunization. We examined potential missed opportunities for EID. We used logistic regression to assess factors influencing maternal intention to report for EID at 6-week immunization visits. Results: EID services were available in .95% of facilities and 72% of immunization service points (ISPs). The majority (68%) of ISPs provide EID for infants with reported or documented (on infant's Road-to-Health Chart/booklet-iRtHC) HIV exposure. Only 9% of ISPs offered provider-initiated counseling and testing for infants of undocumented/unknown HIV exposure. Interviews with selfreported HIV-positive mothers at ISPs revealed that only 55% had their HIV status documented on their iRtHC and 35% intended to request EID during 6-week immunization. Maternal nonreporting for EID was associated with fear of discrimination, poor adherence to antiretrovirals, and inadequate knowledge about mother-to-child HIV transmission. Conclusions: Missed opportunities for EID were attributed to poor documentation of HIV status on iRtHC, inadequate maternal knowledge about mother-to-child HIV transmission, fear of discrimination, and the lack of provider-initiated counseling and testing service for undocumented, unknown, or undeclared HIV-exposed infants.

Research paper thumbnail of Programmatic Impact of the Evolution of WHO Pediatric Antiretroviral Treatment Guidelines for Resource-Limited Countries (Tukula Fenna Project, Uganda)

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2012

Background: World Health Organization (WHO) recommendations for the initiation of antiretroviral ... more Background: World Health Organization (WHO) recommendations for the initiation of antiretroviral therapy (ART) in children were revised in 2010, but the programmatic impact has had limited study. Methods: We used a cohort of 985 Ugandan children followed since 2003 by the Tukula Fenna project to model the differential impact of the 2006, 2008, and 2010 WHO pediatric ART inititation criteria on the proportion of children eligible for ART at enrollment and over time.

Research paper thumbnail of What Strategies to Boost Production of Affordable Fixed-Dose Anti-Retroviral Drug Combinations for Children in the Developing World?

Current HIV Research, 2007

Background: No more than 8% of HIV positive children needing treatment in low-and middle-income c... more Background: No more than 8% of HIV positive children needing treatment in low-and middle-income countries have access to antiretroviral drugs (ARVs). Children presently account for about 4% of all treated patients, while for equitable access they should make up at least 13%. Aims: This study explores key issues, implications and interaction dynamics to boost production of easy-to-use and affordable fixed-dose combination (FDC) ARVs for children in the developing world. Potentials for equitable solutions are examined including priority steps and actions, appropriate treatment options and reliable forecasting methods for paediatric ARVs, as well as combination incentives to generic companies against market unattractiveness and enforced intellectual property (IP) rights. Moreover, implementation strategies to enhance the development and production of affordable ARV paediatric formulations and appropriate supply systems to ensure availability are investigated.

Research paper thumbnail of Monitoring scale-up of antiretroviral therapy programmes

Bulletin of the World Health Organization, 2006

This paper reviews the data sources and methods used to estimate the number of people on, and cov... more This paper reviews the data sources and methods used to estimate the number of people on, and coverage of, antiretroviral therapy (ART) programmes in low-and middle-income countries and to monitor the progress towards the "3 by 5" target set by WHO and UNAIDS. We include a review of the data sources used to estimate the coverage of ART programmes as well as the efforts made to avoid double counting and over-reporting. The methods used to estimate the number of people in need of ART are described and expanded with estimates of treatment needs for children, both for ART and for cotrimoxazole prophylaxis. An estimated 6.5 million people were in need of treatment in low-and middle-income countries by the end of 2004, including 660 000 children under age 15 years. The mid-2005 estimate of 970 000 people receiving ART in low-and middle-income countries (with an uncertainty range 840 000-1 100 000) corresponds to a coverage of 15% of people in need of treatment.

