Implementation of the new WHO recommendations on HIV and infant feeding: Challenges and the way forward

Breast milk provides all the nutrient needs of the infant especially in the first six months of life and also protects the growing infant from pneumonia, diarrhoea, and malnutrition, which are the major causes of morbidity and mortality in the African Region. However breastfeeding is also known to transmit the Human Immunodeficiency Virus (HIV) from mother to the child. Several guidelines have been developed to guide policy makers, health workers and mothers on the most appropriate methods to feed HIV exposed infants. Previous HIV and infant feedingguidelines emphasized on preventing infants from becoming infected with HIV by counseling HIV-infected mothers to avoid all breastfeeding. Over the period, programme implementers and researchers have reported difficulties in implementing earlier recommendations and guidelines on HIV and infant feeding within health-care systems. New evidence now shows that giving Anti-Retroviral therapy (ARVs) to either the HIV-infected mother or HIV-exposed infant can significantly reduce the risk of transmitting HIV through breastfeeding. Thus, in 2010 World HealthOrganization (WHO) issued the latest guidelines on HIV and infant feeding entitled Principles and recommendations for infant feeding in the context of HIV and a summary of evidence. The 2010 WHO guidelines have changed the recommendations on how HIV infected mothers should feed their infants, and how health workers should support them. National authorities in each country can decide which infant feeding practice will be primarily promoted and supported by Maternal and Child Health services, i.e. breastfeeding with an antiretroviral intervention to reduce transmission or avoidance of all breastfeeding. Previous guidelines and  recommendations on infant feeding in the context of HIV have undergone frequent changes over the past decade. The adaptation and implementation of previous and current guidelines at national level have met challenges. These include lack of consensus among key stakeholders, inadequate funding for the additional cost of providing ARVs to the mother or the child and difficulties in communicating the recommendations in the new guidelines clearly to mothers, health workers and policy makers. To address these challenges a number of proposals have been suggested such as coordinated consensus building process, costing of interventions and a phased implementation approach to ensure successful scale up over time. This paper describes the process of adapting global HIV and infant feeding recommendations and guidelines at national level. It also reviews the challenges encountered in implementation and proposes the way forward in addressing them

Global challenges with scale-up of the integrated management of childhood illness strategy: results of a multi-country survey

<p>Abstract</p> <p>Background</p> <p>The Integrated Management of Childhood Illness Strategy (IMCI), developed by WHO/UNICEF, aims to contribute to reducing childhood morbidity and mortality (MDG4) in resource-limited settings. Since 1996 more than 100 countries have adopted IMCI. IMCI case management training (ICMT) is one of three IMCI components and training is usually residential over 11 consecutive days. Follow-up after ICMT is an essential part of training. We describe the barriers to rapid acceleration of ICMT and review country perspectives on how to address these barriers.</p> <p>Methods</p> <p>A multi-country exploratory cross-sectional questionnaire survey of in-service ICMT approaches, using quantitative and qualitative methods, was conducted in 2006-7: 27 countries were purposively selected from all six WHO regions. Data for this paper are from three questionnaires (QA, QB and QC), distributed to selected national focal IMCI persons/programme officers, course directors/facilitators and IMCI trainees respectively. QC only gathered data on experiences with IMCI follow-up.</p> <p>Results</p> <p>33 QA, 163 QB and 272 QC were received. The commonest challenges to ICMT scale-up relate to funding (high cost and long duration of the residential ICMT), poor literacy of health workers, differing opinions about the role of IMCI in improving child health, lack of political support, frequent changes in staff or rules at Ministries of Health and lack of skilled facilitators. Countries addressed these challenges in several ways including increased advocacy, developing strategic linkages with other priorities, intensifying pre-service training, re-distribution of funds and shortening course duration. The commonest challenges to <it>follow-up </it>after ICMT were lack of funding (93.1% of respondents), inadequate funds for travelling or planning (75.9% and 44.8% respectively), lack of gas for travelling (41.4%), inadequately trained or few supervisors (41.4%) and inadequate job aids for follow-up (27.6%). Countries addressed these by piggy backing IMCI follow-up with routine supervisory visits.</p> <p>Conclusions</p> <p>Financial challenges to ICMT scale-up and follow-up after training are common. As IMCI is accepted globally as one of the key strategies to meet MDG4 several steps need to be taken to facilitate rapid acceleration of ICMT, including reviewing core competencies followed by competency-driven shortened training duration or 'on the job' training, 'distance learning' or training using mobile phones. Linkages with other 'better-funded' programmes e.g. HIV or malaria need to be improved. Routine Primary Health Care (PHC) supervision needs to include follow-up after ICMT.</p

