ART Adherence Behaviour and Practices Among HIV Positives in Kolkata, India-a Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Change in antiretroviral medication adherence as measured by weekly IVR surveys
研究概览
简要总结
The purpose of this study is to test whether twice-daily Interactive Voice Response (IVR) calls made at the estimated times of patients' antiretroviral (ART) medication dosing and three reminder calls for monthly clinic appointments, will result in improvements in ART adherence, appointment attendance, health indicators (CD4 cell counts), coping skills, social support, depressive symptoms, and other quality-of-life indicators, compared to a control group receiving one IVR assessment call each week, over six months.
This is a randomized controlled trial of the IVR intervention with n=400 PLH taking first line ART in India on a twice-a-day dosing schedule. The research is supported by an Indo-U.S. Bilateral review and funding collaboration between NIH and ICMR. The research is being implemented in Kolkata by Drs. Smarajit Jana (PI, India) and Protim Ray (Project Director) at Durbar, a community-based organization providing HIV/STD prevention and community development programs with sex workers and other at-risk communities.
This is Phase 2 of a two-phase pilot project. Phase 1 was a one-month no-control pilot (n=46) for feasibility, acceptability, and patient feedback on preferences for messaging content. Phase 2 has two sites, described as Phases 2A and 2b, which will occur simultaneously and differ only in their recruitment sites and corresponding sampling strategy (sample size, gender ratio, eligibility criteria) based on site population characteristics.
- Phase 2A will recruit n=80 women and n=20 men from Durbar's Mamata Care and Treatment Center (MCTC) (providing HIV testing and treatment linkage and support) and associated Mamata Network of Positive Women (MNPW), which focus on HIV+ sex workers and their male partners and networks.
- Phase 2B will recruit n=100 women and n=200 men from the ART Centre at the Calcutta School of Tropical Medicine (STM), which hosts the largest ART center in the Northeast Region of India and has over 3,000 active patients on first line ART.
The sampling plan reflects the gender distribution of clients and patients at the two sites.
Participants will be randomized within each site and gender sub-sample to receive:
- The IVR Intervention: consisting of two (2) automated voice calls ("intervention messages") each day for six months, PLUS one IVR assessment call (consisting of four [4] questions) every week for 6 months; OR,
- The Control Condition: consisting of standard care, PLUS one IVR assessment call (consisting of four [4] questions) every week for 6 months.
All participants will be interviewed in-person by a research team member at baseline and followed-up at 2- 4- and 6-months using structured questionnaires and recording information from the participant's personal medical record (i.e., their "ART Card") to assess background characteristics and intervention impacts on ART adherence, health quality-of-life (i.e., depressive symptoms, social support). All participants will receive one IVR assessment phone call (consisting of four (4) questions during each week of the 6 month study. Each once-a-week IVR assessment will ask about missed medication and the participant's health/quality of life, and participants will respond by keying in a 1 (yes) or 2 (no) on their mobile phone.
详细描述
The originally proposed study aims were revised slightly during the review process from the Indian Council of Medical Research (ICMR), which is NIH equivalent and partner funder of this research (see "ICMR Comments" document). The original proposal examined comprehensive messaging for adherence, risk reduction, and quality of life (i.e., emotional support), compared to medication adherence messages only. The protocol was revised to compare comprehensive messaging to standard care. The IVR intervention is built on Dimagi's original ART adherence text-messaging support system called "ARemind". Therefore, the aims of this study are to:
- Adapt the ARemind mobile phone ART adherence mobile phone messaging system for PLH in Kolkata, India;
- Further develop ARemind to address the co-occurring factors of ART non-adherence, poor mental health, and transmission risks;
- Examine the acceptability, engagement, and adherence by PLH to the IVR messaging system; and
- Examine the efficacy of the twice daily ART reminder calls with health messages compared to standard care, for medication adherence only compared to standard care to improve adherence and mental health, and reduce transmission risks, in a randomized controlled trial.
BACKGROUND The 2.3 million persons living with HIV (PLH) in India are being offered access to anti-retroviral therapies (ART) by the government. ART offers the possibility of improving health and reducing HIV transmission by decreasing HIV viral loads in PLH. Yet, non-adherence remains high globally, with an estimated 50% of PLH in India not maintaining adherence to 95% of ART doses, which is considered the adherence rate needed to maintain HIV viral suppression.
