CompletedNot Applicable

Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users

United States360 participantsStarted 2013-01

Plain-language summary

This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected cocaine (including crack) users by using a two-group randomized, prospective trial. A total of 360 HIV-infected individuals who report cocaine (including crack) use will be randomized across study sites. The primary hypothesis is that more participants randomized to the "Retention Clinic" will have undetectable viral load than will participants randomized to the treatment as usual group.

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

. be at least 18 years old
. be HIV-seropositive (confirmed via medical record/laboratory results or via rapid HIV test in conjunction with confirmatory test or viral load)
. meet one of the following: a) have an (\*)AIDS-defining illness OR b) have a CD4 count \<350 cells/uL AND a viral load \>1000 copies/mL in the medical record in the past 3 months OR c) have a CD4 count \<350 cells/uL AND a viral load \>200 copies/mL as obtained via baseline blood draw OR d) have a clinical profile indicative of a persistently detectable HIV viral load (\>200 copies/mL) attributed to non-adherence to HIV medications as per PI evaluation of the individual and/or individual's medical record
. report (OR have evidence in the medical record of) any cocaine (including crack) use in the past 3 months OR (\*\*)have a positive toxicology result for cocaine via the study toxicology screen
. agree to have their blood drawn for CD4 and viral load testing

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

Virologic suppression

Timeframe: 12 months

Trial details

NCT IDNCT01614106

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More HIV trials

Plain-language summary

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

. be at least 18 years old
. be HIV-seropositive (confirmed via medical record/laboratory results or via rapid HIV test in conjunction with confirmatory test or viral load)
. meet one of the following: a) have an (\*)AIDS-defining illness OR b) have a CD4 count \<350 cells/uL AND a viral load \>1000 copies/mL in the medical record in the past 3 months OR c) have a CD4 count \<350 cells/uL AND a viral load \>200 copies/mL as obtained via baseline blood draw OR d) have a clinical profile indicative of a persistently detectable HIV viral load (\>200 copies/mL) attributed to non-adherence to HIV medications as per PI evaluation of the individual and/or individual's medical record
. report (OR have evidence in the medical record of) any cocaine (including crack) use in the past 3 months OR (\*\*)have a positive toxicology result for cocaine via the study toxicology screen
. agree to have their blood drawn for CD4 and viral load testing

Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria