HIV PreventionPhase 2NCT00886561
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
A Phase 2 study testing HIV risk reduction intervention in people with HIV Prevention and HIV Infections, run by Emory University at 1 site in Armenia.
Trial summary
This pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HIV Infections
- What is being tested?
- HIV risk reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteArmenia
- Study dates
- Jul 2007to Jul 2008
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- traded sex for money in the past 7 days
- cognitive ability to participate in assessment and intervention
Who cannot join
- younger than 18 years of age
- did not trade sex for money in the past 7 days
- cognitively unable to participate in assessment and intervention
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia.
Read the detailed description
The purpose of this pilot study is to evaluate the efficacy of an intervention to reduce sexual risk behaviors and enhance HIV-preventive behaviors among female sex workers (FSWs) in Yerevan, Armenia. The study design is a randomized controlled trial of 120 FSWs aged 18 and over recruited through Hope and Help NGO. Participants will complete an interviewer administered questionnaire collected at baseline, 3- and 6-month follow-up.
Subsequently, participants will be randomly assigned to either the intervention condition or a wait-list control. Those randomized to the intervention condition will receive a 2-hour one-on-one intervention session emphasizing HIV knowledge, self-efficacy, and condom use behaviors. They will also receive a 10-15 minute booster session at 3-month follow-up. The comparison condition is wait-listed, but have the choice of participating in the intervention program upon completion of the study.
The main outcome measure includes consistent condom use, defined as condom use during every episode of vaginal intercourse with clients. Other outcome measures are condom application by FSW and HIV- preventive behaviors such as condom use self-efficacy, knowledge of HIV transmission dynamics,perceived barriers to condom use and condom use errors.
Results from this pilot study are expected to inform a larger trial to be implemented with FSWs in Armenia, in an effort to devise gender and culturally relevant intervention programs to prevent HIV transmission in this vulnerable population.
- Conditions
- HIV Prevention, HIV Infections
- Being tested
- HIV risk reduction intervention
- Keywords
- HIV prevention, female sex workers, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV risk reduction interventionBehavioural
Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia
| Study group | Role | What they receive |
|---|---|---|
| HIV risk reduction intervention | Experimental | Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia Receives: Behavioral: HIV risk reduction intervention |
| Wait list control | Active comparator | Will receive behavioral intervention after completion of study upon request. Receives: Behavioral: HIV risk reduction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistent condom use
Measured: 3 and 6 months post intervention
Secondary outcomes (1)
Condom application
Measured: 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American University of Armenia
- Responsible party
- Principal investigator, Ralph J. DiClemente, Emory University
- Investigators
- Ralph J DiClemente, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886561
- Sponsor's protocol ID
- 0126-2005
- Other IDs
- ARX1-2719-YE-06
- Status last verified
- Nov 2013
- First submitted
- 22 Apr 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
- ClinicalTrials.gov ID
- NCT00886561
- Acronym / sponsor ID
- 0126-2005
- Conditions
- HIV Prevention, HIV Infections
- Keywords
- HIV prevention, female sex workers, HIV seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American University of Armenia
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Apr 2009 (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 pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia.
Detailed description
The purpose of this pilot study is to evaluate the efficacy of an intervention to reduce sexual risk behaviors and enhance HIV-preventive behaviors among female sex workers (FSWs) in Yerevan, Armenia. The study design is a randomized controlled trial of 120 FSWs aged 18 and over recruited through Hope and Help NGO. Participants will complete an interviewer administered questionnaire collected at baseline, 3- and 6-month follow-up.
Subsequently, participants will be randomly assigned to either the intervention condition or a wait-list control. Those randomized to the intervention condition will receive a 2-hour one-on-one intervention session emphasizing HIV knowledge, self-efficacy, and condom use behaviors. They will also receive a 10-15 minute booster session at 3-month follow-up. The comparison condition is wait-listed, but have the choice of participating in the intervention program upon completion of the study.
The main outcome measure includes consistent condom use, defined as condom use during every episode of vaginal intercourse with clients. Other outcome measures are condom application by FSW and HIV- preventive behaviors such as condom use self-efficacy, knowledge of HIV transmission dynamics,perceived barriers to condom use and condom use errors.
Results from this pilot study are expected to inform a larger trial to be implemented with FSWs in Armenia, in an effort to devise gender and culturally relevant intervention programs to prevent HIV transmission in this vulnerable population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV risk reduction intervention | Experimental | Behavioral: HIV risk reduction interventionBehavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia |
| Wait list control | Active comparator | Behavioral: HIV risk reduction interventionWill receive behavioral intervention after completion of study upon request. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- traded sex for money in the past 7 days
- cognitive ability to participate in assessment and intervention
Key exclusion criteria (3 listed)
- younger than 18 years of age
- did not trade sex for money in the past 7 days
- cognitively unable to participate in assessment and intervention
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 |
|---|---|---|
| HIV risk reduction interventionEducation intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia | Behavioural | HIV risk reduction intervention, Wait list control |
Primary outcome
Consistent condom use
Time frame: 3 and 6 months post intervention
1 secondary outcome
Condom application
Time frame: 3 and 6 months post intervention
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 25 Nov 2013.
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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.
Ralph J DiClemente, PhD principal investigator
Emory University
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 HIV risk reduction intervention in people with HIV Prevention and HIV Infections, run by Emory University at 1 site in Armenia.
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 3 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 25 Nov 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 Armenia. 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?
Consistent condom use (time frame: 3 and 6 months post intervention). 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 25 Nov 2013.