HIVPhase 1PLACENCT01423357
Targeting Interventions at Venues Where Risk of HIV Transmission is High
A Phase 1 study testing Condom distribution and peer education in people with HIV, run by University of Zambia at 2 sites in Zambia.
Trial summary
The aim of this study is to investigate whether distribution of condoms and condom demonstrations by youth peer educators in venues where people meet new sexual partners in Livingstone, Zambia, leads to increased condom use among guests socializing in these venues. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Condom distribution and peer education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 2 sitesZambia
- Study dates
- Feb 2009to Mar 2010
- Phase
- Phase 1
- 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
- Socializing in a venue where people are said to be meeting new sexual partners
- Age 18 years and above
Who cannot join
- Too drunk to give sensible answers
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of this study is to investigate whether distribution of condoms and condom demonstrations by youth peer educators in venues where people meet new sexual partners in Livingstone, Zambia, leads to increased condom use among guests socializing in these venues.
Read the detailed description
In countries where the HIV prevalence is high, focusing on high risk places such as venues where people meet new sexual partners is probably more effective in reducing the transmission rate of HIV than targeting interventions just at perceived high risk groups. A survey conducted in 2005 in places where people met new sexual partners in Livingstone found that guests socializing there were engaging in high risk sex, but condoms were not always available in the venues. In this intervention study, youth peer educators will distribute condoms and demonstrate condom use in venues where people meet new sexual partners. After the intervention has run for a year, condom use among guests socializing in such venues in the intervention township will be compared with condom use among people socializing in similar venues in a comparison township.
- Conditions
- HIV
- Being tested
- Condom distribution and peer education
- Keywords
- HIV prevention, condom distribution, youth peer education, high risk places, condom use, prevention through increased condom use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condom distribution and peer educationOther
Condom distribution and condom demonstrations by youth peer educators at least twice a week
| Study group | Role | What they receive |
|---|---|---|
| Condom distribution and peer education | Experimental | Youth peer educators distribute condoms and conduct condom demonstration in venues where people meet new sexual partners, i.e. bars, night clubs, sherbeens, guest houses Receives: Other: Condom distribution and peer education |
| Business as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom use with last sexual partner met in this venue
Guests socializing in venues where people meet new sexual partners are asked about condom use with the last sexual partner met in the venue where interview conducted
Measured: in post-intervention survey (1 year after start of intervention)
Secondary outcomes (1)
Condom availability in the last 12 months in venues where people meet new sexual partners
One person representing each venue included in the survey is asked about the availability of condoms in the venue in the last 12 months
Measured: in post-intervention survey (1 year after start of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startFeb 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Principal investigator, Ingvild Fossgard Sandoy, University of Bergen
- Investigators
- Charles C Michelo, MD, MPH, PhD, Study director, University of ZambiaCosmas M Zyaambo, MD, MPhil, Principal investigator, University of ZambiaKnut M Fylkesnes, DMD. DrPhilos, Study chair, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423357
- Sponsor's protocol ID
- PLACE
- Acronym
- PLACE
- Status last verified
- Aug 2011
- First submitted
- 23 Aug 2011
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandoy IF, Siziya S, Fylkesnes K. Lost opportunities in HIV prevention: programmes miss places where exposures are highest. BMC Public Health. 2008 Jan 24;8:31. doi: 10.1186/1471-2458-8-31.
PubMed 18218124Sandoy IF, Zyaambo C, Michelo C, Fylkesnes K. Targeting condom distribution at high risk places increases condom utilization-evidence from an intervention study in Livingstone, Zambia. BMC Public Health. 2012 Jan 5;12:10. doi: 10.1186/1471-2458-12-10.
PubMed 22221738
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Interventions at Venues Where Risk of HIV Transmission is High
- ClinicalTrials.gov ID
- NCT01423357
- Acronym / sponsor ID
- PLACE / PLACE
- Conditions
- HIV
- Keywords
- HIV prevention, condom distribution, youth peer education, high risk places, condom use, prevention through increased condom use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- University of ZambiaUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Feb 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Aug 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 aim of this study is to investigate whether distribution of condoms and condom demonstrations by youth peer educators in venues where people meet new sexual partners in Livingstone, Zambia, leads to increased condom use among guests socializing in these venues.
Detailed description
In countries where the HIV prevalence is high, focusing on high risk places such as venues where people meet new sexual partners is probably more effective in reducing the transmission rate of HIV than targeting interventions just at perceived high risk groups. A survey conducted in 2005 in places where people met new sexual partners in Livingstone found that guests socializing there were engaging in high risk sex, but condoms were not always available in the venues. In this intervention study, youth peer educators will distribute condoms and demonstrate condom use in venues where people meet new sexual partners. After the intervention has run for a year, condom use among guests socializing in such venues in the intervention township will be compared with condom use among people socializing in similar venues in a comparison township.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condom distribution and peer education | Experimental | Other: Condom distribution and peer educationYouth peer educators distribute condoms and conduct condom demonstration in venues where people meet new sexual partners, i.e. bars, night clubs, sherbeens, guest houses |
| Business as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Socializing in a venue where people are said to be meeting new sexual partners
- Age 18 years and above
Key exclusion criteria (1 listed)
- Too drunk to give sensible answers
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 |
|---|---|---|
| Condom distribution and peer educationCondom distribution and condom demonstrations by youth peer educators at least twice a week | Other | Condom distribution and peer education |
Primary outcome
Condom use with last sexual partner met in this venue
Time frame: in post-intervention survey (1 year after start of intervention)
Guests socializing in venues where people meet new sexual partners are asked about condom use with the last sexual partner met in the venue where interview conducted
1 secondary outcome
Condom availability in the last 12 months in venues where people meet new sexual partners
Time frame: in post-intervention survey (1 year after start of 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 Aug 2011.
- Background: PubMed 18218124Sandoy IF, Siziya S, Fylkesnes K. Lost opportunities in HIV prevention: programmes miss places where exposures are highest. BMC Public Health. 2008 Jan 24;8:31. doi: 10.1186/1471-2458-8-31.
- Derived from this study: PubMed 22221738Sandoy IF, Zyaambo C, Michelo C, Fylkesnes K. Targeting condom distribution at high risk places increases condom utilization-evidence from an intervention study in Livingstone, Zambia. BMC Public Health. 2012 Jan 5;12:10. doi: 10.1186/1471-2458-12-10.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Charles C Michelo, MD, MPH, PhD study director
University of Zambia
Cosmas M Zyaambo, MD, MPhil principal investigator
University of Zambia
Knut M Fylkesnes, DMD. DrPhilos study chair
University of Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Condom distribution and peer education in people with HIV, run by University of Zambia at 2 sites in Zambia.
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 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 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. 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 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.
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?
Condom use with last sexual partner met in this venue (time frame: in post-intervention survey (1 year after start of intervention)). 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 NCT01423357, which also lists 2 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 25 Aug 2011.