Optimal Intervention to Full Viral Suppression: Text Me, Alexis! (NCT06408350) | Clinical Trial Compass
TerminatedNot Applicable
Optimal Intervention to Full Viral Suppression: Text Me, Alexis!
Stopped: President Trump's Executive Order
United States71 participantsStarted 2024-04-11
Plain-language summary
Text Me, Alexis! is a three-arm randomized controlled trial (RCT) to determine the optimal and most cost-effective intervention for advancing trans women living with HIV to full viral suppression. Participants will be randomized (1:1:1) to Peer Health Navigation (PHN) alone, SMS (text messaging) alone, or PHN+SMS. Participants in the PHN alone and PHN+SMS arms will receive unlimited navigation sessions over 3 months. Participants in the SMS alone and PHN+SMS arms will receive 3 daily theory-based text messages for 90 days for a total of 270 unique scripted messages.
Who can participate
Age range
18 Years
Sex
MALE
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:
* Self-identified transgender woman;
* Age 18 or older;
* Verified HIV positive status;
* Not currently in HIV care, and/or had not had an HIV care visit in the previous 6 months, and/or had a viral load of ≥200 copies/ml on her last lab test result, and/or not currently prescribed ART, and/or prescribed ART but does not rate her ability to take all her medications as "excellent";
* Ability to receive daily text messages on either a personal cell phone or via an email account
Exclusion Criteria:
* Does not identify as a transgender woman;
* Under 18 years of age;
* HIV negative status;
* Currently in HIV care, and had a HIV care visit in the previous 6 months, and had a viral load of ≤200 copies/ml on her last lab test result, and currently prescribed ART, and rates her ability to take all her medications as "excellent";
* Does not have the ability to receive daily text messages on either a personal cell phone or via an email account.
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.