HIV Infections Clinical Trial
Official title:
Strategies to Improve the HIV Care Continuum Among Key Populations in India
Verified date | April 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 2314 |
Est. completion date | June 2024 |
Est. primary completion date | March 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
India | YR Gaitonde Center for AIDS Research and Education | Chennai | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Elton John AIDS Foundation, National Institute on Drug Abuse (NIDA), YR Gaitonde Centre for AIDS Research and Education |
India,
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 injec — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | HIV Testing Rate in Integrated Care Centers (ICCs) | HIV tests done per unit time | 6, 12, 18, and 24 months | |
Other | Rate of New HIV Diagnoses at ICCs | New HIV diagnoses per unit time | 6, 12, 18, and 24 months | |
Other | Qualitative Evaluation of Incentive Intervention | In-depth interviews with study participants and ICC staff | 24-36 months | |
Other | Recent HIV Testing, Community-level (Respondent-driven Sampling [RDS] Survey) | Proportion reporting HIV test in prior 12 months among RDS survey participants | 36-48 months | |
Other | Awareness of HIV-positive Status, Community-level (RDS Survey) | Proportion of HIV-positive participants aware of their status | 36-48 months | |
Other | Recent HIV Care Visit, Community-level (RDS Survey) | Proportion of HIV-positive participants with treatment visit in prior 6 months | 36-48 months | |
Other | Current ART Use, Community-level (RDS Survey) | Proportion of HIV-positive participants with ART use in prior 30 days | 36-48 months | |
Other | Viral Load Suppression, Community-level (RDS Survey) | Proportion of HIV-positive participants with suppressed viral load (HIV RNA <150 c/mL) | 36-48 months | |
Other | Prevalence of Viremic Persons, Community-level (RDS Survey) | Proportion of all participants (HIV-negative and HIV-positive) with a measured HIV RNA =150 copies/mL. | 36-48 months | |
Other | HIV Incidence, Community-level (RDS Survey) | Estimated with a validated multi-assay algorithm measured in HIV-positive participants | 36-48 months | |
Other | Costs Per Quality-adjusted Life Year Gained | Evaluation of intervention costs and cost-effectiveness | 6, 12, 18, and 24 months | |
Primary | Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 12 months | |
Secondary | Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 6 months | |
Secondary | Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 18 months | |
Secondary | Proportion of Participants Surviving With Viral Suppression | Viral suppression defined as HIV RNA <150 copies/mL | 24 months | |
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 | 24 months | |
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. | 12 months | |
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. | 12 months | |
Secondary | ART Adherence | Proportion of participants who had a medication possession ratio of 0.9 or higher after starting ART | 12 months | |
Secondary | Mortality | All-cause mortality | 12 months |
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