Integrated Treatment and Prevention for People Who Inject Drugs

Study Overview
=================
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.

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

Conditions
-----------------
HIV Positive

Intervention / Treatment
-----------------
* Behavioral: Integrated Intervention


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard of Care | |
| Experimental: Integrated Intervention<br>Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment | Behavioral: Integrated Intervention<br>* systems navigation, psychosocial counseling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV incidence among network injection partners of index participants | Number of HIV seroconversions to partners to control arm Index participants | 18 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of participants in either arm engaged in substance use treatment | self reported on case report forms | 18 months | 
| size and stability of drug using networks | self reported data via questionnaire of drug sharing habits and partners at each study visit | 18 months | 
| social harms and benefits | self report via questionnaire | 18 months | 
| 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 |