Trial Outcomes & Findings for Strategies to Improve the HIV Care Continuum Among Key Populations in India (NCT NCT02969915)

NCT ID: NCT02969915

Last Updated: 2025-12-15

Results Overview

Viral Suppression defined as HIV RNA \<150 copies/mL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2314 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-12-15

Participant Flow

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.

Unit of analysis: Sites

Participant milestones

Measure	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	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
Overall Study STARTED	1114 8	1200 8
Overall Study 6-month Follow-up	901 8	968 8
Overall Study 12-month Follow-up	826 8	885 8
Overall Study 18-month Follow-up	778 8	824 8
Overall Study COMPLETED	421 8	492 8
Overall Study NOT COMPLETED	693 0	708 0

Reasons for withdrawal

Measure	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	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
Overall Study Death	104	125
Overall Study Lost to Follow-up	108	112
Overall Study Censored due to COVID-19	481	471

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PWID [Usual Care] n=600 Participants People who inject drugs (PWID) in 4 sites assigned to usual care	PWID [Incentives] n=600 Participants People who inject drugs (PWID) in 4 sites assigned to the incentives intervention	MSM [Usual Care] n=600 Participants Men who have sex with men (MSM) in 4 sites assigned to usual care	MSM [Incentives] n=514 Participants Men who have sex with men (MSM) in 4 sites assigned to the incentives intervention	Total n=2314 Participants Total of all reporting groups
Age, Continuous	28 years n=6009 Participants	30 years n=42 Participants	30 years n=77 Participants	32 years n=387 Participants	30 years n=160 Participants
Sex: Female, Male Female	2 Participants n=6009 Participants	152 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	154 Participants n=160 Participants
Sex: Female, Male Male	598 Participants n=6009 Participants	448 Participants n=42 Participants	600 Participants n=77 Participants	514 Participants n=387 Participants	2160 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	600 Participants n=6009 Participants	600 Participants n=42 Participants	600 Participants n=77 Participants	514 Participants n=387 Participants	2314 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants
Race (NIH/OMB) White	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants
HIV RNA <150 copies/mL	61 Participants n=6009 Participants	153 Participants n=42 Participants	108 Participants n=77 Participants	138 Participants n=387 Participants	460 Participants n=160 Participants
CD4 cell count	391 cells/microliter n=6009 Participants	384 cells/microliter n=42 Participants	314 cells/microliter n=77 Participants	276 cells/microliter n=387 Participants	347 cells/microliter n=160 Participants
Secondary school education or beyond	336 Participants n=6009 Participants	381 Participants n=42 Participants	375 Participants n=77 Participants	352 Participants n=387 Participants	1444 Participants n=160 Participants

PRIMARY outcome

Timeframe: 12 months

Viral Suppression defined as HIV RNA <150 copies/mL

Outcome measures

Measure	Incentives n=8 sites 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	Usual Care n=8 sites 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
Proportion of Participants Surviving With Viral Suppression	0.494 proportion of participants	0.353 proportion of participants

SECONDARY outcome

Timeframe: 6 months

Viral suppression defined as HIV RNA <150 copies/mL

Outcome measures

Measure	Incentives n=8 Study sites 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	Usual Care n=8 Study sites 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
Proportion of Participants Surviving With Viral Suppression	0.509 Proportion of participants	0.365 Proportion of participants

SECONDARY outcome

Timeframe: 18 months

Population: 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.

Viral suppression defined as HIV RNA <150 copies/mL

Outcome measures

Measure	Incentives n=8 Study sites 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	Usual Care n=8 Study sites 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
Proportion of Participants Surviving With Viral Suppression	0.497 Proportion of participants	0.358 Proportion of participants

SECONDARY outcome

Timeframe: 24 months

Population: 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.

Viral suppression defined as HIV RNA <150 copies/mL

Outcome measures

Measure	Incentives n=8 Study sites 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	Usual Care n=8 Study sites 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
Proportion of Participants Surviving With Viral Suppression	0.471 Proportion of participants	0.325 Proportion of participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	Incentives n=8 Study sites 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	Usual Care n=8 Study sites 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
Proportion of Participants With Viral Suppression at One or More Follow-up Visits	0.640 Proportion of participants	0.498 Proportion of participants

SECONDARY outcome

Timeframe: 12 months

Population: This analysis includes only participants who had never started ART previously

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

Outcome measures

Measure	Incentives n=8 Study site 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	Usual Care n=8 Study site 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
Antiretroviral Therapy (ART) Initiation	0.721 Proportion of participants	0.708 Proportion of participants

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	Incentives n=8 Study site 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	Usual Care n=8 Study site 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
Retention to HIV Care	0.702 Proportion of participants	0.664 Proportion of participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Incentives n=8 Study sites 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	Usual Care n=8 Study sites 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
ART Adherence	0.645 proportion of participants	0.463 proportion of participants

SECONDARY outcome

Timeframe: 12 months

All-cause mortality

Outcome measures

Measure	Incentives n=8 Study sites 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	Usual Care n=8 Study sites 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
Mortality	0.051 Proportion of participants	0.068 Proportion of participants

Adverse Events

Incentives

Serious events: 104 serious events

Other events: 0 other events

Deaths: 104 deaths

Usual Care

Serious events: 125 serious events

Other events: 0 other events

Deaths: 125 deaths

Serious adverse events

Measure	Incentives n=1114 participants at risk 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	Usual Care n=1200 participants at risk 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
General disorders Death	9.3% 104/1114 • Number of events 104 • 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.	10.4% 125/1200 • Number of events 125 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Gregory M. Lucas

Johns Hopkins University

Phone: 410 614 0560

Email: glucas@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place