Who accepts and who uses community-based secondary distribution HIV self-testing (HIVST) kits? findings from the intervention arm of a cluster-randomized trial of HIVST distribution nested in four HPTN 071 (PopART) communities in Zambia

Background: HPTN 071 (PopART) was a community-randomized trial of a universal testing-and-treatment intervention on HIV incidence at population level in Zambia and South Africa. In Zambia, a trial of community-based distribution of HIV self-testing (HIVST) kits, including secondary distribution, as an option for HIV-testing was nested within 4 PopART intervention communities. We used data from the intervention arm of the nested trial to measure levels of and factors associated with acceptance and use of secondary distribution HIVST kits. Methods: Community HIV care providers offered the PopART combination HIV-prevention intervention door-to-door, systematically visiting all households and enumerating all household members. From 1 February to 30 April 2017, individuals aged 16 years and older consenting to PopART were offered the option to HIV self-test, if eligible for HIV-testing services. Individuals aged 18 years and older who reported a partner absent during household visits were offered an HIVST kit for secondary distribution to this partner. We used two data sources to measure acceptance and use of secondary distribution HIVST kits. Results: Among 9105 individuals aged 18 years and older consenting to PopART, 9.1% (n = 825) accepted an HIVST kit for secondary distribution. Approximately 55.8% reported that the kit had been used. Women were more likely to accept, and men more likely to use, secondary distribution HIVST kits. Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART. Approximately 6.8% had a reactive result. Conclusions: Community-based secondary distribution of HIVST kits reached men absent during community HIV care provider household visits and is a complement to facility- and community-based HIV-testing services, which often miss men

Ensuring Quality in AFRINEST and SATT: Clinical Standardization and Monitoring

Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results

Intrapartum Antibiotic Exposure and Early Neonatal, Morbidity, and Mortality in Africa

Infants born to women who receive intrapartum antibiotics may have higher rates of infectious morbidity and mortality than unexposed infants

Results of a multi-country exploratory survey of approaches and methods for IMCI case management training

<p>Abstract</p> <p>Background</p> <p>The Integrated Management of Childhood Illness Strategy (IMCI) is effective in improving management of sick children, and thus child survival. It is currently recommended that in-service IMCI case management training (ICMT) occur over 11-days; that the participant: facilitator ratio should be ≤4:1 and that at least 30% of ICMT time be spent on clinical practice. In 2006–2007, approximately ten years after IMCI implementation, we conducted a multi-country exploratory questionnaire survey to document country experiences with ICMT, and to determine the acceptability of shortening duration of ICMT.</p> <p>Methods</p> <p>Questionnaires (QA) were sent to national IMCI focal persons in 27 purposively-selected countries. To probe further, questionnaires (QB and QC respectively) were also sent to course-directors or facilitators and IMCI trainees, selected using snowball sampling after applying pre-defined criteria, in these countries. Questionnaires gathered quantitative and qualitative data.</p> <p>Results</p> <p>Thirty-three QA, 163 QB, 272 QC and two summaries were returned from 24 countries. All countries continued to adapt course content to local disease burden. All countries offer shorter ICMT courses, ranging from 3–10 days (commonest being 5–8 days). The shorter ICMT courses offer fewer exercises, more homework, less individual feedback and reduced clinical practice (<30% time). Whereas changes to course content were usually evidence-based, changes to training methodology and course duration evolved as pressure to expand implementation mounted. Participants varied in their self-reported skill and perception about each course. However, the varied methodology and integrated approach to management of illnesses were commonly cited as strengths of ICMT, and the chart booklet and clinical practice sessions were identified as critical components of ICMT. Four themes emerged from the qualitative work, viz. the current 11-day course is too expensive and should be shortened; advocacy around IMCI should increase; content should be regularly updated, new content areas should be introduced cautiously and more attention should be paid to skills-building rather than knowledge accumulation.</p> <p>Conclusion</p> <p>Whilst the 11-day ICMT course is still recommended, as efforts intensify to increase access to quality care and meet MDG4, standardized shorter ICMT courses, that include participatory methodologies and adequate clinical practice, could be acceptable globally.</p

Community based distribution of oral HIV self-testing kits in Zambia: a cluster-randomised trial nested in four HPTN 071 (PopART) intervention communities.

