Trial Outcomes & Findings for Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations (NCT NCT01686750)

NCT ID: NCT01686750

Last Updated: 2019-07-16

Results Overview

Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21726 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-07-16

Participant Flow

Recruited by respondent-driven sampling in 22 sites in India.

Unit of analysis: Clusters

Participant milestones

Measure	Integrated Care Centers Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Overall Study STARTED	11001 11	10725 11
Overall Study COMPLETED	11001 11	10725 11
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

Baseline characteristics by cohort

Measure	Integrated Care Centers n=11 Clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 Clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.	Total n=22 Clusters Total of all reporting groups
Age, Continuous	30 years n=11 Clusters	29 years n=11 Clusters	29 years n=22 Clusters
Sex: Female, Male Female	221 Participants n=5 Participants	272 Participants n=7 Participants	493 Participants n=5 Participants
Sex: Female, Male Male	10780 Participants n=5 Participants	10453 Participants n=7 Participants	21233 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11001 Participants n=5 Participants	10725 Participants n=7 Participants	21726 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
At least secondary school education	8729 Participants n=5 Participants	7455 Participants n=7 Participants	16184 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion Reporting HIV Testing in the Prior 12 Months	36.9 percentage of participants Interval 20.5 to 53.3	26.2 percentage of participants Interval 4.7 to 37.3

SECONDARY outcome

Timeframe: 2 years

Population: Participants who tested HIV-positive at the survey visit

Proportion of HIV-positive participants that were aware of their status at the time of the visit

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion of HIV-infected Participants Aware of Status	65.2 percentage of participants Interval 24.0 to 86.5	59.4 percentage of participants Interval 14.4 to 97.4

SECONDARY outcome

Timeframe: 2 years

Population: HIV-positive survey participants

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months	45.7 percentage of participants Interval 3.5 to 73.9	40.8 percentage of participants Interval 3.1 to 88.0

SECONDARY outcome

Timeframe: 2 years

Population: HIV-positive participants that meet criteria for antiretroviral therapy in India at the time of the study

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy	57 percentage of participants Interval 11.4 to 87.0	46.8 percentage of participants Interval 2.0 to 95.1

SECONDARY outcome

Timeframe: 2 years

Population: Samples were not collected therefore there is no data to report.

Average log(10) HIV RNA concentration among HIV-infected participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: HIV-positive participants who meet criteria for antiretroviral therapy

Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count <350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA <150 copies/mL)

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion of HIV-infected Participants With Suppressed HIV RNA	47.3 percentage of participants Interval 6.7 to 78.6	46.7 percentage of participants Interval 7.4 to 82.9

SECONDARY outcome

Timeframe: 2 years

Population: Samples were not collected therefore there is no data to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Participants from the PWID sites

Outcome measures

Measure	Integrated Care Centers n=6 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=6 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months	30.1 percentage of participants Interval 2.4 to 30.8	31.8 percentage of participants Interval 6.8 to 56.9

SECONDARY outcome

Timeframe: 2 years

Population: Participants at PWID sites

Outcome measures

Measure	Integrated Care Centers n=6 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=6 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months	28.2 percentage of participants Interval 10.4 to 72.9	16.5 percentage of participants Interval 1.7 to 42.3

SECONDARY outcome

Timeframe: 2 years

Population: Participants at MSM sites

Outcome measures

Measure	Integrated Care Centers n=5 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=5 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months	56.2 percentage of participants Interval 39.8 to 78.9	69.3 percentage of participants Interval 41.7 to 84.0

SECONDARY outcome

Timeframe: 2 years

Population: Participants at MSM sites

Outcome measures

Measure	Integrated Care Centers n=5 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=5 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Number of Non-main Male Partners in Prior 6 Months in MSM	3.0 partners Interval 0.6 to 6.4	3.1 partners Interval 1.5 to 8.0

SECONDARY outcome

Timeframe: 2 years

Population: Samples were not collected therefore there is no data to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Participants with Score >=10 on Patient Health Questionnaire-9

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion With Depressive Symptoms	13.4 percentage of participants Interval 1.2 to 26.9	18.2 percentage of participants Interval 3.7 to 35.1

SECONDARY outcome

Timeframe: 2 years

Population: Samples were not collected therefore there is no data to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Vicarious Stigma as Assessed by 6-item Stigma Scale	2.9 score on a scale Interval 2.1 to 4.2	4.6 score on a scale Interval 1.5 to 7.1

SECONDARY outcome

Timeframe: 2 years

Population: Participants with a spouse (opposite sex)

Outcome measures

Measure	Integrated Care Centers n=11 clusters Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach	Standard Services n=11 clusters In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.
Proportion Reporting Spouse Ever Tested for HIV	45.9 percentage of participants Interval 19.2 to 74.3	46.8 percentage of participants Interval 7.7 to 79.9

Adverse Events

Integrated Care Centers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Services

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. 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