HIV Positive Clinical Trial
Official title:
Integrated Treatment and Prevention for People Who Inject Drugs: A Vanguard Study for a Network-based Randomized HIV Prevention Trial Comparing an Integrated Intervention Including Supported Antiretroviral Therapy to the Standard of Care
Verified date | December 2018 |
Source | HIV Prevention Trials Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the feasibility of a future trial that will assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for HIV-infected PWID.
Status | Completed |
Enrollment | 1281 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 16, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: Index participants: - Age 18-45 years at the Screening visit (age verification procedures will be defined in the Study Specific Procedures [SSP] Manual) - Able to provide informed consent - Active injection drug user, defined as self-report of: a) injecting drugs approximately two or more times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff - Reports sharing needles/syringes or drug solutions at least once in the last month - HIV-infected based on a study-defined testing algorithm (defined in the SSP Manual) - Viral load =1,000 copies/mL at Screening - Willing and able to identify, recruit, and have enrolled at least one HIV-uninfected network injection partner who is eligible for study participation according to the criteria below - Have no plans to move outside the study area for at least one year after study enrollment - Willing to participate in intervention activities, including regular phone contact HIV uninfected injection partners: - Age 18-45 years at the Screening visit (age verification procedures will be defined in the SSP Manual) - Able to provide informed consent - Active injection drug user, defined as: a) self-report of injecting drugs approximately two times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff - Confirmed injection partner, using referral identification cards, of index participant within the past 1 month - HIV-uninfected based on the study-defined testing algorithm* (defined in the Study SSP Manual) - Have no plans to move outside the study area for at least one year after study enrollment Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Indonesia | CIPTO | Jakarta | |
Ukraine | Ukrainian Institute on Public Health Policy | Kiev | |
Vietnam | Pho Yen Health Center | Pho Yen | Thai Nguyen |
Lead Sponsor | Collaborator |
---|---|
HIV Prevention Trials Network | National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA) |
Indonesia, Ukraine, Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIV incidence among network injection partners of index participants | Number of HIV seroconversions to partners to control arm Index participants | 18 months | |
Primary | enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners | Number of participants enrolled, and number of participants with a final study visit. | 18 months | |
Secondary | HIV incidence among network injection partners of index participants in the intervention arm | Number of HIV seroconversions to partners of Intervention arm participants | 18 months | |
Secondary | Engagement in care for ART treatment services of control arm vs intervention | Number of participants in both arms who report being in ART (case report forms) care, as well as testing stored plasma for HIV RNA suppression | 18 months | |
Secondary | Number of participants in either arm engaged in substance use treatment | self reported on case report forms | 18 months | |
Secondary | size and stability of drug using networks | self reported data via questionnaire of drug sharing habits and partners at each study visit | 18 months | |
Secondary | social harms and benefits | self report via questionnaire | 18 months | |
Secondary | phylogenetics to describe HIV transmission dynamics | stored plasma samples from those persons who are HIV positive and those who become HIV positive during the study | 18 months |
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