BACKGROUND: The HPTN 071 (PopART) cluster-randomised trial provided door-to-door HIV testing services to a large proportion of individuals residing in 21 intervention communities in Zambia and South Africa from 2014 to 2017 and reached the UNAIDS first 90 target among women in Zambia, yet gaps remained among men and young adults. This cluster-randomised study nested in the HPTN 071 (PopART) trial sought to increase knowledge of HIV status across all groups by offering the choice of oral HIV self-testing in addition to routine door-to-door HIV testing services. METHODS: We nested this cluster-randomised trial in four HTPN 071 (PopART) intervention communities in northern Zambia. 66 zones (clusters) in these communities were randomly allocated (1:1) to either oral HIV self-testing plus routine door-to-door HIV testing services (HIV self-testing group) or the PopART standard of care of door-to-door HIV testing services alone (non- HIV self-testing group) over a 3-month period. All individuals aged 16 years or older were eligible for HIV testing. Randomisation was achieved by randomly selecting one allocation from a list of 10 000 possible allocations during a public ceremony. In HIV self-testing zones, trained lay-counsellors (known as community HIV care providers) visited households and offered eligible individuals the choice of HIV testing using HIV self-testing or routine door-to-door HIV testing services. For individuals aged 18 years or older whose partner was absent during the household visit, an HIV self-test kit could be left for secondary distribution to the absent partner. The primary outcome was knowledge of HIV status (defined as self-reporting HIV positive to the community HIV care providers or accepting an offer of HIV testing services). Outcomes were measured among households that were first visited, and individuals first enumerated as a household member during the HIV self-testing intervention period. We analysed data at the individual level using population-average logistic regression models, accounting for clustering of outcomes by zone, to estimate the effect of the intervention. This trial is registered with ClinicalTrials.gov, number NCT02994329. FINDINGS: Between Feb 1, and April 30, 2017, the community HIV care providers enumerated 13 267 eligible individuals in the HIV self-testing group and 13 706 in the non-HIV self-testing group. After intervention implementation, 9027 (68%) of 13 267 in the HIV self-testing group had knowledge of HIV status compared with 8952 (65%) of 13 706 in the non-HIV self-testing group (adjusted odds ratio 1·30, 95% CI 1·03-1·65; p=0·03). The effect differed by sex (pinteraction=0·01). Among men, knowledge of HIV status was higher in the HIV self-testing group than in the non-HIV self-testing group (3843 [60%] of 6368 vs 3571 [55%] of 6486; adjusted odds ratio 1·31, 95% CI 1·07-1·60; p=0·01). There was no evidence of a between-group difference among female participants. INTERPRETATION: Providing a choice of HIV self-testing during delivery of door-to-door HIV testing services increased knowledge of HIV status, driven by an effect among men. Lay counsellors have a vital role to play in adapting HIV self-testing interventions to local context. FUNDING: The International Initiative for Impact Evaluation (3ie), the Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and the President's Emergency Plan for AIDS Relief

Selected hematologic and biochemical measurements in African HIV-infected and uninfected pregnant women and their infants: the HIV Prevention Trials Network 024 protocol

Reference values for hematological and biochemical assays in pregnant women and in newborn infants are based primarily on Caucasian populations. Normative data are limited for populations in sub-Saharan Africa, especially comparing women with and without HIV infection, and comparing infants with and without HIV infection or HIV exposure. We determined HIV status and selected hematological and biochemical measurements in women at 20-24 weeks and at 36 weeks gestation, and in infants at birth and 4-6 weeks of age. All were recruited within a randomized clinical trial of antibiotics to prevent chorioamnionitis-associated mother-to-child transmission of HIV (HPTN024). We report nearly complete laboratory data on 2,292 HIV-infected and 367 HIV-uninfected pregnant African women who were representative of the public clinics from which the women were recruited. Nearly all the HIV-infected mothers received nevirapine prophylaxis at the time of labor, as did their infants after birth (always within 72 hours of birth, but typically within just a few hours at the four study sites in Malawi (2 sites), Tanzania, and Zambia. HIV-infected pregnant women had lower red blood cell counts, hemoglobin, hematocrit, and white blood cell counts than HIV-uninfected women. Platelet and monocyte counts were higher among HIV-infected women at both time points. At the 4-6-week visit, HIV-infected infants had lower hemoglobin, hematocrit and white blood cell counts than uninfected infants. Platelet counts were lower in HIV-infected infants than HIV-uninfected infants, both at birth and at 4-6 weeks of age. At 4-6 weeks, HIV-infected infants had higher alanine aminotransferase measures than uninfected infants. Normative data in pregnant African women and their newborn infants are needed to guide the large-scale HIV care and treatment programs being scaled up throughout the continent. These laboratory measures will help interpret clinical data and assist in patient monitoring in a sub-Saharan Africa context