Research paper thumbnail of Costing Human Rights and Community Support Interventions as a Part of Universal Access to HIV Treatment and Care in a Southern African Setting

Current HIV Research, 2011

Expanding access to antiretroviral therapy (ART) has both individual health benefits and potentia... more Expanding access to antiretroviral therapy (ART) has both individual health benefits and potential to decrease HIV incidence. Ensuring access to HIV services is a significant human rights issue and successful programmes require adequate human rights protections and community support. However, the cost of specific human rights and community support interventions for equitable, sustainable and non-discriminatory access to ART are not well described. Human rights and community support interventions were identified using the literature and through consultations with experts. Specific costs were then determined for these health sector interventions. Population and epidemic data were provided through the Statistics South Africa 2009 national midyear estimates. Costs of scale up of HIV prevention and treatment were taken from recently published estimates. Interventions addressed access to services, minimising stigma and discrimination against people living with HIV, confidentiality, informed consent and counselling quality. Integrated HIV programme interventions included training for counsellors, 'Know Your Rights' information desks, outreach campaigns for most at risk populations, and adherence support. Complementary measures included post-service interviews, human rights abuse monitoring, transportation costs, legal assistance, and funding for human rights and community support organisations. Other essential non-health sector interventions were identified but not included in the costing framework. The annual costs for the human rights and community support interventions are United States (US) 63.8million(US63.8 million (US 63.8million(US1.22 per capita), representing 1.5% of total health sector HIV programme costs. Respect for human rights and community engagement can be understood both as an obligation of expanded ART programmes and as a critically important factor in their success. Basic rights-based and community support interventions constitute only a small percentage of overall programmes costs. ART programs should consider measuring the cost and impact of human rights and community support interventions as key aspects of successful programme expansion.

Research paper thumbnail of Supporting registration of child-focused clinical trials in Africa: the Child Strategy Project

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2011

Research paper thumbnail of Supporting registration of child-focused clinical trials in Africa: the Child Strategy Project

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2011

Research paper thumbnail of CD4 enumeration technologies: a systematic review of test performance for determining eligibility for antiretroviral therapy

PloS one, 2015

Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HIV patients,... more Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HIV patients, particularly in determining eligibility to initiate antiretroviral treatment (ART). A number of technologies exist for CD4 enumeration, with considerable variation in cost, complexity, and operational requirements. We conducted a systematic review of the performance of technologies for CD4 enumeration. Studies were identified by searching electronic databases MEDLINE and EMBASE using a pre-defined search strategy. Data on test accuracy and precision included bias and limits of agreement with a reference standard, and misclassification probabilities around CD4 thresholds of 200 and 350 cells/μl over a clinically relevant range. The secondary outcome measure was test imprecision, expressed as % coefficient of variation. Thirty-two studies evaluating 15 CD4 technologies were included, of which less than half presented data on bias and misclassification compared to the same reference techno...

Research paper thumbnail of Changes in antiretroviral therapy guidelines: implications for public health policy and public purses

Sexually transmitted infections, 2010

The World Health Organization (WHO) published a revision of the antiretroviral therapy (ART) guid... more The World Health Organization (WHO) published a revision of the antiretroviral therapy (ART) guidelines and now recommends ART for all those with a CD4 cell count ≤350/mm(3), for people with HIV and active tuberculosis (TB) or chronic active hepatitis B irrespective of CD4 cell count and all HIV-positive pregnant women. A study was undertaken to estimate the impact of the new guidelines using four countries as examples. The current WHO/UNAIDS country projections were accessed based on the 2007 estimates for Zambia, Kenya, Cameroon and Vietnam. New projections were created using Spectrum. CD4 progression rates to need for ART were modified and compared with the baseline projections. The pattern of increased need for treatment is similar across the four projections. Initiating treatment at a CD4 count <250/mm(3) will increase the need for treatment by a median of 22% immediately, initiating ART at a CD4 count <350/mm(3) increases the need for treatment by a median of 60%, and th...

