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NRI 13-356 – HSR&D Study

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NRI 13-356
Gastrointestinal Symptoms and Microbial Translocation in HIV Veterans
Natalie Lynn Wilson DNP MPH MSN
Birmingham VA Medical Center, Birmingham, AL
Birmingham, AL
Funding Period: November 2014 - April 2017

BACKGROUND/RATIONALE:
Gastrointestinal (GI) symptoms are prevalent among people living with Human Immunodeficiency Virus (HIV; PLWH) and are often a reason for discontinuation of and non-adherence to combination antiretroviral therapy (cART). Over 60% of HIV-infected Veterans who experience GI symptoms such as diarrhea, bloating, and abdominal pain report that the symptom is bothersome. The VHA has nearly 64,000 Veterans living with HIV disease and more than 50% receive their care in the South. Birmingham VAMC HIV Clinic (BVAMC) has approximately 346 patients enrolled in care. Soluble CD14 (sCD14) is an established surrogate biomarker of microbial translocation and strongly correlates with severity of GI epithelial barrier dysfunction in HIV disease. sCD14 independently is predictive of increased mortality risk when added to the Veterans Aging Cohort Study (VACS) Index but the association with GI symptoms prevalence remains uninvestigated. Poor appetite has been significantly associated with higher sCD14 in the viremic group (n = 494; STD = 0.27, 90% CI: 0.04, 0.5) and was significantly associated with higher sCD14 (n = 973; STD = 0.19, 90% CI: 0.01, 0.37) in the viral suppression group among 1,467 Veterans in the VA Aging Biomarker Cohort Study. However, it is not clear how many HIV-infected Veterans are non-adherent to cART as a result of GI symptoms experienced and if GI symptoms may extend beyond medication toxicity to GI epithelial barrier dysfunction. Although GI symptoms in HIV-infected patients resemble symptoms experienced with Inflammatory Bowel Diseases (IBD) and Irritable Bowel Syndrome (IBS), providers may attribute GI symptoms experience to depression or medications. There is no significant association between symptom prevalence and depression and medication side effect profiles have improved.

OBJECTIVE(S):
The objectives of this pilot study were to (a) investigate symptoms associated with gastrointestinal dysfunction; (b) examine factors that may contribute to the difficulties in cART adherence in the context of GI-related symptoms; and (c) test the feasibility of the method for a multi-center study.

METHODS:
DESIGN
To achieve these objectives, we conducted a prospective Sequential Explanatory mixed methods design using quantitative based questionnaires and blood samples then selecting participants for qualitative interviews.
SETTINGS
HIV specialty care at the BVAMC.

SAMPLE
The local IRB required the physician to discuss the study with patients and then refer to our study. We enrolled 102 Veterans and due to withdrawal our final sample size was 98 Veterans. We had 97% (n=95) males and 3% (n=3) females completed the study. African-Americans represented 81% (n=79) of the sample, and Caucasians the other 19% (n=19). Sixty-eight percent had achieved an undetectable viral load and 64% had a CD4 count above 500 cells/mm3. We were able to access 84 medical charts.

INCLUSION/EXCLUSION CRITERIA:
Veterans at least 19 years of age engaged in VA with a diagnosis of HIV infection on cART for at least 30 days were included. We excluded Veterans with cognitive impairment or inability to complete questionnaires advanced liver disease or active IBD/IBS.

QUALITATIVE RECRUITMENT
Due to the correlation between poor appetite and gut dysfunction we recruited Veterans with poor appetite as our first priority for interview. To explore decision making for adherence, we recruited the 5 people that reported poor appetite and reported missing doses due to poor appetite, a random sample of those persons that reported poor appetite and reported never missing doses, and a random sample of persons with no poor appetite that reported not missing dose. We reached saturation at 14 Veterans.

ANALYSIS:
We counted presence of symptoms and conducted crosstabs to identify non-adherence by symptoms. Content analysis was used for the qualitative interviews.

MEASURES/OUTCOME MEASURES
Symptoms were identified by the HIV Symptom Index; Microbial translocation by levels of sCD14; adherence to cART measured using the AIDS Clinical Trial Group Adherence Survey. In the qualitative phase, we recruited 14 Veterans for cognitive interviews from the quantitative phase participants. Through one-on-one interviews, the qualitative phase investigated the influence of symptoms on cART adherence decision-making.


FINDINGS/RESULTS:
We found that this process contaminated the study as patients disclosed the provider switched cART due to symptoms

Of the 36 Veterans experiencing poor appetite, 89% found this symptom bothersome. Eighteen Veterans experienced nausea/vomiting (18%) and all found the symptom bothersome. Forty-nine Veterans (49%) experienced diarrhea which was bothersome. Finally, of the 48 Veterans experiencing bloating/abdominal pain, 96% found it bothersome. These data suggest that Veterans experience GI symptoms as bothersome. The proportion of those Veterans experiencing loss of appetite, 16% reported missing doses of cART due to poor appetite. The most common symptom leading to missed doses was nausea (35%) and vomiting (33%). Sixteen participants reported marijuana use. Among those reporting marijuana use, 63% also reported poor appetite. Thirty-one percent of those using marijuana reported nausea/vomiting.
Qualitative Results: All participants stated the reason for adherence was to live longer. Veterans admitted to forcing themselves to eat. Some Veterans stated if they took their medicine on an empty stomach they experience nausea/vomiting. Marijuana was a strategy used to increase appetite and support the desire to eat.
Feasibility: We ran into significant barriers with IRB restrictions. IRB required patient recruitment to be done by providers. Providers were aware of the purpose of the study and changed medications if patients reported missing doses as a result of a symptom. During interviews, the patients had been on new medications and were adherent to their medications making it difficult to assess decision-making for non-adherence.


IMPACT:
By understanding GI-related symptoms patterns and influences in HIV+ Veterans we can deliver effective symptom management and help to develop new interventions focused on increasing cART adherence. Nausea and vomiting may be a significant barrier to adherence. However, poor appetite is correlated with dysfunctional gut barrier and may be a barrier to adherence based on food requirements. Interventions to manage these symptoms will support adherence. Marijuana was discussed as a strategy to help with poor appetite and it also helped with nausea and vomiting. Therefore, marijuana may be a strategy to manage poor appetite and nausea in states where it is legal. As this was a pilot study, further research is recommended to explore such strategies among Veterans and PLWH.

PUBLICATIONS:

Journal Articles

  1. Wilson NL, Azuero A, Vance DE, Richman JS, Moneyham LD, Raper JL, Heath SL, Kempf MC. Identifying Symptom Patterns in People Living With HIV Disease. Journal of The Association of Nurses in AIDS Care. 2016 Mar 1; 27(2):121-32.


DRA: Infectious Diseases
DRE: none
Keywords: none
MeSH Terms: none

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