HIV InfectionsPOINTERNCT05165810
Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India
A study testing Same-day ART initiation [experimental], Community-based HIV care [experimental] and Enhanced adherence support [experimental] in people with HIV Infections, run by Johns Hopkins University at 1 site in India.
Trial summary
The goal of this study is to improve HIV care outcomes for people who inject drugs (PWID) in India. The study will implement a two-phase trial to evaluate whether HIV treatment outcomes (HIV viral suppression) in HIV infected PWID can be improved with three different interventions: i) by offering a faster treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Same-day ART initiation [experimental], Community-based HIV care [experimental] and Enhanced adherence support [experimental]
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteIndia
- Study dates
- 9 Mar 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The goal of this study is to improve HIV care outcomes for people who inject drugs (PWID) in India. The study will implement a two-phase trial to evaluate whether HIV treatment outcomes (HIV viral suppression) in HIV infected PWID can be improved with three different interventions: i) by offering a faster treatment start time (same-day antiretroviral therapy [ART] initiation vs. standard), ii) by provided community-based HIV care in PWID-focused centers (vs. centralized government-based HIV care) and, iii) providing an enhanced adherence support to participants who experience treatment failure at six months (vs. routine adherence support). The investigators hypothesize that faster access to ART and HIV treatment in PWID-focused community sites will lead to higher levels of initiation and retention to ART compared with standard care; and use of enhanced navigation and psychosocial support to patients who experience treatment failure at six months will lead to improved viral suppression compared with routine adherence support.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Same-day ART initiation [experimental], Standard ART initiation [usual care], Community-based HIV care [experimental], Government-based HIV care [usual care], Enhanced adherence support [experimental]
- Keywords
- People who inject drugs (PWID), Health services, Behavioral interventions, Antiretroviral Therapy, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-day ART initiation [experimental]Behavioural
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).
Standard ART initiation [usual care]Behavioural
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.
Community-based HIV care [experimental]Other
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.
Government-based HIV care [usual care]Other
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
Enhanced adherence support [experimental]Behavioural
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.
Routine adherence support [usual care]Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: standard ART initiation + government-based HIV care + routine adherence support | Active comparator | 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]. Receives: Behavioral: Standard ART initiation [usual care]; Other: Government-based HIV care [usual care]; Behavioral: Routine adherence support [usual care] |
| Arm 2: same-day ART + government-based HIV care + routine adherence support | Experimental | 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]. Receives: Behavioral: Same-day ART initiation [experimental]; Other: Government-based HIV care [usual care]; Behavioral: Routine adherence support [usual care] |
| Arm 3: standard ART initiation + community-based HIV care + routine adherence support | Experimental | 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]. Receives: Behavioral: Standard ART initiation [usual care]; Other: Community-based HIV care [experimental]; Behavioral: Routine adherence support [usual care] |
| Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support | Experimental | 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]. Receives: Behavioral: Standard ART initiation [usual care]; Other: Government-based HIV care [usual care]; Behavioral: Enhanced adherence support [experimental] |
| Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support | Experimental | 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]. Receives: Behavioral: Same-day ART initiation [experimental]; Other: Community-based HIV care [experimental]; Behavioral: Routine adherence support [usual care] |
| Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support | Experimental | 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]. Receives: Behavioral: Same-day ART initiation [experimental]; Other: Government-based HIV care [usual care]; Behavioral: Enhanced adherence support [experimental] |
| Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support | Experimental | 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]. Receives: Behavioral: Standard ART initiation [usual care]; Other: Community-based HIV care [experimental]; Behavioral: Enhanced adherence support [experimental] |
| Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support | Experimental | 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]. Receives: Behavioral: Same-day ART initiation [experimental]; Other: Community-based HIV care [experimental]; Behavioral: Enhanced adherence support [experimental] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-1 randomization
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
Measured: Measured at 6 months following phase-1 randomization
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-2 randomization
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
Measured: Measured at 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Secondary outcomes (6)
Percentage of participants randomized in phase-1 with viral suppression (HIV RNA <1000 c/mL) at non-primary time points (i.e., 3, 12, and 18 months).
