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A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts Clinical research trials and A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts. A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts  A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts
A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),National Institute of Mental Health (NIMH),National Institute on Drug Abuse (NIDA)
Synopsis: Injection drug use is the major mode of HIV transmission in many countries. Injection drug users (IDUs) transmit HIV not only through shared drug injection equipment but also through heterosexual and homosexual transmission and mother-to-child transmission. Studies have shown that peer education programs can reduce HIV risk behavior in IDUs. However, it is not known if reduced HIV risk behavior leads to fewer HIV infections. The purpose of this study is to find out if a peer education program can reduce the number of new HIV infections by changing the behavior of IDUs and their HIV risk contacts.
Details: More than 20 years of research in implementing interventions for IDUs indicate that HIV transmission among these users can be prevented, slowed, and stopped with the appropriate intervention. Intervening early with multiple strategies can prevent epidemic spread and its consequences. Even after prevalence has increased substantially, prevention interventions can reduce the further spread of HIV in drug-using populations and transmission into other populations. Although research results have been promising, it is unknown if self-reported behavior change is correlated with reducing rates of HIV transmission. This study will determine the efficacy of a peer-educator, network-oriented intervention to prevent HIV transmission among substance users and their risk network members. IDUs will be recruited using street and community outreach methods in Chiang Mai and Chiang Rai, Thailand and in Philadelphia, Pennsylvania, USA. Individuals at the study clinics will undergo a screening survey and HIV counseling and testing; they will return to the clinic to receive their HIV test results, post-test counseling, and further screening. Those who are HIV uninfected, meet preliminary eligibility requirements, and are willing to participate will be enrolled as index participants. Each index participant will be asked to identify and attempt to recruit at least two other people (potential network members) whom he/she has had sex with or taken drugs with in the 3 months prior to screening. Infected and uninfected network members will be eligible for enrollment. Index participants will be randomly assigned with their network members to either the intervention group or a control group. All participants will receive HIV counseling and regular HIV testing. Index participants assigned to the intervention group attend six, two-hour peer educator-training sessions over a period of 4 weeks. The training sessions focus on skills building and promotion of risk-reducing behaviors. A one-hour booster training session is held for index participants after their 6- and 12-month follow-up assessments. The study will last approximately 48 months, with enrollment expected to take about 30 months. Participants will be followed for a minimum of 18 months and a maximum of 30 months. Both index participants and network members have follow-up visits every 6 months, at which they will complete surveys designed to assess HIV risk behavior, network characteristics, the intensity of the intervention delivery, and social harms that may be associated with study participation. Average network HIV incidence rates will be compared for the two study groups.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Index Participants - HIV uninfected within 60 days of study entry - Injected drugs at least 12 times in the last 3 months - Out of methadone maintenance treatment for at least 3 months and have relapsed - Willing to identify and attempt to recruit at least two HIV risk network members who are eligible for study - Able to recruit at least one HIV risk network member eligible for study participation Inclusion Criteria for Network Members - Recruited by an eligible index participant for the study - Have injected drugs with and/or had sex with the relevant index participant within 3 months prior to screening Exclusion Criteria - For index participants: prior or concurrent enrollment in another HIV behavioral or biomedical prevention study (e.g., vaccine or microbicide research, or any other behavioral or clinical research to test an intervention aimed at preventing or reducing the risk of HIV infection) - Already enrolled in another network of HPTN 037 as a network member or index participant - Mental, learning, or any other problems that would interfere with the study
Total Enrollment: 2610
Location and Contact Information:
Overall Study Official:
CarlLatkin, Study Chair, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University
Research Institute for Health Sciences *Recruiting*
Chiang Mai, , 50202
Thailand
Recruiting Peter Lange 01-66-53-221-966
Univ of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Johnnita Prince 215-746-7348
RAP Office *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting David Metzger 215-746-7346
Additional Information:
Study ID Numbers: HPTN 037;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038688
Other Hiv Infections Studies:
1. A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
2. Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
3. A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
4. A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment
5. A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
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A Study of Peer Education to Prevent HIV Transmission among Injection Drug Users and Their HIV Risk Contacts
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