A Mobile Phone SMS Intervention to Increase Retention in HIV Care Among HIV-Positive MSM in Peru (WELTEL PERU)

Study Overview
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Brief Summary
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We will use a web-based system in order to deliver a text messaging-based intervention and assess the efficacy to increase retention in HIV care among HIV+ gay men in Peru.

Detailed Description
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We will determine the efficacy of the SMS-based intervention delivered through a web-based system for increasing retention in HIV care when compared with standard-of-care. We will perform a randomized controlled trial. The main outcome will be retention in HIV care within 1 year after enrollment. Participants will be categorized as retained if they attend three medical appointments for HIV care that are separated by 90 days within a one-year period (at the study clinic). Otherwise they will be classified as not retained. The follow-up period will last 6 months. We will identify and recruit 208 HIV+ MSM over a 12-month period at the research site. Healthcare providers at the clinic will be trained to assess eligibility and obtain consent for this study. After enrollment, the recruiter, who will be masked to the group assignment, will obtain consent and give instructions to all participants on how they should interact if they start receiving SMS (text messages). Participants will be randomized after signing the consent form. They will be assigned a study ID and randomly assigned to the intervention or control arm, 1:1 ratio using computer generated random numbers. Allocations will be sealed in individual, sequentially numbered opaque envelopes. The trained providers in charge of delivering the intervention will be informed when a new participant in the intervention arm is enrolled. Because of the nature of the study, healthcare providers and participants will not be masked to group assignment during the delivery of the intervention. Participants allocated to the intervention arm will have their phones registered into the platform.

Official Title
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A Mobile Phone Short Message Service Intervention to Increase Retention in HIV Care Among HIV-Positive Men Who Have Sex With Men in Peru (WELTEL PERU)

Conditions
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Hiv, Retention in Care

Intervention / Treatment
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* Behavioral: SMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be men who have sex with men; Be 18 years or older; Have been diagnosed HIV positive; Own a cell phone which can send and receive text messages; Reside in Lima, Peru; Exclusion Criteria: 1) Be enrolled in an interventional trial using text messages.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with 2 parallel arms: intervention and control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>SMS-based intervention delivered with a web-based system, which will include weekly health check-ins, appointment reminders all delivered via SMS (text messages). | Behavioral: SMS<br>* Weekly text messages that will be sent automatically by a web-based system to participants' cell-phones. Participants will be able to respond and messages will reach the system. The health providers will be in charge to respond (from the web system) to participants who reply asking for support or any other request.<br>|
| No Intervention: Control<br>Standard of care: Those who test positive in both tests receive post-test counseling, including emotional support, and are linked to a facility for antiretroviral (ART) initiation, ideally within one week. During the 1st medical appointment after diagnosis, lab tests are requested including CD4 and viral load. In most cases, ART initiation occurs at the second medical appointment when safety lab results are available. Currently, it is not mandatory to have CD4/VL results available to start ART. It is recommended that patients have CD4 counts and viral load assessed twice during the first year. A one-month supply of ART is provided initially. If clients are adherent, ART is dispensed every 3 months by nurses who also assess adherence. Standard follow-up is performed by nurses when clients visit the center for their appointments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in HIV care | The main outcome will be retention in HIV care within 1 year after enrollment. Participants will be categorized as retained if they attend three medical appointments for HIV care that are separated by 90 days within a one-year period (at the study clinic). Otherwise they will be classified as not retained. | 1 year |