Quality of LifePhase 1/2NCT01540188
Development of a Family Intervention to Address Drug Use and HIV in Vietnam
A Phase 1/2 study testing Family Intervention to Address Drug Use and HIV in Vietnam in people with Quality of Life, run by University of California, Los Angeles at 1 site in Vietnam.
Trial summary
Vietnam is currently experiencing two epidemics -- injection drug use and HIV. HIV infection is rising rapidly, primarily among injecting drug users (IDUs). Most young IDUs keep daily contact with their family or live in their parent's home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Family Intervention to Address Drug Use and HIV in Vietnam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteVietnam
- Study dates
- Jul 2010to Apr 2012
- Phase
- Phase 1/2
- 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
- IDUs:
- Age 18 or over
- Either HIV + or HIV- in blood test
- A current or past injection drug user
- Disclosure of drug use status and HIV positive status (if positive) to their family members
- Voluntary informed consent
Show all 11Show fewer
- Family members:
- Age 18 or over
- Immediate or extended family member of an IDU and living with the IDU.
- Previous knowledge of the drug use and HIV status (if positive) of the IDU.
- Voluntary informed consent
Who cannot join
- IDUs :
- Inability to give informed consent
- Has not disclosed the drug use status and HIV status (if positive) to family member
- Not a current or past injection drug user
- Family members:
- Inability to give informed consent
- Does not know the drug use status and HIV status (if positive) of the IDU in their family
Trial locations and contacts
1 site in 1 country.
About this study
Vietnam is currently experiencing two epidemics -- injection drug use and HIV. HIV infection is rising rapidly, primarily among injecting drug users (IDUs). Most young IDUs keep daily contact with their family or live in their parent's home. The burden on their families is substantial, and even greater if the IDU is HIV+. In this study, the investigators conduct an intervention pilot to develop and evaluate a family intervention to improve outcomes over time for Vietnamese IDUs and their families. This two-year study is conducted in Phu Tho, a province located about 80 km from Hanoi, Vietnam's capital.
Two teams with complementary expertise collaborate to implement this study: the UCLA team and the Vietnamese team from the Vietnam National Institute of Hygiene \& Epidemiology (NIHE). The study has two phases:
- In Phase 1, the investigators develop the content, format and an implementation plan for the intervention from a focus group of 10 service providers, administrators and community leaders, and through in-depth interviews with 40 IDUs (20 HIV+ and 20 HIV-) recruited from the local drug rehabilitation center (the "06 Center") and from two local communities (Duu Lau and Gia Cam), as well as in-depth interviews with 20 of the IDUs family members (FM). Based on the findings, the investigators collaborate on designing a Vietnamese-specific family intervention for IDUs and their family members.
- In Phase 2, the investigators pilot the intervention in the local commune health centers in Viet Tri, Phu Tho. Eighty IDUs (HIV+/HIV-) and 80 of their family members are recruited from 4 communes and the 06 Center in Viet Tri city, and randomized into a intervention group and a control group. After the 4-week intervention, 3-month and 6-month follow-ups are conducted to assess the effectiveness of the intervention. Participants randomized to the control group only complete the assessments (baseline, 3-, and 6-month) at the same time points.
Read the detailed description
Vietnam is facing the challenge of dual epidemics -injection drug use and HIV. HIV infection is rising exponentially, primarily among injecting drug users (IDUs). Because Vietnamese are highly family oriented, most young IDUs have daily family contact or live in their parents' homes. The burden on the family is substantial, and even greater if the IDU is HIV+. The investigators hypothesize that with assistance, families can be part of the solution for both HIV and HIV+ IDU. This family intervention in Vietnam is based on the Social Action Theory and Social Network Theory, aimed at increasing families' capacities to effectively cope with the impact of IDUs and HIV. The study provides an opportunity to test culturally-specific intervention content and delivery. In addition, the intervention pilot will provide an opportunity to obtain project implementation experience in the local settings. The study also provides the opportunity to pilot test outcome measures.
The specific aims of the study are:
- To document the challenges of drug use and HIV for IDUs and their family members;
- To examine the acceptability and feasibility of a family-based intervention for IDU and their family members;
- To examine whether the IDUs and family members in the intervention group, compared to those in the standard care group, will have significantly improved health, mental health, and quality of life outcomes, including health seeking, reduced sexual and drug use risk behaviors, increased HIV testing, and reduced caregiver burden; and
- To examine how outcomes of the IDUs and family members are mediated by family indicators such as family cohesion, stress and symptom management, stigma and harm reduction, HIV disclosure, and treatment adherence.