Management of latent Mycobacterium tuberculosis infection: WHO guidelines for low tuberculosis burden countries

Latent tuberculosis infection (LTBI) is characterised by the presence of immune responses to previously acquired Mycobacterium tuberculosis infection without clinical evidence of active tuberculosis (TB). Here we report evidence-based guidelines from the World Health Organization for a public health approach to the management of LTBI in high risk individuals in countries with high or middle upper income and TB incidence of <100 per 100 000 per year. The guidelines strongly recommend systematic testing and treatment of LTBI in people living with HIV, adult and child contacts of pulmonary TB cases, patients initiating anti-tumour necrosis factor treatment, patients receiving dialysis, patients preparing for organ or haematological transplantation, and patients with silicosis. In prisoners, healthcare workers, immigrants from high TB burden countries, homeless persons and illicit drug users, systematic testing and treatment of LTBI is conditionally recommended, according to TB epidemiology and resource availability. Either commercial interferon-gamma release assays or Mantoux tuberculin skin testing could be used to test for LTBI. Chest radiography should be performed before LTBI treatment to rule out active TB disease. Recommended treatment regimens for LTBI include: 6 or 9 month isoniazid; 12 week rifapentine plus isoniazid; 3–4 month isoniazid plus rifampicin; or 3–4 month rifampicin alone

Community based distribution of oral HIV self-testing kits in Zambia: a cluster-randomised trial nested in four HPTN 071 (PopART) intervention communities

Background The HPTN 071 (PopART) cluster-randomised trial provided door-to-door HIV testing services to a large proportion of individuals residing in 21 intervention communities in Zambia and South Africa from 2014 to 2017 and reached the UNAIDS first 90 target among women in Zambia, yet gaps remained among men and young adults. This cluster-randomised study nested in the HPTN 071 (PopART) trial sought to increase knowledge of HIV status across all groups by offering the choice of oral HIV self-testing in addition to routine door-to-door HIV testing services. Methods We nested this cluster-randomised trial in four HTPN 071 (PopART) intervention communities in northern Zambia. 66 zones (clusters) in these communities were randomly allocated (1:1) to either oral HIV self-testing plus routine door-to-door HIV testing services (HIV self-testing group) or the PopART standard of care of door-to-door HIV testing services alone (non- HIV self-testing group) over a 3-month period. All individuals aged 16 years or older were eligible for HIV testing. Randomisation was achieved by randomly selecting one allocation from a list of 10 000 possible allocations during a public ceremony. In HIV self-testing zones, trained lay-counsellors (known as community HIV care providers) visited households and offered eligible individuals the choice of HIV testing using HIV self-testing or routine door-to-door HIV testing services. For individuals aged 18 years or older whose partner was absent during the household visit, an HIV self-test kit could be left for secondary distribution to the absent partner. The primary outcome was knowledge of HIV status (defined as self-reporting HIV positive to the community HIV care providers or accepting an offer of HIV testing services). Outcomes were measured among households that were first visited, and individuals first enumerated as a household member during the HIV self-testing intervention period. We analysed data at the individual level using population-average logistic regression models, accounting for clustering of outcomes by zone, to estimate the effect of the intervention. This trial is registered with ClinicalTrials.gov, number NCT02994329. Findings Between Feb 1, and April 30, 2017, the community HIV care providers enumerated 13 267 eligible individuals in the HIV self-testing group and 13 706 in the non-HIV self-testing group. After intervention implementation, 9027 (68%) of 13 267 in the HIV self-testing group had knowledge of HIV status compared with 8952 (65%) of 13 706 in the non-HIV self-testing group (adjusted odds ratio 1·30, 95% CI 1·03–1·65; p=0·03). The effect differed by sex (pinteraction=0·01). Among men, knowledge of HIV status was higher in the HIV self-testing group than in the non-HIV self-testing group (3843 [60%] of 6368 vs 3571 [55%] of 6486; adjusted odds ratio 1·31, 95% CI 1·07–1·60; p=0·01). There was no evidence of a between-group difference among female participants. Interpretation Providing a choice of HIV self-testing during delivery of door-to-door HIV testing services increased knowledge of HIV status, driven by an effect among men. Lay counsellors have a vital role to play in adapting HIV self-testing interventions to local context