HIV/AIDS PreventionNCT02071264
Effects of an HIV Intervention Among Sex Workers in the Philippines
A study testing HIV/STI intervention in people with HIV/AIDS Prevention, run by Lianne Urada at 1 site in Philippines.
Trial summary
This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS Prevention
- What is being tested?
- HIV/STI intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePhilippines
- Study dates
- Aug 2013to Dec 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- self-identification as conducting sex work or working in a venue where sex work occurs.
Who cannot join
- those not actively engaging in sex work activities or working in a venue or area where sex work occurs.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Center for Environment and Sustainable Development Foundation, Inc.
Manila
About this study
Official title: Effects of an HIV Intervention Among Female and Male Entertainers and Spa/Sauna Workers in the Philippines
This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information and condom use and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.
Read the detailed description
This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information, condom use, and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.
The intervention involves targeted and tailored bio-psycho-educational interventions directed at organizational behavior change and social influence modeling through training peers and managers. The intervention site will receive peer and manager trainings consisting of specific information on STIs along with standard care, held on a day convenient to the participants and at the establishment or neutral location.
In addition to quick pre-post tests before and immediately after the intervention, participants will be interviewed 6-12 months after the intervention to evaluate the effects of the intervention on their STI/HIV knowledge, attitudes, beliefs, safer sex practices, and social support.
- Conditions
- HIV/AIDS Prevention
- Being tested
- HIV/STI intervention
- Keywords
- HIV/AIDS, sex work, reproductive health, human rights, ethics
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sex Work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV/STI interventionBehavioural
The intervention covers HIV101 information, reproductive health and human rights national policies, goal setting activities as individuals and as a group, results of prior research on ethics of doing research with sex workers.
| Study group | Role | What they receive |
|---|---|---|
| HIV/STI intervention | Other | This study implements a socio-behavioral intervention in Metro Manila, the Philippines, using a community-based participatory approach with 1-2 psychosocial and health education training workshops for the establishment managers and their workers, including street sex workers, focusing on HIV/AIDS risk reduction information, condom use, and condom negotiation skill-building. Participants participate in dream-building activities to explore personal goals and goals for their organization of peers. The interventions are directed at organizational behavior change and social influence modeling through training peers and managers. The participants receive information on STIs along with standard care, held on a day convenient to the participants and at a neutral location. Receives: Behavioral: HIV/STI intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV/STI knowledge
Knowledge of HIV/STI transmission and ways to protect oneself
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDS PreventionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lianne Urada
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Center for Environment and Sustainable Development Foundation, Inc., National Institute on Drug Abuse (NIDA), The Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI), University of California, San Diego, San Diego State University
- Responsible party
- Sponsor-investigator, Lianne Urada, University of California, San Diego
- Investigators
- Lianne A Urada, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071264
- Sponsor's protocol ID
- Philstudy
- Status last verified
- Apr 2021
- First submitted
- 23 Feb 2014
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Urada LA, Morisky DE, Pimentel-Simbulan N, Silverman JG, Strathdee SA. Condom negotiations among female sex workers in the Philippines: environmental influences. PLoS One. 2012;7(3):e33282. doi: 10.1371/journal.pone.0033282. Epub 2012 Mar 20.
PubMed 22448241Urada LA, Morisky DE, Hernandez LI, Strathdee SA. Social and structural factors associated with consistent condom use among female entertainment workers trading sex in the Philippines. AIDS Behav. 2013 Feb;17(2):523-35. doi: 10.1007/s10461-011-0113-x.
PubMed 22223297Urada LA, Strathdee SA, Morisky DE, Schilling RF, Simbulan NP, Estacio LR Jr, Raj A. Sex work and its associations with alcohol and methamphetamine use among female bar and spa workers in the Philippines. Asia Pac J Public Health. 2014 Mar;26(2):138-46. doi: 10.1177/1010539512471969. Epub 2013 Jan 22.
PubMed 23343641Urada LA, Simmons J, Wong B, Tsuyuki K, Condino-Enrera G, Hernandez LI, Simbulan NP, Raj A. A human rights-focused HIV intervention for sex workers in Metro Manila, Philippines: evaluation of effects in a quantitative pilot study. Int J Public Health. 2016 Nov;61(8):945-957. doi: 10.1007/s00038-016-0875-z. Epub 2016 Sep 6.
