Long Acting Therapy to Improve Treatment SUccess in Daily LifE (The LATITUDE Study)

Brief description of study

This study is meant for patients who have difficulty taking their HIV meds as prescribed. One goal of the study is to test the effectiveness of long-acting antiretroviral therapy (ART) -- a once-a-month injection that replaces daily ART pills. You will also receive compensation for participating in this study, with additional compensation based on your medication adherence.

Detailed description of study

Study Activities and Length:

The study will last up to 180 weeks (three and a half years) and is broken into four "steps." Steps 1-3 involve active participation and Step 4 is for long-term follow-up and observation.

Step 1: The first part of the study lasts up to 24 weeks and involves taking your once-a-day pills as best you can. If you keep your viral load undetectable during this step, you'll be paid a bonus and move onto Step 2.

Step 2: If you are eligible and wish to continue onto Step 2, you will be randomly assigned to receive either pills or injections. Once you complete Step 2 and if you decide to continue on-study, you are guaranteed to start injections in Step 3.

Step 3: You will receive two ART injections each month in the clinic and will come in for visits to have your health monitored. Once you complete Step 3, if you decide to continue on ART injections, the study is complete.

Step 4: is only for people who want to return to taking pills after injections, and involves coming back for regular follow-up visits.

Requirements for Participation:

Note: The following requirements are some but not all requirements for participation. Full eligibility details may be discussed directly with study staff.

Inclusion:

Diagnosis of HIV
Evidence of non-adherence to ART
If a person of child-bearing potential, a willingness to use contraception for the duration of the study

Exclusion:

Unwillingness to receive injections
Currently pregnant or planning to become pregnant
Certain seizure disorders
Advanced liver disease
History of or current active hepatitis B infection
Current or anticipated use for chronic anti-coagulation therapy

Additional Information

For further information, please reach out to our study coordinators, Alexandra Fisher and Alex Shulman, and mention the LATITUDE Study.

Phone: (215) - 349 - 8092

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Antiretroviral Therapy,HIV infection
Age: Between 18 Years - 70 Years
Gender: All

Note: The following requirements are some but not all requirements for participation. Full eligibility details may be discussed directly with study staff.

Inclusion:

Diagnosis of HIV
Evidence of non-adherence to ART
If a person of child-bearing potential, a willingness to use contraception for the duration of the study

Exclusion:

Unwillingness to receive injections
Currently pregnant or planning to become pregnant
Certain seizure disorders
Advanced liver disease
History of or current active hepatitis B infection
Current or anticipated use for chronic anti-coagulation therapy

Updated on 09 Mar 2024. Study ID: 844630

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