Mobile phones have been used in the US and globally to increase ART adherence among PLH. As a low cost, easily diffused intervention strategy in a country such as India in which the mobile phone penetration rate is expected to reach 100% by 2014 (Informa World, 2010), designing a mobile phone intervention to increase ART adherence is a potentially highly efficacious intervention.
However, because HIV is a chronic infectious disease, PLH are also challenged with maintaining mental health and reducing transmission risks (Swendeman et al., 2009a). Furthermore, reviews and meta-analyses have concluded that ART adherence interventions are more effective when a comprehensive approach is adopted (Malta, 2008; Rueda, 2006; Simoni, 2006). In particular, mental health symptoms and transmission acts that co-occur with and undermine ART adherence (Kalichman, 2008, Malta, 2008) are likely to be behaviors that may also be influenced by mobile phone delivered interventions. Thus, this study aims to adapt and develop an intervention to improve and maintain medication and appointment adherence, reduce transmission acts, and improve quality of life including mental health symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Taking 1st-line ART 6 months or longer
- •Missed taking any ART dose in the previous 6 months
- •Able to speak and understand Bengali, Hindi, or English*
- •Willing to receive health-related IVR messages on mobile phones. (If participant will use personal cell phone and is currently registered on the "National Do Not Call" (NDNC) registry, the participant must be willing to be removed from the registry for the duration of the study.)
- •Able to provide informed consent
- •Phase 2A - Client at MCTC or member of MNPW, or peer referral of MCTC client or MNPW member,
- •Phase 2A - Received a CD4 count result in the prior two months**
- •Phase 2B - Patient at Calcutta School of Tropical Medicine ART Centre, or peer referral of a patient,
- •Phase 2B - Received
排除标准
- •Less than age 18
- •Not taking 1st-line ART for 6 months or longer
- •Does not report missing an ART dose in the prior 6 months
- •Not able to speak and understand Bengali, Hindi, or English
- •Is not willing to receive health-related IVR messages on mobile phones. (If participant will use personal cell phone and is currently registered on the "National Do Not Call" (NDNC) registry, the participant is NOT willing to be removed from the registry for the duration of the study.)
- •Unable to provide informed consent.
- •Phase 2A - Not client at MCTC or Member of MNPW, or peer referral of MCTC client or MNPW member
- •Phase 2A - Not received a CD4 count result in the prior two months
- •Phase 2B - Not patient at Calcutta School of Tropical Medicine ART Centre, or peer referral of a patient,
- •Phase 2B - Not received a CD4 count result in the prior month.
结局指标
主要结局
Change in antiretroviral medication adherence as measured by weekly IVR surveys
时间窗: Change over 6 months prospective
Change in antiretrovial medication adherence as indicated by changes in CD4 cell counts as recorded in patients' medical charts
时间窗: Change from up to 18 months before baseline to 6 months prospective
Change in antiretroviral medication adherence as measured by pill counts at monthly medical appointments recorded in medical charts
时间窗: Change from 6 months prior to baseline to 6-months prospective
Change in antiretroviral medication adherence measured by AIDS Clinical Trials Group (ACTG) self-report measure.
时间窗: Change from baseline to 2-, 4-, and 6-months prospective
次要结局
- Change in ART attitudes and adherence expectations as measured by self-report items from the ACTG measure(Change from baseline to 2-, 4-, and 6-months prospective)
- Change in ART clinic appointment non-adherence resulting in lack of ART, as measured by self-report(Change from Baseline to 2-, 4-, and 6-months prospective)
- Change in preferences for IVR messaging as measured IVR call log data(Change over 6 months prospective)
- Change in preferences for IVR messaging as measured by responses to an IVR survey at the end of each IVR message(Change over 6 months prospective)
- Change in depressive symptoms as measured by the depression subscale of the HADS self-report measure(Change from baseline to 2-, 4-, and 6-months prospective)
- Change in coping skills in 8 domains applied to HIV/AIDS and ART as measured by the Brief Cope self-report measure(Change from baseline to 2-, 4-, and 6-months prospective)
- Change in social support as measured by MOS Social Support Survey Brief 8-item self-report measure(Change from baseline to 2-, 4-, and 6-months prospective)
- Change in depressive symptoms as measured 2 questions in weekly IVR surveys(Change over 6-months prospective)
- Change in preferences for IVR messaging as measured by self-report(2-, 4-, and 6-months prospective)
研究者
Dallas Swendeman
Assistant Professor-in-Residence, Center Co-Director
University of California, Los Angeles