CompletedNot Applicable

Tel-Me-Box: Testing a New, Real-time Strategies for Monitoring HIV Medication Adherence in India

India131 participantsStarted 2021-08-13

Plain-language summary

Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS), and devices which wirelessly monitor adherence in real-time, have multiple limitations, including over-reporting, inability to assess pill ingestion, and size/expense. Our multidisciplinary research team at the University of California, San Francisco (UCSF) and in India has designed a new adherence-monitoring device called "Tel-Me-Box" which is small, low-cost, rechargeable, inconspicuous, and could be programmed to deliver tailored real-time adherence reminders following additional hardware modifications. The aim of this study is to modify and validate this discreet Tel-Me-Box (TMB) adherence monitoring and reminder device against hair ARV concentrations as a pharmacologic measure of drug ingestion/adherence, a measure pioneered and validated by our team, with the expectation that this device and intermittent hair monitoring could have widespread utility for HIV and non-HIV adherence science, both in India and globally.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * HIV-positive * Currently on antiretroviral therapy (ART) * Speaks one of the local languages * Able and willing to participate in the study, provide informed consent, contact information, and express a willingness to return for follow-up visits every three months for 12 months after baseline. * Adherence-challenged per self-report, i.e. report of \<90% ART adherence or \>2 ART treatment interruptions of at least 2 days in the past 3 months Exclusion Criteria: * Unwilling or unable to participate in the study and/or return for follow-up appointments * younger than 18 years old * Not HIV-infected * Not currently on ART * Does not speak one of the local languages

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tel-me-box Adherence

Timeframe: 30 days prior to each follow-up assessment (3, 6, 9 and 12 months post baseline).

HIV Viral Load (VL)

Timeframe: Baseline, and 6 and 12 month follow-up

Hair Concentrations of Anti-retroviral Medications (ARV), in ng/mg

Timeframe: 12 month follow-up

Trial details

NCT IDNCT03086655

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-11

Results submitted2024-01-11

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