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Integrated Treatment and Prevention for People Who Inject Drugs

Primary Purpose

HIV Positive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Integrated Intervention
Sponsored by
HIV Prevention Trials Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Positive

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • CIPTO
  • Ukrainian Institute on Public Health Policy
  • Pho Yen Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Integrated Intervention

Arm Description

Standard of Care

Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment

Outcomes

Primary Outcome Measures

HIV incidence among network injection partners of index participants
Number of HIV seroconversions to partners to control arm Index participants
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.

Secondary Outcome Measures

HIV incidence among network injection partners of index participants in the intervention arm
Number of HIV seroconversions to partners of Intervention arm participants
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
Number of participants in either arm engaged in substance use treatment
self reported on case report forms
size and stability of drug using networks
self reported data via questionnaire of drug sharing habits and partners at each study visit
social harms and benefits
self report via questionnaire
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

Full Information

First Posted
October 12, 2016
Last Updated
December 20, 2018
Sponsor
HIV Prevention Trials Network
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02935296
Brief Title
Integrated Treatment and Prevention for People Who Inject Drugs
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HIV Prevention Trials Network
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Positive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
Integrated Intervention
Arm Type
Experimental
Arm Description
Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment
Intervention Type
Behavioral
Intervention Name(s)
Integrated Intervention
Intervention Description
systems navigation, psychosocial counseling
Primary Outcome Measure Information:
Title
HIV incidence among network injection partners of index participants
Description
Number of HIV seroconversions to partners to control arm Index participants
Time Frame
18 months
Title
enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners
Description
Number of participants enrolled, and number of participants with a final study visit.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
HIV incidence among network injection partners of index participants in the intervention arm
Description
Number of HIV seroconversions to partners of Intervention arm participants
Time Frame
18 months
Title
Engagement in care for ART treatment services of control arm vs intervention
Description
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
Time Frame
18 months
Title
Number of participants in either arm engaged in substance use treatment
Description
self reported on case report forms
Time Frame
18 months
Title
size and stability of drug using networks
Description
self reported data via questionnaire of drug sharing habits and partners at each study visit
Time Frame
18 months
Title
social harms and benefits
Description
self report via questionnaire
Time Frame
18 months
Title
phylogenetics to describe HIV transmission dynamics
Description
stored plasma samples from those persons who are HIV positive and those who become HIV positive during the study
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Miller, MD
Organizational Affiliation
Ohio State University
Official's Role
Study Chair
Facility Information:
Facility Name
CIPTO
City
Jakarta
Country
Indonesia
Facility Name
Ukrainian Institute on Public Health Policy
City
Kiev
Country
Ukraine
Facility Name
Pho Yen Health Center
City
Pho Yen
State/Province
Thai Nguyen
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no individual data will be shared
Citations:
PubMed Identifier
31794031
Citation
Sivay MV, Grabowski MK, Zhang Y, Palumbo PJ, Guo X, Piwowar-Manning E, Hamilton EL, Viet Ha T, Antonyak S, Imran D, Go V, Liulchuk M, Djauzi S, Hoffman I, Miller W, Eshleman SH. Phylogenetic Analysis of Human Immunodeficiency Virus from People Who Inject Drugs in Indonesia, Ukraine, and Vietnam: HPTN 074. Clin Infect Dis. 2020 Nov 5;71(8):1836-1846. doi: 10.1093/cid/ciz1081.
Results Reference
derived
PubMed Identifier
30191830
Citation
Miller WC, Hoffman IF, Hanscom BS, Ha TV, Dumchev K, Djoerban Z, Rose SM, Latkin CA, Metzger DS, Lancaster KE, Go VF, Dvoriak S, Mollan KR, Reifeis SA, Piwowar-Manning EM, Richardson P, Hudgens MG, Hamilton EL, Sugarman J, Eshleman SH, Susami H, Chu VA, Djauzi S, Kiriazova T, Bui DD, Strathdee SA, Burns DN. A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet. 2018 Sep 1;392(10149):747-759. doi: 10.1016/S0140-6736(18)31487-9.
Results Reference
derived

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Integrated Treatment and Prevention for People Who Inject Drugs

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