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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA041034 | U.S. NIH Grant/Contract | View source | |
| K24DA035684 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| YR Gaitonde Centre for AIDS Research and Education | OTHER |
| Elton John AIDS Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated care centers | Active Comparator | Participants in the active comparator arm have access to integrated care centers (ICCs) |
|
| ICC + incentives | Experimental | Participants in the experimental arm have access to the ICC intervention and the incentive intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incentives | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Surviving With Viral Suppression | Viral Suppression defined as HIV RNA <150 copies/mL | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 6 months |
| Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shruti H Mehta, PhD | Johns Hopkins University | Principal Investigator |
| Gregory M Lucas, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YR Gaitonde Center for AIDS Research and Education | Chennai | Tamil Nadu | 600010 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38583461 | Result | 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. | |
| 41995596 | Derived |
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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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22 sites were considered for the trial and 16 were selected on the basis of high HIV prevalence. The 16 study sites were matched into pairs and randomized to incentives or usual care. Sites were matched according to key population (people who inject drugs or men who have sex with men) and HIV burden.
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| ID | Title | Description |
|---|---|---|
| FG000 | Incentives | Participants in the experimental arm have access to the ICC intervention and the incentive intervention Incentives: 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 Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services |
| FG001 | Usual Care | Participants in the active comparator arm have access to integrated care centers (ICCs) Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | PWID [Usual Care] | People who inject drugs (PWID) in 4 sites assigned to usual care |
| BG001 | PWID [Incentives] | People who inject drugs (PWID) in 4 sites assigned to the incentives intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Surviving With Viral Suppression | Viral Suppression defined as HIV RNA <150 copies/mL | Posted | Number | proportion of participants | 12 months | sites | sites |
|
24 months
The research procedures are minimal risk (involve only a blood draw) and the intervention is behavioral. Given these considerations, our reporting obligations for the trial focus only on events that are more likely than not to be associated with i) study procedures, or ii) participation in the intervention. Adverse events are reported through complete (24-month) follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Incentives | Participants in the experimental arm have access to the ICC intervention and the incentive intervention Incentives: 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 Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory M. Lucas | Johns Hopkins University | 410 614 0560 | glucas@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 | Nov 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D005298 | Fertility |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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Matched-pair cluster-randomized trial
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|
| Integrated Care Centers | Behavioral | ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services |
|
|
| 18 months |
| Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 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 | 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. | 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. | 12 months |
| ART Adherence | Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART | 12 months |
| Mortality | All-cause mortality | 12 months |
| 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. |
| Censored due to COVID-19 |
|
| BG002 | MSM [Usual Care] | Men who have sex with men (MSM) in 4 sites assigned to usual care |
| BG003 | MSM [Incentives] | Men who have sex with men (MSM) in 4 sites assigned to the incentives intervention |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| HIV RNA <150 copies/mL | Count of Participants | Participants |
|
| CD4 cell count | Normal is >/= 500 cells/microliter. | Median | Inter-Quartile Range | cells/microliter |
|
| Secondary school education or beyond | Count of Participants | Participants |
|
Participants in the active comparator arm have access to integrated care centers (ICCs)
Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services
|
|
|
| Secondary | Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | Posted | Number | Proportion of participants | 6 months | Study sites | Study sites |
|
|
|
|
| Secondary | Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | Overall number of participants analyzed is equal to enrolled cohort minus participants who were censored at the 18-month visit due to COVID-related stoppage. | Posted | Number | Proportion of participants | 18 months | Study sites | Study sites |
|
|
|
|
| Secondary | Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | Overall number of participants analyzed is equal to enrolled cohort minus participants who were censored at the 24-month visit due to COVID-related stoppage. | Posted | Number | Proportion of participants | 24 months | Study sites | Study sites |
|
|
|
|
| Secondary | 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 | Posted | Number | Proportion of participants | 24 months | Study sites | Study sites |
|
|
|
|
| Secondary | 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. | This analysis includes only participants who had never started ART previously | Posted | Number | Proportion of participants | 12 months | Study site | Study site |
|
|
|
|
| Secondary | 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. | Posted | Number | Proportion of participants | 12 months | Study site | Study site |
|
|
|
|
| Secondary | ART Adherence | Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART | Posted | Number | proportion of participants | 12 months | Study sites | Study sites |
|
|
|
|
| Secondary | Mortality | All-cause mortality | Posted | Number | Proportion of participants | 12 months | Study sites | Study sites |
|
|
|
|
| 104 |
| 1,114 |
| 104 |
| 1,114 |
| 0 |
| 1,114 |
| EG001 | Usual Care | Participants in the active comparator arm have access to integrated care centers (ICCs) Integrated Care Centers: ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services | 125 | 1,200 | 125 | 1,200 | 0 | 1,200 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |