Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)
研究概览
简要总结
The EXTEND study is a randomized controlled trial to compare the uptake and acceptability, efficacy, and cost of methods of delivery of an alcohol intervention in reducing unhealthy alcohol use and increasing viral suppression among HIV positive persons in Uganda. The study arms are (a) in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim (b) in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and (c) standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
详细描述
Alcohol consumption is a critical driver of HIV outcomes, especially in sub-Saharan Africa (SSA), where both are extremely common. Heavy alcohol use has been associated with reduced antiretroviral adherence, decreased HIV suppression, and increased mortality among those with HIV. Thus, reducing unhealthy alcohol use may improve HIV outcomes and is a high priority worldwide. Screening and brief counseling for alcohol use, especially multi-session approaches, have shown evidence for reducing alcohol use in resource rich settings and among persons with HIV. However, there are significant cost and human resource barriers to multiple session interventions in SSA, and it is not known whether alcohol interventions can improve HIV outcomes. Thus, the long-term goal of the EXTEND study is to develop and test interventions to reduce alcohol consumption and improve HIV outcomes, that can be feasibly integrated into routine HIV care in SSA.
Multi-session interventions that combine in-person visits with booster phone calls to reinforce the in-person counseling have shown good efficacy. Because cell phone use in Uganda is high, phone-based booster sessions conducted in-between the in-person sessions (that coincide with regularly scheduled clinic visits) may be feasible. However, phone-based booster sessions delivered by a live counselor ("live boosters") can be costly, time-consuming, limited to working hours, and dependent on good phone connections. Alternatively, automated cell phone-based booster sessions ("tech boosters"), can be conducted via interactive systems such as two-way Short Message Service (SMS, i.e. text messaging) or Interactive Voice Response (IVR) that allow for brief interactive sessions, with messages that are tailored to the participants' drinking goals and gender. Such automated tailored mobile phone-based interventions have been successful in improving several health behaviors in diverse populations. However, the uptake, acceptability, cost, and efficacy of live and tech booster calls for interventions for reducing alcohol use and improving HIV outcomes in SSA is not known. The investigators hypothesize that automated mobile phone-based technology can be leveraged as an efficacious way to implement multi-session alcohol interventions at a low burden and cost to both providers and patients in low resource settings.
Objectives
The EXTEND study is a randomized controlled trial (RCT) with a goal of estimating the uptake and acceptability, preliminary efficacy, and cost of methods of delivery of an intervention to reduce unhealthy drinking and HIV viral failure among persons in HIV care in rural Uganda (n=270). The RCT study arms are:
- in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim;
- in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and
- standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The Research Assistant, who will collect study data including the study questionnaire and biological specimens for testing, will be blinded to the participants' study arm assignment.
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 years and older;
- •HIV positive;
- •On ART for at least six months;
- •Reported alcohol use in the prior year at clinic entry;
- •Fluency in Runyakole;
- •Living within two hours travel time from the clinic;
- •Owning or having daily access to a cell phone;
- •Screening positive on the AUDIT-C
排除标准
- •Plans to move out of the catchment area within 6 months;
- •Unable to provide informed consent.
- •Participation in another research study.
结局指标
主要结局
Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)
时间窗: At 6 and 9 month visits (3 and 6 months post intervention).
Alcohol biomarker phosphatidylethanol (PEth) level will be used as an objective measure of prior 21-day alcohol use to confirm the findings obtained using self-report.
Change in Alcohol Use Measured by Self Report
时间窗: At 6 and 9 month visits (3 and 6 months post intervention).
Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back
Percentage of Participants With HIV Viral Suppression
时间窗: At 9 month visit (6 months post intervention).
Undetectable HIV viral load measured through plasma HIV viral load measurements.
次要结局
- Booster Uptake - Counselor Call-back Requests(3 months)
- Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.(At 6 and 9 month visits (3 and 6 months post-intervention))
- Number of Heavy Drinking Days in the Prior 21 Days(At 6 and 9 month visits (3 and 6 months post intervention).)
- Booster Satisfaction - Usability(At 6 month visit (3 months post intervention).)
- Cluster of Differentiation-4 (CD4) Cell Count(At nine months (6 months post intervention).)
- Booster Uptake - Completion(3 months)
- Booster Satisfaction - Client Satisfaction Scale-8(At 6 month visit (3 months post intervention))
- IVR Chosen as Technology Booster Mode(3 months)
- Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.(At 6 and 9 month visits (3 and 6 months post intervention).)