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

NCT05227417 | Completed

• 2 other identifiers: WelTel Peru1K43TW011428
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retention in Care; Hiv

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

SMS BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• \) Be enrolled in an interventional trial using text messages.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Hospital Cayetano Heredia

Lima, 15102, Peru

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The recruiter will be masked to the group assignment. Participants will be randomized after signing the consent form. Because of the nature of the study, healthcare providers and participants will not be masked to group assignment during the delivery of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with 2 parallel arms: intervention and control.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: January 31, 2022
• Primary Completion: May 12, 2024
• Study Completion: December 31, 2024
• Last Updated: May 30, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)