HIV InfectionsSNaPR01NCT03952520
Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial
A study testing Standard Approach (SA) and Tailored Approach (TA) in people with HIV Infections and Drug Use, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
Trial summary
The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention (SNaP) in HIV test sites in Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Drug Use
- What is being tested?
- Standard Approach (SA) and Tailored Approach (TA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Jun 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- PWID participants:
- HIV infection:
- Newly diagnosed HIV infection, based on confirmatory test, and not currently on ART at the time of study enrollment; or
- If previously diagnosed with HIV infection, then must not currently be on ART at the time of study enrollment (self-reported)
- Age 18 years or older
- Injection drug use within the past 6 months (self-reported at time of screening)
Show all 10Show fewer
- Willing to provide informed consent for the study
- Test site director boards and staff:
- All test site director boards and staff, including the navigators and counselors, at the selected HIV test sites
- Willing to provide informed consent for the study
Who cannot join
- PWID participants:
- Residence outside of the catchment area of local antiretroviral therapy (ART) and medication-assisted treatment (MAT, e.g. methadone) clinics
- Currently on ART at time of study enrollment (self-reported)
- Planning to move out of the catchment area within the next 24 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scaling up HIV Prevention Trials Network (HPTN) 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam
The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention (SNaP) in HIV test sites in Vietnam.
Read the detailed description
This is a cluster randomized, controlled implementation trial to compare two implementation approaches (standard and tailored) for scaling-up the SNaP intervention in 42 HIV test sites in Vietnam. The SNaP intervention combines systems navigation and psychosocial counseling for people who inject drugs (PWID), and it is designed to facilitate PWID's engagement in HIV and substance use care.
The two implementation approaches being compared are:
- Standard Approach (SA); vs.
- Tailored Approach (TA)
SNaP is an evidence-based intervention (EBI) that combines systems navigation and psychosocial counseling to facilitate the engagement of HIV-infected people who inject drugs (PWID) into HIV and substance use care.
The 42 HIV test sites will be randomized in a 1:1 ratio to either the standard approach (SA) procedure or a tailored approach (TA), stratified by engagement of site leadership.
At the HIV test sites, the study will enroll:
- A cohort of 630 PWID who are newly diagnosed or previously diagnosed but not on ART will be enrolled for detailed assessments, including follow-up surveys and dried blood spot collection for viral loads. Additional PWID may be enrolled for medical records assessment without recontact. An additional 242 clinic staff will be enrolled to assess implementation outcomes.
- Note that the original design included ~6200 PWID attending the clinics who consented for medical record assessments only. Upon study initiation, the number of PWID with newly diagnosed HIV infection was substantially lower than predicted. The planned cohort sample was then reduced in size to 630 and all PWID meeting eligibility criteria were referred for enrollment in this cohort.
- HIV test site director boards and staff.
Study activities will span across 5 years, with approximately 27 months at each site and recruitment of PWID participants over 21 months. For the cohort PWID or PWID selected for qualitative interviews, maximum study participation time is 24-27 months. For PWID with medical record assessment only, participation is a one-time visit. For HIV test site director boards and staff, maximum time in the study is 24-27 months.
- Conditions
- HIV Infections, Drug Use
- Being tested
- Standard Approach (SA), Tailored Approach (TA)
- Keywords
- Cluster randomized controlled implementation trial, Intervention mapping, People who inject drugs, HIV/AIDS, Systems navigation, Psychosocial counseling, Vietnam
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Approach (SA)Other
The multifaceted implementation strategies for SA sites were identified through centralized Intervention Mapping. Before SNaP implementation starts, the specific set of one-size-fits-all implementation strategies was determined through a formal process with investigators, government stakeholders, and clinical representatives.
