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HIV PositiveNCT02935296

Integrated Treatment and Prevention for People Who Inject Drugs

A study testing Integrated Intervention in people with HIV Positive, run by HIV Prevention Trials Network at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
HIV Positive
What is being tested?
Integrated Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,281 participants
Where
3 sitesin 3 countries
Study dates
4 Feb 2015to 30 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
Show all 17Show fewer
  • 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

Who cannot join

  • -

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Indonesia1 site

  • CIPTO

    Jakarta

Other trials in Indonesia

Ukraine1 site

  • Ukrainian Institute on Public Health Policy

    Kiev

Other trials in Ukraine

Vietnam1 site

  • Pho Yen Health Center

    Hanoi

Other trials in Vietnam

About this study

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

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.

Read the 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.

Conditions
HIV Positive
Being tested
Integrated Intervention
Medical subject headings
HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated InterventionBehavioural

    systems navigation, psychosocial counseling

Study groups in NCT02935296
Study groupRoleWhat they receive
ControlNo interventionStandard of Care
Integrated InterventionExperimentalStandard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment
Receives: Behavioral: Integrated Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV incidence among network injection partners of index participants

    Number of HIV seroconversions to partners to control arm Index participants

    Measured: 18 months

  2. 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.

    Measured: 18 months

Secondary outcomes (6)

  1. HIV incidence among network injection partners of index participants in the intervention arm

    Number of HIV seroconversions to partners of Intervention arm participants

    Measured: 18 months

  2. 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

    Measured: 18 months

  3. Number of participants in either arm engaged in substance use treatment

    self reported on case report forms

    Measured: 18 months

  4. size and stability of drug using networks

    self reported data via questionnaire of drug sharing habits and partners at each study visit

    Measured: 18 months

  5. social harms and benefits

    self report via questionnaire

    Measured: 18 months

  6. 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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2016 (estimated)
  2. Study start4 Feb 2015
  3. Primary completion16 Jun 2017
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02935296
Sponsor's protocol ID
HPTN 074
Other IDs
UM1AI068619
Status last verified
Mar 2025
First submitted
12 Oct 2016
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: no individual data will be shared

Publications

  • 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.

    PubMed 31794031

  • 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.

    PubMed 30191830

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Intervention in people with HIV Positive, run by HIV Prevention Trials Network at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia, Ukraine, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV incidence among network injection partners of index participants (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935296, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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