- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165810
Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India (POINTER)
Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India: a Randomized Factorial Trial With a Randomized Adaptive Component for Those Experiencing Early Treatment Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People who inject drugs (PWID) are at high risk for HIV infection and experience worse antiretroviral therapy (ART) outcomes than other key populations, particularly in low and middle income countries (LMIC). India has the largest number of opioid users in the world, and new injection drug epidemics have emerged in the North and Central regions of the country.
In phase 1, the investigators will evaluate two structural interventions to improve treatment outcomes among HIV-positive PWID in India. First, same-day ART (initiating ART on the day of HIV diagnosis/confirmation rather than waiting until standard evaluations are completed in an HIV clinic), was found to increase viral suppression rates in African studies with generalized HIV epidemics, but has not been evaluated in PWID. The second intervention is community-based HIV care. At present, all publicly-financed HIV treatment is provided at designated government ART centers. In prior work, the investigators found that PWID-centric integrated care centers (ICCs) were effective at engaging the population and increasing HIV testing uptake and were rated favorably by clients in anonymous surveys. ICCs linked HIV-positive PWID to government clinics, but were not equipped to provide primary HIV care. However, ICCs can be scaled-up to provide HIV treatment on-site and the investigators hypothesize this will improve initiation and retention to ART among PWID. The investigators will use a randomized factorial design to determine the individual and joint effects of same-day ART initiation and community-based HIV care. The primary outcome of the phase-1 trial is viral suppression at 6 months, with longer term follow-up to 18 months.
In phase 2, the investigators will evaluate a psychosocial/navigation intervention (enhanced adherence support) among participants who experience treatment failure during the first trial phase, defined as non-suppressed HIV RNA at the 6-month visit. These participants will be randomly assigned (in a second randomization) to enhanced adherence support or routine adherence support. The primary outcome of phase-2 will be viral suppression 6 months following the second randomization (12 months from enrollment in phase-1).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julie L Evans, PhD MPA
- Phone Number: +1 410 614 0146
- Email: jevans64@jh.edu
Study Locations
-
-
-
New Delhi, India
- Recruiting
- POINTER study -YRGCARE
-
Contact:
- Jiban J Baisha, MBBS
- Phone Number: +91 85279 63652
- Email: jbaishy@jhmi.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
PHASE 1 Inclusion Criteria:
- 18 years of age or older
- Reports injection drug use in prior 24 months
- Documented HIV positive
- Antiretroviral therapy naïve
- HIV RNA 1,000 c/mL or higher
- If previously linked to HIV care, able and willing to provide govt. ART book for documentation of care received.
PHASE 1 Exclusion Criteria:
- Pregnant (if female)
- Does not speak English, Hindi, or local language
- Plans to migrate in next 12 months
- Not competent to participate in the study or provide written informed consent.
PHASE 2 Inclusion Criteria:
• Participants who experience treatment failure at 6 months (HIV RNA>1000c/mL)
PHASE 2 Exclusion Criteria:
• Participants who do not experience treatment failure at 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1: standard ART initiation + government-based HIV care + routine adherence support
Participants randomized to Arm 1 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
|
Participants randomized to standard ART initiation will not initiate ART on the day of trial enrollment, but only after linking to their assigned source of HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
In standard ART initiation, patients typically, complete an intake visit at the HIV clinic, with baseline laboratory testing, and return to the clinic approximately 2 weeks later to begin ART.
Participants randomized to government-based HIV care will be referred to government-based HIV clinics for ongoing HIV clinical management.
Government-based clinics provide free HIV care that adheres closely to Indian HIV treatment guidelines
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to routine adherence support will receive a guideline-based, HIV clinic-based adherence counselling intervention lasting a maximum of 6 months
|
Experimental: Arm 2: same-day ART + government-based HIV care + routine adherence support
Participants randomized to Arm 2 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
|
Participants randomized to government-based HIV care will be referred to government-based HIV clinics for ongoing HIV clinical management.
Government-based clinics provide free HIV care that adheres closely to Indian HIV treatment guidelines
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to routine adherence support will receive a guideline-based, HIV clinic-based adherence counselling intervention lasting a maximum of 6 months
Participants assigned to same-day ART initiation will be offered standard, first-line ART on the day of trial enrollment.
Participants, will be provided with focused counseling and instructions on where to follow-up for ongoing HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
|
Experimental: Arm 3: standard ART initiation + community-based HIV care + routine adherence support
Participants randomized to Arm 3 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
|
Participants randomized to standard ART initiation will not initiate ART on the day of trial enrollment, but only after linking to their assigned source of HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
In standard ART initiation, patients typically, complete an intake visit at the HIV clinic, with baseline laboratory testing, and return to the clinic approximately 2 weeks later to begin ART.