Tailored Approach (TA)Other
The Tailored Approach includes the multifaceted strategy that will be offered to the Standard Approach condition. It will also be tailored to match site-specific barriers to implementation of SNaP at that site. The strategy for TA sites involves a 2-day site-specific training, monthly coaching calls, and an external technical assistance hotline to help organizations to tailor implementation strategies to address their site-specific needs. At the 2-day TA training, the TA sites will be guided on developing site-specific implementation plans, in which they may use additional implementation strategies that they have identified themselves or selected from a list developed by the central team.
| Study group | Role | What they receive |
|---|---|---|
| Standard Approach (SA) | Active comparator | The Standard Approach is a one-size-fits-all multifaceted implementation strategy that was systematically developed using Intervention Mapping. Receives: Other: Standard Approach (SA) |
| Tailored Approach (TA) | Experimental | The Tailored Approach includes an implementation strategy that will be tailored to match site-specific barriers to implementation of SNaP at that site. Receives: Other: Tailored Approach (TA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity to SNaP Intervention Procedures
Fidelity measures whether the SNaP intervention was delivered as intended.
Fidelity score = (% Systems navigation sessions completed x Average navigation session quality score) + (% Counseling sessions completed x Average counseling session quality score)
Session completion will be assessed by reviewing the navigator and counselor logs, while session quality will be assessed by central implementation team review and scoring of a random 10% of all forms (navigation) and audio-recordings (psychosocial counseling). Test site fidelity score range: 0-200 (Higher score indicates higher fidelity.)
Measured: Measured over 26 months after SNaP implementation in a clinic
Percent of PWID Who Initiated ART
Percent of PWID who initiated antiretroviral therapy (ART) among the PWID who initiated SNaP, measured through ART clinic records of consenting PWID and/or self-report.
This measures ART uptake among PWID who initiated the SNaP intervention.
Measured: Medical record reviews conducted within 6 months after enrollment; self-report: 6-12 months after enrollment among those who initiated SNaP
Secondary outcomes (8)
Percent of PWID Who Were Contacted and Participated in SNaP
Penetration of SNaP at the test sites is assessed by this measure. Penetration of SNaP is defined as the proportion of newly diagnosed or previously diagnosed and not currently on ART PWID at test sites who are contacted by a navigator and/or counselor and participate in a SNaP session.
Penetration of SNaP will be assessed at 12 and 24 months after implementation of SNaP in a clinic. Only the 24-month assessment is reported.
Measured: Up to 24 months after implementation of SNaP in a clinic
Mean Acceptability Score of SNaP by PWID (AIM)
Acceptability is the perception that the SNaP intervention is agreeable, palatable, or satisfactory to PWID. Acceptability among PWID participants will be assessed using the Acceptability of Intervention Measure (AIM), which consists of 4 items containing responses on a 5-point Likert scale. The AIM score will be the sum of the 4 item responses ranging from 4-20. Higher AIM scores indicate higher acceptability. Acceptability of SNaP by PWID will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first acceptability assessment collected for a participant is reported.
Measured: Up to 24 months after SNap implementation in a clinic
Mean Acceptability Score of SNaP by Test Site Staff (OADRI)
Acceptability is the perception that the SNaP intervention is agreeable, palatable, or satisfactory to test site staff. Acceptability among site staff will be assessed using the Ottawa Acceptability of Decision Rules Instrument (OADRI), a 12-item scale, staff and client acceptability of an innovation in a clinic setting. Eight of the 12 items were included in the assessment, excluding 4 irrelevant questions for the study setting. Scores range from 8-48. Higher OADRI scores indicate higher acceptability. Acceptability of SNaP by Test Site Staff will be assessed at 12 and 24 months after SNaP implementation in a clinic. Only the 24-month assessment is reported.
Measured: 24 months after implementation of SNaP in a clinic
Percent of PWID Who Are Virally Suppressed
Percent of PWID who are virally suppressed among the PWID who initiated SNaP. Viral suppression is defined as <1000 copies/mL. (This outcome will be measured only in the PWID subsample cohort.) Percent of PWID virally suppressed will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first assessment collected for a participant is reported.
Measured: Up to 24 months after implementation of SNaP in a clinic
Percent of PWID on Medication-Assisted Treatment (MAT)
Percent of PWID alive and on MAT among the PWID who initiated SNaP, measured through medical records and/or self-report of consenting PWID. This measures MAT uptake among PWID who initiated SNaP. Percent of PWID on MAT will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first assessment collected for a participant is reported.
