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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH126781 | U.S. NIH Grant/Contract | View source | |
| FHIRB0010738 | Other Identifier | Fred Hutchinson Cancer Center IRB |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Asociación Civil Via Libre, Peru | OTHER |
| Epicentro, Peru | UNKNOWN |
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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:
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 study will also measure:
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.
This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-component HIV testing and linkage-to-services intervention ("Mercury") among MSM in Lima, Peru. The Mercury intervention includes two core components: 1) HIV testing offered at sex-on-premises venues (SOPVs, e.g., saunas, hourly hotels, bars/discos with dark rooms); and 2) a mobile health (mHealth) application consisting of bidirectional SMS text messaging and tailored multimedia content related to HIV treatment/prevention and other sexual health topics.
The Mercury application is adapted from a previously validated mHealth technology platform (WelTel). In addition to its use as a system for secure two-way messaging with healthcare providers, the application is programmed to send two types of standardized weekly text messages:
In this randomized trial, the researchers will compare four HIV testing strategies in the context of the Mercury intervention, corresponding to the following intervention arms:
Every Thursday, Friday, and Saturday during recruitment, the intervention will be offered at a single SOPV in downtown Lima. There will be three recruitment venues overall, which will alternate based on day of the week: SOPV#1 [Thursdays], SOPV#2 [Fridays], SOPV#3 [Saturdays]). On each given recruitment date, only one of the four HIV testing strategies (i.e., intervention arms) will be offered - assigned at random using a block randomization scheme designed to generate an even (1:1:1:1) distribution of recruitment dates by intervention arm, balanced by day of week (Thu vs Fri vs Sat) and recruitment venue (SOPV#1 vs SOPV#2 vs SOPV#3). All participants will receive the mHealth application, including tailored content related to the HIV testing format they received. The study team will approach potential participants as they enter or leave the venue, introducing the study with a brief (< 30 second) standardized script describing the HIV testing format on offer. For those who accept the intervention and enroll in the study, eligibility screening, informed consent, and receipt of the corresponding HIV testing format will be done in a private space (either inside the venue or in a secure van parked outside). All participants will receive standard HIV pre-test counseling according to Peruvian national guidelines and complete a baseline questionnaire collecting data on socio-demographics, use of mobile technology, and experience with HIV testing/prevention. There are no in-person follow-up visits as part of this study. Participants will be enrolled in the mHealth application for a total of 3 months, at which time they will be contacted by the study team and asked to complete a follow-up questionnaire. The researchers may continue to observe participants for up to 6 months, if necessary, to ascertain outcomes.
The study will evaluate two co-primary outcomes: uptake of the intervention (number who accept the intervention divided by the number offered), and continued engagement with the mHealth application (assessed at 3 months). Additionally, the following secondary outcomes will be assessed: HIV test completion, and user satisfaction with the mHealth application. Exploratory outcomes will include: linkage to care and HIV treatment initiation (if HIV+); linkage to prevention and HIV pre-exposure prophylaxis (PrEP) initiation (if HIV-).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Rapid Test | Active Comparator | Participants will receive a rapid HIV test on-site at the time of enrollment. |
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| 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. |
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| Group 3 - Coupon | Active Comparator | Participants will be given a coupon redeemable for a free future HIV test at a participating health center. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component HIV testing and linkage-to-services intervention | Other | The intervention includes two core components:
In this trial, the specific format of HIV testing offered will differ according to intervention arm. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV test completion | The proportion of participants confirmed to have completed an HIV test within 3 months of enrollment. | 3 months |
| User satisfaction | This will be a composite outcome based on an online questionnaire participants will be sent gauging their overall satisfaction with the mHealth component of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Linkage to HIV care | Among participants who test HIV positive, the proportion who establish care with an HIV treatment provider (as indicated by completion of a clinic intake visit) within 3 or 6 months of their study-provided HIV test result. | 3 months, 6 months |
| ART initiation |
Inclusion criteria:
Exclusion criteria:
Male
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| Name | Affiliation | Role |
|---|---|---|
| Alexander J Lankowski, MD | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epicentro | Lima | Lima Province | Peru | |||
| Via Libre |
Deidentified data (baseline and follow-up surveys; primary, secondary, and exploratory outcomes) may be shared upon reasonable request by contacting the Principal Investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2025 | Jan 22, 2026 |
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Intervention arm is randomly assigned at the level of the recruitment date.
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| 3 months |
Among participants who test HIV positive, the proportion who initiate antiretroviral treatment (ART) within 3 or 6 months of their study-provided HIV test result. |
| 3 months, 6 months |
| Linkage to HIV prevention | Among participants who test HIV negative, the proportion who establish care (as indicated by completion of a clinic intake visit) with an HIV pre-exposure prophylaxis (PrEP) provider within 3 or 6 months of their study-provided HIV test result. | 3 months, 6 months |
| PrEP initiation | Among participants who test HIV negative, the proportion who initiate HIV pre-exposure prophylaxis (PrEP) within 3 or 6 months of their study-provided HIV test result. | 3 months, 6 months |
| HIV seropositivity | The proportion of participants with a confirmed HIV positive result on the study-provided test. | 6 months |
| Receipt of viral load testing | Among participants who test HIV positive, the proportion with documentation of at least one viral load test having been performed. | 6 months |
| PrEP attitudes, willingness and intention to use | Among participants who test HIV negative, the motivational PrEP cascade will be assessed using a questionnaire sent 3 months after enrollment. | 3 months |
| Lima |
| Lima Province |
| Peru |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008628 | Mercury |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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