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| ID | Type | Description | Link |
|---|---|---|---|
| PCE-G-98-00036-00 |
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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
| Moi Univeristy | OTHER |
| University of California, Los Angeles | OTHER |
| Heifer Project International |
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Many of the 28 million people with immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) estimated to be living in sub-Saharan Africa also suffer from malnutrition. Reproductive age women, their infants and young children are among the most vulnerable for malnutrition and progression of HIV to AIDS and mortality is increased in the malnourished, as seen in Eastern and Southern Africa. The HIV Nutrition Project (HNP) research evaluates the effect of protein and micronutrients in meat on the health and nutritional well being of Kenyan women living with HIV in rural Kenya and the health and development of their children, by means of a randomized nutrition intervention. We will determine if meat in the diets of HIV- infected women and their children (1) protects the immune system and prevents severe infection, (2) prevents the loss of body mass and enhances the quality of life among drug naïve women not yet ill enough to warrant antiretroviral drugs and (3) positively impacts growth and development of vulnerable children of the HIV-infected women when compared to those given supplements with the same amount of energy but with either soya or wheat protein. The intervention food with beef protein provides significant vitamin B12, lysine and bio-available iron, zinc and selenium when compared to the soya and wheat supplements. Deficiencies of these nutrients may hasten HIV disease progression.
The findings from our project may have implications for the development of initiatives that are either sustainable or subsidized by the local, regional and/or global economies that ensure that all HIV-infected individuals have access to adequate nutrition support that includes foods that provide enough nutrients that are needed to optimize health and well-being. The knowledge gained may significantly impact other populations at high risk for decreased immune function such as those with tuberculosis and malaria.
This is a 3 arm randomized design where 225 HIV-infected rural Kenyan mothers with a CD4 between 250 and 500, WHO Stage 1 or 2, and with no co-existing infections, receive with their child, a nutrition biscuit supplement daily (5 days/week) for 12 months. These women are not yet ill enough to warrant treatment with antiretroviral drugs in Kenya and therefore a food intervention may keep them healthy longer and delay the need for drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meat Biscuit | Experimental | 75 women and one of their children will receive a biscuit containing dried meat as an ingredient for 5 days each week for 12 months. |
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| Soy Biscuit | Active Comparator | 75 women and one of their children will receive a biscuit containing soy flour as an ingredient for 5 days each week for 12 months. |
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| Wheat Biscuit | Sham Comparator | 75 women and one of their children will receive a biscuit containing pm;u wheat flour as a source of protein as an ingredient for 5 days each week for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meat Biscuit | Dietary Supplement | 75 women and one of their children will receive a biscuit containing dried meat as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day. |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of meat intake on mid-upper-arm muscle area; comparisons between groups, of changes from baseline to 3, 6, 9, 12, 15, 18 mos (intervention); 24 mos (6 mos post intervention). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of meat intake on immune function (CD4 as well as percent of CD4 in the total lymphocyte); change from baseline to 6, 12, 18 mos (intervention), 24 months (6 mos post intervention)will be compared between groups | 24 months | |
| The impact of meat intake on opportunistic infection (OI) incidence will be assessed monthly; change over time will be compared between groups from baseline through 18 mos (intervention and at 24 mos (6 mos post intervention). |
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HIV-infected women and their children who live in the Turbo catchment area in the Uasin Gishu District of Kenya and attend the AMPATH clinic there will be invited to participate in the study.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Ernst, DMSc | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moi University-Academic Model for the Prevention and Treatment of HIV | Eldoret | Rift Valley Province | 30100 | Kenya |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| OTHER |
| USDA, Western Human Nutrition Research Center | FED |
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| Soy Biscuit | Dietary Supplement | 75 women and one of their children will receive a biscuit containing soy four as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 21 grams of protein per day and children will receive 350 calories and 14 grams of protein per day. |
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| Wheat Biscuit | Dietary Supplement | 75 women and one of their children will receive a biscuit containing only wheat lour as a source of protein as an ingredient for 5 days each week for 12 months. Women will receive 525 calories and 8 grams of protein per day and children will receive 350 calories and 5 grams of protein per day. |
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| 24 months |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |