WelTelOAKTREE: Text Messaging to Support Patients with HIV/AIDS in British Columbia

WelTelOAKTREE looks at the effectiveness of mHealth for improving anti-retroviral therapy adherence.

Principal Investigator: Dr. Melanie Murray

Primary Contact: Evelyn Maan, Research Program Manager, 604-767-5044, emaan@cw.bc.ca

About the study: WelTel Oak Tree is a study that enrolled 80 HIV+ individuals from the Oak Tree Clinic at BC Women’s Hospital. Participants received a cell phone and/or unlimited text messaging capability if they did not have it already, and for one year received a weekly text message stating “How are you”. Participant problems and non-responses were followed up by a nurse. Data on demographics, CD4 counts, HIV viral loads, HIV medication adherence and attendance at appointments were collected for the year prior to the intervention and during the intervention for comparison. Data assessing quality of life was also collected at three points during the one year study period. Cost effectiveness and cost benefit of the intervention were looked at to assess feasibility of transferring the intervention to a programmatically funded facet of patient care.

Why is this research important? In Canada, around 65,000 people are living with HIV/AIDS, approximately 14,300 of whom are women. AntiRetroviral Therapy (ART) has led to enormous improvements in the health and survival of individuals with HIV. Moreover, by decreasing the amount of virus circulating in the body (viral load), HAART offers the possibility of treatment as a preventative measure. However, high levels of engagement in care, timely initiation of ARVs, and adherence to medication are required to maximize the benefits of HAART in order to prevent resistance, progression to AIDS, transmission or mortality. Unfortunately, engagement in ongoing HIV care can be poor, with one study from the United States (US) showing only 52% retention in care over 1 year. Further, adherence among high-risk populations is low, with women being less adherent partly due to their role as care providers for children and partners, potential abuse in partner relationships, fear of stigma, homelessness, and concerns regarding side effects. Conversely, active drug use (especially cocaine), lack of social supports, and depression are just a few of the variables that affect both men and women alike. Current methods of engagement in care have failed to overcome these barriers to adherence, which makes finding an effective adherence intervention critically important. Mobile health (mHealth), the use of mobile phone technology to deliver health care, is an emerging area of disease management that can assist in patient adherence to prolonged chronic treatment regimens and monitoring of care. A randomized controlled trial (WelTelKenya1), conducted by Dr. Richard Lester et. al, tested the clinical effectiveness of text message support for HIV treatment adherence in Kenya. WelTelKenya1, of which 67% were women, showed that patients receiving text message support had significantly higher rates of treatment adherence and viral suppression than patients who received standard care alone. In Canada, cell phone penetration exceeds 70% and is expected to reach 100% within the next decade. The WelTel system offers a clinical management model that can be carried out using standard services offered by cellular network providers with minimal additional infrastructure and is both flexible and scalable.

Study status: The study is no longer enrolling participants. Data analysis and manuscript preparation is underway.

Study results/publication:

Mean ART adherence improved from 61.7% to 68.3% (p<0.0001), and median population HIV log10VL declined by 0.70 log (p=0.007) from pre-intervention to intervention years.

Median VL decline for responders (response rate ≥50%) was 1.03 log (vs. 0.39 log, p=-.03), and adherence increase 13.7% (vs. 0.8%, p=0.008) versus non-responders (response rate <50%).

Managing “problem” responses required 53 minutes of Health Care Practitioner time per high-risk, vulnerable participant enrolled per year, for a cost per patient of $45.20.

Total intervention cost (including phones, plans, staff time) was $375.74 per patient per year.

Friesen K, Qiu AQ, Goktepe O, Maan EJ, Pick N, Alimenti A, Kestler M, Money D, Lester R, Murray MCM. Weekly text-messaging (Weltel) to engage vulnerable HIV+ populations: It works, what does it cost? (Oral Presentation, 25th Annual CAHR Conference, Winnipeg, MB.  May 12-15, 2016).

Friesen K, Qiu A, Goktepe O, Maan EJ, Pick N, Alimenti A, Kestler M, Smillie K, Money D, Lester R, Murray MCM and the WelTel OAKTREE Study Team. mHealth to Improve Health:  Effectiveness of a weekly text messaging intervention to improve ART adherence and HIV Viral Load in a Canadian Context: WelTel OAKTREE.” (Oral presentation), The 6th International Workshop on HIV and Women, Boston, February 21-22, 2016.