- Conditions
- Quality of Life
- Being tested
- Family Intervention to Address Drug Use and HIV in Vietnam
- Keywords
- Drug user, Family member, Intervention, Community, Support
- Medical subject headings
- Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Intervention to Address Drug Use and HIV in VietnamBehavioural
Intervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community.
Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community
| Study group | Role | What they receive |
|---|---|---|
| Starndard care arm | No intervention | Participants of the standard care arm are control groups of IDUs and family members. They do not attend intervention sessions. |
| Intervention arm | Experimental | Intervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community.
Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community Receives: Behavioral: Family Intervention to Address Drug Use and HIV in Vietnam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health
The IDUs will be assessed using the Medical Outcomes Study (MOS) Short-Form 36 (SF-36). The MOS-SF-36 consists of the following domains: physical functioning; role limitation (physical); role limitation (emotional); social functioning; mental health; energy/vitality; pain; and general health perception. The score for each domain ranges from 0 to 100 with higher values indicating higher functional status.
Measured: Changes from baseline to 3- and 6-month follow-up
Mental health
All of the participants including both IDUs and family members will be assessed by the Zung Self-Rating Depression Scale. This measure, developed by the World Health Organization, is a 20-item self-report scale that is widely used as a screening tool, covering affective, psychological and somatic symptoms associated with depression. Results from this measure will be used as an indicator of psychological (including psychosis) and emotional functioning that can be associated with drug use.
Measured: Changes from baseline to 3- and 6-month follow-up
Secondary outcomes (4)
Drug use
Measures will include data on alcohol use and other drug use. For the IDU participants, their drug use will be measured by a biomarker (Urine drug screen) at the baseline, since the drug rehabilitation sites routinely collect urine to test for drug use. Positive results will be interpreted as signifying drug use, regardless of self-report.
Measured: Changes from baseline to 3- and 6-month follow-up
Sexual risk
This is assessed using the Risk Assessment Battery (RAB; Metzger, 1995) Collecting data on self-reported HIV risk behaviors is especially relevant as there is a well-documented association between drug use and participation in high risk sexual behaviors related to HIV-transmission.
Measured: Changes from baseline to 3- and 6-month follow-up
Caregiver burden
This is assessed using the Perceived Caregiver Burden Scale (PCB) (Stommel et al., 1990). This scale has been used in our studies in Thailand and China (Lee et al., 2009b) to assess caregiver burden in terms of perceptions and feelings about family members' physical and emotional health, family relationships, social life, work, and finances.
Measured: Changes from baseline to 3- and 6-month follow-up
Family/social support
This is measured by two instruments. Social Support Questionnaire (Short; SSQ6) is a 6-item assessment to measure satisfaction of social support. Number of social support providers is captured up to 9 people in various support dimensions (Sarason et al., 1983). Medical Outcomes Study- Social Support Scale (MOS-SS) is a 20-item scale that measures the strength of perceived social support available. The scale consists of five dimensions: emotional support, informational support, tangible support, positive social interaction, and affection.
Measured: Changes from baseline to 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Responsible party
- Principal investigator, Li Li, University of California, Los Angeles
- Investigators
- Li Li, Ph.D, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540188
- Sponsor's protocol ID
- R34DA029493
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2012
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Family Intervention to Address Drug Use and HIV in Vietnam
- ClinicalTrials.gov ID
- NCT01540188
- Acronym / sponsor ID
- R34DA029493
- Conditions
- Quality of Life
- Keywords
- Drug user, Family member, Intervention, Community, Support
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Feb 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.
Vietnam is currently experiencing two epidemics -- injection drug use and HIV. HIV infection is rising rapidly, primarily among injecting drug users (IDUs). Most young IDUs keep daily contact with their family or live in their parent's home. The burden on their families is substantial, and even greater if the IDU is HIV+. In this study, the investigators conduct an intervention pilot to develop and evaluate a family intervention to improve outcomes over time for Vietnamese IDUs and their families. This two-year study is conducted in Phu Tho, a province located about 80 km from Hanoi, Vietnam's capital.
Two teams with complementary expertise collaborate to implement this study: the UCLA team and the Vietnamese team from the Vietnam National Institute of Hygiene \& Epidemiology (NIHE). The study has two phases:
- In Phase 1, the investigators develop the content, format and an implementation plan for the intervention from a focus group of 10 service providers, administrators and community leaders, and through in-depth interviews with 40 IDUs (20 HIV+ and 20 HIV-) recruited from the local drug rehabilitation center (the "06 Center") and from two local communities (Duu Lau and Gia Cam), as well as in-depth interviews with 20 of the IDUs family members (FM). Based on the findings, the investigators collaborate on designing a Vietnamese-specific family intervention for IDUs and their family members.
