HiviSTRIVENCT05819411
Intervention to Improve HIV Self-care Among People Who Inject Drugs
A study testing Project iSTRIVE and incentivized Directly Observed Therapy (iDOT) in people with Hiv and Substance Use Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will implement a pilot randomized controlled trial (RCT, N=50) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among HIV+ people who report opioid and/or stimulant use and are sub-optimally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Substance Use Disorders
- What is being tested?
- Project iSTRIVE and incentivized Directly Observed Therapy (iDOT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Jul 2025
- 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
Who may be able to join
- HIV positive
- HIV virally unsuppressed (>20 copies/mL) in past year or no past-year HIV viral load result
- Opioid and/or stimulant use behavior endorsed in past 6 months
- Able to provide informed consent
- 18 years or older
- English speaking
Who cannot join
- HIV negative
- Denying drug use in past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Fenway Community Health
Boston, Massachusetts, 02215
About this study
Official title: Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People With HIV Who Inject Drugs
This study will implement a pilot randomized controlled trial (RCT, N=50) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among HIV+ people who report opioid and/or stimulant use and are sub-optimally engaged in HIV care.
Read the detailed description
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). All participants will receive substance use treatment referral information if interested. Participants will be randomized to one of two treatment arms. Participants in both arms will receive a mobile application-facilitated incentivized directly observed therapy (iDOT) intervention. Participants in the control arm will receive iDOT alone. Participants in the intervention arm will receive iDOT in combination with the iSTRIVE intervention. After randomization, participants in the iSTRIVE intervention group will be offered 6 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, cognitive restructuring, and assertive communication skills. Participants in the iSTRIVE intervention arm will also receive messages containing customized compassionate self-statements to enhance HIV-related self-care. All participants will be compensated for every research visit and adherence to the iDOT protocol.
- Conditions
- Hiv, Substance Use Disorders
- Being tested
- Project iSTRIVE, incentivized Directly Observed Therapy (iDOT)
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project iSTRIVEBehavioural
This intervention includes 6 face-to-face therapy sessions with a trained clinician to develop skills to counter internalized stigma and shame as barriers to HIV self-care. Both the intervention group and the active control group will also receive a mobile app-based iDOT intervention.
incentivized Directly Observed Therapy (iDOT)Behavioural
Both the intervention group and the active control group will receive a mobile app-based iDOT intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This intervention includes 6 face-to-face therapy sessions with a trained clinician plus an incentivized directly observed therapy (iDOT) intervention facilitated via a mobile application. Receives: Behavioral: Project iSTRIVE; Behavioral: incentivized Directly Observed Therapy (iDOT) |
| incentivized Directly Observed Therapy (iDOT) | Active comparator | Participants in the iDOT condition will be provided a mobile application to facilitate video recording of their daily medication adherence in order to receive small, escalating monetary incentives for HIV medication adherence. Receives: Behavioral: incentivized Directly Observed Therapy (iDOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of iSTRIVE intervention
Percent of sessions completed (≥70% considered indicative of feasibility).
Measured: change from baseline to 12 weeks after intervention completion
Feasibility of iDOT intervention
Percent of DOT video check ins completed by participants (≥50% considered indicative of feasibility).
Measured: change from baseline to 12 weeks after intervention completion
Acceptability of intervention
A qualitative analysis of exit interviews conducted with iSTRIVE study intervention participants.
Measured: 12 weeks after intervention completion
Secondary outcomes (3)
HIV Viral Load
Viral suppression (≤20 copies/mL) will be assessed via blood draw at the final follow up visit and will be the primary outcome variable in the planned subsequent efficacy trial.
Measured: change from baseline to 12 weeks after intervention completion
Substance Use
Addiction Severity Index-Lite will be used to assess self-reported substance use at each research visit and a subset of questions will be asked at all intervention visits. The primary metric will be number of days a participant reports experiencing drug problems in the past month (0-30), with a decrease in days (i.e., lower number) indicating a favorable outcome.
Measured: change from baseline to 12 weeks after intervention completion
Injection Drug Use Behaviors
We will assess injection behaviors associated with HIV risk by self-report by adapting items identified by Shahesmaeili et al. (Brief Scale to Measure HIV Transmission Risk Among Injecting Drug Users). These questions will include injection behaviors and related factors that differ by gender (e.g., needle borrowing, ancillary equipment sharing, being injected by someone else, and whether injection partners are also sexual partners). The total scale is scored from 0-36, with lower scores indicating favorable outcomes (i.e., reduction in HIV risk behavior).
