Efficacy of an Intervention With Text Messaging to Improve Early Retention in HIV Care for People With HIV Who Receive Treatment at VIA LIBRE
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Retention in timely monitoring of viral load (VL)
研究概览
简要总结
Randomized controlled study that will evaluate the effect of a text message-based strategy to improve retention in HIV care.
详细描述
This is a randomized controlled pilot study with a parallel 2-arm design. It will evaluate the effect of a text message-based strategy to improve retention in HIV care at the study clinic, compared to the standard of care. Trained counselors will deliver the text messages. After a block randomization, the trained counselor (a nurse) will send the first welcoming message to participants in the intervention arm. The nurse will send 2 tailored text messages per week. In addition 2 to 4 days before an appointment, the nurse will send a message reminder. In addition, the nurse will have bilateral communication with participants using text messages according to their needs. The participants of the intervention arm will interact with the nurse during 3 months with a semi-structured strategy, that is, with template text messages (predesigned) and open messages (for which the nurse will be trained). Three and six months after started the intervention the variables of interest will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
After consenting, participants will be randomly assigned to the intervention or control with a 1:1 ratio and random block sizes of 2 and 4 using computer generated random numbers. Block sizes will not be disclosed. Allocations will be sealed in individual, sequentially numbered opaque envelopes. The RECRUITER, who will be masked to the group assignment, will give instructions to all participants on how they should interact if they start receiving SMS. After completing the baseline survey, one of the principal investigators will assign the participant to a group by opening the corresponding envelope. The PI will report to one of trained providers in charge of delivering the intervention (different from recruiters) when a new participant of the intervention arm is enrolled. Because of the nature of the participation, providers and participants will not be masked to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male 18 years old or older.
- •Linked to HIV care at the study clinic.
- •Have a cell phone.
- •Diagnosed at the study clinic of referred from other center to start ART.
- •Give consent to participate.
排除标准
- •Enrolled in other HIV study using text messages.
- •Have started ART.
- •Enrolled in a clinical trial.
结局指标
主要结局
Retention in timely monitoring of viral load (VL)
时间窗: 6 months
Rate of participants with a second lab result of VL available 6 months after initiation of ART, verified using lab records
次要结局
未报告次要终点
研究者
ROBINSON CABELLO
Executive Director
NGO Via Libre