Measured: Up to 24 months after SNaP implementation in a clinic
Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation
The incremental cost per incremental ART uptake, comparing TA to SA, measured as: The difference in costs of implementing SNaP in TA compared to SA sites divided by the difference in ART uptake in TA compared to SA sites.
Incremental cost-effectiveness of SNaP implementation will be assessed up to 24 months after SNaP implementation in a clinic.
Measured: Up to 24 months after SNaP implementation in a clinic.
Percent of PWID Alive and Remaining on ART
Percent of PWID alive and on ART among the PWID who initiated SNaP, measured through medical records and/or self-report of consenting PWID. Percent of PWID alive and remaining on ART will be assessed at 12, 18, and 24 months after SNaP implementation in a clinic. Only the first assessment collected for a participant is reported.
Measured: Up to 24 months after SNaP implementation in a clinic
Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities
Sustainment of SNaP at the test sites is assessed by this measure.
Sustainment of SNaP is defined as the % of clinics continuing to offer SNaP after completion of study activities, based on survey of clinic staff
Sustainment of SNaP will be assessed up to 37 months after SNaP implementation in a clinic.
Measured: Up to 37 months after SNaP implementation in a clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start10 Jun 2020
- Primary completion31 Jul 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Ohio State University, Johns Hopkins University, Hanoi Medical University, Vietnam Administration for HIV/AIDS Control
- Responsible party
- Sponsor
- Investigators
- Vivian F Go, PhD, MPH, MA, Principal investigator, University of North Carolina, Chapel HillWilliam C Miller, MD, PhD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952520
- Sponsor's protocol ID
- 18-2901
- Other IDs
- 1R01DA047876-01, IGHID 11844
- Acronym
- SNaPR01
- Status last verified
- Jul 2024
- First submitted
- 14 May 2019
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of an article, after de-identification.
Publications
Go VF, Giang LM, Phan HTT, Chen JS, Powell BJ, Bartels SM, Nguyen MXB, Sripaipan T, Nong HTT, Dang LTH, Pham MD, Vo SH, Tran HV, Hoang VTH, Nguyen NTK, Chu AV, Levintow SN, Dowdy DW, Sohn H, Pence BW, Miller WC. Scaling an intervention for the engagement of people with HIV who inject drugs into care in Viet Nam: an implementation-effectiveness, cluster-randomised trial. Lancet Glob Health. 2025 Dec;13(12):e2111-e2121. doi: 10.1016/S2214-109X(25)00331-6.
PubMed 41240949Nguyen MX, Bartels SM, Akiba CF, Sripaipan T, Nong HT, Dang LT, Tran HV, Hoang VT, Le GM, Go VF, Miller WC, Powell BJ. Tracking modifications to implementation strategies: a case study from SNaP - a hybrid type III randomized controlled trial to scale up integrated systems navigation and psychosocial counseling for PWID with HIV in Vietnam. BMC Med Res Methodol. 2024 Oct 26;24(1):249. doi: 10.1186/s12874-024-02367-3.
PubMed 39462341Nguyen MXB, Chu AV, Powell BJ, Tran HV, Nguyen LH, Dao ATM, Pham MD, Vo SH, Bui NH, Dowdy DW, Latkin CA, Lancaster KE, Pence BW, Sripaipan T, Hoffman I, Miller WC, Go VF. Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial. Implement Sci. 2020 Aug 8;15(1):64. doi: 10.1186/s13012-020-01020-z.
PubMed 32771017
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up HIV Prevention Trials Network (HPTN) 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam
- ClinicalTrials.gov ID
- NCT03952520
- Acronym / sponsor ID
- SNaPR01 / 18-2901
- Conditions
- HIV Infections, Drug Use
- Keywords
- Cluster randomized controlled implementation trial, Intervention mapping, People who inject drugs, HIV/AIDS, Systems navigation, Psychosocial counseling, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Ohio State University, Johns Hopkins University, Hanoi Medical University, Vietnam Administration for HIV/AIDS Control
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Posted 23 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention (SNaP) in HIV test sites in Vietnam.
