Clinical trial NCT05227417: 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
Overall status: COMPLETED
Phase: NA
Conditions: Retention in Care
Hiv
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2022-02-07
Enrollment: 208
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 2 parallel arms: intervention and control.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention in HIV care
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Hospital Cayetano Heredia
Study officials:
References: