HIVNCT01689545
Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU
A study testing Individual level and Structural level in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Vietnam.
Trial summary
The purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Individual level and Structural level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,175 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 2007to Apr 2013
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laboratory confirmed HIV positive diagnosis
- able and wiling to bring an injecting network member for screening
- injected drugs in previous 6 months
- planned residence in Thai Nguyen for next 24 months
- laboratory confirmed HIV negative diagnosis
- injected or shared drug paraphernalia in past 6 months
- interacts at least once a week with index participant
Who cannot join
- unwilling to provide locator information
- unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior
- currently participating in other HIV or drug use intervention activities
- Network member participant
- unwilling to provide locator information
- having psychological or cognitive impairment
- currently participating in other HIV intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users
The purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users.
Read the detailed description
This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) The structural level of the intervention consists of community-based programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive individuals; 2) The individual level of the intervention consists of 2 HIV posttest counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research questions for the overall project are:
- What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs?
- What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors
- Are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among HIV-positive IDUs than individual or structural interventions alone and more effective than the standard HIV VCT?
- Conditions
- HIV
- Being tested
- Individual level, Structural level, Individual level standard of care, Structural level standard of care
- Keywords
- HIV, drug abuse, social stigma, Vietnam
- Medical subject headings
- Substance-Related Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual levelBehavioural
Index participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs.
Structural levelBehavioural
Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.
Individual level standard of careBehavioural
The education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment.
Structural level standard of careBehavioural
Posters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities.
| Study group | Role | What they receive |
|---|---|---|
| Individual level | Experimental | Not described Receives: Behavioral: Individual level; Behavioral: Structural level standard of care |
| Structural level | Experimental | Not described Receives: Behavioral: Structural level; Behavioral: Individual level standard of care |
| Combined individual & structural level | Experimental | Not described Receives: Behavioral: Individual level; Behavioral: Structural level |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Individual level standard of care; Behavioral: Structural level standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV injecting risk behavior
Change in self-reported use of new injecting equipment
Measured: 2 years
HIV sexual risk behavior
Change in self-reported condom use during sexual intercourse
Measured: 2 years
Secondary outcomes (1)
HIV incidence
Change in HIV incidence among network members
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startDec 2007
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian F Go, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689545
- Sponsor's protocol ID
- 5R01DA022962
- Status last verified
- May 2014
- First submitted
- 18 Sep 2012
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levintow SN, Pence BW, Powers KA, Sripaipan T, Ha TV, Chu VA, Quan VM, Latkin CA, Go VF. Estimating the Effect of Depression on HIV Transmission Risk Behaviors Among People Who Inject Drugs in Vietnam: A Causal Approach. AIDS Behav. 2021 Feb;25(2):438-446. doi: 10.1007/s10461-020-03007-9.
PubMed 32833193Levintow SN, Pence BW, Ha TV, Le Minh N, Sripaipan T, Latkin CA, Vu PT, Quan VM, Frangakis C, Go VF. Depressive Symptoms at HIV Testing and Two-Year All-Cause Mortality Among Men Who Inject Drugs in Vietnam. AIDS Behav. 2019 Mar;23(3):609-616. doi: 10.1007/s10461-018-2318-8.
PubMed 30357641Go VF, Frangakis C, Minh NL, Latkin C, Ha TV, Mo TT, Sripaipan T, Davis WW, Zelaya C, Vu PT, Celentano DD, Quan VM. Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial. PLoS One. 2015 May 26;10(5):e0125909. doi: 10.1371/journal.pone.0125909. eCollection 2015.
PubMed 26011427
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users
- ClinicalTrials.gov ID
- NCT01689545
- Acronym / sponsor ID
- 5R01DA022962
- Conditions
- HIV
- Keywords
- HIV, drug abuse, social stigma, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,175 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- 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 purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users.
Detailed description
This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) The structural level of the intervention consists of community-based programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive individuals; 2) The individual level of the intervention consists of 2 HIV posttest counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research questions for the overall project are:
- What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs?
- What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors
- Are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among HIV-positive IDUs than individual or structural interventions alone and more effective than the standard HIV VCT?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individual level | Experimental | Behavioral: Individual level, Behavioral: Structural level standard of care |
| Structural level | Experimental | Behavioral: Structural level, Behavioral: Individual level standard of care |
| Combined individual & structural level | Experimental | Behavioral: Individual level, Behavioral: Structural level |
| Standard of Care | Active comparator | Behavioral: Individual level standard of care, Behavioral: Structural level standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- laboratory confirmed HIV positive diagnosis
- able and wiling to bring an injecting network member for screening
- injected drugs in previous 6 months
- planned residence in Thai Nguyen for next 24 months
- laboratory confirmed HIV negative diagnosis
Key exclusion criteria (7 listed)
- unwilling to provide locator information
- unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior
- currently participating in other HIV or drug use intervention activities
- Network member participant
- unwilling to provide locator information
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 |
|---|---|---|
| Individual levelIndex participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs. | Behavioural | Combined individual & structural level, Individual level |
| Structural levelCommunity members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers. | Behavioural | Combined individual & structural level, Structural level |
| Individual level standard of careThe education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment. | Behavioural | Standard of Care, Structural level |
| Structural level standard of carePosters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities. | Behavioural | Individual level, Standard of Care |
Primary outcome
HIV injecting risk behavior
Time frame: 2 years
Change in self-reported use of new injecting equipment
HIV sexual risk behavior
Time frame: 2 years
Change in self-reported condom use during sexual intercourse
1 secondary outcome
HIV incidence
Time frame: 2 years
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 2014.
- Derived from this study: PubMed 32833193Levintow SN, Pence BW, Powers KA, Sripaipan T, Ha TV, Chu VA, Quan VM, Latkin CA, Go VF. Estimating the Effect of Depression on HIV Transmission Risk Behaviors Among People Who Inject Drugs in Vietnam: A Causal Approach. AIDS Behav. 2021 Feb;25(2):438-446. doi: 10.1007/s10461-020-03007-9.
- Derived from this study: PubMed 30357641Levintow SN, Pence BW, Ha TV, Le Minh N, Sripaipan T, Latkin CA, Vu PT, Quan VM, Frangakis C, Go VF. Depressive Symptoms at HIV Testing and Two-Year All-Cause Mortality Among Men Who Inject Drugs in Vietnam. AIDS Behav. 2019 Mar;23(3):609-616. doi: 10.1007/s10461-018-2318-8.
- Derived from this study: PubMed 26011427Go VF, Frangakis C, Minh NL, Latkin C, Ha TV, Mo TT, Sripaipan T, Davis WW, Zelaya C, Vu PT, Celentano DD, Quan VM. Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial. PLoS One. 2015 May 26;10(5):e0125909. doi: 10.1371/journal.pone.0125909. eCollection 2015.
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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 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 Individual level and Structural level in people with HIV, run by Johns Hopkins Bloomberg School of Public Health 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 7 inclusion and 7 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 5 Jun 2014. 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?
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?
HIV injecting risk behavior (time frame: 2 years). 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 NCT01689545, 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 5 Jun 2014.