WelTelOAKTREE: Text Messaging to Support Patients With HIV/AIDS in British Columbia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Increased viral load/proportion of HIV viral load tests showing virologic suppression (< 40copies/ml)
研究概览
简要总结
WelTel Oak Tree is a repeated measures study that enrolled 85 HIV+ individuals from the Oak Tree Clinic at BC Women's Hospital. Participants were be provided with a cell phone and/or unlimited text messaging capability if they do not have it already, and for one year received a weekly text message stating "How are you". Participant problems and non-responses were be followed up by a nurse. Data on demographics, CD4 counts, HIV viral loads, HIV medication adherence and attendance at appointments was 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 is being studied to assess feasibility of transferring the intervention to a programmatically funded facet of patient care.
详细描述
Purpose:
To provide a weekly text messaging intervention to 85 high risk HIV+ participants attending the Oak Tree HIV Clinic in order to improve medication adherence, attendance at appointments and subsequently, CD4 counts and HIV viral load values over a 1 year period.
Justification:
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.
The investigators have completed one of the first studies of text messaging support for HIV care in Canada. The pilot study called WelTelBC1 involved 25 individuals from five patient groups 1) Non-suppressed (CD4 <200, VL >250); 2) Youth (ages 14-24); 3) Mature (Age ≥50); 4) English as a second language; and 5) Distance (those residing 3+ hours travel time from the clinic), who receive a weekly text message asking them "How are you?" Participants were then instructed to respond with "OK" or to let the investigators know if they had a problem. Participants who responded that they are "not okay" or did not respond were then followed up by a clinic nurse. The pilot study was designed to look at feasibility and acceptability of the weekly text messaging intervention in a Canadian HIV+ population, and resulted showed that the intervention was been perceived as beneficial among participants. In regards to acceptability, the pilot study has been extremely informative, and has enabled investigators to engage participants previously only seen sporadically; overcoming gaps that prevent optimal care and follow-up. In addition, we have seen from our pilot project, that to reach those in most need of a link to care we need to be prepared to provide cell phones and phone plan support to those without one (only 50% of those enrolled in our intervention owned a cell phone, and only 40% had unlimited text messaging - anecdotally these are the patients with whom engagement has most improved during the intervention). It is now critical to expand this program to all individuals at Oak Tree Clinic who could benefit and to study the efficacy of this intervention in engaging patients in care and improving adherence to HAART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •attendance at the Oak Tree Clinic for at least 1 year prior to study entry to permit historical comparison analysis and with at least one clinic visit in the preceding year from date of enrolment
- •age ≥14 years
- •CD4 count ≤500 cells/mm3 or previous prescription for antiretroviral therapy (other than for pregnancy) prior to the control year, (indicating clinical indication for HIV therapy existed during the control year)
- •any detectable viral load (≥200 copies/mL) in the control year OR is one of the 25 participants in the pilot study, WelTelBC1 (H11-03003), and who when approached for consent into the current study, chooses to participate
排除标准
- •attendance at the Oak Tree Clinic for less than one year prior to study entry
- •age <14 years
- •consensus by clinical team that patient does NOT fit high-risk criteria as listed
- •lives in an area where cell phone service is not available
- •unable to communicate via the text-messaging system
结局指标
主要结局
Increased viral load/proportion of HIV viral load tests showing virologic suppression (< 40copies/ml)
时间窗: Two years
Measured using lab results available in the patient charts in the intervention year compared to the year prior to enrollment.
次要结局
- Number of hours spent by health care providers for this intervention(Two years)
- Increased CD4 counts(Two years)
- Improved engagement(Two years)
- Improved antiretroviral medication adherence(Two years)
研究者
Melanie C. M. Murray, MD PhD
Assistant Professor, Div. of Infectious Diseases, Dept. of Medicine, UBC
BC Women's Hospital & Health Centre