Early stages of a ‘Food by Prescription’ programme for HIV infected adults
By Elizabeth Bontrager and Kate Sadler
Elizabeth Bontrager joined the Feinstein International Centre at Tufts University in 2008, where she coordinates Tufts' involvement in the Food by Prescription programme. She holds a M.Sc. in Food Policy and Applied Nutrition.
Kate Sadler is a nutritionist and senior researcher with a focus on nutrition in emergencies at the Feinstein International Centre. She worked previously with Valid International for six years and with Concern World- wide for four years prior to that.
The authors acknowledge the support of USAID and the Food by Prescription team at Save the Children US.
As global interest in Ready-to-Use Therapeutic Foods (RUTFs) has risen, their use has begun expanding beyond the realm of treating children with severe acute malnutrition (SAM). Of recent interest within the humanitarian community is the use of such products in treating malnourished adults living with HIV/AIDS. In this case, the food is used much like a medical prescription, intended to address malnutrition so that the disease can be treated more effectively.
As the medications for anti-retroviral treatment (ART) have become more widely available in developing countries, greater attention has been paid to the associated role of malnutrition in determining the effectiveness of these drugs in HIV treatment programmes. In settings both with and without widespread food insecurity, weight loss and wasting are significant predictors of mortality among people living with HIV/AIDS (PLHIV), even for those undergoing anti-retroviral treatment.1,2 Furthermore, malnutrition at the outset of ART is strongly associated with early mortality after treatment is begun.3,4
Evidence to date
The majority of the existing research in this area has taken place in resource-adequate settings. Here, individuals receiving food supplements have shown improved protein and energy intake, but no consistent improvements in body weight or fat mass, and only minimal improvements in CD4 count, as a measure of disease progression.5
Thus far, little has been done to examine the relationship between HIV, food supplementation and survival in resource-poor environments, where malnutrition among PLHIV may be linked to food scarcity rather than (or in addition to) disease, and where the effects of supplementation may be quite different. One controlled study demonstrated that although a group receiving food supplements (in this case, individual rations of corn soy blend (CSB) and vegetable oil) showed greater adherence to ART than the control group (which received no food), there was no significant difference in survival, CD4 count, or weight gain between the groups.6 Another study compared the effects of a supplementary fortified spread to those of CSB on acutely malnourished adults starting ART in Malawi. It found that those individuals receiving the fortified spread (a lipid paste made from peanuts) showed greater improvements in several measures of wasting than those individuals receiving the CSB, but also showed no significant differences in mortality, CD4 count, ART adherence, or quality of life7.
The Food by Prescription Programme (FBP) in Ethiopia
For all of the above reasons, there is growing interest in programmes designed to address the links between nutrition and HIV, through which malnourished individuals on an ART treatment regimen are 'prescribed' therapeutic food rations in addition to their medications.
In Ethiopia, the Ministry of Health (MoH) began implementing the 'USAID/ Food by Prescription (FBP)' programme in the summer of 2010, with technical assistance provided by Save the Children US. This programme targets beneficiaries diagnosed with either moderate acute malnutrition (MAM) or SAM with two different products for up to six months - fortified blended food (FBF) packaged in individual serving- sized sachets for MAM cases and RUTF (Plumpy'nut) for SAM. The aim is to improve nutritional, clinical, and functional outcomes beyond the time period of the intervention itself.
HIV-infected adults who present with malnutrition at participating health centres are prescribed food rations according to their nutritional status (MAM or SAM). The rations are prescribed during monthly appointments, together with clients' ART medications, and are distributed directly from clinic pharmacies. Clients are monitored closely by health centre staff who collect both anthropometric and disease progression data during monthly appointments.
Examining the impact of food on health and nutrition outcomes
A number of partners are involved in the delivery and assessment of the overall FBP programme, including a group of researchers from the Feinstein International Centre and the Friedman School of Nutrition Science and Policy at Tufts University in the USA. This team from Tufts is carrying out an effectiveness evaluation of the programme, to determine the impact of food supplementation on disease progression and malnutrition among individuals on ART.
Specifically, the Tufts study will examine the effects of a food ration prescribed to malnourished HIV infected adults on recovery from malnutrition, HIV disease progression, patient survival, and persistence of any benefit six months after exit from the programme. Primary outcomes, to be compared between intervention and control groups, include percent weight change, change in CD4 count, survival at six months from programme enrolment, and Body Mass Index (BMI) at six months after discharge. The effects of the food prescriptions will also be disaggregated and compared according to the amount of time individuals have been on ART, and baseline nutritional status.
