Retention in CareNCT05227417
A Mobile Phone SMS Intervention to Increase Retention in HIV Care Among HIV-Positive MSM in Peru (WELTEL PERU)
A study testing SMS in people with Retention in Care and Hiv, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Retention in Care, Hiv
- What is being tested?
- SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 sitePeru
- Study dates
- 31 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 1) Be enrolled in an interventional trial using text messages.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Retention in Care, Hiv
- Being tested
- SMS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start31 Jan 2022
- Primary completion12 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retention in CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 2 parallel arms: intervention and control.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227417
- Sponsor's protocol ID
- WelTel Peru
- Other IDs
- 1K43TW011428
- Status last verified
- May 2024
- First submitted
- 26 Jan 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05227417
- Acronym / sponsor ID
- WelTel Peru
- Conditions
- Retention in Care, Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 12 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 2 parallel arms: intervention and control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SMSSMS-based intervention delivered with a web-based system, which will include weekly health check-ins, appointment reminders all delivered via SMS (text messages). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (1 listed)
- 1) Be enrolled in an interventional trial using text messages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMSWeekly 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. | Behavioural | Intervention |
Primary outcome
Retention in HIV care
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS in people with Retention in Care and Hiv, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in HIV care (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.