An interventional study of Incentives and Integrated Care Centers in HIV Infections, sponsored by Johns Hopkins University. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 2,314 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the active comparator arm have access to integrated care centers (ICCs)
Behavioral: Integrated Care Centers
Participants in the experimental arm have access to the ICC intervention and the incentive intervention
Behavioral: Incentives · Behavioral: Integrated Care Centers
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.
Also known as: ICC+
ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services
Also known as: ICC
Proportion of Participants Surviving With Viral Suppression
Viral Suppression defined as HIV RNA \<150 copies/mL
Time frame: 12 months
Proportion of Participants Surviving With Viral Suppression
Viral suppression defined as HIV RNA \<150 copies/mL
Time frame: 6 months
Proportion of Participants Surviving With Viral Suppression
Viral suppression defined as HIV RNA \<150 copies/mL
Time frame: 18 months
Proportion of Participants Surviving With Viral Suppression
Viral suppression defined as HIV RNA \<150 copies/mL
Time frame: 24 months
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
Time frame: 24 months
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.
Time frame: 12 months
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.
Time frame: 12 months
ART Adherence
Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART
Time frame: 12 months
Mortality
All-cause mortality
Time frame: 12 months
| Milestone | Incentives | Usual Care |
|---|---|---|
| Started | 1114 | 1200 |
| 6-month follow-up | 901 | 968 |
| 12-month follow-up | 826 | 885 |
| 18-month follow-up | 778 | 824 |
| Completed | 421 | 492 |
| Not completed | 693 | 708 |
| Withdrew: Death | 104 | 125 |
| Withdrew: Lost to follow-up | 108 | 112 |
| Withdrew: Censored due to covid-19 | 481 | 471 |
Viral Suppression defined as HIV RNA \<150 copies/mL
| proportion of participants | Incentives | Usual Care |
|---|---|---|
| Proportion of Participants Surviving With Viral Suppression | 0.494 | 0.353 |
Viral suppression defined as HIV RNA \<150 copies/mL
| Proportion of participants | Incentives | Usual Care |
|---|---|---|
| Proportion of Participants Surviving With Viral Suppression | 0.509 | 0.365 |
Viral suppression defined as HIV RNA \<150 copies/mL
| Proportion of participants | Incentives | Usual Care |
|---|---|---|
| Proportion of Participants Surviving With Viral Suppression | 0.497 | 0.358 |
Viral suppression defined as HIV RNA \<150 copies/mL
| Proportion of participants | Incentives | Usual Care |
|---|---|---|
| Proportion of Participants Surviving With Viral Suppression | 0.471 | 0.325 |
Proportion with viral suppression (HIV RNA \<150 copies/mL) at one or more follow-up visits
| Proportion of participants | Incentives | Usual Care |
|---|---|---|
| Proportion of Participants With Viral Suppression at One or More Follow-up Visits | 0.640 | 0.498 |
Rate of ART initiation among those naive to ART at baseline. This is reported as the proportion of participants who initiated ART.
| Proportion of participants | Incentives | Usual Care |
|---|---|---|
| Antiretroviral Therapy (ART) Initiation | 0.721 | 0.708 |
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.
| Proportion of participants | Incentives | Usual Care |
|---|---|---|
| Retention to HIV Care | 0.702 | 0.664 |
Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART
| proportion of participants | Incentives | Usual Care |
|---|---|---|
| ART Adherence | 0.645 | 0.463 |
All-cause mortality
| Proportion of participants | Incentives | Usual Care |
|---|---|---|
| Mortality | 0.051 | 0.068 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Incentives | 104/1,114 (9.3%) | 104/1,114 (9.3%) | 0/1,114 (0%) |
| Usual Care | 125/1,200 (10.4%) | 125/1,200 (10.4%) | 0/1,200 (0%) |
| Event | Incentives | Usual Care |
|---|---|---|
| DeathGeneral disorders | 104/1114 | 125/1200 |
Data are stratified by key population (PWID and MSM). 600 PWID and 514 MSM were at sites assigned to the incentive intervention (1114 total), and 600 PWID and 600 MSM were at sites assigned to usual care (1200 total).
| Age, Continuous(years) | PWID [Usual Care] | PWID [Incentives] | MSM [Usual Care] | MSM [Incentives] | Total |
|---|---|---|---|---|---|
| Median | 28 (24 to 33) | 30 (25 to 35) | 30 (25 to 40) | 32 (26 to 40) | 30 (25 to 37) |
| Sex: Female, Male(Participants) | PWID [Usual Care] | PWID [Incentives] | MSM [Usual Care] | MSM [Incentives] | Total |
|---|---|---|---|---|---|
| Female | 2 | 152 | 0 | 0 | 154 |
| Male | 598 | 448 | 600 | 514 | 2160 |
| Race (NIH/OMB)(Participants) | PWID [Usual Care] | PWID [Incentives] | MSM [Usual Care] | MSM [Incentives] | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 600 | 600 | 600 | 514 | 2314 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| HIV RNA <150 copies/mL(Participants) | PWID [Usual Care] | PWID [Incentives] | MSM [Usual Care] | MSM [Incentives] | Total |
|---|---|---|---|---|---|
| Count of participants | 61 | 153 | 108 | 138 | 460 |
| CD4 cell count(cells/microliter) | PWID [Usual Care] | PWID [Incentives] | MSM [Usual Care] | MSM [Incentives] | Total |
|---|---|---|---|---|---|
| Median | 391 (282 to 499) | 384 (242 to 514) | 314 (183 to 477) | 276 (147 to 434) | 347 (210 to 491) |
| Secondary school education or beyond(Participants) | PWID [Usual Care] | PWID [Incentives] | MSM [Usual Care] | MSM [Incentives] | Total |
|---|---|---|---|---|---|
| Count of participants | 336 | 381 | 375 | 352 | 1444 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
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