AzTrials
AzTrials

HIV InfectionsNCT02969915

Strategies to Improve the HIV Care Continuum Among Key Populations in India

A study testing Incentives and Integrated Care Centers in people with HIV Infections, run by Johns Hopkins University at 1 site in India.

Completed

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

Official record
Search all trials

Trial summary

This clinical trial will compare the effectiveness of integrated care centers vs. integrated care centers plus HIV patient treatment incentives for achieving HIV treatment targets among people who inject drugs and men who have sex with men in India. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Incentives and Integrated Care Centers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,314 participants
Where
1 siteIndia
Study dates
30 Oct 2017to 30 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Speaks Hindi, English, or local language
  • HIV-positive
  • Antiretroviral therapy (ART) naive or has used ART less than 12 months
  • Registered client at the local integrated care center (ICC), which serves either people who inject drugs (PWID) or men who have sex with men (MSM).

Who cannot join

  • Not competent to provide informed consent or participate in the study.
  • Receives HIV care in the private sector
  • Plans to migrate in next 12 months

Trial locations and contacts

1 site in 1 country.

India1 site

  • YR Gaitonde Center for AIDS Research and Education

    Chennai, Tamil Nadu, 600010

Other trials in India

About this study

This clinical trial will compare the effectiveness of integrated care centers vs. integrated care centers plus HIV patient treatment incentives for achieving HIV treatment targets among people who inject drugs and men who have sex with men in India. The investigators will also assess cost-effectiveness and barriers and facilitators to implementation through targeted mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key populations in low to middle-income countries.

Read the detailed description

The trajectory of the HIV epidemic in coming decades will be determined by the degree to which we can identify infected persons and engage them in care - a point implicit in the ambitious UNAIDS "90-90-90" target, which sets 90% goals for HIV diagnosis, linkage of infected persons to sustained antiretroviral therapy (ART), and viral suppression in those treated. Meeting this target requires successful engagement of difficult to reach populations, such as people who inject drugs (PWID) and men who have sex with men (MSM), who bear a disproportionate share of the epidemic, particularly in low to middle income countries. Our team is nearing completion of a multi-site cluster-randomized trial in India to assess the effectiveness of integrated care centers (ICCs) for PWID and MSM compared to usual care. ICC process measures from the first year show robust uptake of HIV counseling and testing, the primary outcome for that trial, but slower than anticipated ART uptake. Demand-side interventions in public health (such as treatment incentives) can be particularly effective when paired with optimized treatment accessibility (i.e., supply). Consequently, the investigators propose to examine whether provision of HIV care and treatment incentives to ICC clients will improve overall utilization of the clinics and downstream HIV care continuum outcomes.

The investigators propose a hybrid effectiveness-implementation design. This will include a 16-site, pair-matched cluster randomized trial to compare the effectiveness of adding of HIV care incentives to ICCs (ICC+) versus standard ICCs on HIV care continuum outcomes, including ART initiation, adherence and viral suppression. Effectiveness will be compared at the ICC level (from a cohort of HIV-infected ART-eligible clients followed in each ICC and process measures deriving from all ICC clients) and at the community-level through a cross-sectional sample accrued via respondent-driven sampling (RDS) 2 years after initiation of the intervention. Because PWID and MSM will be sampled independently from the ICCs in the RDS, it provides an opportunity to characterize outcomes like community viral load and HIV incidence, reflecting impact within the broader PWID/MSM communities. As an exploratory sub-aim, we will use a rigorous scientific design to assess the effects of withdrawing (vs. continuing) incentives beyond the initial intervention phase. Additionally, the investigators will determine the cost-effectiveness of the ICC+ intervention.

Conditions
HIV Infections
Being tested
Incentives, Integrated Care Centers
Keywords
people who inject drugs, men who have sex with men, HIV, India
Medical subject headings
HIV Infections, Homosexuality

What participants receive

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

  • IncentivesBehavioural

    Also called ICC+

    Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.

