Retrospective analysis of routinely collected outcomes from the ARV program in two health centers in Kigali, combined with interviews with key health center and Médecins Sans Frontières (MSF) staff. MSF reports since program inception were also reviewed.
Rwanda, with a population of around 9 million inhabitants, has an overall HIV prevalence of 3% and more than 7% in urban areas [20
]. The national ART program, launched in 2003, was first established mostly in the district hospitals, with subsequent decentralization to the health centers. From 2004 on, a gradual scaling-up was seen. The latest estimate in 2006 by TRAC (Treatment and Research AIDS Center) of the number of HIV-infected children was 13,901 with half of them (6951) in need of ARVs [21
]. By the end of May 2007, almost half (3255) had benefited from ART.
Health worker distribution in Rwanda and their roles within the HIV care program
With one physician/50,000 habitants and one nurse/3900 habitants, Rwanda is clearly short of physicians but is relatively better resourced with nurses [22
]. In addition, 80–90% of the population is living in rural areas and mainly relies on care from primary health centers, staffed by nurses. Up to now, HIV/ART care delivery has essentially been provided by physicians, with nurses only playing a supporting role (see Table ). In the traditional model, physicians were responsible for all tasks. Equally, at primary health centers, the bulk of medical care was provided by the visiting physician, who was based in the district hospital. When relating to HIV care for children, this reliance on physicians/hospital-based care was even more pronounced as it was believed to be more difficult care.
Traditional and modified tasks for nurses and physicians within the HIV/ART care program
In the Rwandan health system, nurses are classified into three levels according to their level of training: 1) A3 nurses may have no/minimal secondary training and minimal health training; 2) A2 nurses (the bulk of the health workforce) have two years of secondary education and two years of nursing training; 3) A1 nurses have received two additional years of nursing training after finishing secondary school [22
]. Whereas initially A1 nurses were rarely found at health centers, this is gradually changing. Currently, no other non-physician clinician cadres are being trained.
The two clinics in this report were Kimironko and Kinyinya health centers, located in Kigali. Kimironko was an urban government health center with a catchment area of about 75,000 people while Kinyinya was semi-rural, being located at the outskirts of Kigali, with an estimated population of 17,000.
In addition to routine health care, the health centers provided comprehensive HIV care and started offering ARVs at a decentralized level, beginning in October 2003 in Kimironko and followed in January 2004 in Kinyinya. They were among the first services in the country to offer ART. By July 2007, 3252 patients had been started on ART within these two clinics and of these, 332 children were enrolled in the ART program. These two clinics have been supported by MSF since 2002.
The analysis included all children enrolled in the HIV program who qualified for ARVs from the launch of the ART program from October 2003 till Jan 1/2007. With data collected until June 30/2007, all children had been on ART for at least six months. See Figure for details about how children were selected for ARVs and their treatment paths.
Flow diagram of the pediatric HIV program. ART: antiretroviral treatment; PMTCT: Prevention of Mother To Child Transmission; WHO: World Health Organization.
Description of the Pediatric HIV program
National government's commitment and external support
The pediatric program in the two clinics was part of the Rwandan national ART program, essentially run by government health care staff. The national program has seen a successful scaling-up over the last years, organized through the National AIDS Control Commission (NACC) and TRAC. A constructive collaboration with various international partners has taken place, with substantial financial support provided by the Global Fund to fight AIDS, Tuberculosis and Malaria. The government's commitment was demonstrated by providing additional nursing and laboratory staff as well as ongoing laboratory services, training and ARV procurement. MSF's contributions were essentially aimed at increasing the clinics capacity for ARV care and included training and supervising staff, refurbishing clinic buildings, upgrading the labs and providing financial incentives.
Nurse-based treatment and care
Increase and retention of nursing staff
At the launch of the HIV program in 2002, the health centers were poorly staffed. The increased staffing by the Ministry of Health was a critical factor. Whereas the health center's staff included 7 trained nurses before the launch of the HIV program in 2002, this had gradually increased to 28 by the end of 2004 (mainly A2 nurses), when scaling-up began. Overall, around 50% of the entire staff's time was dedicated to HIV care. To compensate for the substantial increase in work-load associated with the fast scaling-up of the ART program, a performance-based financing mechanism was put in place, initially backed by MSF.
