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

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:

1. A rapid HIV test done on-site (participants will get their result right away)
2. An HIV self-testing kit to take home
3. A coupon for a free HIV test at a participating health center
4. Their choice of any one of the previous three options

Only one of these options will be offered at a time, depending on the date. The specific HIV testing option offered on each date will be randomly assigned. All participants will receive the mobile app, which will send weekly messages with links to different types of online content (infographics, maps, videos) over the next 3 months. The specific sequence of messages and content will be different depending on the type of HIV test the person received and their HIV test result, once it is known.

The study will measure two main outcomes related to the acceptability and feasibility of the program:

* 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

Interventions

OTHER

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

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Asociación Civil Via Libre, Peru

  collaborator OTHER

• Epicentro, Peru

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Alexander J Lankowski, MD · Fred Hutchinson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-12

Primary Completion

2025-12-13

Completion

2026-03-31

Countries

• Peru

Study Locations