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to routine adherence support will receive a guideline-based, HIV clinic-based adherence counselling intervention lasting a maximum of 6 months
Participants randomized to community-based HIV care will be referred to PWID-focused integrated care centers (ICCs) for ongoing HIV clinical management - a prototype of decentralized HIV care in India.
ICCs will provide free HIV care that will adhere closely to Indian HIV treatment guidelines and, when relevant, to local HIV treatment standards.
|
Experimental: Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support
Participants randomized to Arm 4 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
|
Participants randomized to standard ART initiation will not initiate ART on the day of trial enrollment, but only after linking to their assigned source of HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
In standard ART initiation, patients typically, complete an intake visit at the HIV clinic, with baseline laboratory testing, and return to the clinic approximately 2 weeks later to begin ART.
Participants randomized to government-based HIV care will be referred to government-based HIV clinics for ongoing HIV clinical management.
Government-based clinics provide free HIV care that adheres closely to Indian HIV treatment guidelines
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to enhanced adherence support will receive an intensive, tailored adherence intervention lasting a maximum of 6 months, with two components: 1) tracking and outreach, and 2) psychosocial support and navigation.
These will aim to equip PWID with skills to independently manage their ART using motivational interviewing and strengths-based case management.
|
Experimental: Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support
Participants randomized to Arm 5 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
|
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to routine adherence support will receive a guideline-based, HIV clinic-based adherence counselling intervention lasting a maximum of 6 months
Participants assigned to same-day ART initiation will be offered standard, first-line ART on the day of trial enrollment.
Participants, will be provided with focused counseling and instructions on where to follow-up for ongoing HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
Participants randomized to community-based HIV care will be referred to PWID-focused integrated care centers (ICCs) for ongoing HIV clinical management - a prototype of decentralized HIV care in India.
ICCs will provide free HIV care that will adhere closely to Indian HIV treatment guidelines and, when relevant, to local HIV treatment standards.
|
Experimental: Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support
Participants randomized to Arm 6 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
|
Participants randomized to government-based HIV care will be referred to government-based HIV clinics for ongoing HIV clinical management.
Government-based clinics provide free HIV care that adheres closely to Indian HIV treatment guidelines
Participants assigned to same-day ART initiation will be offered standard, first-line ART on the day of trial enrollment.
Participants, will be provided with focused counseling and instructions on where to follow-up for ongoing HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to enhanced adherence support will receive an intensive, tailored adherence intervention lasting a maximum of 6 months, with two components: 1) tracking and outreach, and 2) psychosocial support and navigation.
These will aim to equip PWID with skills to independently manage their ART using motivational interviewing and strengths-based case management.
|
Experimental: Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 7 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
|
Participants randomized to standard ART initiation will not initiate ART on the day of trial enrollment, but only after linking to their assigned source of HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
In standard ART initiation, patients typically, complete an intake visit at the HIV clinic, with baseline laboratory testing, and return to the clinic approximately 2 weeks later to begin ART.
Participants randomized to community-based HIV care will be referred to PWID-focused integrated care centers (ICCs) for ongoing HIV clinical management - a prototype of decentralized HIV care in India.
ICCs will provide free HIV care that will adhere closely to Indian HIV treatment guidelines and, when relevant, to local HIV treatment standards.
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to enhanced adherence support will receive an intensive, tailored adherence intervention lasting a maximum of 6 months, with two components: 1) tracking and outreach, and 2) psychosocial support and navigation.
These will aim to equip PWID with skills to independently manage their ART using motivational interviewing and strengths-based case management.
|
Experimental: Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 8 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
|
Participants assigned to same-day ART initiation will be offered standard, first-line ART on the day of trial enrollment.
Participants, will be provided with focused counseling and instructions on where to follow-up for ongoing HIV care (either community-based HIV care or government-based HIV care, depending on randomization).
Participants randomized to community-based HIV care will be referred to PWID-focused integrated care centers (ICCs) for ongoing HIV clinical management - a prototype of decentralized HIV care in India.
ICCs will provide free HIV care that will adhere closely to Indian HIV treatment guidelines and, when relevant, to local HIV treatment standards.
Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to enhanced adherence support will receive an intensive, tailored adherence intervention lasting a maximum of 6 months, with two components: 1) tracking and outreach, and 2) psychosocial support and navigation.