PubMed 27600733
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an HIV Intervention Among Female and Male Entertainers and Spa/Sauna Workers in the Philippines
- ClinicalTrials.gov ID
- NCT02071264
- Acronym / sponsor ID
- Philstudy
- Conditions
- HIV/AIDS Prevention
- Keywords
- HIV/AIDS, sex work, reproductive health, human rights, ethics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lianne UradaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Center for Environment and Sustainable Development Foundation, Inc., National Institute on Drug Abuse (NIDA), The Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI), University of California, San Diego, San Diego State University
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Feb 2014 (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 study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information and condom use and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.
Detailed description
This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information, condom use, and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.
The intervention involves targeted and tailored bio-psycho-educational interventions directed at organizational behavior change and social influence modeling through training peers and managers. The intervention site will receive peer and manager trainings consisting of specific information on STIs along with standard care, held on a day convenient to the participants and at the establishment or neutral location.
In addition to quick pre-post tests before and immediately after the intervention, participants will be interviewed 6-12 months after the intervention to evaluate the effects of the intervention on their STI/HIV knowledge, attitudes, beliefs, safer sex practices, and social support.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV/STI intervention | Other | Behavioral: HIV/STI interventionThis study implements a socio-behavioral intervention in Metro Manila, the Philippines, using a community-based participatory approach with 1-2 psychosocial and health education training workshops for the establishment managers and their workers, including street sex workers, focusing on HIV/AIDS risk reduction information, condom use, and condom negotiation skill-building. Participants participate in dream-building activities to explore personal goals and goals for their organization of peers. The interventions are directed at organizational behavior change and social influence modeling through training peers and managers. The participants receive information on STIs along with standard care, held on a day convenient to the participants and at a neutral location. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- self-identification as conducting sex work or working in a venue where sex work occurs.
Key exclusion criteria (1 listed)
- those not actively engaging in sex work activities or working in a venue or area where sex work occurs.
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/STI interventionThe intervention covers HIV101 information, reproductive health and human rights national policies, goal setting activities as individuals and as a group, results of prior research on ethics of doing research with sex workers. | Behavioural | HIV/STI intervention |
Primary outcome
HIV/STI knowledge
Time frame: 6 months
Knowledge of HIV/STI transmission and ways to protect oneself
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 27 Apr 2021.
- Background: PubMed 22448241Urada LA, Morisky DE, Pimentel-Simbulan N, Silverman JG, Strathdee SA. Condom negotiations among female sex workers in the Philippines: environmental influences. PLoS One. 2012;7(3):e33282. doi: 10.1371/journal.pone.0033282. Epub 2012 Mar 20.
- Background: PubMed 22223297Urada LA, Morisky DE, Hernandez LI, Strathdee SA. Social and structural factors associated with consistent condom use among female entertainment workers trading sex in the Philippines. AIDS Behav. 2013 Feb;17(2):523-35. doi: 10.1007/s10461-011-0113-x.
- Background: PubMed 23343641Urada LA, Strathdee SA, Morisky DE, Schilling RF, Simbulan NP, Estacio LR Jr, Raj A. Sex work and its associations with alcohol and methamphetamine use among female bar and spa workers in the Philippines. Asia Pac J Public Health. 2014 Mar;26(2):138-46. doi: 10.1177/1010539512471969. Epub 2013 Jan 22.
- Results publication: PubMed 27600733Urada LA, Simmons J, Wong B, Tsuyuki K, Condino-Enrera G, Hernandez LI, Simbulan NP, Raj A. A human rights-focused HIV intervention for sex workers in Metro Manila, Philippines: evaluation of effects in a quantitative pilot study. Int J Public Health. 2016 Nov;61(8):945-957. doi: 10.1007/s00038-016-0875-z. Epub 2016 Sep 6.
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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.
Lianne A Urada, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV/STI intervention in people with HIV/AIDS Prevention, run by Lianne Urada at 1 site in Philippines.
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 1 inclusion and 1 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 27 Apr 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 Philippines. 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/STI knowledge (time frame: 6 months). 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 NCT02071264, which also lists 4 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 27 Apr 2021.