Efficacy of SMS to Improve Early Retention in HIV Care for PLWH in Lima

Study Overview
=================
Brief Summary
-----------------
Randomized controlled study that will evaluate the effect of a text message-based strategy to improve retention in HIV care.

Detailed Description
-----------------
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.

Official Title
-----------------
Efficacy of an Intervention With Text Messaging to Improve Early Retention in HIV Care for People With HIV Who Receive Treatment at VIA LIBRE

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: Tailored text messages to improve retention in HIV care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Enrolled in other HIV study using text messages. Have started ART. Enrolled in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled pilot study with a parallel 2-arm design.The intervention arm will receive 2 tailored text messages weekly from a trained counselor during 3 months. The control arm will receive the standard of care, which consists of pre and post counseling after the HIV diagnosis and referral to a health facility to start antiretroviral treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will receive 2 tailored text messages weekly from a trained counselor during 3 months. | Behavioral: Tailored text messages to improve retention in HIV care<br>* 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.<br>|
| No Intervention: Control<br>Participants will receive standard of care: pre and post counseling after being diagnosed with HIV | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in timely monitoring of viral load (VL) | Rate of participants with a second lab result of VL available 6 months after initiation of ART, verified using lab records | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention, retention, mHealth