Murray, MCM, Friesen K, O’Shaughnessy S, Albert A, Maan EJ, Pick N, Alimenti A, Kestler M, Smillie K, Money D, Lester R, and the WelTel OAKTREE Study Team.  mHealth to Improve Health:  Effectiveness of a weekly text messaging intervention to improve ART adherence and HIV Viral Load in a Canadian Context: WelTel OAKTREE. (Poster Presentation), International AIDS Society Meeting, July 19-22, 2015. Abstract WEPED849, http://www.ias2015.org/WebContent/File/IAS_2015__MED2.pdf.

Friesen K, O’Shaughnessy S, Maan EJ, Makela N, Pickering B, Lester R, Pick N, Murray M.   How R U?  WelTelOAKTREE: Text messaging and nursing support to improve care for HIV positive patients taking antiretroviral therapy (cART) in British Columbia.  (Oral Presentation), 2014 Canadian Association of Nurses in AIDS Care (CANAC) Conference, April 24-26, 2014.

Co-Investigators: Dr. Ariane Alimenti, Karen Friesen, Dr. Richard Lester, Dr. Deborah Money, Dr. Neora Pick, and Dr. Laura Sauve.

Funded by: Gilead Sciences Inc. and Bristol-Myers Squibb

Prospective study of an interdisciplinary pelvic pain & endometriosis clinic (Etiology of dyspareunia in endometriosis)

The purpose of this study is to prospectively collect data from patients at the Centre for Pelvic Pain and Endometriosis clinic to investigate long-term patient outcomes, and the etiology and treatment of chronic pelvic pain.

Principal Investigator: Dr. Paul Yong

Primary Contact: Heather Noga, Research Coordinator, WHRI, 604-875-2424 ext 4924, Heather.Noga@cw.bc.ca

About the study: BC Women’s Centre for Pelvic Pain and Endometriosis is a tertiary referral centre in British Columbia dedicated to managing chronic pelvic pain (CPP) and endometriosis. The Centre offers a unique interdisciplinary approach that includes pain education workshops, pelvic floor physiotherapy, counselling, and medical and surgical management. The purpose of this study is to prospectively collect data from patients at the clinic to investigate long-term patient outcomes, and the etiology and treatment of CPP. Participants in the study will have their clinical intake questionnaires, physical exam, surgery, and pathology data included in the research and answer follow-up questionnaires at 6 months and 1-5 years.

Why is this research important? Chronic pelvic pain (CPP) (pelvic pain that lasts at least 3-6 months in duration) affects 15% of reproductive-aged women. It is a condition that can involve many physical, psychological, and behavioural consequences and have a devastating impact on quality-of-life. One of the most common origins of CPP is endometriosis, a condition in which endometrial tissue that usually lines the uterus grows outside of the uterus. However, pelvic pain may also result from numerous other gynaecological, musculoskeletal, gastrointestinal, or urological conditions, and can be difficult to manage. Therefore, there is benefit to an interdisciplinary approach in the management of CPP compared to standard treatment.

Study status: Recruitment, data collection, data analysis, and manuscript development is ongoing.

Who can participate: All patients referred for chronic pelvic pain and/ or endometriosis to the BC Women’s Centre for Pelvic Pain and Endometriosis.

Study results/publications:

Yosef, A., Allaire, C., Williams, C., Ahmed, G., Al-Hussaini, T., Abedellah, M., Wong, W., Lisonkova, S., Yong, P. (2016). Multifactorial contributions to the severity of chronic pelvic pain in women. American Journal of Obstetrics & Gynecology, epub ahead of print.

Co-Investigators: Dr. Catherine Allaire, Dr. Christina Williams, Dr. Mohamed Bedaiwy.

Funded by: Canadian Institutes of Health Research (CIHR), Vancouver Coastal Health Research Institute (VCHRI), University of British Columbia (UBC), Women’s Health Research Institute (WHRI).

Clinic website: http://www.womenspelvicpainendo.com/

Clinic page on research: http://www.womenspelvicpainendo.com/research/

Research Newsletter:

October 2016 Research Newsletter

Endometriosis – Determinants of Oncogenesis (ENDO-ONC) Full Scale Study

The aim of this study is to determine whether there are unique genetic changes in endometriosis that may play a role in malignant transformation to ovarian cancer or in the symptoms of pelvic pain and infertility.