Detailed description
This is a cluster randomized, controlled implementation trial to compare two implementation approaches (standard and tailored) for scaling-up the SNaP intervention in 42 HIV test sites in Vietnam. The SNaP intervention combines systems navigation and psychosocial counseling for people who inject drugs (PWID), and it is designed to facilitate PWID's engagement in HIV and substance use care.
The two implementation approaches being compared are:
- Standard Approach (SA); vs.
- Tailored Approach (TA)
SNaP is an evidence-based intervention (EBI) that combines systems navigation and psychosocial counseling to facilitate the engagement of HIV-infected people who inject drugs (PWID) into HIV and substance use care.
The 42 HIV test sites will be randomized in a 1:1 ratio to either the standard approach (SA) procedure or a tailored approach (TA), stratified by engagement of site leadership.
At the HIV test sites, the study will enroll:
- A cohort of 630 PWID who are newly diagnosed or previously diagnosed but not on ART will be enrolled for detailed assessments, including follow-up surveys and dried blood spot collection for viral loads. Additional PWID may be enrolled for medical records assessment without recontact. An additional 242 clinic staff will be enrolled to assess implementation outcomes.
- Note that the original design included ~6200 PWID attending the clinics who consented for medical record assessments only. Upon study initiation, the number of PWID with newly diagnosed HIV infection was substantially lower than predicted. The planned cohort sample was then reduced in size to 630 and all PWID meeting eligibility criteria were referred for enrollment in this cohort.
- HIV test site director boards and staff.
Study activities will span across 5 years, with approximately 27 months at each site and recruitment of PWID participants over 21 months. For the cohort PWID or PWID selected for qualitative interviews, maximum study participation time is 24-27 months. For PWID with medical record assessment only, participation is a one-time visit. For HIV test site director boards and staff, maximum time in the study is 24-27 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Approach (SA) | Active comparator | Other: Standard Approach (SA)The Standard Approach is a one-size-fits-all multifaceted implementation strategy that was systematically developed using Intervention Mapping. |
| Tailored Approach (TA) | Experimental | Other: Tailored Approach (TA)The Tailored Approach includes an implementation strategy that will be tailored to match site-specific barriers to implementation of SNaP at that site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HIV infection:
- Age 18 years or older
- Injection drug use within the past 6 months (self-reported at time of screening)
- Willing to provide informed consent for the study
- All test site director boards and staff, including the navigators and counselors, at the selected HIV test sites
Key exclusion criteria (4 listed)
- Residence outside of the catchment area of local antiretroviral therapy (ART) and medication-assisted treatment (MAT, e.g. methadone) clinics
- Currently on ART at time of study enrollment (self-reported)
- Planning to move out of the catchment area within the next 24 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 |
|---|---|---|
| Standard Approach (SA)The multifaceted implementation strategies for SA sites were identified through centralized Intervention Mapping. Before SNaP implementation starts, the specific set of one-size-fits-all implementation strategies was determined through a formal process with investigators, government stakeholders, and clinical representatives. | Other | Standard Approach (SA) |
| Tailored Approach (TA)The Tailored Approach includes the multifaceted strategy that will be offered to the Standard Approach condition. It will also be tailored to match site-specific barriers to implementation of SNaP at that site. The strategy for TA sites involves a 2-day site-specific training, monthly coaching calls, and an external technical assistance hotline to help organizations to tailor implementation strategies to address their site-specific needs. At the 2-day TA training, the TA sites will be guided on developing site-specific implementation plans, in which they may use additional implementation strategies that they have identified themselves or selected from a list developed by the central team. | Other | Tailored Approach (TA) |
Primary outcome
Fidelity to SNaP Intervention Procedures
Time frame: Measured over 26 months after SNaP implementation in a clinic
Fidelity measures whether the SNaP intervention was delivered as intended. Fidelity score = (% Systems navigation sessions completed x Average navigation session quality score) + (% Counseling sessions completed x Average counseling session quality score) Session completion will be assessed by reviewing the navigator and counselor logs, while session quality will be assessed by central implementation team review and scoring of a random 10% of all forms (navigation) and audio-recordings (psychosocial counseling). Test site fidelity score range: 0-200 (Higher score indicates higher fidelity.)
