Evaluation of a Multi-Component Intervention to Support HIV Testing and Linkage to Services Among MSM in Peru

NCT07074899 | Active Not Recruiting

• 3 other identifiers: RG1121536K23MH126781FHIRB0010738
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 2

Brief Summary

This study is testing a new program designed to improve access to HIV testing and help connect people with available treatment or prevention services, based on their test result. The version of the program being tested in this study was designed for men who have sex with men (MSM) in Lima, Peru. The program has two main parts: 1) offering HIV testing at venues where people go for sex (called "sex-on-premises venues" or SOPVs), and 2) a text messaging app that shares useful information about HIV treatment/prevention; users can also message back to get support from a healthcare worker. Before doing this study, the researchers worked with community members and healthcare providers in the area to make sure that the HIV testing approach and mobile app were designed in a way that would be engaging and meet their needs. Every Thursday, Friday, and Saturday night during recruitment, the researchers will go to SOPVs popular among the MSM community in Lima and invite people to take an HIV test. On each recruitment date, they will offer one of the following HIV testing options:

• The number and percentage of people who accept the program when offered
• The number and percentage of participants who continue to engage with the mobile app after 3 months The study will also measure:
• overall satisfaction with the app (based on a questionnaire sent at 3 months)
• the number and percentage of participants who completed any form of HIV testing after 3 months
• the number and percentage of participants who started HIV treatment (out of those with a positive HIV test)
• the number and percentage of participants who started HIV pre-exposure prophylaxis, or "PrEP" (out of those with a negative HIV test) All follow-up will be done remotely. Participants will have the app for 3 months. After 3 months, they will get a follow-up questionnaire asking about their experiences with the program. The researchers will keep tracking results related to the HIV treatment/prevention services that people receive for up to 6 months.

Conditions

HIV/AIDS; Mobile Health; Feasibility Studies; Qualitative Research; Implementation Science; Social Determinants of Health; Health Services Accessibility; Global Health; HIV Prevention; HIV Testing; Linkage to Care

Keywords

HIV self-test; HIV prevention; Latin America; Linkage to care; Community-based HIV testing

Outcome Measures

Primary Outcomes (2)

• Intervention Uptake

  The proportion of individuals who accept the intervention and enroll in the study among those who are approached and offered the intervention at the recruitment venue.

  30 minutes

• Continued Engagement

  The proportion of participants who remain engaged with the mHealth component of the intervention over time, as indicated by having either 1) sent at least one text message reply (either responding directly to a programmed message or spontaneously messaging the provider team) or 2) logged into the WelTel online portal (or otherwise accessed the application content) within the previous 15 days.

  3 months

Secondary Outcomes (2)

• HIV test completion

  3 months

• User satisfaction

  3 months

Other Outcomes (7)

• Linkage to HIV care

  3 months, 6 months

• ART initiation

  3 months, 6 months

• Linkage to HIV prevention

  3 months, 6 months

Study Arms (4)

Group 1 - Rapid Test

ACTIVE COMPARATOR

Participants will receive a rapid HIV test on-site at the time of enrollment.

Other: Multi-component HIV testing and linkage-to-services intervention

Group 2 - HIV Self-Test

ACTIVE COMPARATOR

Participants will be given an HIV self-test kit that they may use at the time and place of their choosing.

Other: Multi-component HIV testing and linkage-to-services intervention

Group 3 - Coupon

ACTIVE COMPARATOR

Participants will be given a coupon redeemable for a free future HIV test at a participating health center.

Other: Multi-component HIV testing and linkage-to-services intervention

Group 4 - "Choice"

ACTIVE COMPARATOR

Participants will be offered their choice of any one of the three HIV testing formats (rapid test, self-test, referral coupon).

Other: Multi-component HIV testing and linkage-to-services intervention

Interventions

Multi-component HIV testing and linkage-to-services intervention OTHER

The intervention includes two core components: 1. HIV testing offered at sex-on-premises-venues \[SOPVs\]; 2. mHealth-supported linkage to treatment/prevention services (enrollment in a two-way text messaging application adapted from the WelTel platform). In this trial, the specific format of HIV testing offered will differ according to intervention arm.

Also known as: Mercury

Group 1 - Rapid Test; Group 2 - HIV Self-Test; Group 3 - Coupon; Group 4 - "Choice"

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• identifies as gay, bisexual, or other man who has sex with men (MSM)
• attendance at the designated recruitment venue (SOPV) and is willing to receive the form HIV testing (i.e., intervention arm) offered on that recruitment date
• has a mobile phone device and service capable of two-way SMS text messaging via the WelTel platform and is willing to send/receive text messages using their primary mobile phone number
• able to read and write

You may not qualify if:

• self-reports having a previous HIV diagnosis
• cognitively or psychologically unable to participate in HIV testing (e.g. visibly intoxicated or self-reports being intoxicated)
• unable to provide informed consent

Sponsors & Collaborators

• Epicentro, Peru: collaborator
• Fred Hutchinson Cancer Center: lead
• Asociación Civil Via Libre, Peru: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Epicentro

Lima, Lima Province, Peru

Location

Via Libre

Lima, Lima Province, Peru

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Mercury

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Alexander J Lankowski, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate in VIDD

Model Details: Intervention arm is randomly assigned at the level of the recruitment date.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: June 12, 2025
• Primary Completion: December 13, 2025
• Study Completion: March 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

PE (2)