HIVEncuentroNCT01279421
High Risk Crack Use Settings and HIV in El Salvador
A study testing Social Network HIV Testing and Peer Network Intervention in people with HIV and Sexually Transmitted Diseases, run by Medical College of Wisconsin at 1 site in El Salvador.
Trial summary
This project will first increase the accessibility and acceptability of rapid HIV testing in health clinics located in or near four low-income communities in San Salvador, El Salvador. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Diseases
- What is being tested?
- Social Network HIV Testing and Peer Network Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,382 participants
- Where
- 1 siteEl Salvador
- Study dates
- Nov 2010to Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- used crack cocaine in the last 2 weeks
Who cannot join
- not giving informed consent
- under 18 years of age
- considered by research staff to be unfit or unable to give informed consent
- engages in continued disruptive behavior while participating in the project
- not using crack or cocaine in the last month
Trial locations and contacts
1 site in 1 country.
About this study
This project will first increase the accessibility and acceptability of rapid HIV testing in health clinics located in or near four low-income communities in San Salvador, El Salvador. The investigators will use crack users' social networks and small incentives, as recommended by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network Intervention among 400 crack users to change norms supporting HIV protective behaviors. The intervention will include monthly meetings open to crack using and non-crack using community residents to reinforce HIV risk reduction skills, and discussion of other topics related to HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness events. Our hypothesis is that these two intervention features will singly, and in combination, reduce HIV risk behaviors among Salvadoran crack users.
- Conditions
- HIV, Sexually Transmitted Diseases
- Being tested
- Social Network HIV Testing, Peer Network Intervention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Network HIV TestingBehavioural
Crack users will be recruited for HIV testing and receive 3 coupons to recruit other crack users for HIV testing.
Peer Network InterventionBehavioural
Peer leaders will recruit small networks of crack users and facilitate a three-day prevention intervention.
| Study group | Role | What they receive |
|---|---|---|
| Social Network HIV Testing | Experimental | Participants in this arm will be recruited through social networks and will receive an HIV test. Receives: Behavioral: Social Network HIV Testing |
| Peer Network Intervention | Experimental | Eight (8) current or former crack users will be recruited to facilitate small networks of crack users in a three-day intervention. They will also facilitate monthly meetings open to all community members regarding HIV prevention and interpersonal violence. Receives: Behavioral: Peer Network Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased HIV testing rates among crack users
Measured: 24 months
Decreased number of sexual risk behaviors among crack users
Measured: 12 months
Secondary outcomes (1)
Community and organizational factors associated with successful implementation of multi-level, community-based HIV prevention intervention
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 posted19 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2016
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Julia Dickson-Gomez, Medical College of Wisconsin
- Investigators
- Julia B. Dickson-Gomez, Ph.D., Principal investigator, Medical College of WisconsinGloria Bodnar, Ph.D., Study director, Fundacion Antidrogas de El Salvador (FUNDASALVA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279421
- Sponsor's protocol ID
- PRO00013931
- Other IDs
- R01DA020350
- Acronym
- Encuentro
- Status last verified
- May 2021
- First submitted
- 17 Jan 2011
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dickson-Gomez J, Bodnar G, Petroll A, Johnson K, Glasman L. HIV Treatment for Alcohol and Non-Injection Drug Users in El Salvador. Qual Health Res. 2015 Dec;25(12):1719-32. doi: 10.1177/1049732314568322. Epub 2015 Jan 16.
PubMed 25595149Dickson-Gomez J, Corbett AM, Bodnar G, Zuniga MO, Guevara CE, Rodriguez K, Navas V. Context and group dynamics in a CBPR-developed HIV prevention intervention. Health Promot Int. 2016 Mar;31(1):93-105. doi: 10.1093/heapro/dau058. Epub 2014 Jul 28.
PubMed 25070835Dickson-Gomez J. Substance abuse disorders treatment in El Salvador: analysis of policy-making-related failure. Subst Use Misuse. 2012 Nov-Dec;47(13-14):1546-51. doi: 10.3109/10826084.2012.705698.
PubMed 23186469Dickson-Gomez J, McAuliffe T, Rivas de Mendoza L, Glasman L, Gaborit M. The relationship between community structural characteristics, the context of crack use, and HIV risk behaviors in San Salvador, El Salvador. Subst Use Misuse. 2012 Feb;47(3):265-77. doi: 10.3109/10826084.2011.635325.
PubMed 22217125Dickson-Gomez J, Bodnar G, Guevara CE, Rodriguez K, De Mendoza LR, Corbett AM. With God's help i can do it: crack users? Formal and informal recovery experiences in El Salvador. Subst Use Misuse. 2011;46(4):426-39. doi: 10.3109/10826084.2010.495762. Epub 2010 Aug 24.
PubMed 20735191Dickson-Gomez J. Structural factors influencing patterns of drug selling and use and HIV risk in the San Salvador metropolitan area. Med Anthropol Q. 2010 Jun;24(2):157-81. doi: 10.1111/j.1548-1387.2010.01095.x.
PubMed 20550091Dickson-Gomez J, Corbett AM, Bodnar G, Rodriguez K, Guevara CE. Resources and obstacles to developing and implementing a structural intervention to prevent HIV in San Salvador, El Salvador. Soc Sci Med. 2010 Feb;70(3):351-359. doi: 10.1016/j.socscimed.2009.10.029. Epub 2009 Nov 10.
PubMed 19910099Glasman LR, Dickson-Gomez J, Lechuga J, Tarima S, Bodnar G, de Mendoza LR. Using Peer-Referral Chains with Incentives to Promote HIV Testing and Identify Undiagnosed HIV Infections Among Crack Users in San Salvador. AIDS Behav. 2016 Jun;20(6):1236-43. doi: 10.1007/s10461-015-1267-8.