- In Phase 2, the investigators pilot the intervention in the local commune health centers in Viet Tri, Phu Tho. Eighty IDUs (HIV+/HIV-) and 80 of their family members are recruited from 4 communes and the 06 Center in Viet Tri city, and randomized into a intervention group and a control group. After the 4-week intervention, 3-month and 6-month follow-ups are conducted to assess the effectiveness of the intervention. Participants randomized to the control group only complete the assessments (baseline, 3-, and 6-month) at the same time points.
Detailed description
Vietnam is facing the challenge of dual epidemics -injection drug use and HIV. HIV infection is rising exponentially, primarily among injecting drug users (IDUs). Because Vietnamese are highly family oriented, most young IDUs have daily family contact or live in their parents' homes. The burden on the family is substantial, and even greater if the IDU is HIV+. The investigators hypothesize that with assistance, families can be part of the solution for both HIV and HIV+ IDU. This family intervention in Vietnam is based on the Social Action Theory and Social Network Theory, aimed at increasing families' capacities to effectively cope with the impact of IDUs and HIV. The study provides an opportunity to test culturally-specific intervention content and delivery. In addition, the intervention pilot will provide an opportunity to obtain project implementation experience in the local settings. The study also provides the opportunity to pilot test outcome measures.
The specific aims of the study are:
- To document the challenges of drug use and HIV for IDUs and their family members;
- To examine the acceptability and feasibility of a family-based intervention for IDU and their family members;
- To examine whether the IDUs and family members in the intervention group, compared to those in the standard care group, will have significantly improved health, mental health, and quality of life outcomes, including health seeking, reduced sexual and drug use risk behaviors, increased HIV testing, and reduced caregiver burden; and
- To examine how outcomes of the IDUs and family members are mediated by family indicators such as family cohesion, stress and symptom management, stigma and harm reduction, HIV disclosure, and treatment adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starndard care arm | No intervention | –Participants of the standard care arm are control groups of IDUs and family members. They do not attend intervention sessions. |
| Intervention arm | Experimental | Behavioral: Family Intervention to Address Drug Use and HIV in VietnamIntervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community. Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- IDUs:
- Age 18 or over
- Immediate or extended family member of an IDU and living with the IDU.
- Previous knowledge of the drug use and HIV status (if positive) of the IDU.
- Voluntary informed consent
Key exclusion criteria (7 listed)
- IDUs :
- Inability to give informed consent
- Does not know the drug use status and HIV status (if positive) of the IDU in their family
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 |
|---|---|---|
| Family Intervention to Address Drug Use and HIV in VietnamIntervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community. Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community | Behavioural | Intervention arm |
Primary outcome
Physical health
Time frame: Changes from baseline to 3- and 6-month follow-up
The IDUs will be assessed using the Medical Outcomes Study (MOS) Short-Form 36 (SF-36). The MOS-SF-36 consists of the following domains: physical functioning; role limitation (physical); role limitation (emotional); social functioning; mental health; energy/vitality; pain; and general health perception. The score for each domain ranges from 0 to 100 with higher values indicating higher functional status.
Mental health
Time frame: Changes from baseline to 3- and 6-month follow-up
All of the participants including both IDUs and family members will be assessed by the Zung Self-Rating Depression Scale. This measure, developed by the World Health Organization, is a 20-item self-report scale that is widely used as a screening tool, covering affective, psychological and somatic symptoms associated with depression. Results from this measure will be used as an indicator of psychological (including psychosis) and emotional functioning that can be associated with drug use.
4 secondary outcomes
Drug use
Time frame: Changes from baseline to 3- and 6-month follow-up
Sexual risk
Time frame: Changes from baseline to 3- and 6-month follow-up
Caregiver burden
Time frame: Changes from baseline to 3- and 6-month follow-up
Family/social support
Time frame: Changes from baseline to 3- and 6-month follow-up
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 18 Feb 2016.
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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.
Li Li, Ph.D principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Family Intervention to Address Drug Use and HIV in Vietnam in people with Quality of Life, run by University of California, Los Angeles 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 11 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 18 Feb 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical health (time frame: Changes from baseline to 3- and 6-month follow-up). 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 18 Feb 2016.