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
Measured: Measured at 3, 12, and 18 months after phase-1 randomization
Percentage of participants randomized in phase-2 with viral suppression (HIV RNA <1000 c/mL) at non-primary time point (18 months).
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
Measured: Measured at 12 months following phase-2 randomization (corresponding to 18 months after phase-1 randomization)
All-cause mortality rate
Research staff and outreach workers collected reports on participant deaths. Verified deaths required one of the following: i) hospital records or death certificate, ii) confirmation of death from a family member, or iii) confirmation of death from an eyewitness (usually another PWID). Rate will be presented as events per unit observation time.
Measured: Measured up to 21 months
Percentage of participants who link to ART at a clinic by 3- or 6-months following randomization
Linkage to ART will be defined as collecting one or more ART prescriptions from a clinic by 3 months and 6 months, captured by medical record abstraction or, in the absence of medical record data, participant self-report of ART collection from a clinic.
Measured: Measured at 3 months and 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Percentage of participants adherent to ART measured by self-report
Participants will be classified as adherent if they report taking ART in the prior 30 days and report adherence of 80% or higher using a visual analog scale (range: 0% to 100%), with higher numbers indicating higher adherence.
Measured: Measured at 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Percentage of participants adherent to ART measured by medication possession ratio (MPR)
ART fill data will be abstracted from medical records. In phase 1, participants will be classified as adherent if they have at least one ART refill by 3 months (91 days) and have an MPR of 80% or higher in the period between the first ART fill in the clinic and 6 months (182 days).
In phase 2, participants will be classified as adherent if they have at least one ART refill by 3 months (91 days) following the second randomization (or prior to the second randomization) and have an MPR of 80% or higher in the period between the first ART refill (or the second randomization if the first ART refill was prior to the second randomization) and 6 months (182 days following the second randomization).
Measured: Measured at 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start9 Mar 2023
- Primary completion16 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a non-blinded, randomized, factorial trial with a secondary adaptive randomization, designed to assess the effectiveness of three interventions (relative to standard care) to increase viral suppression among HIV-positive PWID in India.
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- YR Gaitonde Centre for AIDS Research and Education, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Gregory M Lucas, PhD MD, Principal investigator, Johns Hopkins UniversityShruthi H Mehta, PhD MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165810
- Sponsor's protocol ID
- IRB00232746
- Other IDs
- R01DA049301
- Acronym
- POINTER
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05165810
- Acronym / sponsor ID
- POINTER / IRB00232746
- Conditions
- HIV Infections
- Keywords
- People who inject drugs (PWID), Health services, Behavioral interventions, Antiretroviral Therapy, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- YR Gaitonde Centre for AIDS Research and Education, National Institute on Drug Abuse (NIDA)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to improve HIV care outcomes for people who inject drugs (PWID) in India. The study will implement a two-phase trial to evaluate whether HIV treatment outcomes (HIV viral suppression) in HIV infected PWID can be improved with three different interventions: i) by offering a faster treatment start time (same-day antiretroviral therapy [ART] initiation vs. standard), ii) by provided community-based HIV care in PWID-focused centers (vs. centralized government-based HIV care) and, iii) providing an enhanced adherence support to participants who experience treatment failure at six months (vs. routine adherence support). The investigators hypothesize that faster access to ART and HIV treatment in PWID-focused community sites will lead to higher levels of initiation and retention to ART compared with standard care; and use of enhanced navigation and psychosocial support to patients who experience treatment failure at six months will lead to improved viral suppression compared with routine adherence support.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This is a non-blinded, randomized, factorial trial with a secondary adaptive randomization, designed to assess the effectiveness of three interventions (relative to standard care) to increase viral suppression among HIV-positive PWID in India.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: standard ART initiation + government-based HIV care + routine adherence support | Active comparator | Behavioral: Standard ART initiation [usual care], Other: Government-based HIV care [usual care], Behavioral: Routine adherence support [usual care]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]. |
| Arm 2: same-day ART + government-based HIV care + routine adherence support | Experimental | Behavioral: Same-day ART initiation [experimental], Other: Government-based HIV care [usual care], Behavioral: Routine adherence support [usual care]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]. |