Percent of PWID Who Initiated ART
Time frame: Medical record reviews conducted within 6 months after enrollment; self-report: 6-12 months after enrollment among those who initiated SNaP
Percent of PWID who initiated antiretroviral therapy (ART) among the PWID who initiated SNaP, measured through ART clinic records of consenting PWID and/or self-report. This measures ART uptake among PWID who initiated the SNaP intervention.
8 secondary outcomes
Percent of PWID Who Were Contacted and Participated in SNaP
Time frame: Up to 24 months after implementation of SNaP in a clinic
Mean Acceptability Score of SNaP by PWID (AIM)
Time frame: Up to 24 months after SNap implementation in a clinic
Mean Acceptability Score of SNaP by Test Site Staff (OADRI)
Time frame: 24 months after implementation of SNaP in a clinic
Percent of PWID Who Are Virally Suppressed
Time frame: Up to 24 months after implementation of SNaP in a clinic
Percent of PWID on Medication-Assisted Treatment (MAT)
Time frame: Up to 24 months after SNaP implementation in a clinic
Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation
Time frame: Up to 24 months after SNaP implementation in a clinic.
Percent of PWID Alive and Remaining on ART
Time frame: Up to 24 months after SNaP implementation in a clinic
Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities
Time frame: Up to 37 months after SNaP implementation in a clinic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41240949Go VF, Giang LM, Phan HTT, Chen JS, Powell BJ, Bartels SM, Nguyen MXB, Sripaipan T, Nong HTT, Dang LTH, Pham MD, Vo SH, Tran HV, Hoang VTH, Nguyen NTK, Chu AV, Levintow SN, Dowdy DW, Sohn H, Pence BW, Miller WC. Scaling an intervention for the engagement of people with HIV who inject drugs into care in Viet Nam: an implementation-effectiveness, cluster-randomised trial. Lancet Glob Health. 2025 Dec;13(12):e2111-e2121. doi: 10.1016/S2214-109X(25)00331-6.
- Derived from this study: PubMed 39462341Nguyen MX, Bartels SM, Akiba CF, Sripaipan T, Nong HT, Dang LT, Tran HV, Hoang VT, Le GM, Go VF, Miller WC, Powell BJ. Tracking modifications to implementation strategies: a case study from SNaP - a hybrid type III randomized controlled trial to scale up integrated systems navigation and psychosocial counseling for PWID with HIV in Vietnam. BMC Med Res Methodol. 2024 Oct 26;24(1):249. doi: 10.1186/s12874-024-02367-3.
- Derived from this study: PubMed 32771017Nguyen MXB, Chu AV, Powell BJ, Tran HV, Nguyen LH, Dao ATM, Pham MD, Vo SH, Bui NH, Dowdy DW, Latkin CA, Lancaster KE, Pence BW, Sripaipan T, Hoffman I, Miller WC, Go VF. Comparing a standard and tailored approach to scaling up an evidence-based intervention for antiretroviral therapy for people who inject drugs in Vietnam: study protocol for a cluster randomized hybrid type III trial. Implement Sci. 2020 Aug 8;15(1):64. doi: 10.1186/s13012-020-01020-z.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of an article, after de-identification.
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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.
Vivian F Go, PhD, MPH, MA principal investigator
University of North Carolina, Chapel Hill
William C Miller, MD, PhD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Approach (SA) and Tailored Approach (TA) in people with HIV Infections and Drug Use, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
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 10 inclusion and 4 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 11 May 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 Vietnam. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fidelity to SNaP Intervention Procedures (time frame: Measured over 26 months after SNaP implementation in a clinic). 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?
On the ClinicalTrials.gov record for NCT03952520, which also lists 3 linked publications.
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 11 May 2025.