PubMed 26687093
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk Crack Use Settings and HIV in El Salvador
- ClinicalTrials.gov ID
- NCT01279421
- Acronym / sponsor ID
- Encuentro / PRO00013931
- Conditions
- HIV, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,382 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 19 Jan 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.
This project will first increase the accessibility and acceptability of rapid HIV testing in health clinics located in or near four low-income communities in San Salvador, El Salvador. The investigators will use crack users' social networks and small incentives, as recommended by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network Intervention among 400 crack users to change norms supporting HIV protective behaviors. The intervention will include monthly meetings open to crack using and non-crack using community residents to reinforce HIV risk reduction skills, and discussion of other topics related to HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness events. Our hypothesis is that these two intervention features will singly, and in combination, reduce HIV risk behaviors among Salvadoran crack users.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Network HIV Testing | Experimental | Behavioral: Social Network HIV TestingParticipants in this arm will be recruited through social networks and will receive an HIV test. |
| Peer Network Intervention | Experimental | Behavioral: Peer Network InterventionEight (8) current or former crack users will be recruited to facilitate small networks of crack users in a three-day intervention. They will also facilitate monthly meetings open to all community members regarding HIV prevention and interpersonal violence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- used crack cocaine in the last 2 weeks
Key exclusion criteria (5 listed)
- not giving informed consent
- under 18 years of age
- considered by research staff to be unfit or unable to give informed consent
- engages in continued disruptive behavior while participating in the project
- not using crack or cocaine in the last month
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 |
|---|---|---|
| Social Network HIV TestingCrack users will be recruited for HIV testing and receive 3 coupons to recruit other crack users for HIV testing. | Behavioural | Social Network HIV Testing |
| Peer Network InterventionPeer leaders will recruit small networks of crack users and facilitate a three-day prevention intervention. | Behavioural | Peer Network Intervention |
Primary outcome
Increased HIV testing rates among crack users
Time frame: 24 months
Decreased number of sexual risk behaviors among crack users
Time frame: 12 months
1 secondary outcome
Community and organizational factors associated with successful implementation of multi-level, community-based HIV prevention intervention
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 14 May 2021.
- Background: PubMed 25595149Dickson-Gomez J, Bodnar G, Petroll A, Johnson K, Glasman L. HIV Treatment for Alcohol and Non-Injection Drug Users in El Salvador. Qual Health Res. 2015 Dec;25(12):1719-32. doi: 10.1177/1049732314568322. Epub 2015 Jan 16.
- Background: PubMed 25070835Dickson-Gomez J, Corbett AM, Bodnar G, Zuniga MO, Guevara CE, Rodriguez K, Navas V. Context and group dynamics in a CBPR-developed HIV prevention intervention. Health Promot Int. 2016 Mar;31(1):93-105. doi: 10.1093/heapro/dau058. Epub 2014 Jul 28.
- Background: PubMed 23186469Dickson-Gomez J. Substance abuse disorders treatment in El Salvador: analysis of policy-making-related failure. Subst Use Misuse. 2012 Nov-Dec;47(13-14):1546-51. doi: 10.3109/10826084.2012.705698.
- Background: PubMed 22217125Dickson-Gomez J, McAuliffe T, Rivas de Mendoza L, Glasman L, Gaborit M. The relationship between community structural characteristics, the context of crack use, and HIV risk behaviors in San Salvador, El Salvador. Subst Use Misuse. 2012 Feb;47(3):265-77. doi: 10.3109/10826084.2011.635325.
- Background: PubMed 20735191Dickson-Gomez J, Bodnar G, Guevara CE, Rodriguez K, De Mendoza LR, Corbett AM. With God's help i can do it: crack users? Formal and informal recovery experiences in El Salvador. Subst Use Misuse. 2011;46(4):426-39. doi: 10.3109/10826084.2010.495762. Epub 2010 Aug 24.
- Background: PubMed 20550091Dickson-Gomez J. Structural factors influencing patterns of drug selling and use and HIV risk in the San Salvador metropolitan area. Med Anthropol Q. 2010 Jun;24(2):157-81. doi: 10.1111/j.1548-1387.2010.01095.x.
- Background: PubMed 19910099Dickson-Gomez J, Corbett AM, Bodnar G, Rodriguez K, Guevara CE. Resources and obstacles to developing and implementing a structural intervention to prevent HIV in San Salvador, El Salvador. Soc Sci Med. 2010 Feb;70(3):351-359. doi: 10.1016/j.socscimed.2009.10.029. Epub 2009 Nov 10.
- Results publication: PubMed 26687093Glasman LR, Dickson-Gomez J, Lechuga J, Tarima S, Bodnar G, de Mendoza LR. Using Peer-Referral Chains with Incentives to Promote HIV Testing and Identify Undiagnosed HIV Infections Among Crack Users in San Salvador. AIDS Behav. 2016 Jun;20(6):1236-43. doi: 10.1007/s10461-015-1267-8.
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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.
Julia B. Dickson-Gomez, Ph.D. principal investigator
Medical College of Wisconsin
Gloria Bodnar, Ph.D. study director
Fundacion Antidrogas de El Salvador (FUNDASALVA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Network HIV Testing and Peer Network Intervention in people with HIV and Sexually Transmitted Diseases, run by Medical College of Wisconsin at 1 site in El Salvador.
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 2 inclusion and 5 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 14 May 2021. 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 El Salvador. 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?
Increased HIV testing rates among crack users (time frame: 24 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 NCT01279421, which also lists 8 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 14 May 2021.