Measured: change from baseline to 12 weeks after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Sep 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fenway Community Health, National Institute on Drug Abuse (NIDA), Boston University
- Responsible party
- Principal investigator, Abigail Batchelder, Ph.D., M.P.H., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819411
- Sponsor's protocol ID
- 2021P002094
- Other IDs
- R34DA053686
- Acronym
- iSTRIVE
- Status last verified
- Nov 2025
- First submitted
- 22 Mar 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People With HIV Who Inject Drugs
- ClinicalTrials.gov ID
- NCT05819411
- Acronym / sponsor ID
- iSTRIVE / 2021P002094
- Conditions
- Hiv, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Fenway Community Health, National Institute on Drug Abuse (NIDA), Boston University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Apr 2023 (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.
This study will implement a pilot randomized controlled trial (RCT, N=50) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among HIV+ people who report opioid and/or stimulant use and are sub-optimally engaged in HIV care.
Detailed description
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). All participants will receive substance use treatment referral information if interested. Participants will be randomized to one of two treatment arms. Participants in both arms will receive a mobile application-facilitated incentivized directly observed therapy (iDOT) intervention. Participants in the control arm will receive iDOT alone. Participants in the intervention arm will receive iDOT in combination with the iSTRIVE intervention. After randomization, participants in the iSTRIVE intervention group will be offered 6 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, cognitive restructuring, and assertive communication skills. Participants in the iSTRIVE intervention arm will also receive messages containing customized compassionate self-statements to enhance HIV-related self-care. All participants will be compensated for every research visit and adherence to the iDOT protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Project iSTRIVE, Behavioral: incentivized Directly Observed Therapy (iDOT)This intervention includes 6 face-to-face therapy sessions with a trained clinician plus an incentivized directly observed therapy (iDOT) intervention facilitated via a mobile application. |
| incentivized Directly Observed Therapy (iDOT) | Active comparator | Behavioral: incentivized Directly Observed Therapy (iDOT)Participants in the iDOT condition will be provided a mobile application to facilitate video recording of their daily medication adherence in order to receive small, escalating monetary incentives for HIV medication adherence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV positive
- HIV virally unsuppressed (>20 copies/mL) in past year or no past-year HIV viral load result
- Opioid and/or stimulant use behavior endorsed in past 6 months
- Able to provide informed consent
- 18 years or older
Key exclusion criteria (2 listed)
- HIV negative
- Denying drug use in past 6 months
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 |
|---|---|---|
| Project iSTRIVEThis intervention includes 6 face-to-face therapy sessions with a trained clinician to develop skills to counter internalized stigma and shame as barriers to HIV self-care. Both the intervention group and the active control group will also receive a mobile app-based iDOT intervention. | Behavioural | Intervention |
| incentivized Directly Observed Therapy (iDOT)Both the intervention group and the active control group will receive a mobile app-based iDOT intervention. | Behavioural | Intervention, incentivized Directly Observed Therapy (iDOT) |
Primary outcome
Feasibility of iSTRIVE intervention
Time frame: change from baseline to 12 weeks after intervention completion
Percent of sessions completed (≥70% considered indicative of feasibility).
Feasibility of iDOT intervention
Time frame: change from baseline to 12 weeks after intervention completion
Percent of DOT video check ins completed by participants (≥50% considered indicative of feasibility).
Acceptability of intervention
Time frame: 12 weeks after intervention completion
A qualitative analysis of exit interviews conducted with iSTRIVE study intervention participants.
3 secondary outcomes
HIV Viral Load
Time frame: change from baseline to 12 weeks after intervention completion
Substance Use
Time frame: change from baseline to 12 weeks after intervention completion
Injection Drug Use Behaviors
Time frame: change from baseline to 12 weeks after intervention completion
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 8 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project iSTRIVE and incentivized Directly Observed Therapy (iDOT) in people with Hiv and Substance Use Disorders, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. 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 8 Dec 2025. 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 United States. 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?
Feasibility of iSTRIVE intervention (time frame: change from baseline to 12 weeks after intervention completion). The study lists 3 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 8 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.