Division
HEAL Study
Title
Assessing Long-term CTN-0049 Outcomes, HCV Prevalence and Progression along the HCV Care Continuum among HIV/HCV Co-infected Substance Users in the U.S.
Short Description
This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group).
Release Date
Oct 24, 2024
Description
CTN 0064 has two main components: Component 1 is the baseline assessment for CTN 0064. It will also serve as a long-term follow-up assessment for CTN 0049 for those who consent to participate in CTN 0064. Participants whose HCV antibody test result is positive in this baseline assessment will be invited to enroll in Component 2. Component 2 is an RCT that will assess the effectiveness of a Care Facilitation intervention (compared to Control) in moving HIV/HCV co-infected substance users forward along the HCV care continuum. The study's primary objective is based on Component 2 and will be operationalized as movement through a series of (potentially non-sequential) pre-defined, clinical steps along the HCV care continuum (including the ultimate step, sustained virologic response to treatment at 12 weeks post treatment completion [SVR12]) (AASLD/IDSA/IAS-USA). Secondary objectives will be to assess: 1) success at each step in the HCV care continuum, 2) engagement in HIV care and substance use treatment, and 3) HIV viral suppression as well as 4) to examine other long-term outcomes of the CTN 0049 cohort.
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Health Literacy

Submitted by cbethel on
Abbreviation
HLT
Description
A set of three health literacy screening questions for detecting patients with inadequate or marginal health literacy
Category
Health Cognitions & QOL
Physical/General Health
Division
HEAL Study
Investigator(s)
Title
Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
Short Description
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
Release Date
Jul 19, 2024
Description
This is a 19-week, multi-center, parallel group study that includes: 1) up to 3 weeks for screening; 2) a 13-week Treatment Phase consisting of a 1-week, single-blind run-in period, when all subjects receive twice daily 15 mg acetazolamide capsules (a medication adherence marker), followed by randomization to either twice daily 10 mg lorcaserin or placebo capsules for the remaining 12 weeks; and 3) a 3-week follow-up period, with scheduled visits during Study Weeks 14 and 16.
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Study Data
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Drug and Drug Problems Perceptions Questionnaire

Submitted by cbethel on
Abbreviation
DDPPQ
Description
The 22-item DDPPQ was developed to measure mental health professionals' attitudes to working with drug users. One of its possible uses is to help ascertain the training requirements of staff who work with drug users. It may also be used to evaluate the impact of education programs on staff's attitudes. The 22-items in the DDPPQ include statements such as "I feel I have a working knowledge of drugs and drug related problems," "I feel I know how to counsel drug users over the long term," "I feel I have the right to ask patients/clients questions about their drug use when necessary," and "I feel there is little I can do to help drug users." Respondents rate each statement on a 7-point Likert scale with 1 corresponding to "strongly agree" and 7 to "strongly disagree."
Category
Mental Health
Substance Use
Impulsivity and General Trait & Behavior Scales
Clinical Measures
Subcategory
Diagnostic
Drugs