  • Integrated Care CentersBehavioural

    Also called ICC

    ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services

Study groups in NCT02969915
Study groupRoleWhat they receive
Integrated care centersActive comparatorParticipants in the active comparator arm have access to integrated care centers (ICCs)
Receives: Behavioral: Integrated Care Centers
ICC + incentivesExperimentalParticipants in the experimental arm have access to the ICC intervention and the incentive intervention
Receives: Behavioral: Incentives; Behavioral: Integrated Care Centers

What is being measured

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

  1. Proportion of Participants Surviving With Viral Suppression

    Viral Suppression defined as HIV RNA <150 copies/mL

    Measured: 12 months

Secondary outcomes (8)

  1. Proportion of Participants Surviving With Viral Suppression

    Viral suppression defined as HIV RNA <150 copies/mL

    Measured: 6 months

  2. Proportion of Participants Surviving With Viral Suppression

    Viral suppression defined as HIV RNA <150 copies/mL

    Measured: 18 months

  3. Proportion of Participants Surviving With Viral Suppression

    Viral suppression defined as HIV RNA <150 copies/mL

    Measured: 24 months

  4. Proportion of Participants With Viral Suppression at One or More Follow-up Visits

    Proportion with viral suppression (HIV RNA <150 copies/mL) at one or more follow-up visits

    Measured: 24 months

  5. Antiretroviral Therapy (ART) Initiation

    Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART.

    Measured: 12 months

  6. Retention to HIV Care

    Proportion of participants who attended one or more visits to a government ART clinic in both the 0 to 6 month period and the 6 to 12 month period.

    Measured: 12 months

  7. ART Adherence

    Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART

    Measured: 12 months

  8. Mortality

    All-cause mortality

    Measured: 12 months

Timeline

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

  1. First posted21 Nov 2016 (estimated)
  2. Study start30 Oct 2017
  3. Primary completion23 Mar 2020
  4. Study completion30 May 2024

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Matched-pair cluster-randomized trial
Masking
None (open label)
Enrolment
2,314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969915
Sponsor's protocol ID
IRB00082575
Other IDs
R01DA041034, K24DA035684
Status last verified
Dec 2025
First submitted
18 Nov 2016
Last updated
15 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will require prospective collaborators to submit concept sheets to the study PIs that include a brief summary of the proposed hypothesis, summary of research methods, specific data or specimens that are being requested, and plans for analysis. Reasonable requests that address relevant scientific questions will be welcomed and supported to the extent possible.

Publications

  • Solomon SS, McFall AM, Srikrishnan AK, Verma V, Anand S, Khan RT, Kushwaha BS, Vasudevan C, Saravanan S, Paneerselvam N, Kumar MS, Das C, Celentano DD, Mehta SH, Lucas GM. Voucher incentives to improve viral suppression among HIV-positive people who inject drugs and men who have sex with men in India: a cluster randomised trial. Lancet HIV. 2024 May;11(5):e309-e320. doi: 10.1016/S2352-3018(24)00005-5. Epub 2024 Apr 4.

    PubMed 38583461

  • Hamill MM, Gunaratne MP, McFall AM, Iqbal HS, Vasudevan CK, Anand S, Solomon SS, Mehta SH, Krishnan AK, Celentano DD, Lucas GM. Increasing Syphilis Prevalence Among MSM Across India Despite Improvements in the HIV Care Continuum. J Acquir Immune Defic Syndr. 2026 Jun 1;101(6):633-642. doi: 10.1097/QAI.0000000000003860.

    PubMed 41995596

Questions about this trial

What is this clinical trial studying?

A study testing Incentives and Integrated Care Centers in people with HIV Infections, run by Johns Hopkins University at 1 site in India.

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 4 inclusion and 3 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. 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?

Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Participants Surviving With Viral Suppression (time frame: 12 months). 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 NCT02969915, 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 15 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in