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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05227417
Enrollment
208
Registered
2022-02-07
Start date
2022-01-31
Completion date
2024-12-31
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Retention in Care

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.

Detailed description

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.

Interventions

BEHAVIORALSMS

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.

Sponsors

Fogarty International Center of the National Institute of Health
CollaboratorNIH
Universidad Peruana Cayetano Heredia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Be men who have sex with men; 2. Be 18 years or older; 3. Have been diagnosed HIV positive; 4. Own a cell phone which can send and receive text messages; 5. Reside in Lima, Peru;

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Retention in HIV care1 yearThe 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.

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026