| Arm 3: standard ART initiation + community-based HIV care + routine adherence support | Experimental | Behavioral: Standard ART initiation [usual care], Other: Community-based HIV care [experimental], Behavioral: Routine adherence support [usual care]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]. |
| Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support | Experimental | Behavioral: Standard ART initiation [usual care], Other: Government-based HIV care [usual care], Behavioral: Enhanced adherence support [experimental]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]. |
| Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support | Experimental | Behavioral: Same-day ART initiation [experimental], Other: Community-based HIV care [experimental], Behavioral: Routine adherence support [usual care]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]. |
| Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support | Experimental | Behavioral: Same-day ART initiation [experimental], Other: Government-based HIV care [usual care], Behavioral: Enhanced adherence support [experimental]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]. |
| Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support | Experimental | Behavioral: Standard ART initiation [usual care], Other: Community-based HIV care [experimental], Behavioral: Enhanced adherence support [experimental]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]. |
| Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support | Experimental | Behavioral: Same-day ART initiation [experimental], Other: Community-based HIV care [experimental], Behavioral: Enhanced adherence support [experimental]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]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same-day ART initiation [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). | Behavioural | Arm 2: same-day ART + government-based HIV care + routine adherence support, Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support, Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support, Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support |
| Standard ART initiation [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. | Behavioural | Arm 1: standard ART initiation + government-based HIV care + routine adherence support, Arm 3: standard ART initiation + community-based HIV care + routine adherence support, Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support, Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support |
| Community-based HIV care [experimental]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. | Other | Arm 3: standard ART initiation + community-based HIV care + routine adherence support, Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support, Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support, Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support |
| Government-based HIV care [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 | Other | Arm 1: standard ART initiation + government-based HIV care + routine adherence support, Arm 2: same-day ART + government-based HIV care + routine adherence support, Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support, Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support |
| Enhanced adherence support [experimental]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. | Behavioural | Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support, Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support, Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support, Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support |
| Routine adherence support [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 | Behavioural | Arm 1: standard ART initiation + government-based HIV care + routine adherence support, Arm 2: same-day ART + government-based HIV care + routine adherence support, Arm 3: standard ART initiation + community-based HIV care + routine adherence support, Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support |
Primary outcome
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-1 randomization
Time frame: Measured at 6 months following phase-1 randomization
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-2 randomization
Time frame: Measured at 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
6 secondary outcomes
Percentage of participants randomized in phase-1 with viral suppression (HIV RNA <1000 c/mL) at non-primary time points (i.e., 3, 12, and 18 months).
Time frame: Measured at 3, 12, and 18 months after phase-1 randomization
Percentage of participants randomized in phase-2 with viral suppression (HIV RNA <1000 c/mL) at non-primary time point (18 months).
Time frame: Measured at 12 months following phase-2 randomization (corresponding to 18 months after phase-1 randomization)
All-cause mortality rate
Time frame: Measured up to 21 months
Percentage of participants who link to ART at a clinic by 3- or 6-months following randomization
Time frame: Measured at 3 months and 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Percentage of participants adherent to ART measured by self-report
Time frame: Measured at 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Percentage of participants adherent to ART measured by medication possession ratio (MPR)
Time frame: Measured at 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Lucas, PhD MD principal investigator
Johns Hopkins University
Shruthi H Mehta, PhD MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same-day ART initiation [experimental], Community-based HIV care [experimental] and Enhanced adherence support [experimental] in people with HIV Infections, run by Johns Hopkins University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-1 randomization (time frame: Measured at 6 months following phase-1 randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.