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=9 Participants
|
30 years
n=32 Participants
|
30 years
n=18 Participants
|
32 years
n=78 Participants
|
30 years
n=16 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
152 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
154 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
598 Participants
n=9 Participants
|
448 Participants
n=32 Participants
|
600 Participants
n=18 Participants
|
514 Participants
n=78 Participants
|
2160 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
600 Participants
n=9 Participants
|
600 Participants
n=32 Participants
|
600 Participants
n=18 Participants
|
514 Participants
n=78 Participants
|
2314 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
HIV RNA <150 copies/mL
|
61 Participants
n=9 Participants
|
153 Participants
n=32 Participants
|
108 Participants
n=18 Participants
|
138 Participants
n=78 Participants
|
460 Participants
n=16 Participants
|
|
CD4 cell count
|
391 cells/microliter
n=9 Participants
|
384 cells/microliter
n=32 Participants
|
314 cells/microliter
n=18 Participants
|
276 cells/microliter
n=78 Participants
|
347 cells/microliter
n=16 Participants
|
|
Secondary school education or beyond
|
336 Participants
n=9 Participants
|
381 Participants
n=32 Participants
|
375 Participants
n=18 Participants
|
352 Participants
n=78 Participants
|
1444 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 12 monthsViral Suppression defined as HIV RNA \<150 copies/mL
Outcome measures
| Measure |
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
|
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
|
|---|---|---|
|
Proportion of Participants Surviving With Viral Suppression
|
0.353 proportion of participants
|
0.494 proportion of participants
|
SECONDARY outcome
Timeframe: 6 monthsViral suppression defined as HIV RNA \<150 copies/mL
Outcome measures
| Measure |
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
|
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
|
|---|---|---|
|
Proportion of Participants Surviving With Viral Suppression
|
0.365 Proportion of participants
|
0.509 Proportion of participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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 |
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
|
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
|
|---|---|---|
|
Proportion of Participants Surviving With Viral Suppression
|
0.358 Proportion of participants
|
0.497 Proportion of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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 |
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
|
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
|
|---|---|---|
|
Proportion of Participants Surviving With Viral Suppression
|
0.325 Proportion of participants
|
0.471 Proportion of participants
|
SECONDARY outcome
Timeframe: 24 monthsProportion with viral suppression (HIV RNA \<150 copies/mL) at one or more follow-up visits
Outcome measures
| Measure |
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
|
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
|
|---|---|---|
|
Proportion of Participants With Viral Suppression at One or More Follow-up Visits
|
0.498 Proportion of participants
|
0.640 Proportion of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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 |
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
|
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
|
|---|---|---|
|
Antiretroviral Therapy (ART) Initiation
|
0.708 Proportion of participants
|
0.721 Proportion of participants
|
SECONDARY outcome
Timeframe: 12 monthsProportion 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 |
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
|
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
|
|---|---|---|
|
Retention to HIV Care
|
0.664 Proportion of participants
|
0.702 Proportion of participants
|
SECONDARY outcome
Timeframe: 12 monthsProportion of participants who had a medication possession ratio of 0.9 or higher after starting ART
Outcome measures
| Measure |
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
|
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
|
|---|---|---|
|
ART Adherence
|
0.463 proportion of participants
|
0.645 proportion of participants
|
SECONDARY outcome
Timeframe: 12 monthsAll-cause mortality
Outcome measures
| Measure |
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
|
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
|
|---|---|---|
|
Mortality
|
0.068 Proportion of participants
|
0.051 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place