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The AIM-PrEP Trial: Study Protocol for a Multicenter Randomized Controlled Trial of an AI Agent-Driven Intervention to Enhance PrEP Adherence and Monitoring in Men Who Have Sex with Men

The AIM-PrEP Trial: Study Protocol for a Multicenter Randomized Controlled Trial of an AI Agent-Driven Intervention to Enhance PrEP Adherence and Monitoring in Men Who Have Sex with Men

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111280
Enrollment
Unknown
Registered
2025-10-29
Start date
2026-02-26
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Control group:Conventional PrEP intervention
PrEP-bot Intervention Group:AI-chabot for PrEP to mediated PrEP medication and health check-ups
PrEP-bot Smart Pillbox Intervention Group:Comprising AI-chatbot for PrEP (PrEP-bot) and Smart pill box (SPB) to mediated PrEP medication and health check-ups

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.assigned male at birth; 2.reported anal sex with a man; 3.aged 18–65 years; 4.currently using PrEP and have been using it for less than half an hour; 5.self-reported HIV-negative status confirmed by a fourth-generation HIV test; 6.fully understand the study's purpose, procedures, and methods, voluntarily provide written informed consent, and are willing to participate in regular follow-up visits.

Exclusion criteria

Exclusion criteria: 1.Those who have not disclosed their sexual orientation to family members and are unable to use the electronic pillbox at home; 2.Those with mental or psychological disorders; 3.Those unable to operate a smartphone; 4.Other situations deemed unsuitable for participation by the researchers.

Design outcomes

Primary

MeasureTime frame
PrEP adherence at months 3 of the follow-up period;

Secondary

MeasureTime frame
PrEP-related health check-ups;The consistency between methods for assessing PrEP adherence;PrEP adherence at the 6th month of follow-up;The effectiveness of PrEP-bot;The acceptability of PrEP-bot;PrEP adherence at months 12 of the follow-up period;HIV incidence rate;The feasibility of PrEP-bot;

Countries

China

Contacts

Public ContactXu Junjie

Peking University Shenzhen Hospital

xjjcmu@163.com+86 755 83923333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 6, 2026