Integrated Treatment and Prevention for People Who Inject Drugs

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935296
• Other study ID #: HPTN 074
• Secondary ID: UM1AI068619
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: December 2018
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a multi-site, two-arm, randomized, vanguard study. Network units will consist of an HIV-infected index participant and his/her HIV-uninfected network injection partner(s). Network units will be randomized to the intervention or standard of care arms in a 1:3 ratio, stratified by site. To assess feasibility of the intervention, additional interviews will be conducted with study staff (systems navigators and counselors) and clinic-based stakeholders at each study site.

Approximately 500 Index participants and their partners will be enrolled.

Recruitment information / eligibility

• 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:

Related Conditions & MeSH terms

• HIV Positive
• HIV Seropositivity

Intervention

Behavioral:
• Integrated Intervention
systems navigation, psychosocial counseling

Locations

Country	Name	City	State
Indonesia	CIPTO	Jakarta
Ukraine	Ukrainian Institute on Public Health Policy	Kiev
Vietnam	Pho Yen Health Center	Pho Yen	Thai Nguyen

Sponsors (3)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

Indonesia,  Ukraine,  Vietnam, 

Outcome

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