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

Primary Purpose

Retention in Care, Hiv

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
SMS
Sponsored by
Universidad Peruana Cayetano Heredia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retention in Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Cayetano Heredia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2022
Last Updated
August 1, 2022
Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Fogarty International Center of the National Institute of Health
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1. Study Identification

Unique Protocol Identification Number
NCT05227417
Brief Title
A Mobile Phone SMS Intervention to Increase Retention in HIV Care Among HIV-Positive MSM in Peru (WELTEL PERU)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
Fogarty International Center of the National Institute of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retention in Care, Hiv

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with 2 parallel arms: intervention and control.
Masking
Care Provider
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.
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
SMS-based intervention delivered with a web-based system, which will include weekly health check-ins, appointment reminders all delivered via SMS (text messages).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention in HIV care
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Cayetano Heredia
City
Lima
ZIP/Postal Code
15102
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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