N/A N=21,726 Randomized Health Services Research

Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT01686750 ↗

Enrolled (actual)

21,726

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Proportion Reporting HIV Testing in the Prior 12 Months — 36.9; 26.2 percentage of participants — p=0.09

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Integrated care centers (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion Reporting HIV Testing in the Prior 12 Months	36.9; 26.2	0.09
SECONDARY Proportion of HIV-infected Participants Aware of Status	65.2; 59.4	—
SECONDARY Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months	45.7; 40.8	—
SECONDARY Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy	57; 46.8	—
SECONDARY Community Viral Load	—	—
SECONDARY Proportion of HIV-infected Participants With Suppressed HIV RNA	47.3; 46.7	—
SECONDARY Prevalence of Recent HIV Infection	—	—
SECONDARY Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months	30.1; 31.8	—
SECONDARY Proportion of IDU Reporting Drug Abstinence in Prior 6 Months	28.2; 16.5	—
SECONDARY Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months	56.2; 69.3	—
SECONDARY Number of Non-main Male Partners in Prior 6 Months in MSM	3.0; 3.1	—
SECONDARY Proportion Reporting Substance Abuse Among MSM	—	—
SECONDARY Proportion With Depressive Symptoms	13.4; 18.2	—
SECONDARY Number of Unprotected Sexual Acts Reported by MSM	—	—
SECONDARY Vicarious Stigma as Assessed by 6-item Stigma Scale	2.9; 4.6	—
SECONDARY Proportion Reporting Spouse Ever Tested for HIV	45.9; 46.8	—

Summary

This is a cluster randomized trial to evaluate the effectiveness of integrated care centers (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to stratify sites according to key baseline characteristics. We will perform stratified randomization to assign sites to either the ICC intervention or to standard services. ICCs, which will be either IDU or MSM-focused, will provide an accepting atmosphere in which members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be scaled-up from existing governmental or non-governmental organizations and services provided at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After providing services in communities for two years, we will conduct an evaluation survey (with biological and behavioral measures) of approximately 1000 subjects in the target populations in each of the 22 study sites. Integrated care centers have the potential to improve access to HIV prevention and treatment services among vulnerable, high-risk populations.

Eligibility Criteria

Inclusion Criteria

Key Informant Interviews:

Persons may be included in the key informant interviews if they meet all of the following criteria:

18 years of age or older
Knowledge of the local HIV risk group of interest (IDU or MSM)
Psychologically fit to participate in the study and to understand the consent
Ability to comprehend one of the consent translation languages
Provide informed consent

Focus groups:

Persons may be included in the focus groups if they meet all of the following criteria:

18 years of age or older
Member of a target HIV risk group, meeting criterion 2a or 2b
IDU: self-reported injection drug use in prior 12 months
MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
Psychologically fit to participate in the study and to understand the consent
Ability to comprehend one of the consent translation languages
Provide informed consent

Baseline or evaluation respondent-driven sampling (RDS) survey

Persons may be included in the baseline or evaluation RDS survey if they meet all of the following criteria:

18 years of age or older
Member of a target HIV risk group, meeting criterion 2a or 2b
IDU: self-reported injection drug use in prior 24 months
MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
Psychologically fit to participate in the study and to understand the consent
Ability to comprehend one of the consent translation languages
Present a valid RDS referral coupon (unless a seed)
Provide informed consent

Exclusion Criteria

Key Informant Interviews:

Persons will be excluded from the key informant interviews if they meet any of the following criteria:

Younger than 18 years
Do not have knowledge of the local HIV risk group of interest (IDU or MSM)
Are not psychologically fit to participate in the study or to understand the consent
Do not have ability to comprehend one of the consent translation languages
Do not provide informed consent

Focus groups:

Persons will be excluded from the focus groups if they meet any of the following criteria:

Younger than 18 years
Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b
IDU: self-reported injection drug use in prior 12 months
MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
Are not psychologically fit to participate in the study or to understand the consent
Do not have ability to comprehend one of the consent translation languages
Do not provide informed consent

Baseline or evaluation RDS survey

Persons will be excluded in the baseline or evaluation RDS survey if they meet any of the following criteria:

Younger than 18 years
Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b
IDU: self-reported injection drug use in prior 24 months
MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
Are not psychologically fit to participate in the study or to understand the consent
Do not have ability to comprehend one of the consent translation languages
Do not present a valid RDS referral coupon and are not a seed
Do not provide informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01686750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.