Research paper thumbnail of Role of the Laboratory in Ensuring Global Access to ARV Treatment for HIV-Infected Children: Consensus Statement on the Performance of Laboratory Assays for Early Infant Diagnosis

The Open AIDS Journal, 2008

A two day meeting hosted by the World Health Organization (WHO) and the U.S. Centers for Disease ... more A two day meeting hosted by the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) was held in May 2006 in Entebbe, Uganda to review the laboratory performance of virologic molecular methods, particularly the Roche Amplicor DNA PCR version 1.5 assay, in the diagnosis of HIV-1 infection in infants. The meeting was attended by approximately 60 participants from 17 countries. Data on the performance and limitations of the HIV-1 DNA PCR assay from 9 African countries with high-burdens of HIV/AIDS were shared with respect to different settings and HIV-subtypes. A consensus statement on the use of the assay for early infant diagnosis was developed and areas of needed operational research were identified. In addition, consensus was reached on the usefulness of dried blood spot (DBS) specimens in childhood as a means for ensuring greater accessibility to serologic and virologic HIV testing for the paediatric population.

Research paper thumbnail of First population-level effectiveness evaluation of a national programme to prevent HIV transmission from mother to child, South Africa

Journal of epidemiology and community health, Jan 4, 2014

There is a paucity of data on the national population-level effectiveness of preventing mother-to... more There is a paucity of data on the national population-level effectiveness of preventing mother-to-child transmission (PMTCT) programmes in high-HIV-prevalence, resource-limited settings. We assessed national PMTCT impact in South Africa (SA), 2010. A facility-based survey was conducted using a stratified multistage, cluster sampling design. A nationally representative sample of 10 178 infants aged 4-8 weeks was recruited from 565 clinics. Data collection included caregiver interviews, record reviews and infant dried blood spots to identify HIV-exposed infants (HEI) and HIV-infected infants. During analysis, self-reported antiretroviral (ARV) use was categorised: 1a: triple ARV treatment; 1b: azidothymidine >10 weeks; 2a: azidothymidine ≤10 weeks; 2b: incomplete ARV prophylaxis; 3a: no antenatal ARV and 3b: missing ARV information. Findings were adjusted for non-response, survey design and weighted for live-birth distributions. Nationally, 32% of live infants were HEI; early mothe...

Research paper thumbnail of O progresso global da PTV e tratamento do HIV pediátrico em países de baixa e média renda em 2004-2005

Resumo: Um crescente número de países busca ampliar as intervenções para prevenção da transmissão... more Resumo: Um crescente número de países busca ampliar as intervenções para prevenção da transmissão vertical do HIV de mãe para filho (PTV) nos serviços de saúde materna e infantil. Similarmente, muitos desses países estão trabalhando para melhorar o acesso ao tratamento do HIV pediátrico. Este artigo analisa dados de programas nacionais de 2004-2005 de países de baixa e média renda, acompanhando os progressos desses programas. A realização do objetivo do UNGASS de reduzir as infecções do HIV em 50% até 2010 necessita que 80% de todas as grávidas fazendo pré-natal recebam cuidados de PTV. Em 2005, apenas sete dos 71 países estavam alinhados com esse objetivo. Todavia, a cobertura de PTV aumentou de 7% em 2004 (58 países) para 11% em 2005 (71 países). Em 2005, 8% de todas as crianças nascidas de mães HIV-positivo receberam profilaxia anti-retroviral para PTV, comparados a 5% em 2004, apesar de somente 4% terem recebido o cotrimoxazole. Em 2005, 11% das crianças HIV-positivo que necessitavam tratamento anti-retroviral o receberam. Em 31 países que apresentaram dados, 28% das mulheres que receberam anti-retrovirais para PTV também relataram receber tratamento anti-retroviral para sua própria saúde. Atingir o objetivo do UNGASS é possível, mas serão necessários investimentos substanciais e compromissos para fortalecer os serviços de saúde materna e infantil, a força de trabalho em saúde e os sistemas de saúde, para passar de projetos pilotos a uma abordagem descentralizada e integrada. Palavras-chave: PTV, tratamento do HIV pediátrico, testagem e aconselhamento em HIV, tratamento anti-retroviral, cotrimoxazole, saúde materno-infantil, ampliação dos serviços.