Principal Investigator: Dr. Paul Yong

Primary Contact: Heather Noga, Research Coordinator, 604-875-2424 ext 4924, Heather.Noga@cw.bc.ca 

About the study: The aim of this study is to determine whether there are unique genetic changes in endometriosis that may play a role in malignant transformation to ovarian cancer or in the symptoms of pelvic pain and infertility. This will be done by comparing surgical tissue samples from women with endometriosis to women without endometriosis.

Participants in this study agree to provide for research purposes: a saliva sample, tissue removed from their surgery, endometrial biopsy (a sample from the lining of the uterus – only if a sample is not already being removed for clinical purposes).

Why is this research important? Endometriosis affects 10% of reproductive aged women, causes pain and infertility, and is now known to also be associated with ovarian cancer. Studying gene mutations and expression changes in surgical tissue samples of women with or without endometriosis will help us understand how it can lead to pain, infertility, ovarian cancer, and other associated symptoms.

Study status: Recruitment and data collection is ongoing.

Who can participate: You have (or are suspected to have) endometriosis OR another benign gynaecological condition, You have chosen surgical treatment.

Co-Investigators: Dr. Catherine Allaire, Dr. Christina Williams, Dr. Mohamed Bedaiwy, Dr. Jessica McAlpine, Dr. David Huntsman.

Funded by: Canadian Institutes of Health Research (CIHR), Canadian Cancer Society Research Institute (CCSRI), Women’s Health Research Institute (WHRI)

Partners: Ovarian Cancer Research Group (OvCaRe), Centre for Translational and Applied Genomics (CTAG).

Clinic website: http://www.womenspelvicpainendo.com/

Clinic Research Page: http://www.womenspelvicpainendo.com/research/

Does a Women’s Heart Center Change Clinical Outcomes?

It is not yet known whether specialized care centers like the Women’s Heart Center improves outcomes in women compared to usual care. Through this study we hope to better understand how gender specific care can impact the outcome for woman with a range of different cardiac conditions.

Principal Investigator: Dr. Tara Sedlak

Primary Contact: Dr. Tara Sedlack, Principle Investigator, VCH, 604-875-5487, Tara.Sedlak@vch.ca

About the study: This study has two aims: firstly, to create a database of patients attending the VGH/BCWH Women’s Heart Center (WHC) to facilitate the ability of future investigators to conduct research on a number of different of issues surrounding women and heart disease. The second aim is to examine whether attendance at a WHC improves outcomes of patients with heart disease or at risk for heart disease. We will collect clinical information and some basic demographic information and store this in a de-identified database. We will also ask participants to complete a total of 4 questionnaires over a 5 year period.

Why is this research important? It is not yet known whether specialized care centers like the Women’s Heart Center improves outcomes in women compared to usual care. Through this study we hope to better understand how gender specific care can impact the outcome for woman with a range of different cardiac conditions.

Study status: Ethics approval in progress.

Who can participate? Any woman who is being seen within the Women’s Heart Center at Vancouver General Hospital and/or BC Women’s Hospital will be invited to participate in this study who is fluent in English.

Co-Investigators: Natasha Prodan-Bhalla, Dr. Karin H. Humphries.

CARMA-1-PREG

CARMA-1-PREG is investigating factors related to pre-term deliveries among HIV positive women.

Principal Investigator: Dr. Deborah Money

Mitochondrial and Telomere Studies in Pregnancy
– AND –
Placental Mitochondrial Toxicity in HIV Therapy during Pregnancy
– AND –
Measuring Mitochondrial Aging, Application to HIV Infection and Therapy AND Cellular Aging and HIV Comorbidities in Women and Children

(CARMA-1-PREG)


Primary Contact: Evelyn Maan, Research Manager, 604-875-2000 ext. 2463, emaan@cw.bc.ca

About the study: CARMA-1-PREG is investigating factors related to pre-term deliveries among HIV positive women. Research has shown that HIV+ pregnant women are 2x more likely to deliver their babies early (more than 3 weeks before their due dates), compared to women without HIV. The purpose of CARMA-1-PREG is to study the effects of particular anti-HIV medications on pregnant women and on their infants by examining two markers of cell function: the length of DNA at the ends of chromosomes (“telomeres”) and the energy producing parts of the cell (“mitochondrial DNA”). CARMA-1-PREG also investigates how HIV, anti-HIV medications and other factors (e.g. the bacterial environment of a pregnant woman’s vagina) may affect early delivery.

