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

Not Applicable

Active, not recruiting

• Conditions: Hiv; Retention in Care
• Interventions: Behavioral: SMS

• Registration Number: NCT05227417
• Lead Sponsor: Universidad Peruana Cayetano Heredia

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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study Start: 2022-01-31
• Study First Posted: 2022-02-07
• Status Verified: 2024-05
• Primary Completion: 2024-05-12
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	SMS	SMS-based intervention delivered with a web-based system, which will include weekly health check-ins, appointment reminders all delivered via SMS (text messages).

Primary Outcome Measures

Name	Time	Method
Retention in HIV care	1 year	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.

Trial Locations

Locations (1)

Hospital Cayetano Heredia; 🇵🇪 Lima, Peru