To avoid overloading the nurses, most of the tasks traditionally performed by nurses were taken over by new or reinforced cadres in the health centers: receptionists for administrative work and data collection/monitoring; counsellors and community support groups for counselling; and lab-staff for blood collection.
Training for nurse-based treatment and care
When the ART program was launched, each health center was supported by a HIV physician. Given the high number of patients in (urgent) need of ART, one of their main duties was to build local capacity, facilitating a rapid scaling-up of HIV treatment and care within the health facilities. From the onset, nursing staff received theoretical and bed-side training in comprehensive HIV care in general, and in pediatric aspects in particular, from the HIV physician, gradually increasing their knowledge and confidence. Using this knowledge, they were able to initiate and change ARV treatment (for toxicity or contra-indications), with medical confirmation, and perform routine follow-up of the children, aided by simplified treatment protocols and growth curve charts provided in the consultation rooms. Protocols for recognizing side-effects of ARVs were standardized and indications for referral to the physician were defined. Ongoing training and supervision was ensured by having one full-time equivalent physician per health center, who was ultimately responsible for the medical care. As the program matured, physician involvement decreased to a presence two to three times a week. A great deal of emphasis was placed on comprehensive care with a family-centered approach including methods to address the psychosocial issues of HIV. ARVs were dispensed by a nurse with extensive practical experience in ARVs and additional training through the national program.
Mentoring and supervision
Besides consulting the complex/referred cases, the physician played a major role in assuring the quality of care provided in the program (Table ). The physician did not have a separate consultation office, but reviewed patients together with the nurses, allowing for ongoing training and skills-building. In addition, this permitted ongoing evaluation of the quality of care provided by the nurses, and to identify areas where additional training was needed. At the same time, a sample of patient files was reviewed to assess completeness of care and to trace medical problems. Only if the physician was confident in their knowledge and skills, were nurses allowed to consult in the ART program, but they still continued to receive ongoing training and supervision.
Voluntary Counseling and HIV testing (VCT) for children: overcoming barriers among caregivers
Early in the program, we observed that barriers existed among the caregivers towards testing their children. Caregivers themselves were distressed by their own recent HIV diagnosis. They were reluctant to discuss testing of their children, since they felt guilty, fearing the reaction of the child to their own and the child's disclosure, and being worried about the health and future of the child [23
]. Thus, from the start of the program, support and discussion groups were organized for the caregivers, designed to increase their acceptance of their HIV-positive status, a prerequisite for discussing testing of their children. In addition, prior to starting ARVs, individual in-depth counseling sessions were held with the caregivers to discuss testing of children in detail [23
]. Subsequently, the health center-based support groups were transformed into community-based support groups. Within these, the group leaders, serving as role-models of positive living with HIV, helped to make HIV more easily discussed within the community and to raise issues like testing of partners and children.
Timely and careful disclosure and ongoing psychosocial support
In our experience, children were generally not well prepared when they came for testing. Few children knew exactly why they were there, had little knowledge of HIV and rarely knew about the status of the caregiver [25
]. However, the children preferred to be informed about their and their caretaker's status from the caretaker and felt cheated when they were not told the truth. Consequently, we tried to involve the caretaker as much as possible during disclosure. Caretakers were first counseled on why it was important to talk openly with their children about HIV, why their active participation was important for the child, how the child might react, and how they should respond to questions. During disclosure, we tried to have the caregiver explain their and the child's status, while being supported by the counselor [26
]. The use of a booklet explaining HIV provided a common language around HIV (Figure ).
Picture from the booklet used to explain HIV/AIDS to children. The booklet is used by caregivers and health center staff. This picture is used to explain "what actually is blood ?" to the child.
Testing of children was done on a dedicated day, ensuring that enough time was available for every child, making the environment/event more child-friendly and facilitating on-site training of health care staff in counseling of children. Disclosure was considered when the child was > 6 years old [27
Within the child support groups, an environment was created by the counselors where the children could express themselves, raise their questions and worries and develop a positive attitude towards life with HIV. Most of the issues discussed were raised by the children themselves and reflected their deeper feelings: HIV (what, why and how?), life and death, sexuality, manipulation in the caregiver-child relationship and discrimination. The issues were addressed in several ways using open discussions, games, fairy-tales and drawings [27
]. These groups (consisting of 12–15 children) were organized according to age and were open to all children from the age of 7 years on, irrespective of taking ARVs. Our approach was based on general recommendations available within MSF [27
] that were adapted to the local context and taken into account the capacity/possibilities within the program.
