HIVPhase 2WorkshopNCT01380613
Neighborhoods, Networks, Depression, and HIV Risk
A Phase 2 study testing Workshop in people with HIV and Depression, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The goal of this study is to examine how social networks, neighborhood, and depression are related to HIV risk. The intervention is designed to train individuals to cope with feelings of depression or stress as a way to reduce their risk for HIV. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV, Depression, Drug Use
- What is being tested?
- Workshop
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 965 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2013
- Phase
- Phase 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-55 years old
- HIV Risk Behavior:
- 3a. Injected drugs more than 3 times in the past week OR
- 3b. Snorted/sniffed heroin or cocaine or smoked crack in the past 6 months AND had 1 of the following sex risks in the past 6 months: i) 2 or more sex partners ii) Had a sex partner who injected drugs iii)Had a sex partner who smoked crack iv) Had a sex partner who was HIV+
- 4. Willingness to attend group sessions
Who cannot join
- Enrolled in another HIV behavioral intervention or depression study in past the 3 years
- Enrolled in another Lighthouse study in past the 5 years
- Enrolled in the formative research (Phase 1) or pilot (Phase 2) of the current project.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lighthouse Studies @ Peer Points- JHSPH
Baltimore, Maryland, 21205
About this study
Official title: The Impact of Neighborhoods, Networks, and Depression on Drug Users' HIV Risk
The goal of this study is to examine how social networks, neighborhood, and depression are related to HIV risk. The intervention is designed to train individuals to cope with feelings of depression or stress as a way to reduce their risk for HIV.
Read the detailed description
This study included implementation and evaluation of a small group, randomized controlled, phase II intervention to reduce depressive symptoms and HIV risk behaviors among inner city drug users. The intervention included elements of cognitive behavioral therapy (CBT) for depression among impoverished individuals, emphasizing depressive cognitions and behaviors theorized to be associated with depression and with HIV risk behaviors among mildly to moderately depressed drug users. In addition, the study examined active drug users' social and environmental pathways to depression and subsequent HIV risk behaviors. Specifically, we will hypothesized mediating/moderating effects of neighborhood characteristics, social network factors, and individual level factors on depressive symptoms and HIV risk behaviors.
- Conditions
- HIV, Depression, Drug Use
- Being tested
- Workshop, Workshop control
- Keywords
- HIV, depression, drug use,, risk reduction
- Medical subject headings
- Depression, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkshopBehavioural
10 session intervention
Workshop controlBehavioural
1 session intervention on standard HIV/STD information
| Study group | Role | What they receive |
|---|---|---|
| Workshop Control | Active comparator | Participants receive HIV/STDs risk reduction information. Receives: Behavioral: Workshop control |
| Intervention Workshop | Experimental | Participants learn skills to cope with depressive symptoms and stress as well as safer sex and injection skills. Receives: Behavioral: Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 6 months
Measured: 6 months
Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 12 months
Measured: 12 months
Secondary outcomes (4)
Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 6 months
Measured: 6 months
Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 6 months
Measured: 6 months
Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 12 months
Measured: 12 months
Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 965 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Carl Latkin, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Carl A Latkin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380613
- Sponsor's protocol ID
- DESPR-DA022961-03
- Other IDs
- R01DA022961
- Acronym
- Workshop
- Status last verified
- Sep 2013
- First submitted
- 7 Mar 2011
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tobin K, Davey-Rothwell MA, Nonyane BAS, Knowlton A, Wissow L, Latkin CA. RCT of an integrated CBT-HIV intervention on depressive symptoms and HIV risk. PLoS One. 2017 Dec 14;12(12):e0187180. doi: 10.1371/journal.pone.0187180. eCollection 2017.
PubMed 29240757
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neighborhoods, Networks, and Depression on Drug Users' HIV Risk
- ClinicalTrials.gov ID
- NCT01380613
- Acronym / sponsor ID
- Workshop / DESPR-DA022961-03
- Conditions
- HIV, Depression, Drug Use
- Keywords
- HIV, depression, drug use,, risk reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 965 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jun 2011 (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 goal of this study is to examine how social networks, neighborhood, and depression are related to HIV risk. The intervention is designed to train individuals to cope with feelings of depression or stress as a way to reduce their risk for HIV.
Detailed description
This study included implementation and evaluation of a small group, randomized controlled, phase II intervention to reduce depressive symptoms and HIV risk behaviors among inner city drug users. The intervention included elements of cognitive behavioral therapy (CBT) for depression among impoverished individuals, emphasizing depressive cognitions and behaviors theorized to be associated with depression and with HIV risk behaviors among mildly to moderately depressed drug users. In addition, the study examined active drug users' social and environmental pathways to depression and subsequent HIV risk behaviors. Specifically, we will hypothesized mediating/moderating effects of neighborhood characteristics, social network factors, and individual level factors on depressive symptoms and HIV risk behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workshop Control | Active comparator | Behavioral: Workshop controlParticipants receive HIV/STDs risk reduction information. |
| Intervention Workshop | Experimental | Behavioral: WorkshopParticipants learn skills to cope with depressive symptoms and stress as well as safer sex and injection skills. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-55 years old
- HIV Risk Behavior:
- 3a. Injected drugs more than 3 times in the past week OR
- 3b. Snorted/sniffed heroin or cocaine or smoked crack in the past 6 months AND had 1 of the following sex risks in the past 6 months: i) 2 or more sex partners ii) Had a sex partner who injected drugs iii)Had a sex partner who smoked crack iv) Had a sex partner who was HIV+
- 4. Willingness to attend group sessions
Key exclusion criteria (3 listed)
- Enrolled in another HIV behavioral intervention or depression study in past the 3 years
- Enrolled in another Lighthouse study in past the 5 years
- Enrolled in the formative research (Phase 1) or pilot (Phase 2) of the current project.
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 |
|---|---|---|
| Workshop10 session intervention | Behavioural | Intervention Workshop |
| Workshop control1 session intervention on standard HIV/STD information | Behavioural | Workshop Control |
Primary outcome
Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 6 months
Time frame: 6 months
Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 12 months
Time frame: 12 months
4 secondary outcomes
Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 6 months
Time frame: 6 months
Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 6 months
Time frame: 6 months
Change from Baseline in Sex Risk Behavior Based on Number of Sex Partners and Condom Use at 12 months
Time frame: 12 months
Change from Baseline in Injection Risk Behavior Based on Sharing Needles, Cookers, and Cotton For Injection and Drug Splitting at 12 months
Time frame: 12 months
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 Sep 2013.
- Derived from this study: PubMed 29240757Tobin K, Davey-Rothwell MA, Nonyane BAS, Knowlton A, Wissow L, Latkin CA. RCT of an integrated CBT-HIV intervention on depressive symptoms and HIV risk. PLoS One. 2017 Dec 14;12(12):e0187180. doi: 10.1371/journal.pone.0187180. eCollection 2017.
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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.
Carl A Latkin, 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 Phase 2 study testing Workshop in people with HIV and Depression, run by Johns Hopkins Bloomberg School of Public Health 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 5 inclusion and 3 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 Sep 2013. 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.
What does this phase mean?
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?
Change from Baseline in Depressive Symptoms Measured by the CESD Scale at 6 months (time frame: 6 months). 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 NCT01380613, which also lists 1 linked publication.
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 Sep 2013.