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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02969915
• Other study ID #: IRB00082575
• Secondary ID: R01DA041034K24DA
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
India	YR Gaitonde Center for AIDS Research and Education	Chennai	Tamil Nadu

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Elton John AIDS Foundation, National Institute on Drug Abuse (NIDA), YR Gaitonde Centre for AIDS Research and Education

Country where clinical trial is conducted

India, 

References & Publications (1)

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

Outcome

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