Initially, children were followed medically together with the adult patients, but had their support groups on separate days. Subsequently, a special consultation for children, integrating both medical and psychosocial aspects, was introduced once a week, reducing the amount of traveling and out-of-school time for the children. It also allowed them to receive care and follow-up in the presence of other children, making the whole experience more child-friendly [27
Who were the caregivers ?
Close to 65 % of the children were taken care of by one or both parent(s). Twenty-five percent received care from the extended family (grand-parents, brothers/sisters, cousins,...), and about 10 % of children were orphans with adoptive caregivers. In general, no child was tested without the caretaker being tested.
ART eligibility, regimens and safety
Children were started on ART according to the national guidelines, based on the World Health Organization (WHO) immunological and clinical eligibility criteria and using WHO-recommended first line regimens [29
]. To simplify treatment regimens and limit calculation errors, four weight categories were used to choose the appropriate dosing of the ARVs, as has been described elsewhere [9
]. Generic, scored fixed-dose combinations (FDC) were prescribed as much as possible (Triviro 30/40, Ranbaxy), containing stavudine/lamivudine/nevirapine. No quarter-tablets were used (as use of these had not been validated), only whole or half tablets were prescribed. When scored FDCs were not available, children were given either separate medications or were switched to a zidovudine-containing FDC (Duovir-N, Cipla). Initially, small children needing syrup formulation were referred to the central referral hospital in Kigali (CHUK) but from mid-2005, the syrup was available at the health center level.
For most children (orphans in particular), a home-visit was done before ARV initiation to assess the socio-economic situation of the family and to provide support where necessary. Adherence to treatment was evaluated by self-report using calendars, regular clinical attendance (monthly pharmacy refills/visits after start-up period) and pill counts. As well, viral load counts were performed routinely after the first year of treatment from 2005 [31
]. HIV care, including ARVs, consultations, lab tests and OI medications, were provided free of charge. Transport costs for the children were covered for families in need.
Side effects were evaluated at each follow-up visit, and treatment changes were made for grade 3 and 4 events [29
]. Liver function tests were performed at baseline, 2, 4, 8 weeks and then every 6 months and on clinical grounds. A full blood count was done at baseline, 12 weeks and then every 6 months and on clinical grounds. For children on zidovudine, an additional control was done at 4 and 8 weeks.
At the outset, absolute CD4 counts and percentages, checked every 6 months, were measured with the FACSCalibur™ Flow Cytometry System (Becton-Dickenson) at the National Reference Laboratory (NRL). From 2003–2004, the FACSCount apparatus (Becton-Dickenson) was used and percentage counts were calculated based on total lymphocyte counts of a separate sample.
CD4 percentage counts at baseline were missing for several reasons (n = 33). First, due to limitations in the number of samples that could be handled at the NRL in the initial stages of the program, some children had no baseline CD4 counts because they met clinical criteria for starting ART. Second, for some children transferred from other sites, the information was unavailable. Finally, if the total lymphocyte count was not known, the CD4 percentage could not be calculated, and absolute CD4 counts were used for consideration of ART. The median time from baseline CD4 sample collection to initiation of ARVs was 53 days (interquartile range 30–79). Viral loads were analyzed at the NLR by the Ultrasensitive Amplicor assay, version 1.5 (Roche). All other biochemical tests were performed at Kinyinya health center.
Data collection and statistical analysis
Data were routinely collected during the consultations using Access® software. Treatment and safety outcomes of the cohort were analyzed by Stata software 9.0® (STATA Corp., College Station, Texas, USA). Kaplan-Meier survival methods were used to estimate the probability of remaining in care (failure defined as death or lost to follow-up). CD4 percentages were used for children under 5 years to evaluate immunological status and both CD4 counts and absolute counts used for children above 5 years. Weight-for age Z-scores (WAZ) were calculated with Epi-Info (version 4.3.1; Centers for Disease Control and Prevention). Data for this study were collected from October 1/2003 until June 30/2007.
This study analyzed routinely collected data from the pediatric HIV program. Approval for publication of this data and report was received from the NACC and TRAC. Confidentiality was maintained with no patient identifiers being used. The Ethics Review Board of MSF and the Rwandan National Ethics Committee gave exemption from formal ethical review. No informed consent was obtained for this study.