Discussing ART admissions, Hawassa Hospital ART clinic
The study follows a sample of recruited FBP participants from a number of randomly selected health centres included in Phase I of the programme and a 'control' sample recruited from sites that have access to ART but are not yet being prescribed a food ration (to be included in Phase II of FBP programme rollout). Data for study participants, including all variables needed to assess outcomes of interest as well as confounders, are collected during scheduled monthly clinic appointments. This includes completion of a patient register and a Household Food Security Questionnaire.
A qualitative component will be added to the impact study during the second year, to examine issues of compliance to the food protocol and utilisation of the ration. Data will be collected for this through a series of focus groups and key informant interviews.
Challenges thus far
In the early stages of FBP implementation, one particular challenge for the Tufts study has been the reliance on health centre staff for data collection. As this programme is included in the Ethiopian MoH National Guidelines for HIV/AIDS and Nutrition, MoH clinic workers are required to participate in the implementation and data collection activities for the programme. This often represents an additional burden on understaffed clinics with large caseloads. It is essential that health workers receive comprehensive training as part of the FBP programme rollout, since many are otherwise unfamiliar with the measurement of malnutrition indicators such as BMI and mid-upper arm circumference (MUAC). A clinic worker training regimen serves as part of the introduction to and rollout of FBP, but it is often difficult for programme staff to identify and locate all the relevant staff. This means that some eligible clients may present at the clinic but not be seen by trained personnel, and thus not be enrolled in either the programme or the study. In addition, once health workers have been adequately trained and are comfortable with the measurement of relevant indicators, high rates of staff turnover have meant that trained workers may be lost over time and replaced by new, untrained staff. FBP programme staff and the Tufts team will continue to visit these sites frequently to ensure that the implementation of the programme and the data collection are being performed as necessary for both the study and the programme as a whole.
Such large programmes inevitably run into challenges in the way of delays in procurement and pipeline breaks as these systems are first put into place. The rollout phase of FBP in Ethiopia has experienced this as well, and both the programme and the study have needed to accommodate changes to the nutrition protocol as programme staff have worked to address these challenges. The standardisation of the food protocol to account for changes in the availability of commodities has been accommodated into the study design.
Strenthening national capacity
The Tufts team is also supporting preservice training curriculum development, piloting, and dissemination on nutrition and HIV, in partnership with the Department of Nutrition at Hawassa University (see news item in this issue). This establishment of an HIV and nutrition educational component for health professionals is intended to alleviate some of the inconsistencies in training and awareness of the nutritional needs of PLHIV at the service provider level.
Conclusions
This FBP programme has the potential to improve both the capacity of health professionals to address the nutritional needs of PLHIV and the effectiveness of HIV care and treatment in Ethiopia. Currently, there is almost no documented programme data that can help answer questions around the additional benefits to PLHIV and costs of adding food to an ART regimen, or of the successes and challenges to scaling up a programme of this type. As HIV programmes embrace the need for a nutrition component, there is an urgent need to 'learn by doing' and the phased rollout of the FBP programme in Ethiopia provides a great opportunity to do just this. Data collection is anticipated to take place until December 2011, with results expected in early 2012.
For more information on the research, contact Kate Sadler, email: kate.sadler@tufts.edu or Elizabeth Bontrager, email: elizabeth.bontrager@tufts.edu
1Tang A, et al. Weight loss and survival in HIV-positive patients in the era of highly active antiretroviral therapy. JAIDS 2002;31:230-36.
2Paton, NI, Sangeetha, A Earnest and R Bellamy. The impact of malnutrition on survival and the CD4 count response in HIV-infected patients starting antiretroviral therapy. HIV Medicine (2006), 7, 323-330.
3Zachariah, R., Fitzgerald, M., Massaquoi, M., Pasulani, O., Arnould, L., Makombe, S., Harries, A.D., 2006. Risk factors for high early mortality in patients on antiretroviral treatment in a rural district of Malawi. AIDS 20, 2355-2360.
4See footnote 2
5Koethe JR, Chi B, Megazzini K, Heimburger D, Stringer JS. (2009a) Macronutrient Supplementation for Malnourished HIV-Infected Adults: A Review of the Evidence in Resource- Adequate and Resource-Constrained Settings. CID 2009;49: 787-798.
6Cantrell R, Sinkala M, Megazinni K, Lawson-Marriott S, Washington S, Chi B, Tambatamba- Chapula B, Levy J, Stringer E, Mulenga L, Stringer J. A pilot study of food supplementation to improve adherence to antiretroviral therapy among food-insecure adults in Lusaka, Zambia. J Acquir Immune Defic Syndr 2008; 49:190-195.
7Ndekha M, van Oosterhout JJ, Zijlstra EE, Manary M, Saloojee H, Manary MJ. (2009b) Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: a randomized, investigator blinded, controlled trial. BMJ 2009; 338:b1867.
Imported from FEX website