These will aim to equip PWID with skills to independently manage their ART using motivational interviewing and strengths-based case management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with viral load suppression at 6 months after phase 1 randomization
Time Frame: Measured at 6 months after phase 1 randomization
|
HIV RNA ≤1000 c/mL
|
Measured at 6 months after phase 1 randomization
|
Number of participants with viral load suppression at 12 months after phase 1 randomization
Time Frame: Measured at 6 months after the second randomization (12 months since phase 1 randomization)
|
HIV RNA ≤1000 c/mL.
Restricted to participants with treatment failure at 6 months who are allocated to either enhanced or routine adherence support in phase-2 randomization
|
Measured at 6 months after the second randomization (12 months since phase 1 randomization)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with HIV viral suppression in each intervention at non-primary time points
Time Frame: Measured at 3, 12 and 18 months since phase 1 randomization
|
HIV RNA ≤1000 c/mL
|
Measured at 3, 12 and 18 months since phase 1 randomization
|
Mortality rate among participants
Time Frame: Measured at 3, 6, 12 and 18 months since phase 1 randomization
|
To determine whether same-day ART, community HIV care, or enhanced adherence support affects mortality among HIV-positive PWID, relative to their control conditions.
|
Measured at 3, 6, 12 and 18 months since phase 1 randomization
|
Number of participants who are linked or re-linked (if in care previously) to HIV care
Time Frame: Measured up to 18 months after phase 1 randomization
|
To determine whether same-day ART, community HIV care, or enhanced adherence support increases indices of the care continuum among HIV-positive PWID, relative to their control conditions.
|
Measured up to 18 months after phase 1 randomization
|
Number of participants who initiate or re-initiate ART
Time Frame: Measured up to 18 months after phase 1 randomization
|
To determine whether same-day ART, community HIV care, or enhanced adherence support increases indices of the care continuum among HIV-positive PWID, relative to their control conditions.
|
Measured up to 18 months after phase 1 randomization
|
Number of participants who remain in HIV care
Time Frame: Measured up to 18 months after phase 1 randomization
|
To determine whether same-day ART, community HIV care, or enhanced adherence support increases indices of the care continuum among HIV-positive PWID, relative to their control conditions.
|
Measured up to 18 months after phase 1 randomization
|
Number of participants who adhere to their ART medication refills
Time Frame: Measured up to 18 months after phase 1 randomization
|
To determine whether same-day ART, community HIV adherence support, or enhanced care increases indices of the care continuum among HIV-positive PWID, relative to their control conditions.
|
Measured up to 18 months after phase 1 randomization
|
Number of participants who report increased quality of life since baseline
Time Frame: Measured at 3, 6, 12 and 18 months since phase 1 randomization
|
Self-reported quality of life score based on amended version of validated instrument EQ-5D.
To determine whether same-day ART, community HIV care, or enhanced adherence support increases quality of life (QOL) among HIV-positive PWID, relative to their control conditions.
|
Measured at 3, 6, 12 and 18 months since phase 1 randomization
|
Number of participants who engage with or are retained on medication for opioid use disorder (MOUD)
Time Frame: Measured at 3, 6, 12 and 18 months since phase 1 randomization
|
To determine whether same-day ART, community HIV care, or enhanced adherence support increases use of and retention to medication for opioid use disorder (MOUD) among HIV-positive PWID, relative to their control conditions.
|
Measured at 3, 6, 12 and 18 months since phase 1 randomization
|
Number of participants who experience HIV-related stigma (anticipated, enacted, internalized)
Time Frame: Measured at 1, 3, 6, 12 and 18 months since phase 1 randomization
|
Self-reported stigma scores based on 18-item likert scale
|
Measured at 1, 3, 6, 12 and 18 months since phase 1 randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who develop antiretroviral drug resistance at follow-up compared with baseline
Time Frame: Measured at baseline, 3, 6, 12 and 18 months
|
Measured using HIV-1 RNA-based genotyping assays.
|
Measured at baseline, 3, 6, 12 and 18 months
|
Cost effectiveness analysis of providing each intervention relative to health outcomes
Time Frame: Measured from data captured across duration of trial up to five years
|
Incremental cost-effectiveness ratios.
Programmatic inputs will be measured separately and combined with prices (converted from local currency to US$) to generate total and per-client unit costs (e.g.
average cost of patient enrolled).
Unit prices for inputs will be obtained from financial records, itemized bills/receipts and sales catalogues.
Personnel time will be costed by estimating time spent on intervention activities and apportioning salaries for staff in the market accordingly.
|
Measured from data captured across duration of trial up to five years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory M Lucas, PhD MD, Johns Hopkins University
- Principal Investigator: Shruthi H Mehta, PhD MPH, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- IRB00232746
- R01DA049301 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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