Why is this research important?  Anti-HIV medication has dramatically reduced the risk of infants getting HIV from their HIV+ mothers (from 25% to less than 1%). However, research has demonstrated that HIV+ pregnant women are twice as likely to have a pre-term delivery when compared to women without HIV. Better understanding the factor(s) which cause these pre-term deliveries among HIV+ women is integral to the health of mothers and infants living with or exposed to HIV.

Study status: Recruiting

Who can participate: Pregnant women living with HIV who are taking, or are going to be taking, anti-HIV medication during their pregnancy.

Study Results/Publications: 

Money DM, Wagner EC, Maan EJ, Chaworth-Musters T, Gadawski I, van Schalkwyk JE, Forbes JC, Burdge D, Albert AYK, Lohn Z, Côté HCF, and The Oak Tree Clinic Research Group “Evidence of subclinical mtDNA alterations in HIV-infected pregnant women receiving combination antiretroviral therapy compared to HIV-negative pregnant women” PLoS One. 2015 Aug 6;10(8):e0135041. doi: 10.1371/journal.pone.0135041. eCollection 2015.

Imam T, Jitratkosol MH, Soudeyns H, Sattha B, Gadawski I, Maan E, Forbes JC, Alimenti A, Lapointe N, Lamarre V, Money DM, Côté HC; CIHR Emerging Team Grant on HIV Therapy and Aging: CARMA. Leukocyte telomere length in HIV-infected pregnant women treated with antiretroviral drugs during pregnancy and their uninfected infants. J Acquir Immune Defic Syndr. 2012 Aug 15;60(5):495-502. PMID: 22580562

Jitratkosol MH, Sattha B, Maan EJ, Gadawski I, Harrigan PR, Forbes JC, Alimenti A, van Schalkwyk J, Money DM, Côté HC; CIHR Emerging Team Grant on HIV Therapy and Aging (CARMA). Blood mitochondrial DNA mutations in HIV-infected women and their infants exposed to HAART during pregnancy. AIDS. 2012 Mar 27;26(6):675-83. PMID: 22436539

Co-Investigators: Dr. Helene Cote, Dr. Julie van Schalkwyk, Dr. Isabelle Boucoiran, Dr. Melanie Murray, Dr. Ariane Alimenti, Dr. Neora Pick

Funded by: CIHR

Partners: Positive Women’s Network

CARMA 1 Participant Consent Form

CARMA 7: Bone and Renal Outcomes in HIV-Exposed, Uninfected Infants with Perinatal Exposure to Tenofovir

The purpose of CARMA 7 is to investigate how fetal exposure to the anti-HIV medication Tenofovir may affect the bone and kidney health of infants who are born to HIV+ women.

Principal Investigator: Dr. Ariane Alimenti

Primary Contract: Evelyn Maan, Research Manager, 604-875-2000 ext. 2463, emaan@cw.bc.ca

About the Study: Anti-HIV medication has reduced the risk of HIV transmission from mother to child from 25% to less than 1%. However, the effects of some of these anti-HIV medications on the developing fetus have not yet been thoroughly studied. One medication in particular, called “Tenofovir”, can cause some bone and kidney problems for HIV+ adults when taken for a long time, especially with existing bone and kidney diseases. The purpose of CARMA 7 is to investigate how fetal exposure to Tenofovir may affect the bone and kidney health of infants who are born to HIV+ women.

Why is this research important? The use of Tenofovir is becoming far more common in anti-HIV medication regimens because it is so well tolerated. As a result, an increasing number of women are getting pregnant while taking this particular medication (almost 25% of HIV+ pregnancies in BC in 2011). Accordingly, it is very important for the current and future health of infants born to HIV+ women to study the effects of this anti-HIV medication.

Study Status: Recruiting

Who can participate:  Infants who do not have HIV, born at term (>35 weeks +2 days) to an HIV+ mother who took anti-HIV medication during her pregnancy, specifically Tenofovir, Abacavir, or Zidovudine (the last two for the control group).  Infants have visits for the CARMA-7 study at 1 month, 6 months, and 18 months of age.

Co-Investigators: Dr. Helene Cote, Dr. Deborah Money, Dr. Laura Sauve, Dr. Jason Brophy

Funded by: CIHR, Canadian HIV Trials Network

CARMA 7 Participant Consent Form